LOW HYGROSCOPIC ARIPIPRAZOLE DRUG SUBSTANCE AND PROCESSES FOR THE PREPARATION THEREOF
0 Assignments
0 Petitions
Accused Products
Abstract
The present invention provides low hygroscopic forms of aripiprazole and processes for the preparation thereof which will not convert to a hydrate or lose their original solubility even when a medicinal preparation containing the anhydrous aripiprazole crystals is stored for an extended period.
3 Citations
370 Claims
-
1-48. -48. (canceled)
-
49. Anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); and
an endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (50, 51, 52, 53, 54, 55, 56, 57, 58, 59)
- C. and a humidity level of 100%,
-
60. Anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray. - View Dependent Claims (61, 62, 63, 64, 65, 66)
- C. and a humidity level of 100%,
-
67. Anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thereogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (68, 69, 70, 71, 72, 73, 74, 75, 76, 77)
- C. and a humidity level of 100%,
-
78. Anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray. - View Dependent Claims (79, 80, 81, 82, 83, 84)
- C. and a humidity level of 100%,
-
85. A process for preparing anhydrous aripiprazole crystals having low hygroscopicity, wherein said process comprises heating hydrous aripiprazole having one or more of the following properties:
-
a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=12.6°
, 15.4°
, 17.3°
, 18.0°
, 18.6°
, 22.5°
, and 24.8°
using a Cu Kα
, x-ray;an endothermic curve comprising a first endothermic peak at about 71°
C. and a second endothermic peak around 60°
to 120°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan infrared absorption spectrum comprising infrared absorption bands at 2951, 2822, 1692, 1577, 1477, 1378, 1187, 963, and 784 cm−
1 on the IR (KBr) spectrum,wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
C. and a humidity level of 100%,wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (86, 87, 88, 89, 97, 98, 99, 100, 101)
-
-
90. A process for preparing anhydrous aripiprazole crystals having low hygroscopicity, wherein said process comprises heating hydrous aripiprazole having one or more of the following properties:
-
a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=12.6°
, 15.4°
, 17.3°
, 18.0°
, 18.6°
, 22.5°
, and 24.8°
using a Cu Kα
x-ray;an endothermic curve comprising a first endothermic peak at about 71°
C. and a second endothermic peak around 60°
to 120°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan infrared absorption spectrum comprising infrared absorption bands at 2951, 2822, 1692, 1577, 1477, 1378, 1187, 963, and 784 cm−
1 on the IR (KBr) spectrum,wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
C. and a humidity level of 100%,wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (91, 92, 93, 94)
-
-
95. A process for preparing anhydrous aripiprazole crystals having low hygroscopicity, wherein said process comprises heating hydrous aripiprazole having one or more of the following properties:
-
a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 3 using a Cu Kα
x-ray, andan endothermic curve which is substantially the same as the thermogravimetric or differential thermal analysis (heating rate 5°
C./min) curve shown inFIG. 1 ,wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
C. and a humidity level of 100%,wherein the anhydrous aripiprazole trysts have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
-
-
96. A process for preparing anhydrous aripiprazole crystals having low hygroscopicity, wherein said process comprises heating hydrous aripiprazole having one or more of the following properties:
-
a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 3 using a Cu Kα
x-ray; andan endothermic curve which is substantially the same as the thermogravimetric or differential thermal analysis (heating rate 5°
C./min) curve shown inFIG. 1 ,wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
C. and a humidity level of 100%,wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
-
-
102. Anhydrous aripiprazole crystals having low hygroscopicity prepared by a process comprising heating hydrous aripiprazole having one or more of the following properties:
-
a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=12.6°
, 15.4°
, 17.3°
, 18.0°
, 18.6°
, 22.5°
, and 24.8°
using a Cu Kα
x-ray;an endothermic curve comprising a first endothermic peak at about 71°
C. and a second endothermic peak around 60°
to 120°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan infrared absorption spectrum comprising infrared absorption bands at 2951, 2822, 1692, 1577, 1477, 1378, 1187, 963, and 784 cm−
1 on the IR (KBr) spectrum,wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
C. and a humidity level of 100%,wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (103, 104, 105, 106, 114, 115, 116, 117, 118)
-
-
107. Anhydrous aripiprazole crystals having low hygroscopicity prepared by a process comprising heating hydrous aripiprazole having one or more of the following properties:
-
a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=12.6°
, 15.4°
, 17.3°
, 18.0°
, 18.6°
, 22.5°
, and 24.8°
using a Cu Kα
x-ray;an endothermic curve comprising a first endothermic peak at about 71°
C. and a second endothermic peak around 60°
to 120°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan infrared absorption spectrum comprising infrared absorption bands at 2951, 2822, 1692, 1577, 1477, 1378, 1187, 963, and 784 cm−
1 on the IR (KBr) spectrum,wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
C. and a humidity level of 100%,wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (108, 109, 110, 111)
-
-
112. Anhydrous aripiprazole crystals having low hygroscopicity prepared by a process comprising heating hydrous aripiprazole having one or more of the following properties:
-
a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 3 using a Cu Kα
x-ray; andan endothermic curve which is substantially the same as the thermogravimetric or differential thermal analysis (heating rate 5°
C./min) curve shown inFIG. 1 ,wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
C. and a humidity level of 100%,wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
-
-
113. Anhydrous aripiprazole crystals having low hygroscopicity prepared by a process comprising heating hydrous aripiprazole having one or more of the following properties:
-
a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 3 using a Cu Kα
x-ray; andan endothermic curve which is substantially the same as the thermogravimetric or differential thermal analysis (heating rate 5°
C./min) curve shown inFIG. 1 ,wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
C. and a humidity level of 100%,wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
-
-
119. A pharmaceutical composition comprising anhydrous aripiprazole crystals having low hygroscopicity and at least one pharmaceutically acceptable carrier, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
using a Cu Kα
, x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (120, 121, 122, 123, 125, 126, 127, 128, 129)
- C. and a humidity level of 100%,
-
124. A pharmaceutical composition comprising anhydrous aripiprazole crystals having low hygroscopicity and at least one pharmaceutically acceptable carrier, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
130. A pharmaceutical composition comprising anhydrous aripiprazole crystals having low hygroscopicity and at least one pharmaceutically acceptable carrier, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (131, 132, 133, 134, 136, 137, 138, 139, 140)
- C. and a humidity level of 100%,
-
135. A pharmaceutical composition comprising anhydrous aripiprazole crystals having low hygroscopicity and at least one pharmaceutically acceptable carrier, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
141. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curie comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (142, 143, 144, 145)
- C. and a humidity level of 100%,
-
146. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
147. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (148, 149, 150, 151)
- C. and a humidity level of 100%,
-
152. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
153. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (154, 155, 156, 157)
- C. and a humidity level of 100%,
-
158. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
159. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./rain); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (160, 161, 162, 163)
- C. and a humidity level of 100%,
-
164. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
165. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (166, 167, 168, 169)
- C. and a humidity level of 100%,
-
170. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
171. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (172, 173, 174, 175)
- C. and a humidity level of 100%,
-
176. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
177. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (178, 179, 180, 181)
- C. and a humidity level of 100%,
-
182. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100,
-
183. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
, x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (184, 185, 186, 187)
- C. and a humidity level of 100%,
-
188. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
189. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (190, 191, 192, 193)
- C. and a humidity level of 100%,
-
194. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
195. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (196, 197, 198, 199)
- C. and a humidity level of 100%,
-
200. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
201. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (202, 203, 204, 205)
- C. and a humidity level of 100%,
-
206. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
207. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=. 11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (208, 209, 210, 211)
- C. and a humidity level of 100%,
-
212. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
213. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (214, 215, 216, 217)
- C. and a humidity level of 100%,
-
218. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
219. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (220, 221, 222, 223)
- C. and a humidity level of 100%,
-
224. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
225. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (226, 227, 228, 229)
- C. and a humidity level of 100%,
-
230. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
231. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (232, 233, 234, 235)
- C. and a humidity level of 100%,
-
236. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
237. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (238, 239, 240, 241)
- C. and a humidity level of 100%,
-
242. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
243. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (244, 245, 246, 247)
- C. and a humidity level of 100%,
-
248. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
249. A method for the treatment of autism which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (250, 251, 252, 253)
- C. and a humidity level of 100%,
-
254. A method for the treatment of autism which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
255. A method for the treatment of autism which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./rain); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./rain). - View Dependent Claims (256, 257, 258, 259)
- C. and a humidity level of 100%,
-
260. A method for the treatment of autism which comprises administering to a patient in need thereof an effective amount of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
261. A method for the treatment of autism which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (262, 263, 264, 265)
- C. and a humidity level of 100%,
-
266. A method for the treatment of autism which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
267. A method for the treatment of autism which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
, x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (268, 269, 270, 271)
- C. and a humidity level of 100%,
-
272. A method for the treatment of autism which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of anhydrous aripiprazole crystals having low hygroscopicity per 1 kg of body weight, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
273. A method for the treatment of autism which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (274, 275, 276, 277)
- C. and a humidity level of 100%,
-
278. A method for the treatment of autism which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
279. A method for the treatment of autism which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (280, 281, 282, 283)
- C. and a humidity level of 100%,
-
284. A method for the treatment of autism which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%,
wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
- C. and a humidity level of 100%,
-
285. A kit comprising:
-
a pharmaceutical composition comprising anhydrous aripiprazole crystals having low hygroscopicity in an amount effective to treat schizophrenia and at least one pharmaceutically acceptable carrier, and instructions for using the pharmaceutical composition to treat schizophrenia, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
C. and a humidity level of 100%,wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.0°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray,an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (286, 287, 288, 289)
-
-
290. A kit comprising:
-
a pharmaceutical composition comprising anhydrous aripiprazole crystals having low hygroscopicity in an amount effective to treat schizophrenia and at least one pharmaceutically acceptable carrier, and instructions for using the pharmaceutical composition to treat schizophrenia, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
C. and a humidity level of 100%,wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
-
-
291. A kit comprising:
-
a pharmaceutical composition comprising anhydrous aripiprazole crystals having low hygroscopicity in an amount effective to treat schizophrenia and at least one pharmaceutically acceptable carrier, and instructions for using the pharmaceutical composition to treat schizophrenia, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
C. and a humidity level of 100%,wherein the anhydrous aripiprazole crystals have one or more of the following properties; a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ
=11.03°
, 16.6°
, 19.3°
, 20.3°
, and 22.1°
, using a Cu Kα
x-ray;an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm−
1 on the IR (KBr) spectrum;an endothermic curve comprising an endothermic peak at about 141.5°
C. in a thermogravimetric or differential thermal analysis (heating rate 5°
C./min); andan endothermic curve comprising an endothermic peak at about 140.7°
C. in a differential scanning calorimetry analysis (heating rate 5°
C./min). - View Dependent Claims (292, 293, 294, 295)
-
-
296. A kit comprising:
-
a pharmaceutical composition comprising anhydrous aripiprazole crystals having low hygroscopicity in an amount effective to treat schizophrenia and at least one pharmaceutically acceptable carrier, and instructions for using the pharmaceutical composition to treat schizophrenia, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°
C. and a humidity level of 100%,wherein the anhydrous aripiprazole crystals have a powder x-ray diffraction spectrum which is substantially the same as the powder x-ray diffraction spectrum shown in FIG. 5 using a Cu Kα
x-ray.
-
-
297. Anhydrous Aripiprazole Crystals B having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%, wherein the Anhydrous Aripiprazole Crystals B have a mean particle size of 50 μ
m or less. - View Dependent Claims (298, 299, 300, 301, 302)
- C. and a humidity level of 100%, wherein the Anhydrous Aripiprazole Crystals B have a mean particle size of 50 μ
-
303. Anhydrous Aripiprazole Crystals B having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60°
- C. and a humidity level of 100%, wherein the Anhydrous Aripiprazole Crystals B have a mean particle size of 50 μ
m or less. - View Dependent Claims (304, 305, 306, 307, 308)
- C. and a humidity level of 100%, wherein the Anhydrous Aripiprazole Crystals B have a mean particle size of 50 μ
-
309. A process for preparing Anhydrous Aripiprazole Crystals B having low hygroscopicity, wherein said process comprises heating Hydrate A of aripiprazole,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
- View Dependent Claims (310, 311, 312, 313, 314)
-
315. A process for preparing Anhydrous Aripiprazole Crystals B having low hygroscopicity, wherein said process comprises heating Hydrate A of aripiprazole,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
- View Dependent Claims (316, 317, 318, 319, 320)
-
321. Anhydrous Aripiprazole Crystals B having low hygroscopicity prepared by a process comprising heating Hydrate A of aripiprazole,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
- View Dependent Claims (322, 323, 324, 325, 326)
-
327. Anhydrous Aripiprazole Crystals B having low hygroscopicity prepared by a process comprising heating Hydrate A of aripiprazole,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
- View Dependent Claims (328, 329, 330, 331, 332)
-
333. A pharmaceutical composition comprising Anhydrous Aripiprazole Crystals B having low hygroscopicity and at least one pharmaceutically acceptable carrier,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
- View Dependent Claims (334, 335, 336, 337, 338)
-
339. A pharmaceutical composition comprising Anhydrous Aripiprazole Crystals B having low hygroscopicity and at least one pharmaceutically acceptable carrier,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
- View Dependent Claims (340, 341, 342, 343, 344)
-
345. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof an effective amount of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
346. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof an effective amount of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
347. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity per 1 kg of body weight,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
348. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity per 1 kg of body weight,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
349. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
350. A method for the treatment of schizophrenia which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
351. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof an effective amount of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
352. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof an effective amount of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
353. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity per 1 kg of body weight,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
354. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity per 1 kg of body weight,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
355. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
356. A method for the treatment of bipolar disorder which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
357. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof an effective amount of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
358. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof an effective amount of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
359. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity per 1 kg of body weight,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
360. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity per 1 kg of body weight,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
361. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
362. A method for the treatment of anxiety, depression, or mania which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
363. A method for the treatment of autism which comprises administering to a patient in need thereof an effective amount of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
364. A method for the treatment of autism which comprises administering to a patient in need thereof an effective amount of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
365. A method for the treatment of autism which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity per 1 kg of body weight,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
366. A method for the treatment of autism which comprises administering to a patient in need thereof from about 0.1 milligrams to about 10 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity per 1 kg of body weight,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
367. A method for the treatment of autism which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
368. A method for the treatment of autism which comprises administering to a patient in need thereof a unit dose comprising from about 1 milligram to about 100 milligrams of Anhydrous Aripiprazole Crystals B having low hygroscopicity,
wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60° - C. and a humidity level of 100%.
-
369. A kit comprising:
-
a pharmaceutical composition comprising Anhydrous Aripiprazole Crystals B having low hygroscopicity in an amount effective to treat schizophrenia and at least one pharmaceutically acceptable carrier, and instructions for using the pharmaceutical composition to treat schizophrenia, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60°
C. and a humidity level of 100%.
-
-
370. A kit comprising:
-
a pharmaceutical composition comprising Anhydrous Aripiprazole Crystals B having low hygroscopicity in an amount effective to treat schizophrenia and at least one pharmaceutically acceptable carrier, and instructions for using the pharmaceutical composition to treat schizophrenia, wherein said low hygroscopicity is defined as a moisture content of 0.10% or less when the Anhydrous Aripiprazole Crystals B are placed for 24 hours in a dessicator maintained at a temperature of 60°
C. and a humidity level of 100%.
-
Specification