Dosage forms and methods of use thereof

• US 20070259010A1
• Filed: 05/18/2007
• Published: 11/08/2007
• Est. Priority Date: 11/26/2004
• Status: Active Grant

• Current Assignee: Aprecia Pharmaceuticals Company
• Original Assignee: Aprecia Pharmaceuticals Company
• Inventors: SURPRENANT, Henry, WEST, Thomas, MONKHOUSE, Donald, YOO, Jae
• Granted Patent: US 8,828,411 B2
• Time in Patent Office: Days
• US Class Current: 424/400
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

Pharmaceutical dosage forms with external or internal features to complicate counterfeiting and support authentication are described. External features include surface texture, surface markings defined by patterns of physical or chemical markers, or complex interlocking shapes. Internal features also include physical or chemical markers in two or three-dimensional patterns observable after sectioning, or after breaking along designed fracture lines. Methods of manufacture using solid freeform fabrication (SFF) techniques such as three-dimensional printing (3DP) are described. Method of authentication using dosage form patterns and batch codes are also described.

Claims

1-12. -12. (canceled)

13. A three-dimensionally printed dosage form comprising:

a. at least one active ingredient and at least on inactive ingredient; and

b. at least one or more chemical markers, wherein said one or more chemical markers define one or more internal patterns that may be used to authenticate the dosage form.

14-44. -44. (canceled)

45. A three-dimensionally printed dosage form comprising:

a. at least one active ingredient and at least on inactive ingredient; and

b. one or more internal three-dimensional patterns that may be used to authenticate the dosage form, wherein the one or more patterns constitutes three-dimensional arrangements that are non-concentric, asymmetrical or otherwise locally variable.

46-60. -60. (canceled)

61. A three-dimensionally printed dosage form comprising:

a. at least one active ingredient and at least on inactive ingredient; and

b. at least one or more internal patterns that may be used to authenticate the dosage form, wherein one or more internal patterns include lettering, numbering, a dot pattern, or a bar code.

62-75. -75. (canceled)

76. A three-dimensionally printed dosage form comprising:

a. at least one active ingredient and at least on inactive ingredient; and

b. at least one or more chemical markers, wherein said one or more chemical markers define one or more internal three-dimensional patterns that may be used to authenticate the dosage form, and wherein one or more patterns extends globally throughout the dosage form, is confined to specific regions of the dosage form, or a combination thereof.

77. The dosage form of claim 76, wherein one or more internal patterns comprises dye, pigment, color-shift substance, UV-active substance, fluorescent substance, or inactive pharmaceutical ingredient.

78. The dosage form of claim 76, wherein one or more chemical markers is imperceptible to the naked eye.

79. The dosage form of claim 76, wherein one or more internal patterns is detectable just below the outer surface of the dosage form.

80. The dosage form of claim 76, wherein one or more internal patterns includes lettering, numbering, a dot pattern, or a bar code.

81. The dosage form of claim 80, wherein the numbering is separated into individual digits for subsequent addition to obtain a secondary value.

82. The dosage form of claim 80, wherein the number is a numerical code and the sum of the digits of the code corresponds to the amount of concentration of chemical marker used to indicate the code.

83. The dosage form of claim 76 further comprising an external feature used to identify, distinguish or authenticate a genuine dosage form from a counterfeit dosage form.

84. The dosage form of claim 83, wherein the external feature comprises a logo, specific regions with raised or lowered surface features, pattern of color, pattern of chemical marker, or a combination thereof.

85. The dosage form of claim 76, wherein one or more patterns constitutes three-dimensional arrangements that are non-concentric, asymmetrical or otherwise locally variable.

86. The dosage form of claim 76, wherein upon breaking or sectioning of the dosage form, one or more patterns is readily observable, requires exposure to a chemical or common substance for observation, requires use of analytical equipment for detection, or a combination thereof.

87. The dosage form of claim 76 further comprising one or more three-dimensionally printed fracture lines.

88. The dosage form of claim 87, wherein the dosage form is designed to break in one or more predetermined ways.

89. The dosage form of claim 88, wherein the dosage form is designed to break in one or more predetermined ways to expose said one or more patterns.

90. The dosage form of claim 89, wherein one or more patterns includes letters and numbers that lie along different axes of the same dosage form.

91. The dosage form of claim 90, wherein a three-dimensional pattern is designed to expose prespecified two-dimensional patterns on the exposed interior surface of the dosage form when the dosage form is broken or cut along specific axes of the dosage form.

92. The dosage form of claim 89, wherein one or more patterns includes a batch code.

93. The dosage form of claim 76, wherein the dosage form comprises interlocking pieces.

94. A three-dimensionally printed dosage form comprising:

a. at least one active ingredient and at least on inactive ingredient; and

b. at least one or more chemical markers, wherein said one or more chemical markers define one or more internal three-dimensional patterns that may be used to authenticate the dosage form, wherein one or more internal patterns comprises dye, pigment, color-shift substance, UV-active substance, fluorescent substance, or inactive pharmaceutical ingredient, and wherein one or more internal patterns includes lettering, numbering, a dot pattern, or a bar code.

95-109. -109. (canceled)