Pharmaceutical methods, dosing regimes and dosage forms for the treatment of Alzheimer's disease
First Claim
1. A pharmaceutical unit dosage form comprising R-flurbiprofen as the active ingredient, and one or more pharmaceutically acceptable excipients, wherein said pharmaceutical unit dosage form, when orally administered to a fasting subject, provides a plasma Cmax of about 30 to about 95 μ
- g per mL.
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Abstract
In general, the invention relates to a pharmaceutical dose having R-flurbiprofen as the active ingredient that upon oral administration of a single dose to a fasting subject provides a Cmax of about 30-95 μg per mL. When the dose is administered to an individual having mild-to-moderate Alzheimer'"'"'s disease (or desiring protection against Alzheimer'"'"'s disease) twice daily for at least 4 months according to the described guidelines, an improvement or lessening in decline of cognitive function as characterized by cognition tests is observed in the patient. The composition of the invention is formulated with one or more pharmaceutically acceptable excipients, salts or carriers.
131 Citations
93 Claims
- 1. A pharmaceutical unit dosage form comprising R-flurbiprofen as the active ingredient, and one or more pharmaceutically acceptable excipients, wherein said pharmaceutical unit dosage form, when orally administered to a fasting subject, provides a plasma Cmax of about 30 to about 95 μ
-
44. The method of 16 where said individual has, prior to taking R-flurbiprofen, taken a non-drug substance for the treatment of Alzheimer'"'"'s disease.
- 54. A pharmaceutical unit dosage form comprising R-flurbiprofen as the active ingredient, and one or more pharmaceutically acceptable excipients, wherein said pharmaceutical dose, when orally administered to a fasting subject, provides a plasma Cmax of about 100 to about 600 μ
-
57. A pharmaceutical unit dosage form comprising R-flurbiprofen as the active ingredient, and one or more pharmaceutically acceptable excipients, wherein said pharmaceutical unit dosage form, when orally administered to a fasting subject, provides a Cmax in cerebrospinal fluid of about 0.05 to about 7.5 μ
- g per mL.
- View Dependent Claims (58, 59, 66)
- 60. A pharmaceutical unit dosage form comprising R-flurbiprofen as the active ingredient, and one or more pharmaceutically acceptable excipients, wherein said pharmaceutical unit dosage form, when orally administered to a fasting subject, provides a Cmax in cerebrospinal fluid of about 2 to about 30 μ
-
67. A method of administering R-flurbiprofen to an individual in need thereof comprising orally administering R-flurbiprofen to said individual in an amount sufficient to achieve a plasma Cmax of about 25 to about 150 μ
- g per mL in 1.0 to 3.75 hours after administration.
- View Dependent Claims (68, 69, 70, 71, 72, 84, 85, 92, 93)
-
73. A method of administering R-flurbiprofen to an individual in need thereof comprising orally administering R-flurbiprofen to said individual in an amount sufficient to achieve a plasma Cmax of about 100 to about 600 μ
- M in 1.0 to 3.75 hours after administration.
- View Dependent Claims (74, 75, 76, 77, 78)
-
79. A method of administering R-flurbiprofen to an individual in need thereof comprising orally administering R-flurbiprofen to said individual in an amount sufficient to achieve a Cmax in cerebrospinal fluid of about 0.05 to about 7.5 μ
- g per mL in about 1.0 to about 6 hours after administration.
- View Dependent Claims (80)
-
81. A method of administering R-flurbiprofen to an individual in need thereof comprising orally administering R-flurbiprofen to said individual in an amount sufficient to achieve a Cmax in cerebrospinal fluid of about 2 to about 30 μ
- M in about 1.0 to about 6 hours after administration.
- View Dependent Claims (82, 83, 88, 89)
-
86. A pharmaceutical unit dosage form of R-flurbiprofen composed of about 400 mg R-flurbiprofen;
- microcrystalline cellulose;
colloidal silicon dioxide; and
magnesium stearate.
- microcrystalline cellulose;
-
87. A pharmaceutical unit dosage form of R-flurbiprofen composed of about 200 mg R-flurbiprofen;
- microcrystalline cellulose;
colloidal silicon dioxide; and
magnesium stearate.
- microcrystalline cellulose;
Specification