Pharmaceutical tablet formulation containing gabapentin with improved physical and chemical characteristics and method of making the same
AssigneePurepac Pharmaceutical Co.
InventorZalman Vilkov
Life of this patent
Estimating the term…
Abstract
A pharmaceutical formulation form with improved physical and chemical characteristics, comprising gabapentin in tablet form for oral administration. The tablet form can be prepared by spray-coating gabapentin with a binder solution and compressing the spray-coated gabapentin into non-friable, stable tablets. This method is particularly useful for tablet formulations that require large doses of active drug.
Claims20
A pharmaceutical tablet comprising more than about 76% by weight of gabapentin.
A pharmaceutical tablet comprising:
- (a) more than about 76% by weight of gabapentin;
- (b) a friability of less than about 1%;
- (c) a hardness of about 10 kp to about 20 kp;
- and
- (d) a lactam level of less than about 0.4% by weight of the tablet.
A pharmaceutical tablet comprising more than about 76% by weight of gabapentin, the tablet being formed from particles of gabapentin spray-coated with a binder solution, mixed with a disintegrant, and a lubricant, and then compressed into the tablet.
A pharmaceutical tablet comprising more than about 88% by weight of gabapentin, the tablet being formed from particles of gabapentin spray-coated with hydroxypropyl cellulose dissolved in alcohol, mixed with crospovidone, and calcium stearate, and compressed into the tablet.
A method of producing pharmaceutical tablet comprising:
- (a) dissolving binder in a solvent to produce a binder solution;
- (b) spray-coating the binder solution on gabapentin particles to achieve a spray-coated gabapentin;
- and
- (c) compressing the spray-coated gabapentin into a tablet for oral administration to a patient;
- where the tablet contains more than about 76% by weight of gabapentin.
A method of producing a pharmaceutical tablet comprising:
- a) dissolving hydroxypropyl cellulose in alcohol to produce a binder solution;
- b) spray-coating the binder solution on gabapentin particles to produce spray-coated gabapentin;
- c) mixing the spray-coated gabapentin with crospovidone and calcium stearate to obtain a final blend;
- and
- d) compressing the final blend into a tablet for administration to a patient;
- where the tablet contains more than about 88% by weight of gabapentin.
A method of producing a pharmaceutical tablet comprising:
- (a) dissolving binder in a solvent to produce a binder solution;
- (b) spray-coating the binder solution on active drug particles to achieve spray-coated active drug particles;
- (c) compressing the spray-coated drug particles into a tablet for oral administration to a patient;
- where the tablet contains about 500 mg to about 1200 mg of active drug.
Dependencies are inferred from the claim text.