Stabilized pharmaceutical composition of a nonsteroidal anti-inflammatory agent and a prostaglandin
AssigneePharmascience Inc.
InventorsAomar Ouali, Abul Kalam Azad
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Abstract
A pharmaceutical composition is provided for the oral administration of an NSAID and a prostaglandin. The composition is a solid dosage form wherein the NSAID is enterically coated and the prostaglandin is present along with an effective stabilizing amount of a prostaglandin stabilizing agent such as hydroxypropyl methylcellulose or polyvinylpyrrolidone. Exemplary dosage forms are bilayer tablets in which the prostaglandin is misoprostol and the NSAID is diclofenac, piroxicam, or a pharmaceutically acceptable salt thereof. Methods for using the composition to treat NSAID-responsive conditions, disorders and diseases are provided as well.
Claims35
A solid pharmaceutical composition for oral administration, comprising:
- a therapeutically effective amount of enterically coated granules of a nonsteroidal anti-inflammatory drug (NSAID);
- an effective anti-ulcerogenic amount of a prostaglandin;
- and
- an effective stabilizing amount of a prostaglandin stabilizing agent.
A bilayer tablet for oral administration of a nonsteroidal anti-inflammatory drug (NSAID), comprising:
- (a) a first layer containing a therapeutically effective amount of enterically coated granules of an NSAID selected from the group consisting of acetylsalicylic acid, apazone, diclofenac, difenpiramide, diflunisal, etodolac, fenbufen, flufenamic acid, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, meclofenamate, mefenamic acid, nabumetone, naproxen, oxaprozin, piroxicam, sulindac, suprofen, tiaprofenic acid, tolmetin, pharmaceutically acceptable salts thereof, and combinations of any of the foregoing;
- and
- (b) a second layer containing an effective anti-ulcerogenic amount of a prostaglandin selected from the group consisting of misoprostol, PGE0, PGE1, PGA1, PGB1, PGF1α, 19-hydroxy-PGA1, 19-hydroxy-PGB1, PGE2, PGA2, PGB2, 19-hydroxy-PGA2, 19-hydroxy-PGB2, PGE3, PGF3α, PGI2, carboprost tromethamine, dinoprost tromethamine, gemeprost, metenoprost, sulprostone, tiaprost and combinations thereof, and an effective stabilizing amount of a prostaglandin stabilizing agent selected from the group consisting of hydroxypropyl cellulose, hydroxyethyl cellulose, methyl cellulose, ethyl cellulose, cellulose acetate, cellulose acetate phthalate, cellulose acetate trimellitate, hydroxypropyl methylcellulose, hydroxypropyl methylcellulose phthalate, microcrystalline cellulose, carboxymethylcellulose sodium, polyvinylpyrrolidone, polyvinyl acetate, polyvinylacetate phthalate, and vinylacetate crotonic acid copolymer, and combinations thereof.
A bilayer tablet for oral administration of a nonsteroidal anti-inflammatory drug (NSAID), comprising:
- (a) a first layer containing a therapeutically effective amount of enterically coated granules of an NSAID selected from the group consisting of diclofenac, piroxicam, naproxen and pharmaceutically acceptable salts thereof;
- and
- (b) a second layer containing an effective anti-ulcerogenic amount of misoprostol and an effective stabilizing amount of a prostaglandin stabilizing agent selected from the group consisting of hydroxypropyl methylcellulose and polyvinylpyrrolidone.
A tablet comprising an admixture of (a) a therapeutically effective amount of enterically coated granules of an NSAID selected from the group consisting of diclofenac, piroxicam and pharmaceutically acceptable salts thereof;
- (b) an effective anti-ulcerogenic amount of misoprostol;
- and (c) an effective stabilizing amount of a prostaglandin stabilizing agent selected from the group consisting of hydroxypropyl methyl cellulose and polyvinylpyrrolidone.
An improved method for reducing the undesirable gastrointestinal side effects associated with the oral administration of an NSAID by coadministering a prostaglandin with the NSAID, wherein the improvement comprises administering the NSAID in a composition containing (a) a therapeutically effective amount of enterically coated granules of the NSAID, (b) an effective anti-ulcerogenic amount of a prostaglandin, and (c) an effective stabilizing amount of a prostaglandin stabilizing agent.
Dependencies are inferred from the claim text.