Gastroretentive tablets

• US 9,393,205 B2
• Filed: 01/29/2013
• Issued: 07/19/2016
• Est. Priority Date: 01/30/2012
• Status: Active Grant

• Current Assignee: Sun Pharmaceutical Industries Limited
• Original Assignee: Sun Pharmaceutical Industries Limited
• Inventors: Kumar, Varinder, Ahmad, Shavej, Singh, Romi Barat
• Primary Examiner(s): HENLEY III, RAYMOND J
• Application Number:
  US14/374,568
• Publication Number:
  US 20150025146A1
• Time in Patent Office: 1,267 Days
• Field of Search: 514/561, 424/465
• US Class Current: 1/1
• CPC Class Codes: A61K 31/197 the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid carnitine A61K31/205
• CPC Class Codes: A61K 9/0065 Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
• CPC Class Codes: A61K 9/2009 Inorganic compounds
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2018 Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• CPC Class Codes: A61K 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61K 9/205 Polysaccharides, e.g. alginate, gums; Cyclodextrin
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• 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

Abstract

The present invention relates to a gastroretentive tablet comprising pregabalin, at least one swellable polymer, and other pharmaceutically acceptable excipients. It further relates to a process for the preparation of same.

Claims

1. A gastroretentive tablet comprising pregabalin, at least one swellable polymer, and other pharmaceutically acceptable excipients.

2. The gastroretentive tablet according to claim 1, wherein the tablet further comprises a gas generating agent.

3. The gastroretentive tablet according to claim 1, wherein the other pharmaceutically acceptable excipients are selected from diluents, binders, disintegrants, glidants, lubricants, and coloring agents.

4. The gastroretentive tablet according to claim 1, wherein the swellable polymer is selected from cellulose polymers, gums, polyethylene oxide, carbomer, superdisintegrant polymers, and combinations thereof.

5. The gastroretentive tablets according to claim 2, wherein the gas generating agent is selected from carbonates, bicarbonates, sufites, and mixtures thereof.

6. The gastroretentive tablet according to claim 5, wherein the gas generating agent additionally comprises an acid source.

7. The gastroretentive tablet according to claim 1, wherein the tablet additionally comprises a matrix forming agent.

8. The gastroretentive tablet according to claim 7, wherein the matrix forming agent is a formulated mixture of polyvinyl acetate and polyvinylpyrrolidone.

9. A process for the preparation of a gastroretentive tablet comprising pregabalin, at least one swellable polymer, and other pharmaceutically acceptable excipients selected from diluents, binders, disintegrants, glidants, lubricants, and coloring agents, wherein the process comprises the conventional methods of dry granulation, wet granulation, and direct compression.

10. The process according to claim 9, wherein the process includes using a gas generating agent.