Alternatively, this blend may instead be compressed to make slugs. Others features, objects and advantages of the inventions will be apparent from the description and claims. The dry granulation process includes a blending bupropion hydrochloride and one or more pharmaceutically acceptable excipient sb compacting or slugging the material of step ac sizing the compacted or slugged material of step b into granules, and d compressing the granules of step c.
The method may further include lubricating the sized granules of step c before compressing the granules.
The present invention relates to a stable bupropion hydrochloride tablet and a method of stabilizing bupropion hydrochloride tablets, which also serves as an improved tabletting process for the preparation of sustained release bupropion hydrochloride tablets.
Disclosed herein is a stabilized sustained release pharmaceutical composition of bupropion hydrochloride and process for preparing the same, wherein said pharmaceutical composition comprising therapeutically effective amount of uncoated fine bupropion hydrochloride and pharmaceutically acceptable adjuvants, and wherein the composition is free of an acidic stabilizer and contains less than about 0.
Modified release pharmaceutical composition containing Bupropion HCI as active substance. The method according to claim 21, wherein the cellulose derivative comprises hydroxypropyl cellulose. The ratio of bupropion hydrochloride to lipophilic release retardant material ranges from about 0. The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below.
Granules for high-speed tabletting or encapsulation are produced with reproducible granule size distribution. In accordance with another aspect of the invention, there is provided a process for preparing said stable oral sustained release pharmaceutical composition comprising bupropion hydrochloride that exhibits sustained release of the drug.
The results in the table above clearly depict that the content of undegraded bupropion hydrochloride in the compositions of the present invention in the form of sustained release tablets Example 1, 2, 3 and 4 are comparable to the content of undegraded bupropion hydrochloride in the commercially available Wellbutrin SR tablets.
The tablet may include bupropion hydrochloride, one or more release rate controlling polymers, and one or more diluents, binders, lubricants, glidants and coloring agents. The seal-coating layer of the present invention is water soluble in nature and is designed to disintegrate rapidly in an aqueous medium. Hydrochloric acid is described as being a preferred stabilizer. The above bupropion hydrochloride formulations were prepared using the following process:.
The inventors also have discovered that the process of dry granulation further serves as an improved tabletting process for the preparation of sustained release bupropion hydrochloride tablets. Swelling enhancers are members of a special category of excipients that swell rapidly to a large extent when placed in a liquid medium resulting in an increase in the size of the tablet.
Stabilized, acid-free formulation for sustained release of bupropion hydrochloride.
The ' patent states that suitable stabilizers include inorganic acids meeting the above criteria and include hydrochloric acid, phosphoric acid, nitric acid, and sulfuric acid, or combinations thereof. The method according to claim 12, wherein the one or more pharmaceutically acceptable excipients comprise one or more of release rate controlling polymers, diluents, binders, lubricants, glidants, and coloring agents.