Article Subject

The present invention relates to controlled release compositions of galantamine, processes to prepare the compositions, there in vitro release profiles and methods of use and methods of treatment using the said compositions. It is a reversible inhibitor of acetylcholinesterase that binds specifically to the nicotinic receptors. Galantamine hydrobromide is been approved in the United States for treating Alzheimer's disease. The extended release pharmaceutical composition of the present study exhibits a desired in vitro dissolution profile and can serve as an economical alternative to the marketed brand product, RAZADYNE™ ER extended release capsules. The present study reveals a pharmaceutical composition comprises a capsule containing pharmacologically inert particles having a coating comprising galantamine or a salt thereof and a rate controlling substance, and having an exterior coating comprising one or more rate controlling substance. Further the formulation evaluated according to the present study includes, a pharmaceutical composition comprises a portion of the contained galantamine, which is present in more than one extended release form. In the present study, controlled release compositions of galantamine provides a release of at least about 20% to about 60% of galantamine in about 1 hour and more than about 80% of galantamine in about 12 hours, as measured in a buffer pH 6.8 at 37° C., using USP dissolution apparatus 2 at 50 rpm. The major focus of the present study was to design the controlled release composition behaving similar to the brand product using only water insoluble pharmaceutical grade excipients.

Article PDF
PDF (For Download)