The present invention relates to controlled-release microsphere composition comprisingfluvastatin or a salt thereof having a bilayer shell structure comprising an outer polymer layerand an inner layer, and a core comprising the fluvastatin or a salt thereof, wherein themicrospheres have a mean size diameter in a range from 100 ?m to 500 ?m; and wherein, thedrug to polymer ratio is in the range of 1:1 to 1:5. The present invention also relates to10 optimization of the process for preparation of controlled-release microsphere by response surfacemethodology such that high entrapment efficiency and high yield of the microspheres isobtained.
Inventors
Neelam Sharma, Sukhbir Singh, Sandeep Arora
