Oral pharmaceutical compositions of nebivolol and process for their preparation
OwnerBandi Parthasaradhi Reddy, Podili Khadgapathi +1inventors
InventorsBandi Parthasaradhi Reddy, Podili Khadgapathi, Goli Kamalakar Reddy
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Abstract
The present invention is directed to pharmaceutical compositions comprising nebivolol. More particularly, the present invention is directed to oral pharmaceutical compositions comprising nebivolol hydrochloride having a specific surface area of less than 22×103 cm2/g, and process for preparing the same.
Claims12
A pharmaceutical composition comprising nebivolol hydrochloride, having a specific surface area of less than 22×103 cm2/g, wherein the composition comprises an inert seed, crystal or granule having deposited thereon the nebivolol hydrochloride and at least one pharmaceutically acceptable excipient.
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A process for preparing a pharmaceutical composition of nebivolol having a specific surface area of less than 22×103 cm2/g, by solution/suspension layering comprising:
- (i) preparing a dispersion of nebivolol in methanol together with one or more excipients,
- (ii) coating the drug dispersion of step (i) on an inert seed, crystal or granule to provide drug pellets,
- (iii) preparing a solution comprising a cushioning agent and coating the solution onto the step (ii) drug pellets to form coated drug pellets, and
- (iv) lubricating the coated drug pellets and loading the coated drug pellets into capsules or compressing the coated drug pellets into tablets with an extra granular material.
A process for preparing a pharmaceutical composition of nebivolol having a specific surface area of less than 22×103 cm2/g, by Extrusion-spheronization comprising:
- (i) blending nebivolol with one or more excipients to form a blended mixture,
- (ii) granulating the blended mixture of step (i) with a binder solution to form wet mass,
- (iii) extruding the wet mass of step (ii) followed by spheronizing using a spherodizer to provide spheroids, and
- (iv) lubricating the spheroids and compressing the spheroids into tablets or filling the spheroids into capsules.
Dependencies are inferred from the claim text.