Pharmaceutical compositions comprising nebivolol or a nebivolol analogue
AssigneeMylan Pharmaceuticals ULC
InventorsMostafa Akbarieh, Fazal M. Mohideen, Shetal Shah
Life of this patent
Estimating the term…
Abstract
The present application provides pharmaceutical compositions comprising as the active medicinal ingredient nebivolol, a nebivolol analog or a pharmaceutically acceptable acid addition salt thereof and a wetting agent. The invention also relates to methods of preparing and using said compositions.
Claims5
A pharmaceutical composition for oral administration comprising an active ingredient and a wetting agent, wherein the pharmaceutical composition is a solid pharmaceutical composition in the form of a tablet, wherein the active ingredient is nebivolol hydrochloride, the wetting agent is polysorbate 80, the pharmaceutical composition comprises, on a weight percentage basis, from about 0.01% to about 0.04% of the wetting agent and from about 0.5% to about 10% of the active ingredient, and the ratio (w/w) of wetting agent to active ingredient is less than 0.025,
- wherein the composition further comprises from about 20% to about 80% of a spray dried mixture of microcrystalline cellulose and lactose and/or lactose monohydrate, from about 1% to about 4% of hydroxypropylmethylcellulose, from about 2% to about 30% of corn starch and/or croscarmellose sodium, from about 0.25% to about 2% of magnesium stearate and from about 0.1% to about 2% of colloidal silicon dioxide, and
- wherein the active ingredient is added to the pharmaceutical composition in the form of unmicronized solid particles having a specific surface area of less than 23×103 cm2/g.
Dependencies are inferred from the claim text.