Stabilized ramipril compositions and methods of making
OwnerEdward Wilson, Martin Beasleyinventors
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Abstract
The present invention relates to ramipril compositions with improved stability. More particularly, the present invention is directed to pharmaceutical compositions comprising ramipril that are stabilized against decomposition into degradation products, namely, ramipril-diketopiperazine and ramipril-diacid, during formulation and storage conditions. The present invention also relates to methods for making and methods of manufacturing stabilized ramipril compositions.
Claims88
A pharmaceutical composition comprising ramipril coated by a blending agent, wherein the blending agent is selected from;
- glyceryl behenate, glyceryl stearate, stearyl alcohol, macrogol stearate ether, palmitostearate, ethylene glycol, polyethylene glycol, stearic acid, cetyl alcohol, lauryl alcohol, amylopectin, poloxymer or combinations thereof.
A pharmaceutical composition comprising ramipril, wherein the ramipril is coated by a blending agent, wherein the rate of decomposition of the ramipril to ramipril-diketopiperazine is less than about 0.4% of the total weight of ramipril during the first 3 months when the pharmaceutical composition is at room temperature.
The composition of claim 29, wherein the composition is a tablet.
A pharmaceutical composition comprising ramipril, wherein the ramipril is coated by a blending agent, wherein the rate of decomposition of the ramipril to ramipril-diketopiperazine is less than about 0.75% of the total weight of ramipril during the first 6 months when the pharmaceutical composition is at room temperature.
The composition of claim 39, wherein the composition is a tablet.
A pharmaceutical composition comprising ramipril, wherein the ramipril is coated by a blending agent, wherein the rate of decomposition of the ramipril to ramipril-diketopiperazine is less than about 3.0% of the total weight of ramipril during the first 36 months when the pharmaceutical composition is at room temperature.
A pharmaceutical composition comprising ramipril, wherein the ramipril is coated by a blending agent, wherein the rate of decomposition of the ramipril to ramipril-diketopiperazine is less than about 0.09%, on average, of the total weight of ramipril per month when the pharmaceutical composition is at room temperature.
A method of making a pharmaceutical composition comprising combining ramipril with a blending agent, wherein the ramipril is coated by blending agent.
A method of making a pharmaceutical composition comprising first pre-blending or co-milling ramipril with a blending agent, wherein the blending agent is selected from;
- glyceryl behenate, glyceryl stearate, stearyl alcohol, macrogol stearate ether, palmitostearate, ethylene glycol, polyethylene glycol, stearic acid, cetyl alcohol, lauryl alcohol, amylopectin, poloxymer or combinations thereof.
A method of making a pharmaceutical composition comprising first pre-blending and/or co-milling ramipril and glyceryl behenate;
- and combining the ramipril and glyceryl behenate with microcrystalline cellulose and croscarmellose sodium.
Dependencies are inferred from the claim text.