Stable formulations of angiotensin converting enzyme (ACE) inhibitors
OwnerScott Stofik, Robert Gwozdz +2inventors
InventorsScott Stofik, Robert Gwozdz, Christopher Pelloni, John C. James
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Abstract
A stable pharmaceutical composition comprising a) a therapeutically effective amount of an Angiotensin Converting Enzyme (“ACE”) inhibitor which is susceptible to degradation or its salt; b) a greater than stoichiometric amount of an alkali or alkaline earth metal carbonate, relative to the amount of ACE inhibitor or its salt; and c) a pharmaceutically acceptable carrier, including a process for the manufacture of such compositions.
Claims44
A pharmaceutical composition comprising:
- a) a therapeutically effective amount of an ACE inhibitor which is susceptible to degradation or its salt;
- b) a greater than stoichiometric amount of an alkali or alkaline earth metal carbonate, relative to the amount of ACE inhibitor or its salt;
- and
- c) a pharmaceutically acceptable carrier.
A pharmaceutical composition characterized by improved stability comprising:
- a) a therapeutically effective amount of Moexipril.HCl;
- and
- b) a greater than stoichiometric amount of sodium bicarbonate, relative to the amount of Moexipril.HCl,
- so as to form a pharmaceutical composition characterized by improved stability relative to compositions having stoichiometric amounts of sodium bicarbonate or less.
A process for manufacturing a pharmaceutical solid composition comprising an ACE inhibitor which is susceptible to degradation or its salt, the process comprising:
- a) intimately mixing for a predetermined period of time the ACE inhibitor or its salt with alkali or alkaline earth metal carbonate;
- b) loading the product of step a) into a high shear granulator and mixing for a predetermined period of time with at least one of a pharmaceutically acceptable carrier, a disintegrant, or a binder;
- c) granulating the mixture of step b) in the granulator by adding a predetermined amount of water;
- d) discharging the granulation of step c) into a holding tank where it is allowed to sit for a predetermined amount of time, after which it is wet milled;
- e) drying the product of step d) for a predetermined amount of time and to a predetermined moisture content;
- f) further processing the dried material into the solid pharmaceutical composition.
Dependencies are inferred from the claim text.