Losartan liquid formulations and methods of use
AssigneeScienture, Inc.
InventorsBhavya Teja KOLLA, Rahul SURANA, Suketu SANGHVI, Jigar BHATT
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Abstract
The present disclosure relates to stable, liquid pharmaceutical compositions of losartan or pharmaceutically acceptable salts thereof for oral administration. The present disclosure further provides powder compositions for reconstitution to provide a liquid formulation. In further aspects, the present disclosure relates to processes for preparation of such pharmaceutical compositions, and methods of treating a subject in need of losartan by administration of a formulation described herein.
Claims21
1-123. (canceled)
A method of treating a disease or condition responsive to angiotensin II receptor inhibition comprising administering to a subject in need thereof a therapeutically effective amount of an oral pharmaceutical composition comprising:
- about 1 mg/mL to about 50 mg/mL of losartan or a pharmaceutically acceptable salt thereof,
- about 0.5 mg/mL to about 1.5 mg/mL of a suspending agent,
- about 0.5 mg/mL to about 1.5 mg/mL of a pH modifying agent,
- about 5 mg/mL to about 15 mg/mL of a crystallization inhibitor,
- about 0.1 mg/mL to about 3 mg/mL of a preservative,
- about 1 mg/mL to about 10 mg/mL of an antifoaming agent, and
- about 20 mg/mL to about 60 mg/mL of a solubilizer,
- wherein the pharmaceutical composition is a suspension, and
- wherein the suspension is stable, as determined by meeting one or both of the following characteristics after storage at room temperature and 60% relative humidity:
- after 12 months of storage, the suspension comprises less than about 0.5 wt/wt % losartan impurity D and losartan impurity E, relative to the weight of losartan in the suspension, and
- after 12 months of storage, the suspension comprises at least about 95% of the losartan that was in the suspension prior to storage.
A method of treating a disease or condition responsive to angiotensin II receptor inhibition comprising administering to a subject in need thereof a therapeutically effective amount of an oral pharmaceutical composition comprising:
- about 1 mg/mL to about 50 mg/mL of losartan or a pharmaceutically acceptable salt thereof,
- about 0.5 mg/mL to about 1.5 mg/mL of a suspending agent,
- about 0.5 mg/mL to about 1.5 mg/mL of a pH modifying agent, and
- about 0.1 mg/mL to about 3 mg/mL of a preservative,
- wherein the pharmaceutical composition is a suspension, and
- wherein the suspension is stable, as determined by meeting one or both of the following characteristics after storage at room temperature and 60% relative humidity:
- after 12 months of storage, the suspension comprises less than about 0.5 wt/wt % losartan impurity D and losartan impurity E, relative to the weight of losartan in the suspension, and
- after 12 months of storage, the suspension comprises at least about 95% of the losartan that was in the suspension prior to storage.
Dependencies are inferred from the claim text.