Soft gelatin capsules containing fexofenadine
AssigneeEnspire Group LLC
InventorsAbdul Rashid, Dahai Guo, Minh Tran, Zhang Julia Zhang
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Abstract
Bioavailable liquid softgel fill compositions comprising a) fexofenadine or a fexofenadine salt; b) a matrix comprising a pharmaceutically acceptable poly(alkylene glycol), a pharmaceutically acceptable alkylene glycol, a pharmaceutically acceptable polymeric solubilizing agent, and a pharmaceutically acceptable surfactant; and c) a pharmaceutically acceptable acidulant are disclosed. Also disclosed are methods for the preparation of such fill compositions, and softgel capsules containing the bioavailable liquid fill composition.
Claims28
A bioavailable liquid softgel fill composition comprising:
- a) 4-40% by weight of fexofenadine or a fexofenadine salt;
- b) a matrix comprising:
- i) 40-80% by weight of a pharmaceutically acceptable poly(alkylene glycol);
- ii) 5-30% by weight of a pharmaceutically acceptable alkylene glycol;
- iii) 1-10% by weight of a pharmaceutically acceptable polymeric solubilizing agent;
- and
- iv) 0.001-0.5% by weight of a pharmaceutically acceptable surfactant;
- and
- c) 0.001-2% by weight of a pharmaceutically acceptable acidulant;
- based on the total weight of the composition.
A bioavailable liquid softgel fill composition consisting essentially of:
- a) 4-40% by weight of fexofenadine hydrochloride;
- b) a matrix comprising:
- i) 40-80% by weight of PEG 400;
- ii) 5-30% by weight of propylene glycol;
- iii) 1-10% by weight of polyvinylpyrrolidone;
- and
- iv) 0.001-0.5% by weight of sodium lauryl sulfate;
- c) 0.001-2% by weight of citric acid;
- and
- d) 1-10% of water;
- based on the total weight of the composition.
A bioavailable liquid softgel fill composition consisting essentially of:
- a) about 13.9% by weight of fexofenadine hydrochloride;
- b) a matrix comprising:
- i) about 64.2% by weight of PEG 400;
- ii) about 15.2% by weight of propylene glycol;
- iii) about 3.4% by weight of polyvinylpyrrolidone;
- and
- iv) about 0.3% by weight of sodium lauryl sulfate;
- c) about 0.5% by weight of citric acid;
- and
- d) about 2.5% of water;
- based on the total weight of the composition.
26-27. (canceled)
Dependencies are inferred from the claim text.