Soft gelatin capsules containing a mixture of analgesics and decongestants, expectorants, antitussives and/or antihistamines
AssigneePuraCap Pharmaceutical LLC
InventorsDahai Guo, Minh Tran, Zhang Julia Zhang
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Abstract
Clear bioavailable liquid softgel fill compositions comprising a) at least one analgesic and one or more of decongestants, expectorants, antitussives and/or antihistamines; b) a matrix comprising a pharmaceutically acceptable poly(alkylene glycol) and a pharmaceutically acceptable alkylene glycol; c) a solubilizing agent comprising a pharmaceutically acceptable polymeric solubilizing agent and water are disclosed. Also disclosed are methods for the preparation of such clear fill compositions, and softgel capsules containing the clear bioavailable liquid fill composition.
Claims3
A method of preparing a clear liquid softgel fill composition consisting of the steps of:
- a) stirring polyethylene glycol or a mixture of polyethylene glycols, and propylene glycol with heating to 70° C.±10° C. until a clear solution is obtained;
- followed by
- b) slowly adding polyvinylpyrrolidone in small quantities with continuous mixing and heating to 70° C.±10° C., until a clear solution is obtained;
- followed by
- c) adding purified water with continuous mixing and heating to 70° C.±10° C., until a clear solution is obtained;
- followed by
- d) adding acetaminophen in small quantities with continuous mixing and heating to 70° C.±10° C., until a clear solution is obtained;
- thereafter
- e) adding guaifenesin with continuous mixing and heating to 70° C.±10° C., until a clear solution is obtained;
- f) successively adding i) dextromethorphan HBr and ii) phenylephrine HCl with continuous mixing and optionally heating up to 80° C., until a clear solution is obtained;
- and
- g) cooling to ambient temperature and deaerating the clear solution from step f;
- whereby said clear liquid softgel fill composition is stable to storage for at least two years,
- wherein steps a) to g) are performed in a single container and in an order as set forth above.
Dependencies are inferred from the claim text.