Enhanced stability of novel liquid compositions
The present invention relates to compositions of pharmaceutical agents in combination with additional pharmaceutical agents in a mixture of polyethylene glycol, polyvinylpyrrolidone, and propylene glycol and a process of making the compositions.
1. A liquid oral pharmaceutical composition comprising:
(i) from about 0.1% to about 20% w/v polyvinylpyrrolidone;
(ii) from about 5% to about 70% w/v polyethylene glycol;
(iii) from about 1% to about 30% w/v propylene glycol;
(iv) from about 1% to 10% w/v guaifenesin; and
(v) from about 0.01% to about 1.0% w/v phenylephrine;
further comprising one or more additional pharmaceutical agent selected from the group consisting of analgesics, decongestants, expectorants, antitussives, antipyretics, anti-inflammatory agents, cough suppressants, and antihistamines; and wherein the composition comprises about less than 2% total phenylephrine degradants, as a percent weight over weight phenylephrine, and about less than 2% loss of phenylephrine from the initial total phenylephrine content, measured over a 3 month time period while stored at 40° C. and 75% relative humidity.