Enhanced stability of novel liquid compositions

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 about 4% w/v guaifenesin and about 0.10% w/v phenylephrine, wherein the composition is visually free of guaifenesin precipitation for 14 days at −20° C.

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,
• wherein the composition comprises about 4% w/v guaifenesin and about 0.10% w/v phenylephrine, 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.

A process for preparing an oral liquid composition, comprising the steps of:

• a.) mixing until dissolved from about 0.1% to about 20% w/v of polyvinylpyrrolidone in an aqueous phase;
• b.) adding and mixing from about 1% to about 20% w/v of at least one pharmaceutical agent;
• c.) subsequently adding and mixing:
• i.) water;
• ii.) from about 1% to about 30% w/v of a propylene glycol;
• iii.) from about 5% to about 70% w/v of a polyethylene glycol;
• and
• d.) subsequently adding and mixing one or more additional ingredients.