Enhanced stability of novel liquid compositions
View Patent ↗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
wherein the composition is visually free of guaifenesin precipitation for at least 62 days at 4° C.
2. 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.
3. 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.
4. 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.
5. The process of claim 4 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.
6. The process of claim 4 , wherein the composition is visually free of guaifenesin precipitation for at least 62 days at 4° C.