CPC A61K 31/4178 (2013.01) [A61K 9/0053 (2013.01); A61K 9/08 (2013.01); A61K 9/10 (2013.01); A61K 9/107 (2013.01); A61K 47/14 (2013.01); A61K 47/32 (2013.01); A61K 47/34 (2013.01); A61K 47/36 (2013.01); A61K 47/38 (2013.01)] | 20 Claims |
1. An oral pharmaceutical composition comprising:
i.) about 1 mg/mL to about 10 mg/mL of losartan or a pharmaceutically acceptable salt thereof,
ii.) about 0.5 mg/mL to about 1.5 mg/mL of a suspending agent selected from the group consisting of hydroxyethylcellulose, methylcellulose, hydroxymethylcellulose, hydroxypropylmethylcellulose, microcrystalline cellulose, sodium carboxymethylcellulose, xanthan gum, acacia, an alginate, and guar gum, or a combination thereof,
iii.) a pH modifying agent,
iv.) about 5 mg/mL to about 15 mg/mL of a crystallization inhibitor selected from the group consisting of polyvinylpyrrolidone, hydroxypropyl methylcellulose, polyvinyl acetate, cyclodextrin, and hydroxypropyl P-cyclodextrin, or a combination thereof,
v.) about 0.1 mg/mL to about 3 mg/mL of a preservative selected from the group consisting of methyl paraben, ethyl paraben, propyl paraben, butyl paraben, benzoic acid, sodium benzoate, and benzalkonium chloride, or a combination thereof,
vi.) about 1 mg/mL to about 10 mg/mL of an antifoaming agent, and
vii.) about 20 mg/mL to about 60 mg/mL of a solubilizer selected from the group consisting of cremophor, vitamin E, polyethylene glycol (PEG 400), propylene glycol, and co-solvent, or a combination thereof, and
wherein the pharmaceutical composition is a suspension,
wherein the suspension has a pH of about 7, and
wherein the suspension has the following characteristics after storage at room temperature and 60% relative humidity:
after 12 months of storage, the suspension comprises less than about 0.5 wt/wt % losartan impurity D and losartan impurity E, relative to the weight of losartan in the suspension, and
after 12 months of storage, the suspension comprises at least about 95% of the losartan that was in the suspension prior to storage.
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