Patent ID: 11890273
Assignee: SCIENTURE, INC.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 3:
4. 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.) about 0.5 mg/mL to about 1.5 mg/mL of 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 pharmaceutical composition is stable for 6 months at 40° C. at 75% relative humidity, and wherein stability is determined by the pharmaceutical composition having the following characteristics after storage at 40° C. at 75% relative humidity:
after 6 months of storage, the suspension comprises less than about 2 wt/wt % losartan impurity D and losartan impurity E, relative to the weight of losartan in the suspension, and after 6 months of storage, the suspension comprises at least about 97% of the amount of losartan in the suspension prior to storage; or

wherein the pharmaceutical composition is stable for 12 months at 30° C. at 65% relative humidity, wherein stability is determined by the pharmaceutical composition having one or both of the following characteristics after storage at 30° C. at 65% relative humidity:
after 12 months of storage, the suspension comprises less than about 1 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 98% of the amount of losartan in the suspension prior to storage; or

wherein the pharmaceutical composition is stable for 12 months at 2-8° C., wherein stability is determined by the pharmaceutical compositions having one or both of the following characteristics after storage at 2-8° C.;
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 99% of the amount of losartan in the suspension prior to storage.