| 主权项 |
1. An oral liquid pharmaceutical composition comprising a stable dispersion or suspension comprising:
a. budesonide in an amount of about 0.02 mg/mL to about 0.75 mg/mL of the composition, b. disodium edetate in an amount of about 0.05 mg/mL to about 25 mg/mL of the composition, c. a buffer, wherein the buffer is chosen from the group consisting of sodium citrate, citric acid, a carbonate buffer, a hydroxide buffer, a phosphate buffer, an acetate buffer, or combinations thereof, d. polysorbate 80 in an amount of about 0.01 mg/mL to about 1 mg/mL of the composition, e. a preservative, wherein the preservative is potassium sorbate present in an amount of about 0.2 mg/mL to about 10 mg/mL of the composition, sodium benzoate present in an amount of about 0.2 mg/mL to about 10 mg/mL of the composition, or a combination thereof, f. a flavoring agent, a sweetener, or a combination thereof, g. dextrose in an amount of 0-250 mg/mL of the composition, h. at least one additional excipient comprising maltodextrin present in an amount of about 10 mg/mL to about 1 g/mL of the composition, and one or more of hydroxyethylcellulose (HEC), hydroxypropylmethyl-cellulose (HPMC), carboxymethyl-cellulose (CMC), microcrystalline cellulose (MCC), carbomer, and combinations thereof, present in an amount of about 5 mg/mL to about 100 mg/mL of the composition; and i. water, wherein the composition is physically and chemically stable, wherein during and after storage the particles of the dispersion or suspension do not cake or aggregate, wherein the composition remains substantially uniform for at least 1 day, and wherein the composition is suitable for single or multiple dose administration, the composition having a viscosity of at least 50 cP. |
