Non-aqueous oily injectable formulation exhibiting preservative efficacy

摘要

Disclosed herein is preferably a multi-dose type non-aqueous oily injectable formulation including; an active ingredient (drug) expressing therapeutic effects, which is dissolved, dispersed or suspended in a therapeutically effective amount, in oil. The disclosed non-aqueous oily injectable formulation may include; an oil-affinitive preservative, and a hydrophilic excipient non-phase separable from the oil-affinitive preservative when the excipient is mixed with the oil-affinitive preservative.

主权项

1. An injectable formulation, comprising:
a physiologically effective amount of active ingredient; oil containing the active ingredient; a hydrophilic excipient non-phase separable from the oil; and a lipophilic preservative combined with the hydrophilic excipient, which exhibits higher preservative efficacy, compared to administration of the lipophilic preservative alone, wherein the hydrophilic excipient is at least one selected from the group consisting of propyleneglycol, polyethyleneglycol, polypropyleneglycol, acetic acid, citric acid, dimethylsulfoxide (DMSO), N-methylpyrolidone (NMP) and dimethylacetamide (DMA), wherein the lipophilic preservative is at least one selected from the group consisting of: phenol, m-cresol, benzyl alcohol, methyl paraben, propyl paraben, penzalkonium chloride, thiomerosal, chlorobutanol, ethanol and phenoxyethanol, and wherein said formulation is an injectable non-aqueous formulation.