Sterilization of solid non-electrolyte medicinal agents employing sodium chloride

Claim 1

A process for preparing a sterile isotonic aqueous pharmaceutical suspension of a solid non-electrolyte medicinal agent selected from the group consisting of a corticosteroid, a steroid and a non-steroid wherein the corticosteroid is selected from the group consisting of cortisone, cortisone acetate, dexamethasone, dexamethasone acetate, dexamethasone tertiary butyl acetate, hydrocortisone acetate, predisolone, prednisolone acetate, betamethasone acetate, triamcinolone acetonide and methyl prednisolone; the steroid is selected from the group consisting of androsterone, 17-methyltestosterone, testosterone, testosterone borate, dienstrol, diethylstilbesterol, estradiol, estradiol-17-acetate, estradiol benzoate and ethinyl estradiol-3-methyl ether; and the non-steroid is selected from the group consisting of propylidone, primidone, diphenylhydantoin, indomethacin and thiabendazole, which comprises adding the medicinal agent to a mixture of sodium chloride and water, the concentration of sodium chloride being sufficient for a saturated solution at 100°C, heating at a temperature of from about 100°-130°C for a time sufficient to sterilize the medicinal agent and the aqueous system and after cooling to room temperature, adding sterile water for dilution to obtain the desired concentration of said medicinal agent in an effective amount in suspension.