Abstract
AbstractThe stability of hydrocortisone in aqueous solutions containing (v/v) either 20% ethyl alcohol, 50% glycerin or 50% propylene glycol with or without other excipients was investigated. The study was conducted at higher temperatures (50° or 60°) and for some solutions at room temperature also. The effect of four antioxidants (ascorbic acid, L-cysteine hydrochloride monohydrate, propyl gallate, and sodium bisulfite), two surface active agents (polysorbate 80, and sodium lauryl sufate) and a thickening agent (hydroxypropyl methylcellulose) were also investigated.At a higher temperature (60°) propylene glycol proved to be better than glycerin for the stability of hydrocortisone. None of the antioxidants improved the stability. Cysteine hydrochloride and sodium lauryl sulfate had an adverse effect on the stability of hydrocortisone. Propylene glycol and polysorbate 80 may be used for the preparation of stable hydrocortisone solutions provided that the pH is acidic (3.5).
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