Formulation of a stable pilocarpine hydrochloride solution.

Abstract A stable 1% pilocarpine hydrochloride solution was formulated without added buffers which requires a minimum amount of alkali for neutralization. The solution has an equilibrium pH of about 3.8, contains about 93% of the original pilocarpine used in the formulation, and is self-buffered by a pilocar- pine-pilocarpic acid system formed at equilibrium. A solution of pilocarpine hydrochloride is adjusted to about pH 5, and then equilibrium conditions are attained involving a slow, acid-catalyzed resynthesis of pilocarpine from its hydrolysis products.

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