Stable pilocarpine formulations with modified buffer characteristics and related methods

Abstract

Disclosed herein, are, among other things, stable, pharmaceutically acceptable and ophthalmologically suitable reduced buffer content and reduced buffering capacity pilocarpine compound compositions. In aspects, such compositions comprise therapeutically effective amounts of a pilocarpine compound, an effective amount of a uniform buffer component, wherein the concentrations of pilocarpine compound and uniform buffer component are limited to specific relative amounts and wherein the uniform buffer component is defined by one or more markedly distinguishing characteristics from buffers used in developed pilocarpine products (e.g., a unique pKa and/or concentration). Aspects of the invention include compositions defined by unique concentrations of such and other ingredients. Such compositions surprisingly exhibit pharmaceutically acceptable stability and, in aspects, stability equal to or statistically significantly greater than that of one or more on-market/developed reference product(s). Further, the invention provides methods of manufacturing such and similar compositions, and methods of their use in treating ocular conditions such as presbyopia.