Abstract
Miosis-time profiles were obtained using rabbits following the instillation of 25.0 μl of 1.0% pilocarpine nitrate solutions, which were buffered at a pH of 4.75 with different concentrations of citrate buffer. Relative pharmacological response, as measured by the areas under the miosis-time profiles and the maximum observed pupillary diameter changes, decreased as the citrate buffer concentration was increased. A reduction in the miosis-time profile area of greater than 5-fold was observed at the highest buffer concentration studied. The study demonstrates that a non-drug formulation component, such as a buffer system, can dramatically affect the relative pharmacological response from a simple ophthalmic solution dosage form. These results are of importance both in basic ophthalmic research studies and in ophthalmic product research and development.
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