A METHOD OF STABILIZING A DRY POWDER PHARMACEUTICAL FORMULATION

摘要

A method of stabilizing a dry powder formulation is disclosed. The method comprises calculating the moisture content as a function of time required for normal or accelerated storage of the formulation. This calculation is carried out using a mathematical equation to predict a calculated value for added water required for achieving the possible maximum water content of a formulation. The moisture content of the formulation is then adjusted from its initial value to the calculated maximum value using the calculated maximum moisture content for the product at the respective storage temperature and humidity conditions.