Manufacture and Evaluation of an Experimental 37.5 kg Scale Batch of 0.103% w/w Ethinyl Estradiol Triturate (Formulation Number WC3074-01I)

Abstract

Actavis Fajardo, is a Pharmaceutical company dedicated to the manufacturing and packaging of oral contraceptive products. Ethinyl Estradiol is an intermediate product used to incorporate Ethinyl Estradiol active in tablet formulations. Ethinyl Estradiol is a high potency drug; therefore, low dosages are required to achieve its therapeutic range (for example 10µg equivalent to 0.014% of the powder blends of the formulations). The triturate is prepared as an intermediate product to aid in the distribution of the active ingredient in the final blend tablets formulation. The manufacturing process of the intermediate product consists of wet massing and drying cycles in a solid processor. Tablet formulations containing this Ethinyl Estradiol triturate are showing a significant variability in the In Process Content Uniformity Test. Therefore, one of the solution was identified to improve the variability in the In Process Content Uniformity Test is to change the formulation of the Ethinyl Estradiol from a concentration of 0.206% w/w to 0.103% w/w. This report will shows the new formulation, manufacturing process and results obtained for a new Ethinyl Estradiol Triturate with a concentration of 0.103% w/w. Key Terms - Blend Uniformity, Ethinyl Estradiol, Formulation Triturate.