Formulation Development of Megesterol Acetate, a Novel Approach to Improve Therapeutic Efficacy

Megesterol acetate a synthetic derivative of naturally occurring steroidal hormone progesterone, used in the treatment of breast cancer. The drug is poorly soluble and thermosensitive. The rate of dissolution and its bioavailability is less. In this investigation an attempt was made to develop novel drug to enhance the dissolution of solid oral formulation of Megesterol acetate using solid dispersion and hydrotropic techniques. The tablets can be prepared using less complicated and less expensive excipients, process, as well as to fulfill better therapeutic action for pharmaceutical use. In the study the approach of hydrotropic technique used hydrotropic agents like sodium acetate, sodium benzoate, sodium citrate and urea. In the solid dispersion technique PEG 6000 is used as a carrier. The dissolution pattern of optimized formulation was compared with Innovator product and it was found to be superior to the Innovator product. Key words: Megesterol acetate, solid dispersion technique, hydrotropic techniques