Formulation of Modified Liquid-Solid Compact for Dissolution Enhancement of Raloxifene Hydrochloride

Raloxifene hydrochloride (RLX), used in post-menopausal osteoporosis, is a class–II drug as per Biopharmaceutics Classification System. The purpose of this research was to formulate modified liquisolid compacts (MLSC) of RLX for improved dissolution in immediate-release tablet formulations. Preliminary trials on selection of excipients were performed. Fourier transform infrared spectra illustrated no interaction between drug and MLSC powder. The X-ray diffraction studies demonstrated the transformation of the crystalline nature of drug into partial amorphous state in MLSC. After all experimental results on selection of excipients were analyzed, the final tablet formulation was derived and manufactured. The results of an in-vitro drug release study from the selected batch illustrated a remarkable improvement in the dissolution rate as compared to reference product. An accelerated stability study as per the ICH Q1 (R2) guideline of the optimized batch was performed for six months and showed no significant change in critical quality attributes of formulation.

Peer-Reviewed

Submitted: August 26, 2020
Accepted: December 15, 2020

About the authors

Gayatri Patel* is Professor, gayatripatel26@gmail.com, Dharmang Pandya is Assistant Professor, and Pushti Gandhi is Research Scholar, all at Charotar University of Science and Technology, Ramanbhai Patel College of Pharmacy, Department of Pharmaceutics & Pharmaceutical Technology, CHARUSAT Campus, Changa- 388421, Gujarat, India. Rajesh Parikh is Director at Graduate School of Pharmacy, Gujarat Technological University, Gandhinagar Campus, Nr. Government Polytechnic K-6 Circle, Sector - 26, Gandhinagar-382028, Gujarat, India.

*To whom all correspondence should be addressed.

Article Details

Pharmaceutical Technology
Volume 45, Number 7
July 2017
Pages: 48-52

Citation

When referring to this article, please cite it as G. Patel et al., "Formulation of Modified Liquid-Solid Compact for Dissolution Enhancement of Raloxifene Hydrochloride," Pharmaceutical Technology 45(7) 2021.