Development and Evaluation of Conventional Release Eperisone HCl Tablets by Direct Compression Method

Background: Lower back pain one of the frequent complaints in primary care centers. Treatment is challenging due to its variable and multifactorial nature. Eperisone HCl is a centrally acting muscle relaxant with both analgesic and antispastic properties also absence of sedative effect makes it unique from other muscle relaxants and very effective in the treatment of lower back pain. Objective: The study aimed to develop conventional release dosage form of the antispastic agent Eperisone HCl by direct compression method. Methodology: In this study different immediate release tablet formulations (F1-F9) containing 50 mg of Eperisone HCl were developed by using various excipients (different diluents alone or in combination) through direct compression technique. The formulations were subjected to different Pharmacopeial and non-Pharmacopeial tests to evaluate its performance. The impact of formulation variables on tablet performance was also evaluated and optimized formulation was developed. Result: The formulation (F1) containing only Microcrystalline cellulose (pH-101) (39% w/w) was selected as optimized formulation. Friability of formulation (F1) was lower as compared to formulations containing Lactose DC and Dicalcium phosphate. Optimized formulation subjected to FTIR and accelerated stability studies was found compatible with a shelf life of 28.13 months. Optimized formulation dissolution profile was similar to the marketed (similarity factor: f2). The optimized formulation disintegrated in shorter time (0.31 min) as compared to marketed brand (4.61 min). Conclusion: Eperisone HCl immediate release tablets manufactured successfully by Direct compression method. The formulation using only MCC as diluent (39%) was found to be the most acceptable one. The optimized formulation meets all official quality standards, confirming that DC method offers simple and easier approach in tablet manufacturing.