Abstract

DESIGN OF SOLID ORAL DOSAGE FORM AND ITS QUALITY CONTROL ASSESSMENT OF URAI MATHIRAI – A TABLET FROM SIDDHA FORMULATION FOR IMMUNO MODULATION IN PEDIATRIC COMMUNITY

Sathiyarajeswaran P.*, Dhanaraj K., Shree Devi. M. S., Muthu Tamizh M. and Patturayan R.

Abstract

Urai Mathirai has been use traditionally for the past five decades as an Immunomodulator. The details of preparation and its indications were listed in Hospital Pharmacopeia of Indian medicine. However, there is no uniformity in dosage mentioned and no clinical evidence to support its efficacy. The present study was focused to develop standard operating procedure for the preparation of Uraimathirai at a dose of 50 mg, once daily for six months and to test its efficacy in preventing recurrent respiratory illness. Pre-formulation studies were carried out to rule out the interaction between the formulation and excipients. Three formulations (viz F1, F2 & F3) of Uraimathirai 50 mg were developed by wet granulation method using microcrystalline cellulose (diluents), polyvinyl pyrrolidone (binder), and talc (glidant & lubricant). The tablets were evaluated for both pre-compression and post compression parameters. Among three formulations, F3 showed the best results and abide with standards of PLIM guidelines.

Keywords: Urai Mathirai, Conventional tablet dosage forms, Wet granulation method, PLIM guidelines.