Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF EXTENDED RELEASE TABLETS OF TAPENTADOL HCl

S. Maheswara Rao*, P. Prem Kumar and Manohar Babu S.

Abstract

Patients experiencing acute or chronic pain require an analgesic agent that is both effective and well tolerated for management of moderate to severe pain. Therefore to overcome such pain there is need to formulate effective and stable dosage form of Tapentadol HCl with following objectives. Development and evaluation of the extended release oral tablet, which matches with innovators formulation. Performed the preformulation studies to study compatibility between drug and excipients. Evaluated the physical parameters for the prepared tablets. The marketed product was characterized for various properties of the dosage forms like assay, dissolution and other physical properties. F10 formulation found pharmaceutical equivalent to competitor product. The Final trial was packed in PVC/PVDC blister packing and kept at 40°C/75%RH±5% for 6 month and 25°C±2°C/60%RH±5% upto 24 month. Formulation found to be robust and stable.

Keywords: Chronic pain, Tapentadol HCl, Dissolution Studies, pharmaceutical equivalent.