Formulation and Evaluation of Bilayer Tablet of Tramadol Hydrochloride and Diclofenac Sodium

ABOUT AUTHOR
Thakor Namita M*, Bhavsar dhaval N, Varde Neha M, Patel Jitendra k, Upadhyay U.M.
Sigma Institute of Pharmacy, Bakrol, Vadodara, Gujarat, India
E-mail: [email protected]

ABSTRACT:
The aim and objective of present study is to formulate and evaluate the bilayer tablet containing Tramadol Hydrochloride immediate release layer and Diclofenac Sodium sustain release layer in order to produce a single tablet containing two different classes of drugs. Which are used to treat severe and moderately severe pain. Diclofenac Sodium and Tramadol Hydrochloride, resulting peripheral and central analgesia a “balanced analgesia” used in wider spectrum of pain management and which results in synergistically enhanced analgesic action, cost effectiveness and reduces the undesired symptoms. Tramadol Hydrochloride (IR Layer provide shorter analgesia onset (t-max) and Diclofenac Sodium (SR Layer) provide analgesic action for prolong duration. In which Immediate release layer of Tramadol Hydrochloride was prepared by wet granulation technique using sodium starch glycolate, crospovidone and croscarmellose sodium as a super disintegrants. The sustained release layer of Diclofenac Sodium was prepared by wet granulation technique using hydrophilic matrix polymers like HPMC K4 M, HPMC K15M, HPMC K100M. Formulated bilayered tablets were evaluated for different parameters like hardness, thickness, weight variation, friability, disintegration time and % cumulative drug release.
Key words: Bilayer tablet, hydrophilic polymer, Superdisintegrant, Diclofenac sodium, Tramadol hydrochloride