Formulation and Evaluation of the Tramadol HCl Oral Disintegrating Film by Using The Co-processed Superdisntegrants

摘要

ABSTRACT Oral fast disintegrating films (OFDF) is an emerging technology brings out “formulations taken without water” with quick onset of action and improved patient compliance. The present aim of study is to enhance the dissolution rate of the dosage form by using the different superdisintegrants and co-processed superdisintegrants. The films were prepared by solvent casting method using hydrophilic polymers that rapidly dissolves on the tongue or buccal cavity, delivering the drug to the systemic circulation. The polymer was used  HPMC E15, PEG 6000 as plasticizer, citric acid as the saliva stimulating agent, sucrose as the sweetening agents and sodium starch glycolate, crosscarmelose sodium and crospovidone as the superdisintegrants and tween 80 as surfactant . The FTIR reports suggest that drug and excipients were compatible. These oral disintegrating films were evaluated for various evaluation parameters. The in-vitro dissolution studies were conducted as per USP II with sinker. There were three ODFs prepared by using different types of the superdisintegrants, two were prepared by using the co-processed superdisintegrants and one was without any superdisintegrants. Among all formulation, the F6 shown the better in-vitro drug release profile which was prepared by using co-procesed superdisintegrants. It can be concluded that the co-processed superdisintegrants enhances the dissolution rate by comparing with other formulation. Keywords: HPMC E15, PEG 6000, SSG, CCS, Crospovidone, co-processed superdisintegrants, Tramadol hydrochloride.