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Published January 8, 2022 | Version v1
Journal article Open

AN ENDEAVOUR TO MASK THE BITTER TASTE OF TRAMADOL HCL BY ION EXCHANGE TECHNIQUE

  • 1. 1Hi-Tech College Pharmacy, Bhubaneswar, Odisha, India. 2Royal college of Pharmacy and Health Sciences, Berhampur, Odisha, India. 3St. Ann's College of Pharmacy, Vizianagaram, A.P., India. 4Institute of Pharmacy and Technology, Salipur, Cuttack Odisha, India.

Description

The rationale of this research work was to mask the bitter and unagreeable taste of Tramadol HCl which will improve the organoleptic and physicochemical properties such as taste, feel and other molecular properties of drug by making complexes with ion exchange resin (IER) on the basis of ion exchange technique. Tramadol HCl is a central acting opoid analgesic. In this work an effort has been shown to formulate a bitter less form of the drug which can be acceptable for oral administration with enhanced palatability and patient compliance. Indion- 234, Tulsion-335 and Tulsion-344 were the three ion exchange resins chosen for preparation of drug resin complex (DRC) or resinate and on the basis of drug loading Tulsion-335 selected as the best among them. The ratio of drug and resin (Tulsion-344) in 1:2 had shown excellent drug loading and taste masking ability. The confirmation of complexation between drug and resin was confirmed by infrared spectroscopy, thermal analysis and x-ray diffraction. Infrared spectroscopy revealed the complexation of Tramadol HCl with Tulsion- 344 IER. The thermal analysis (differential scanning calorimetry-DSC) has shown a sharp change in endothermic peak between drug and drug resin complex (DRC).The x-ray diffraction pattern of DRC signified complete disappearance of crystalline peaks of drug. The crystalline form of the drug changed to amorphous form was confirmed by these two tests. The extent of taste masking ability of drug resin complex (resinate) was assured by time intensity method followed by determining the amount of drug release in phosphate buffer of pH 6.8(simulated salivary fluid) and 0.1N Hydrochloric acid (simulated gastric fluid) and the results authenticated the successful masking of bitter taste of the drug. This taste masked drug resin complex (resinate) will be a tool to fabricate fast disintegrating tablets which will mitigate swallowing problem in pediatrics and geriatrics patients and will provide better palatability to liquid dosage forms.

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