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Abstract

Kyron T-114 as an effective Precursor for development of fixed dose combination Orodispersible Formulation using taste masked Resinate

The objective of the present work was to develop taste masked fixed dose combination orodispersible tablet of dextromethorphan HBr (DXM), chlorpheniramine maleate (CPM) and phenylephrine HCl (PHE) using polymer (Eudragit E-100) and various grades of ion exchange resins (Kyron® and Tulsion®). The taste masking agents were explored for their effectiveness by investing drugs in ratios of 1:1, 1:2 and 1:3, with taste masking agents and coded as DS1 – DS18. After the evaluation for taste masking drug: Kyron T-114 (1: 3; DS6) was found as an effectively taste masked resinate and was optimized, evaluated for pharmacotechnical parameters, and characterized by diffuse reflectance spectroscopy, differential scanning calorimetry and surface morphology. DS6 was formulated as orodispersible tablets by direct compression and official and unofficial tests and orodispersion characteristics were evaluated. Resinate DS6 of DXM, CPM and PHE with Kyron T-114 in the ratio of 1:3 successfully masked the bitter taste of drugs in fixed dose combination and developed as orodispersible formulation (K1). Developed orodispersible formulation was subjected to evaluation for various evaluation parameters and was found unsatisfactory in terms of friability. Formulation K1 was then modified to K2 by adding PVP K-30 that exhibited desired friability and displayed a dissolution efficiency of 94.70±2.46% for DXM, 89.45±0.92% for CPM and 96.83±1.39% for PHE at 45 min. The study highlighted the importance of development of an orodispersible dosage form for administration of taste masked resinates to geriatric and pediatric patients, for effective management of cough, cold and allergy.


Author(s): Deepesh Sahu, Om Prakash Sharma, Jatinder Dhari, Arun Kumar Sinha,Vijay Sharma and Kamla Pathak

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