Abstract
Present work was aimed to develop a platform technology for pediatric dosage form which masks the bitter taste of a drug and to prepare flexible solid oral dosage form using hot melt extrusion (HME). Eudragit EPO, a cationic co-polymer insoluble in pH above 5, was used as a taste masking polymer to restrict the drug release in saliva. Soluplus, a graft co-polymer freely soluble in water was used as solubility enhancer. Test formulation released less than 10 % drug Tenofovir Disoproxil Fumarate (TDF) in pH 6.8 compared to 89% of marketed formulation simulated to limited release of drug in the saliva and thus avoiding the bitterness. DSC and XRD tests confirmed the existence of molecularly dispersed drug. FTIR confirmed the presence of unchanged functional groups of drug in its tablet form after HME processing. Proposed platform technology successfully masked the bitter taste in the ratio of D:P 1:2 and overcame this challenge of oral dosage form.
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