“DEVELOPMENT AND OPTIMIZATION OF CLARITRHOMYCIN PEDIATRIC CHOCOLATE DOSAGE FORM”
Juhi Patel*, Ankita Bhavsar, and Pratik patel
ABSTRACT
Clarithromycincn is an antibiotic used for skin and urinary tract infection. It is available in suspension and tablet dosage form but due to its bitter taste pediatric patient compliance is very poor.The objective of present study was to develop a chocolate formulation containing Clarithromycin for pediatric administration. The formulation consist of chocolate base containing cocoa butter, cocoa powder and mannitol. Clarithromycin is Biopharmaceutics classification system class II drug with low solubility and high permeability. Solubility of Clarithromycin was enhanced by using β-cyclodextrin. The prepared chocolate formulation was evaluated for appearance, blooming test, in vitro drug content, in vitro drug release, etc. Batch was optimized using 32 factorial design on the basis of hardness and drug dissolution. Fourier transfer infra-red and Differential scanning calorimetry study showed that the drug and excipients were compatible with each other’s. No significant changes were observed in melting point and wave number. Phase solubility study showed 1:3 ratio of drug and β-cyclodextrin enhancement in solubility. The quantitative effect of dependent and independent variable at different level was determined by polynomial equation. Linearity was observed between actual and predicted values. Optimized batch showed 95% cumulative drug release in 70 min. Stability study of optimized batch was studied at 0-8°C and at 25°±5°C.It showed no changes in physical and chemical characteristic. Clarithromycin containing medicated chocolate was successfully formulated as effective pediatric dosage form with improved patient compliance.
Keywords: Clarithromycin, Medicated chocolate, ?-CD, 32 full factorial design.
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