Abstract

FORMULATION AND EVALUATION OF PEDIATRIC ORAL DRUG DELIVERY SYSTEM WITH ENHANCED SOLUBILITY

*Drishya M., Dr. Geetha V. S., Anagha George and Raeesa K. U.

ABSTRACT

Historically, solid dispersions have been employed as a successful technique to enhance the bioavailability and dissolving characteristics of medications that are not very water soluble. The oral antiplatelet medication clopidogrel (CLP) is a member of the thienopyridine class. For patients who are susceptible to cardiovascular events such as myocardial infarction, peripheral vascular disease, and stroke, it is a crucial therapeutic drug. It has extremely low water solubility and is classified as Class II in the Biopharmaceutical Classification System (BCS). The current study's objectives were to assess the potential of Eudragit RL-100 and RS-100 as carriers for solid dispersions and to increase the solubility and rate of dissolution of the weakly water-soluble medication clopidogrel using a solid dispersion approach.Using various carriers in varying ratios, solid dispersions were created usingthe solvent evaporation approach, and they demonstrated improved solubility in comparison to API. Drug content, solubility, and in vitro drug release analyses were performed on the solid dispersions. Sodium carboxymethyl cellulose was used as a suspending agent and sodium starch glycolate as a granule disintergrant to manufacture the solid dispersion into dry syrup. The drug concentration, sedimentation ratio, viscosity, redispersibility, FTIR, and in vitro drug release of the prepared dry syrup were all assessed.The refined solid dispersion formulation F3 was used to create dry syrups with different sodium carboxymethylcellulose concentrations. It can be concluded that solid dispersion of clopidogrel formulated as dry syrup is effectively increases the solubility of the drug, thereby increases its bioavailability and it is suitable for paediatric use.

Keywords: Clopidogrel, Solid Dispersion, Dry Syrup, Eudragit RL 100.