Abstract

ROLE OF POLYMERIC INTERACTION IN SOLUBILITY ENHANCEMENT OF ETODOLAC BY BALL MILLING AND HOT MELT EXTRUSION TECHNIQUES

Sachin Bhusari* and Puja Rathod and Pravin Wakte

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Abstract

The objective of present work was to study the drug-polymeric interaction to improve solubility and hence dissolution rate of poorly soluble drug Etodolac by milling and melt extrusion techniques. During milling high shear generated which increases high interfacial area of drug and polymer promotes amorphous powder formation. However in melt extrusion, high shear mixing of the molten mass cause dispersion of the drug and the polymer at molecular level with drug–polymer interactions promotes amorphizations. Etodolac is weak acid with poor water solubility. The polymers selected for study were Copovidone (Kollidon® VA64) and Eudragit EPO (cationic). Ball mill was used for milling amorphization whereas, single screw Hot Melt Extruder (HME) was used for fusion amorphization. The formulation optimized for drug polymer weight ratio, milling time, Screw speed of (HME) and HME temperature. In-vitro dissolution rate of Etodolac formulation is improved in pH 1.2 buffer solution as compared to that of the pure drug and physical mixtures. The amorphous material was characterized for Crystallinity (DSC and XRD), Drug polymeric interaction study and drug chemical stability (FTIR). Extrusion was found efficient technique for carrier based amorphization as compared to ball mill. Hot melt extruder parameter optimized in order to form uniform molecular level dispersion (Screw speed 50 rpm and temperature 120oC). Extruded product of Etodolac and Eudragit EPO has shown significant.

Keywords: Etodolac, HME, DSC, XRD, FTIR, Amorphizaton.