Abstract
FORMULATION AND EVALUATION OF CONTROLLED RELEASE PELLETS OF ELUXADOLINE

Dhaval Prajapati* and Jaini Patel

ABSTRACT

In the present research work, controlled release pellets of eluxadoline were developed and evaluated analytically by FTIR Spectra for drug absorption and bioavailability. Eluxadoline was chosen as a model drug because its peak plasma concentration occurs after 1.5-2 hours of oral administration and controlled release formulation has not been developed yet. Pre-formulation studies were carried out to optimize the required quantity for polymers and excipients. Fourier transform Infrared spectroscopy confirmed the absence of any drug/polymers/excipient’s interactions. A total of nine batches of controlled release pellets of eluxadoline were prepared by direct compression technique, using polymers such as HPMC K4M, HPMC K100M, HPMC K15M in different combinations with other standard excipients like PVP K30, lactose and avicel pH 102. Tablets were evaluated for physical parameters viz. hardness, friability, thickness, weight variation and stability studies. Further, tablets were evaluated in-vitro for drug release. All results were found to be in acceptance criteria; hence it was concluded that controlled release pellets of eluxadoline can be formed as marketed formulation also.

Keywords: Eluxadoline, HPMC K4M, HPMC K100M, HPMC K15M, HPMC, PVP K30, lactose, avicel Ph 102, controlled release.


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