Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF FINGOLIMOD CAPSULES BY ORAL DRUG DELIVERY

G. Venkatesh *, S. Poonguzhali and Manohar Babus

ABSTRACT

The study was undertaken with an aim to develop an optimized formulation of Fingolimod capsules by oral drug delivery. The active pharmaceutical ingredient, Fingolimod was selected and formulated as capsule contained 0.50 mg of Fingolimod Comparable to the innovators product. Capsules were prepared by using wet granulation technique. Finished products were evaluated for disintegration time, assay, and In-vitro release studies. The developed trials were tested for In-vitro dissolution profile and compared with the reference product. The In-vitro dissolution profile of formula7 was similar to that of reference product. The optimized batch capsules were packed in HDPE containers and performed stability studies at 40°C/75%RH and 25 C / 60% RH. All the results were found to be satisfactory. Hence the designed and developed formula of Fingolimod was stable. The objective of the present project was successfully achieved by developing the product, giving the same release profile to that of innovators product.

Keywords: Fingolimod capsules, Reference product, Dissolution profile, stability studies.