FORMULATION AND IN–VITRO EVALUATION OF CONTROLLED RELEASE MICROSPHERES OF DULOXETINE HYDROCHLORIDE

Dr. P SHASHIDHAR; Dr. M Sunitha; Dr. D RAMAKRISHNA; Sumaiya Firdose

Volume : VII, Issue : X, October - 2017

FORMULATION AND IN–VITRO EVALUATION OF CONTROLLED RELEASE MICROSPHERES OF DULOXETINE HYDROCHLORIDE

Dr. P Shashidhar, Dr. M Sunitha, Dr. D Ramakrishna, Sumaiya Firdose

Abstract :

Duloxetine Hydrochloride is a FDA approved is Serotonin and Nor–epinephrine reuptake inhibitor (SNRI) Anti–depressant drug, which is sold under the name Cymbalta. It shows good bioavailability, averaging up to 50% upon oral administration and its lambda max was found to be 289nm. Floating microspheres after administration orally, resist in stomach for long period of time to increase the bioavailability of the drugs which has the maximum absorption site from proximal part of the small and large intestine. After oral administration of Duloxetine Hcl would be stay in the stomach and issue the drug in a sustained manner, so that the drug could be released unceasingly to its site of absorption in the upper GIT. This method of administration would be finest achieving the effect of the drug. Based on this, an effort was made to design Controlled release Microspheres of Duloxetine hydrochloride using different proportions of polymers and combinations.

In the present effort, an effort has made to develop controlled release Microspheres of Duloxetine hydrochloride by selecting Sodium Alginate and Methocel E50 as checking polymers. The polymers are used in different ratios of groupings. All the formulations were prepared by Solvent Evaporation method. The preparation of all the formulations showed respectable flow properties such as angle of repose, bulk density, tapped density. The prepared Microspheres show good post formulation parameters such as content uniformity, percentage yield, dissolution studies, stability studies and they passed all the quality control evaluation parameters as per I.P limits. Among all the formulations T6 and T8 formulation showed maximum % drug release, but the ideal formulation was found to be T8 for showing best drug release i.e., 100% in 10 hours. Hence it is considered as optimized formulation with the least possible concentration of polymers. It was observed that the combination ratio of Sodium Alginate 400mg and Methocel E 50 20mg has distinct effect on in vitro drug release profiles when compared to all the other combinations of polymers.