Impact of pH and Time-Dependent Polymers on Colon-Targeted Mebeverine Hydrochloride Drug Delivery System

Document Type : Original research articles

Authors

1 Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy (Girls), Al-Azhar University, Cairo, Egypt

2 Department of Clinical Pharmacy, Faculty of Pharmacy (Girls), Al-Azhar University, Cairo, Egypt

Abstract

The primary goal of this study is to formulate and assess sustained colon-targeted mebeverine hydrochloride (MbH) tablets using pH as well as time dependent coating polymers at different concentrations for the management of inflammatory bowel illness. Drug-polymer interaction did not occur according to the results of the DSC analyses. Cores containing 5% superdisintegrant C1 (crosspovidone), C2 (sodium starch glycolate) and C3 (croscarmellose sodium) were chosen to be coated, since they achieved gradual release patterns. The drug core tablets were coated with different controlling release polymers (pH and time dependent polymers) via compression coating technique. Press coated tablets were assessed for their weight, thickness, hardness, friability and drug content and in-vitro release. The developed MbH tablets F8, F9, F11, F14 and F17 that displayed a 5- to 6 hours lag period before the full MbH release were chosen for short term accelerated test of stability at two different temperatures of 35 ± 2 and 45 ± 2 ºC/75 ± 5% relative humidity (RH). In-vivo study was carried out formulated tablet (F14) that displayed the highest of both T90 value and similarity factor and commercial ones as they were administered to healthy human volunteers and the plasma MbH was analyzed. F14 exhibited the highest Tmax and AUC(0-24) in comparison with the commercial tablets. According to the findings, this strategy can offer a practical way for colon targeting.

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Azhar International Journal of Pharmaceutical and Medical Sciences
Volume 5, Issue 1
January 2025
Pages 297-310

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