Use of Eudragit RS PO, HPMC K100M, Ethyl Cellulose, and Their Combination for Controlling Nicorandil Release from the Bi
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ORIGINAL ARTICLE
Use of Eudragit RS PO, HPMC K100M, Ethyl Cellulose, and Their Combination for Controlling Nicorandil Release from the Bilayer Tablets with Atorvastatin as an Immediate-Release Layer Wajiha Iffat 1,2 & Muhammad Harris Shoaib 3 & Rabia Ismail Yousuf 3 & Faaiza Qazi 3 & Zafar Alam Mahmood 1 & Iyad Naeem Muhammad 1 & Kamran Ahmed 1 & Farrukh Rafiq Ahmed 1 & Muhammad Suleman Imtiaz 1 Accepted: 27 October 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Purpose To develop a bilayer tablet containing sustained-release (SR) nicorandil and immediate-release (IR) atorvastatin components in separate layers for the effective treatment of angina accompanied by hyperlipidemia with less dosing frequency and improved patient compliance. Methods Sustained-release nicorandil layer was formulated using HPMC K100M with or without Eudragit RS PO and Ethyl Cellulose 10FP. An immediate-release atorvastatin layer was developed using crospovidone and sodium carbonate. The formulations were optimized using a central composite design with the help of Design Expert software. The bilayer tablets were manufactured using a double-compression technique. Dissolution test study was conducted using three different media (pH 1.2, 4.5, and pH 6.8 buffers). Dissolution profiles were analyzed through model-dependent and model-independent methods using DDSolver, an Excel-based add-in program. Selected formulations were subjected to accelerated stability study according to ICH guidelines. Results The bilayer tablets were successfully developed with desired quality attributes. Nicorandil release kinetics followed anomalous diffusion, and in vitro release profile was best expressed through the Higuchi equation, while atorvastatin release exhibited Weibull kinetics. The shelf-life of optimized formulations was found to be about 13 months. Conclusion The combination of ethyl cellulose and HPMC K100M successfully controlled the release of nicorandil from the bilayer tablet containing immediate-release atorvastatin. The formulation can be subjected to pharmacokinetic studies and clinical trials in the future for better management of cardiovascular diseases and enhancing patient compliance. Keywords Bilayer tablets . Nicorandil . Atorvastatin . HPMC . Eudragit . Ethyl cellulose
* Muhammad Harris Shoaib [email protected]; [email protected]
Kamran Ahmed [email protected] Farrukh Rafiq Ahmed [email protected]
Wajiha Iffat [email protected]
Muhammad Suleman Imtiaz [email protected]
Rabia Ismail Yousuf [email protected]; [email protected] Faaiza Qazi [email protected] Zafar Alam Mahmood [email protected] Iyad Naeem Muhammad [email protected]
1
Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan
2
Department of Pharmaceutics, Dow College of Pharmacy, Dow University of Health Sciences, Karachi, Sind 75270, Pakistan
3
Department of Pharmaceutics and Bioavailability and Bioequiva
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