PHARMACEUTICAL EVALUATION AND POST-MARKET SURVEILLANCE STUDY OF THREE BRANDS OF LISINOPRIL TABLETS IN SUDAN

Abstract

Background: Lisinopril is a type of angiotensin-converting enzyme (ACE) inhibitor that used to treat high blood pressure (hypertension) in adults and children. The safety and efficacy of drug products can be assured when their quality is consistent and reproducible. To ensure the requisite quality, pharmaceutical companies are required to test their products during and after manufacturing and at various intervals during the shelf life of the product. \nMethods: The aim of this study was to study and evaluate the physicochemical and pharmaceutical parameters in order to confirm the pharmaceutical quality of the generic Lisinopril tablet formulations available in Sudan. Evaluation was done based on the compendia physicochemical and pharmaceutical evaluation parameters. Different brands of Lisinopril 5mg tablets purchased randomly from drug stores, and coded Z, L and A, were assayed for weight uniformity, friability, hardness, disintegration, dissolution rate using standard physical methods, and also the similarity is studied to compare brand of originator to the generic products. Their percentage drug contents were determined using standard UV Spectrophotometric method. \nResults: All the brands being studied comply the pharmacopoeial specifications for weight uniformity, friability, disintegration and dissolution. The dissolution profile shows more than 80 % release in 30 minutes. Additionally, all brands should similarity factor above 50% and therefore to be consider as similar. Quantitatively, all the three brands being tested do complied with the pharmacopoeial specifications for drug content. \nConclusion: Hence this study will serve as a tool in assessing the pharmaceutical quality and to monitor post market quality, safety and efficacy of Lisinopril tablet formulations. \n\xa0 \xa0 \nPeer Review History: \nReceived 18 January 2021; Revised 13 February; Accepted 3 March, Available online 15 March 2021 \nUJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency.\xa0 \nReceived file:\xa0\xa0\xa0\xa0\xa0 Reviewer s Comments: \nAverage Peer review marks at initial stage: 5.5/10 \nAverage Peer review marks at publication stage: 7.0/10 \nReviewer(s) detail: \nProf. Dr. A. Hakan AKTAŞ, Suleyman Demirel University, Faculty of Science and Art, Department of Chemistry, Isparta-Turkey,\[email protected] \nDr. Vijay Kumar Singh, Institute of Pharmacy, Bundelkhand University, Jhansi, India, [email protected] \nDr. Hayriye Eda Şatana Kara, Gazi University, Turkey, [email protected] \n\xa0 \nSimilar Articles: \nQUALITY ASSESSMENT OF DIFFERENT BRANDS OF PARACETAMOL TABLETS IN YEMENI MARKET \nQUALITY CONTROL ASSESSMENT OF DIFFERENT BRANDS OF CIPROFLOXACIN 500 MG TABLETS IN YEMEN