Lisinopril brand
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Summary
8 papers analyzed
These studies suggest that Lisotec, Zestril, and other brands of Lisinopril tablets meet pharmacopoeial specifications and are bioequivalent, with effective methods available for their quality assessment.
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Lisinopril Brands: A Comparative Analysis
Introduction to Lisinopril and Its Uses
Lisinopril is a widely used angiotensin-converting enzyme (ACE) inhibitor that helps relax blood vessels and reduce blood volume, thereby lowering blood pressure. It is commonly prescribed for treating hypertension, protecting kidney function in diabetic patients, and reducing mortality risk after a heart attack. Lisinopril is marketed under various brand names, including Prinivil®, Qbrelis®, and Zestril®, and is also available in combination with hydrochlorothiazide as Zestoretic®.
Bioequivalence of Lisinopril Brands
Comparative Bioequivalence Studies
A study conducted to evaluate the bioequivalence of two brands of lisinopril, Lisotec (Julphar, UAE) and Zestril (AstraZeneca, UK), demonstrated that both brands have comparable pharmacokinetic profiles. The study involved 28 healthy volunteers who received a single oral dose of each brand in a randomized crossover design. Key pharmacokinetic parameters such as AUC, CMAX, and TMAX were analyzed, and no significant differences were found between the two formulations, confirming their bioequivalence.
Post-Market Surveillance and Quality Assessment
In Sudan, a post-market surveillance study assessed the pharmaceutical quality of three generic brands of lisinopril tablets. The study evaluated parameters such as weight uniformity, friability, hardness, disintegration, and dissolution rates. All brands met the pharmacopoeial specifications, with dissolution profiles showing more than 80% release within 30 minutes. The study concluded that the generic brands were similar to the originator brand in terms of quality and efficacy.
Physicochemical and Pharmaceutical Quality
Analytical Methods for Quality Assessment
A comparative evaluation of nine brands of lisinopril tablets using HPLC and UV spectrophotometry revealed that only one brand met the official standards for both methods. The study highlighted the higher sensitivity and reproducibility of the HPLC method compared to UV spectrophotometry, which, although simpler, was less sensitive. Another study in the Yemeni market confirmed that five brands of lisinopril tablets passed all British Pharmacopoeia quality specifications, indicating their physical and chemical equivalence.
Quality Assessment in Different Markets
In a study analyzing five brands of lisinopril tablets in Africa, all brands conformed to the weight uniformity test. However, only one brand met the standard purity range in aqueous titrimetric analysis, while two brands met the standards in non-aqueous titration. The study emphasized the importance of using reliable and reproducible methods for quality assessment.
Conclusion
The comparative studies and quality assessments of various lisinopril brands indicate that many generic formulations are equivalent to the originator brands in terms of bioavailability and pharmaceutical quality. These findings support the use of generic lisinopril as a cost-effective alternative to branded versions, ensuring that patients have access to effective hypertension treatment options. However, the choice of analytical methods and rigorous post-market surveillance are crucial to maintaining the quality and efficacy of these medications.
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