Generic Drug For Lisinopril

Generic Drug for Lisinopril: Quality and Equivalence

Introduction to Lisinopril and Its Uses

Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor widely used to treat high blood pressure (hypertension), protect kidney function in diabetic patients, and reduce the risk of death following a heart attack. It is available under various brand names, including Prinivil®, Qbrelis®, and Zestril®, and can also be combined with the diuretic hydrochlorothiazide in formulations like Zestoretic®.

Evaluation of Generic Lisinopril Tablets

Quality Assessment in Sudan

A study conducted in Sudan evaluated the pharmaceutical quality of three generic brands of Lisinopril 5mg tablets. The brands, coded as Z, L, and A, were assessed for weight uniformity, friability, hardness, disintegration, and dissolution rates. The results indicated that all brands complied with pharmacopoeial specifications, showing more than 80% drug release within 30 minutes and a similarity factor above 50%, confirming their equivalence to the originator brand.

Comparative Analysis in Yemen

Similarly, a study in Yemen analyzed five different brands of Lisinopril 5mg tablets. The assessment included tests for weight uniformity, friability, crushing strength, disintegration, and dissolution, as well as chemical assays. All brands met the British Pharmacopoeia (BP) standards, demonstrating physical and chemical equivalence. This suggests that generic Lisinopril tablets available in the Yemeni market are of comparable quality to branded versions.

Bioequivalence and Pharmacokinetics

A pharmacokinetic and bioequivalence study in China compared the generic Lisinopril/hydrochlorothiazide (10mg/12.5mg) tablets with the reference product under fasting and postprandial conditions. The study involved 96 healthy participants and found no significant differences in pharmacokinetic parameters between the test and reference formulations. Both products were bioequivalent, with the 90% confidence intervals for key pharmacokinetic measures falling within the acceptable range of 80%-125%. The study also noted a significant food effect, with a 20%-25% reduction in systemic exposure when taken postprandially.

Conclusion

The research indicates that generic Lisinopril tablets are of high quality and equivalent to branded versions in terms of physicochemical properties and pharmacokinetic profiles. Studies from Sudan and Yemen confirm that generic formulations meet stringent pharmacopoeial standards, ensuring their safety and efficacy . Additionally, bioequivalence studies in China support the use of generic Lisinopril/hydrochlorothiazide combinations as effective alternatives to branded products. These findings provide confidence in the use of generic Lisinopril as a cost-effective option for managing hypertension and related conditions.

Summary

Not a yes or no question