Response to the comparison of generic Ritonavir (Ritomune, Cipla) and Lopinavir/Ritonavir Tablets (Lopimune, Cipla) and the abbott brand (Norvir Soft-Gel Capsules and Kaletra Tablets)
✍ Scribed by Siddarth Chachad; Jaideep Gogtay; Geena Malhotra; Shrinivas Purandare
- Publisher
- John Wiley and Sons
- Year
- 2010
- Tongue
- English
- Weight
- 62 KB
- Volume
- 99
- Category
- Article
- ISSN
- 0022-3549
No coin nor oath required. For personal study only.
✦ Synopsis
The availability of generic antiretroviral drugs has made a dramatic impact on morbidity and mortality of HIV/AIDS patients in the developing countries. These drugs which cost less than 10% of the innovator have led to a reduction in mortality rates of nearly 80% in India. With increasing use of first-line agents the challenge is now to provide cost effective second-line drugs, an important component of which are protease inhibitors.
Recently, Dr. Kevin and colleagues from Abbott Laboratories, USA compared the bioavailability of generic Ritonavir (Ritomune, Cipla) and Lopinavir/Ritonavir Tablets (Lopimune, Cipla) with the innovator products in a dog model. Bioequivalence studies were conducted using a randomized, two-period crossover study design under fasting conditions in groups of 12 beagle dogs with a washout of 1 week between two periods. The concentrations of Lopinavir and Ritonavir were determined by HPLC-MS/MS and the point estimates for pharmacokinetic