Comparative Evaluation of Different Brands of Nitroglycerine Controlled Release Tablets Available in Indian Market
Rajesh Agrawal *
Central Research Incubation Center, Swami Vivekanand Subharti University, Subhartipuram, Delhi-Haridwar, Meerut Bypass Road, NH-58, Meerut-250005, India and GM – R&D, Modi-Mundipharma R&D Centre, Modipuram, Meerut-250110, India.
Ganesh Prasad Mishra
Faculty of Pharmacy, Kharvel Subharti College of Pharmacy, Swami Vivekanand Subharti University, Subhartipuram, Delhi-Haridwar, Meerut Bypass Road, NH-58, Meerut-250005, India.
*Author to whom correspondence should be addressed.
Abstract
The nitroglycerine oral solid preparations are available in the international and Indian market as – Sublingual tablets and Controlled Release tablets since a very long time. However, the quality issues (like few of the mentioned below) are consistently there. Due to this poor stability issues, even the Pharmacopoeial monographs insists on wider Dosage content uniformity limits (75 – 135% of label claim) and relaxed assay limits (90 – 115% of label claim). In the present study a comparison for the most critical quality parameters such as, Dissolution and Related substance among the In-House developed product and different brands of 2.6 mg Nitroglycerin Controlled Release tablet available in Market was carried out. It was observed that Impurity 1 MNG was not observed in any of the market product while Impurity 2 MNG was observed initially in two branded products but on stability this impurity observed in all branded products except In-house developed product. Initially, drug dissolution result of In-house developed product was comparable with the all branded product. On stability, Drug release profile of all branded product varies to a significant level from its initial value while the drug release profile of the In-house developed product remain unchanged.
Keywords: Nitroglycerine, drug dissolution, drug release, pharmacopoeial monographs