Author : Kartik Hariharan1, Maulik Panchal2, Tejal Mehta1* 1Department of Pharmaceutics, Institute of Pharmacy, Nirma University, Ahmedabad, India 2Associate Vice President, XenaMed Corporation, Minnesota, USA
The landscape of dissolution media has been dynamically evolving with newer drugs entering the market among which most of them are either BCS class II or BCS class IV drugs exhibiting poor solubility. Conventional dissolution raises lot of doubts in the pharmaceutical industry owing to its composition which fails to adequately mimic in-vivo conditions. The effect of bile salts, enzymes are prevalent factors which are often neglected by conventional dissolution media. To overcome these hurdles biorelevant media was suggested by several research groups and several developments have been witnessed to maintain a proximity to the required in-vivo conditions during dissolution. Media such as simulated gastric fluid, simulated intestinal fluid, milk-based dissolution media (Ensure®) have been suggested for fast and fed state taking into the considerations several factors like pH, surfactant concentration, etc. The recent improvement has been on fast state simulated intestinal fluid (FaSSIF- V2) where replacement of acetic acid by maleic acid is evident. Though biorelevant dissolution media has solved the primary hurdle of mimicking in-vivo conditions, it has still not been accepted as a quality control tool to test batch to batch consistency in pharmaceutical industry. The reasons being cost, time consumption and basic requirement of dissolution as test as discriminatory tool where biorelevant media fails at certain fronts where conventional dissolution passes fairly well. The use of surfactants like bile salts in biorelevant media shows increased dissolution profile of different batches and fails to discriminate between them. It is a common understanding that those compounds which show increased dissolution in conventional media are obvious to show better dissolution in biorelevant media. This is the reason why conventional media are preferred over biorelevant media during quality control evaluation and batch to batch variability tests to save cost and time. Biorelevant media are being used today majorly during developmental stages and still need to go a long way to be used as quality control tool.