Abstract:
Background: Domperidone is a BCS Class II drug that has been used for the management of GERD as an add-on treatment in adults and children. As precision of dosing and patient’s compliance become important prerequisite for quick relief from emesis, there is a need to develop a formulation for this drug which overcomes problems such as difficulty in swallowing, inconvenience in administration while traveling and better compliance. Pharmacokinetic studies help to determine bioavailability and to understand in vivo behaviour of drugs which could be further translated to assess therapeutic efficacy and safety profiles. Recently FDA has approved the use of Physiology Based Pharmacokinetic Modeling (PBPK) simulations as an alternative to clinical trials for pharmacokinetic assessments. Use of simulation software helps to manage experimental workload, time, and lack of resources required for in-vivo studies. In the current study, effect of formulation variables on pharmacokinetic response was evaluated. Objectives: The current study was conducted to assess pharmacokinetics of fast release tablets of domperidone (oro dispersible tablets and effervescent tablets) and their comparison with conventional marketed tablets. Methodology: Both ODTs and effervescent tablets were prepared by direct compression method. All formulations were evaluated for different quality control parameters like physical characteristics (physical appearance, shape, weight, weight variation and thickness), mechanical strength (crushing strength, specific crushing strength, tensile strength and friability), disintegration behavior (in vitro disintegration time, oral disintegration time and effervescence time) assay and in vitro drug release. All the parameters were determined as per official compendia (USP and BP). In silico pharmacokinetics was assessed in Asian and European population, using physiology based pharmacokinetic (PBPK) modeling software platform PK-Sim/MoBi (Bayer Technology Services, Leverkusen, Germany) version 10.
Page(s):
109-109
DOI:
DOI not available
Published:
Journal: Abstract Book on International Conference on Life Sciences (ICLS-23) 11-12 May 22-23, Volume: 0, Issue: 0, Year: 2023