Abstract
AbstractMeasuring tablet disintegration is essential for quality control purposes; however, no established method adequately accounts for the timeframe or small volumes of the medium associated with the dissipation process for fast disintegrating tablets (FDTs) in the mouth. We hypothesised that digital imaging to measure disintegration in a low volume of the medium might discriminate between different types of FTD formulation. A digital image disintegration analysis (DIDA) was designed to measure tablet disintegration in 0.05–0.7 mL of medium. A temperature-controlled black vessel was 3D-printed to match the dimensions of each tablet under investigation. An overhead camera recorded the mean grey value of the tablet as a measure of the percentage of the formulation which remained intact as a function of time. Imodium Instants, Nurofen Meltlets and a developmental freeze-dried pilocarpine formulation were investigated. The imaging approach proved effective in discriminating the disintegration of different tablets (p < 0.05). For example, 10 s after 0.7 mL of a saliva simulant was applied, 2.0 ± 0.3% of the new pilocarpine tablet remained, whereas at the same time point, 22 ± 9% of the Imodium Instants had not undergone disintegration (temperature within the vessel was 37 ± 0.5°C). Nurofen Meltlets were observed to swell and showed a percentage recovery of 120.7 ± 2.4% and 135.0 ± 6.1% when 0.05 mL and 0.7 mL volumes were used, respectively. Thus, the new digital image disintegration analysis, DIDA, reported here effectively evaluated fast disintegrating tablets and has the potential as a quality control method for such formulations.
Publisher
Springer Science and Business Media LLC
Subject
Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics
Reference45 articles.
1. Nachajski MJ, Bazela A, Zarzycka M, Broszczyk A, Kołba A, Kołodziejczyk MK. Effect of API on powder flowability, direct compression and properties of orally disintegrating tablets: a preformulation study. Indian J Pharm Sci. 2019;81(3):489–95.
2. Dhagla R. Choudhary, Vishnu A. Patel and AJK. Development and characterization of pharmacokinetic parameters of fast-dissolving films containing levocetirizine. Sci Pharm. 2012;80(3):779–87.
3. Agiba AM, Eldin AB. Insights into formulation technologies and novel strategies for the design of orally disintegrating dosage forms: a comprehensive industraial review. Int J Pharm Pharm Sci. 2019;11(9).
4. Sharma D, Kumar D, Singh M, Singh G, Rathore MS. Fast disintegrating tablets: a new era in novel drug delivery system and new market opportunities. J Drug Deliv Ther. 2012;2(3):74–86.
5. European Pharmacopoeia. European pharmacopoeia. 2020. Available from: https://www.edqm.eu/en/european_pharmacopoeia_10th_edition
Cited by
8 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献