Upping the ante in ODT formulations – characterization of ODT formulations as a function of drug loading

Jan. 1, 2018, midnight - by Graeme Macleod , Brian Wilson , Bruno Leclercq

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The present study aims to provide insights into formulating robust, high-dose orally disintegrating tablets (ODTs). To create a viable product, the formulator must consider the functional limitations of the excipients used and their correlation with the final product's Critical Quality Attributes (CQAs). We have explored the impact of the Active Pharmaceutical Ingredient (API) dose using formulations developed with Pharmaburst® 500 and Actimask® 92M, a commercially available ODT platform, and taste-masked paracetamol, respectively. With active loads of 250 mg and 500 mg, the tablet sizes reach or exceed the upper limit specified in the FDA Guideline. However, achieving these objectives presents a practical formulation challenge for ODTs with larger doses.