Discriminatory in vitro dissolution tests of oral dosage forms containing poorly soluble drugs for a Quality by Design approach

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Lauretta Maggi Valeria Friuli Paola Perugini Giorgio Musitelli Ubaldo Conte


The challenge of oral formulations, containing drugs that show pH-dependent solubility, is to increase the dissolution rate in different media that simulate the gastrointestinal conditions, to guarantee their availability for absorption. In this work, some dosage forms containing poorly soluble drugs (diclofenac sodium, ketoprofen and meloxicam) are evaluated in different media: pH 1.0 (simulating fasted state), pH 4.5 buffer (simulating fed state), deionised water and phosphate buffer pH 6.8 or pH 7.5. These last buffers are required by the U.S. Pharmacopoeia monographs. The results obtained in sink and non-sink conditions could show possible critical quality attributes of the drugs and these properties are highly significant for a Quality by Design (QbD) approach. Completely different performances were obtained in the four dissolution media by the products considered. This approach could be useful for the predictive analytics, for the critical risk assessment and control during production, for the design and the development of new drugs in QbD approach.

Keywords: Quality by Design (QbD), Dissolution rate, solid dosage form(s), Solubility, US Pharmacopoeia (USP)

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How to Cite
MAGGI, Lauretta et al. Discriminatory in vitro dissolution tests of oral dosage forms containing poorly soluble drugs for a Quality by Design approach. Medical Research Archives, [S.l.], v. 6, n. 11, nov. 2018. ISSN 2375-1924. Available at: <https://esmed.org/MRA/mra/article/view/1855>. Date accessed: 30 sep. 2023. doi: https://doi.org/10.18103/mra.v6i11.1855.
Research Articles


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