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• W2317033060 endingPage "3300" @default.
• W2317033060 startingPage "3286" @default.
• W2317033060 abstract "The LFCS Consortium was established to develop standardized in vitro tests for lipid-based formulations (LBFs) and to examine the utility of these tests to probe the fundamental mechanisms that underlie LBF performance. In this publication, the impact of bile salt (sodium taurodeoxycholate, NaTDC) concentration and drug loading on the ability of a range of representative LBFs to generate and sustain drug solubilization and supersaturation during in vitro digestion testing has been explored and a common driver of the potential for drug precipitation identified. Danazol was used as a model poorly water-soluble drug throughout. In general, increasing NaTDC concentrations increased the digestion of the most lipophilic LBFs and promoted lipid (and drug) trafficking from poorly dispersed oil phases to the aqueous colloidal phase (APDIGEST). High NaTDC concentrations showed some capacity to reduce drug precipitation, although, at NaTDC concentrations ≥3 mM, NaTDC effects on either digestion or drug solubilization were modest. In contrast, increasing drug load had a marked impact on drug solubilization. For LBFs containing long-chain lipids, drug precipitation was limited even at drug loads approaching saturation in the formulation and concentrations of solubilized drug in APDIGEST increased with increased drug load. For LBFs containing medium-chain lipids, however, significant precipitation was evident, especially at higher drug loads. Across all formulations a remarkably consistent trend emerged such that the likelihood of precipitation was almost entirely dependent on the maximum supersaturation ratio (SRM) attained on initiation of digestion. SRM defines the supersaturation “pressure” in the system and is calculated from the maximum attainable concentration in the APDIGEST (assuming zero precipitation), divided by the solubility of the drug in the colloidal phases formed post digestion. For LBFs where phase separation of oil phases did not occur, a threshold value for SRM was evident, regardless of formulation composition and drug solubilization reduced markedly above SRM > 2.5. The threshold SRM may prove to be an effective tool in discriminating between LBFs based on performance." @default.
• W2317033060 created "2016-06-24" @default.
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• W2317033060 date "2012-10-22" @default.
• W2317033060 modified "2023-10-17" @default.
• W2317033060 title "Toward the Establishment of Standardized <i>in Vitro</i> Tests for Lipid-Based Formulations. 2. The Effect of Bile Salt Concentration and Drug Loading on the Performance of Type I, II, IIIA, IIIB, and IV Formulations during <i>in Vitro</i> Digestion" @default.
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• W2317033060 doi "https://doi.org/10.1021/mp300331z" @default.
• W2317033060 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/23030411" @default.
• W2317033060 hasPublicationYear "2012" @default.
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