ArticleMolecular pharmaceutics2025
Simulation of Antral Conditions for Estimating Drug Apparent Equilibrium Solubility after a High-Calorie, High-Fat Meal.
Article in Molecular pharmaceutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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1 citing paper in PubMed.
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The simulation of antral conditions for estimating drug apparent equilibrium solubility after a high-calorie, high-fat meal is challenging. In this study, (1) we measured the apparent equilibrium solubility of two model lipophilic drugs, ketoconazole and danazol, in antral aspirates collected at various time points after a minced high-calorie, high-fat meal and a glass of water 30 min after initiation of meal administration, and we designated one point estimate for ketoconazole and one point estimate for danazol; (2) we evaluated the usefulness of FeSSGF-V2 and FEDGAS pH = 3 in reproducing the two point estimates; (3) we evaluated potential compositions of FeSSGF-V3 that simulate the pH, the buffer capacity toward both less acidic and more acidic values, and the antral lipid and protein contents with easily accessible, commercially available products, and (4) we identified the most useful composition of FeSSGF-V3 for reproducing the two point estimates. For both model drugs, apparent solubility in FeSSGF-V2 and in FEDGAS pH 3 deviated substantially from the corresponding point estimate. For FeSSGF-V3, hydrochloric acid, acetates, and FEDGASbuffer pH 3 were evaluated for regulating the pH and buffer capacity, FEDGASgel was used for simulating the lipid content, and Régilait skimmed milk powder was used for simulating the protein content. Level III FeSSGF-V3 prepared with hydrochloric acid, 6.1% (w/v) Régilait, and 2.83% (w/v) FEDGASgel, i.e., one-sixth of FEDGASgel concentration in FEDGAS pH 3, was comparatively the most useful medium for point estimating ketoconazole and danazol apparent solubility in antral contents after water administration in the fed state, induced as requested by regulatory authorities in oral drug bioavailability studies. Level III FeSSGF-V3 prepared by using hydrochloric acid as the principal pH controlling species could be useful in the evaluation of food effects on drug absorption with
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