Drug dissolution and transit in a heterogenous gastric chyme after fed administration: Semi-mechanistic modeling and simulations for an immediate-release and orodispersible tablets containing a poorly soluble drug

Danielak, Dorota; Gajda, Maciej; Bołtromiuk, Tomasz; Sulikowska, Katarzyna; Kubiak, Bartłomiej; Romański, Michał

doi:10.1016/j.ejpb.2024.114341

European Journal of Pharmaceutics and Biopharmaceutics

2024

DOI: 10.1016/j.ejpb.2024.114341

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Drug dissolution and transit in a heterogenous gastric chyme after fed administration: Semi-mechanistic modeling and simulations for an immediate-release and orodispersible tablets containing a poorly soluble drug

Dorota Danielak,

Maciej Gajda,

Tomasz Bołtromiuk

et al.

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Application of a Novel Dissolution Medium with Lipids for In Vitro Simulation of the Postprandial Gastric Content

Felicijan,

Rakoše,

Prislan

et al. 2024

Pharmaceutics

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Food can change various physiological parameters along the gastrointestinal tract, potentially impacting postprandial drug absorption. It is thus important to consider different in vivo conditions during in vitro studies. Therefore, a novel dissolution medium simulating variable postprandial pH values and lipid concentrations was developed and used in this study. Additionally, by establishing and validating a suitable analytical method, the effects of these parameters on the dissolution of a model drug, cinnarizine, and on its distribution between the lipid and aqueous phases of the medium were studied. Both parameters, pH value and lipid concentration, were shown to influence cinnarizine behavior in the in vitro dissolution studies. The amount of dissolved drug decreased with increasing pH due to cinnarizine’s decreasing solubility. At pH values 5 and 7, the higher concentration of lipids in the medium increased drug dissolution, and most of the dissolved drug was distributed in the lipid phase. In all media with a lower pH of 3, dissolution was fast and complete, with a significant amount of drug distributed in the lipid phase. These results are in accordance with the in vivo observed positive food effect on cinnarizine bioavailability described in the literature. The developed medium, with its ability to easily adjust the pH level and lipid concentration, thus offers a promising tool for assessing the effect of co-ingested food on the dissolution kinetics of poorly soluble drugs.

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Application of a Novel Dissolution Medium with Lipids for In Vitro Simulation of the Postprandial Gastric Content

Felicijan,

Rakoše,

Prislan

et al. 2024

Pharmaceutics

View full text Add to dashboard Cite

show abstract

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Drug dissolution and transit in a heterogenous gastric chyme after fed administration: Semi-mechanistic modeling and simulations for an immediate-release and orodispersible tablets containing a poorly soluble drug

Cited by 1 publication

References 43 publications

Application of a Novel Dissolution Medium with Lipids for In Vitro Simulation of the Postprandial Gastric Content

Application of a Novel Dissolution Medium with Lipids for In Vitro Simulation of the Postprandial Gastric Content

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