Evaluating the IVIVC by Combining Tiny-tim Outputs and Compartmental PK Model to Predict Oral Exposure for Different Formulations of Ibuprofen.
J Pharm Sci
; 111(7): 2018-2029, 2022 07.
Article
em En
| MEDLINE
| ID: mdl-35120962
ABSTRACT
Nowadays, the ever-increasing costs of research and development in the pharmaceutical industry have created a big demand for predicting the performances of drug candidates. Of those, the desire to establish an in vitro-in vivo correlation (IVIVC) to better predict the oral drug exposure for different drug products is a growing need. Once a robust IVIVC is established, the performance of different drug products can be predicted and selected for testing in clinical trials with greater confidence. This tool will significantly reduce the cost and speed of drug development and provide new therapy to the patient faster. In this study, we explore combining the outputs of Triskelion's Gastro-Intestinal Model (Tiny-TIM) and multi-compartment pharmacokinetic model for a 200 mg ibuprofen product. The Loo-Riegelman method was used to calculate the amount of ibuprofen absorbed and was combined with the Tiny-TIM data to establish the IVIVC. The IVIVC was used to predict the exposures of both fast release and liquid gel formulations in humans. In general, the predicted exposure using Tiny-TIM-based IVIVC has good agreement with the clinical findings.
Palavras-chave
Texto completo:
1
Temas:
ECOS
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Estado_mercado_regulacao
Bases de dados:
MEDLINE
Assunto principal:
Ibuprofeno
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Indústria Farmacêutica
Tipo de estudo:
Prognostic_studies
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Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
J Pharm Sci
Ano de publicação:
2022
Tipo de documento:
Article