Prediction of in vivo performance of oral extended release formulations prior to clinical evaluation: A case study for enteric coated polymeric beads formulation.
Eur J Pharm Biopharm
; 158: 222-232, 2021 Jan.
Article
en En
| MEDLINE
| ID: mdl-33279603
ABSTRACT
To reduce cost and time for product development, an ideal strategy for the development of oral extended release (ER) product is to identify the desired formulation with minimum needsfor clinical evaluation. The aim of this work was to demonstrate the feasibility of adopting a "prediction-then-validation" strategy for the development of oral ER formulations. Instead of the traditional approach using multiple ER formulations for IVIVC development, an enteric-coated fast release formulation was successfully utilized for the development of a biopredictive tool to estimate the drug release from enteric coated polymeric ER formulations in the intestine. A TS1 (time scale factor between Tvitro and Tvivo equals to 1) system was designed and developed, based on which the in vivo pharmacokinetic (PK) performance of ER formulations in dog and in human were well predicted prior to in vivo evaluations. The model further passed a posteriori validation using the criteria for level A IVIVC and, as designed, provided a Tscale value of 1 for the IVIVC model.
Palabras clave
Texto completo:
1
Ejes tematicos:
Pesquisa_clinica
Banco de datos:
MEDLINE
Asunto principal:
Portadores de Fármacos
/
Preparaciones de Acción Retardada
/
Modelos Biológicos
Tipo de estudio:
Clinical_trials
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Prognostic_studies
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Risk_factors_studies
Límite:
Adult
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Animals
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Año:
2021
Tipo del documento:
Article