On the Design of Food Effect Studies in Adults for Extrapolating Oral Drug Absorption Data to Infants:an Exploratory Study Highlighting the Importance of Infant Food
Autor: | Maria Vertzoni, Nikoletta Fotaki, Mira Symillides, Christos Reppas, Marina Statelova, Konstantinos Goumas, René Holm |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
Adult
Male paracetamol Cmax Physiology Pharmaceutical Science Ibuprofen 030226 pharmacology & pharmacy Dosage form Food-Drug Interactions Young Adult 03 medical and health sciences 0302 clinical medicine food effect Humans Medicine Acetaminophen ibuprofen FOOD EFFECT Meal business.industry infants digestive oral and skin physiology Infant infant formula Analgesics Non-Narcotic Middle Aged Healthy Volunteers Infant Formula 3. Good health Gastric Emptying Infant formula 030220 oncology & carcinogenesis business Pharmacokinetic interaction Oral retinoid medicine.drug |
Zdroj: | Statelova, M, Goumas, K, Fotaki, N, Holm, R, Symillides, M, Reppas, C & Vertzoni, M 2020, ' On the Design of Food Effect Studies in Adults for Extrapolating Oral Drug Absorption Data to Infants : an Exploratory Study Highlighting the Importance of Infant Food ', AAPS Journal, vol. 22, no. 1, 6 . https://doi.org/10.1208/s12248-019-0380-4 The AAPS Journal |
Popis: | In the present investigation, it was explored whether food effect on drug absorption in adults is similar with the food effect after administration of an infant meal with the drug product to adults. After confirming lack of pharmaceutical and pharmacokinetic interaction, a paracetamol suspension and an ibuprofen suspension were co-administered to eight healthy adults on a crossover basis in three different occasions, i.e. in the fasted state (as defined by regulatory agencies, fasted conditions), in the fed state (as defined by regulatory agencies, fed conditions) and under conditions simulating the fed state in infants (infant fed conditions). Unlike under fed conditions, under infant fed conditions early exposure was significantly lower than under fasted conditions for both paracetamol and ibuprofen. Also, for ibuprofen, Cmax values under infant fed conditions were significantly higher than under fed conditions. These data suggest that, even for drugs with non-problematic absorption administered in simple dosage forms, food effects in infants may not be adequately evaluated if the protocol suggested by regulatory agencies is applied. The usefulness of the methodology employed in the present investigation for simulating the fed state in infants deserves further evaluation. Until then, food effects in infants should be considered cautiously or be evaluated in infants. |
Databáze: | OpenAIRE |
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