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Intra- and inter-subject variability in gastric pH following a low-fat, low-calorie meal
Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Butler University, IN 46208, USA.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Gastroenterology/Hepatology.ORCID iD: 0000-0001-8428-0772
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Gastroenterology/Hepatology.ORCID iD: 0000-0002-6979-9194
2022 (English)In: International Journal of Pharmaceutics, ISSN 0378-5173, E-ISSN 1873-3476, Vol. 625, article id 122069Article in journal (Refereed) Published
Abstract [en]

Food can alter drug bioavailability through gastric pH changes. Time spent at gastric pH ranges is reported here, including variability data following ingestion of a light, mixed, 260 kcal meal. pH data was obtained for 20 healthy subjects undergoing SmartPill™ wireless motility capsule investigations on three separate visits. Gastric phase pH was sorted into pH < 2, 2-3, 3-4, 4-5 and > 5. All visits and all subjects were pooled to determine median time (25-75th percentiles) in minutes. Gastric emptying time was 176 (137-205) min with the majority of time, 111 (67 - 163), spent at pH < 2. Times spent at pH 2-3 and 3-4 were similar: 17 (5.7 - 35.6) and 18 (7.2-29.3). Time spent at pH 4-5 was 9 (1.3-20.6) and at pH > 5 was 0.7 (0-4.4). Intra-subject variability as determined by robust coefficient of variation (RCV)% was 30 % for pH < 2, 57 % for pH 2-3, 71 % for pH 3-4, 106 % for pH 4-5 and 144 % for pH > 5. Inter-subject variability RCV% was 49 % for pH < 2, 89 % for pH 2-3, 54 % for pH 3-4, 97 % for pH 4-5 and 148 % for pH > 5. Inter-subject variability can be up to approximately twofold higher than intra-subject variability at the lower pH ranges.

Place, publisher, year, edition, pages
Elsevier, 2022. Vol. 625, article id 122069
Keywords [en]
Basic drugs, Controlled release, Dissolution, Drug delivery, Enteric, Gastric emptying, Oral peptides
National Category
Pharmaceutical Sciences
Identifiers
URN: urn:nbn:se:uu:diva-481959DOI: 10.1016/j.ijpharm.2022.122069ISI: 000891282900003PubMedID: 35917873OAI: oai:DiVA.org:uu-481959DiVA, id: diva2:1688149
Funder
Erik, Karin och Gösta Selanders FoundationO.E. och Edla Johanssons vetenskapliga stiftelseSwedish Research Council, 2017-02243Available from: 2022-08-17 Created: 2022-08-17 Last updated: 2022-12-28Bibliographically approved

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Hellström, Per M.Webb, Dominic-Luc

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