Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

An Emulsified Liquid Paraffin Formulation for Functional Constipation: Pharmacokinetics of Vitamins K1, D3, A, and E in a Rat Model

Version 1 : Received: 29 September 2023 / Approved: 29 September 2023 / Online: 29 September 2023 (09:52:43 CEST)

How to cite: Perez Agudo, F.; Mannila, J.; Rinne, V.; Kallio, E.; Moilanen, V. An Emulsified Liquid Paraffin Formulation for Functional Constipation: Pharmacokinetics of Vitamins K1, D3, A, and E in a Rat Model. Preprints 2023, 2023092096. https://doi.org/10.20944/preprints202309.2096.v1 Perez Agudo, F.; Mannila, J.; Rinne, V.; Kallio, E.; Moilanen, V. An Emulsified Liquid Paraffin Formulation for Functional Constipation: Pharmacokinetics of Vitamins K1, D3, A, and E in a Rat Model. Preprints 2023, 2023092096. https://doi.org/10.20944/preprints202309.2096.v1

Abstract

The pharmacokinetic profile of fat-soluble vitamins A, E, K1, and D3 co-administered with liquid paraffin or water in an experimental rat model was investigated. Animals received a solution of the four vitamins orally through a probe, followed 10 minutes later by the administration of either the liquid paraffin product dissolved in water (Emuliquen Simple®) or water (control). Vitamin formulations were 20, 50, 0.30 and 0.10 mg/kg for vitamins A, E, K1, and D3, respectively. Blood samples were collected before dosing and at 0.17, 1, 2, 4, 8, and 24 hours post-dosing. Vitamin concentrations were quantified by liquid chromatography coupled with mass spectrometry. No relevant differences in the absorption of vitamins in terms of AUC0-last (area under the curve up to the last measurable concentration) or Cmax in the absence or presence of co-administration of the liquid paraffin product were observed. The difference of these parameters between the treatment groups for all vitamins was in the range of bioequivalence (≤ 20%). The liquid paraffin-based laxative product did not interfere with the absorption of vitamins A, E, K1, and D3 that are ingested in the diet, which is clinically relevant due to the high prevalence of functional constipation in children and adults.

Keywords

constipation; laxatives; liquid paraffin; fat-soluble vitamins; vitamin A; vitamin E; vitamin D3; vitamin K1; pharmacokinetics; experimental model.

Subject

Medicine and Pharmacology, Gastroenterology and Hepatology

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