Preclinical Pharmacokinetic Study on Caffeine as an Excipient for Monoclonal Antibody Formulations.

Autor: Zeng Y; Comera Life Sciences, Inc., 12 Gill Street Suite 4650, Woburn, MA 01801, USA. Electronic address: yzeng@comerals.com., Naik S; Comera Life Sciences, Inc., 12 Gill Street Suite 4650, Woburn, MA 01801, USA., Tran T; Comera Life Sciences, Inc., 12 Gill Street Suite 4650, Woburn, MA 01801, USA., Wuthrich P; Comera Life Sciences, Inc., 12 Gill Street Suite 4650, Woburn, MA 01801, USA., Muni N; Comera Life Sciences, Inc., 12 Gill Street Suite 4650, Woburn, MA 01801, USA., Mahoney RP; Comera Life Sciences, Inc., 12 Gill Street Suite 4650, Woburn, MA 01801, USA.
Jazyk: angličtina
Zdroj: Journal of pharmaceutical sciences [J Pharm Sci] 2023 Nov; Vol. 112 (11), pp. 2933-2937. Date of Electronic Publication: 2023 Jul 28.
DOI: 10.1016/j.xphs.2023.07.023
Abstrakt: Caffeine is a novel excipient that effectively reduces viscosity of high concentration mAb formulations intended for subcutaneous (SQ) delivery. Two preclinical studies were conducted in rats to evaluate pharmacokinetic (PK) parameters of caffeine as well as its effects on the PK profile of a model mAb, namely ipilimumab. Results show that SQ absorption and elimination of caffeine was rapid, with the average T max of 0.4 h and T 1/2 of 1.6 h, administered with or without ipilimumab. Furthermore, caffeine did not affect ipilimumab SQ PK profiles. Independent of caffeine concentration, ipilimumab serum T 1/2 was between 2 and 3 days, T max was between 3 and 4 days and SQ bioavailability was about 64%. In addition, SQ injection of caffeine at different dose levels showed no irritation at the injection site or adverse effects. Results from the current PK studies warrant further development of caffeine as a viscosity reducing excipient for mAb SQ formulations.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The study reported in this manuscript was funded by Comera Life Sciences. All the listed authors are current employees of Comera Life Sciences.
(Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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