A Critical Assessment of Extemporaneous Formulations for Proton Pump Inhibitors: The Importance of Proper Vehicle Selection

J Pediatr Pharmacol Ther. 2022;27(7):618-624. doi: 10.5863/1551-6776-27.7.618. Epub 2022 Sep 26.

Abstract

Objective: To examine the influence of vehicles on the stability of extemporaneous suspensions of proton pump inhibitors (PPIs), to single out the formulation most suitable for children, providing appropriate evidence and arguments.

Methods: A review was performed of data identified from Medline, Embase, Science Direct, as well as public digital archive PubMed, including reference texts, related to the field of stability testing of extemporaneous PPI suspensions.

Results: Fourteen selected formulations of extemporaneous suspensions are presented and discussed. Depending on the vehicle and its composition, which was analyzed and explained in detail, the suspensions had various beyond-use dates (BUDs).

Conclusions: Selected vehicles and the process of preparation had great influence on the stability of extemporaneous PPI suspensions. The suspension with the longest BUD has been singled out, which is especially suitable for use in newborns. Because an explanation is provided for the influence of individual vehicle components on the stability of the mentioned suspensions, this can aid not only in the selection of an adequate formulation, but also in the development of new ones, which will be suited to individual patients.

Keywords: extemporaneous suspensions; proton pump inhibitors; stability; vehicle.

Grants and funding

Disclosures. The authors declare no financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honoraria.