"Pharmacological Study of a New Pharmaceutical Form of a Fixed Combination of Ibuprofen and Omeprazole"

Abstract

Based on literature research, we can comment that there are reasons for bioequivalence studies (in vitro and in vivo) but also clinical studies that would concern a pharmaceutical form of a stable combination of ibuprofen and omeprazole. The already existing pharmaceutical form of a fixed combination of naproxen-isomeprazole concerns a wide audience and paves the way for many corresponding pharmaceutical forms.

Of course, it would be useful to refer to the Biopharmaceutical classification system (BCS), an important pharmaceutical tool based on the correlation of the solubility of a drug with its bioavailability in the human body, allowing the assessment of the role of 3 main factors: dissolution, solubility and intestinal permeability. Based on BCS, drugs are divided into 4 categories according to their solubility and permeability, as shown in the table below.

Ibuprofen and omeprazole both belong to class (II), that is, they show low solubility and increased permeability. The development of an FDC product can have good prospects especially when the two drugs of the possible fixed combination belong to different BCS classes, i.e. when the limiting factors for their absorption are different. This data must be further examined with clinical studies in order to draw a safe conclusion on how the solubilities and permeabilities of the two drugs under study are related.

The above is just one of the factors that could be a brake on the development of the preparation to be studied. As with all pharmaceutical preparations, extensive studies must be done and a lot of time and scientific work must be invested before the preparation can finally get all the necessary approvals and certifications to be produced and marketed.

MAKRI Xristina