COMPATIBILITY STUDIES BETWEEN DRUGS
AND EXCIPIENTS IN THE PREFORMULATION
PHASE OF BUCCAL MUCOADHESIVE SYSTEMS
ELENA DINTE1, EDE BODOKI2*, SORIN LEUCUTA1, CRISTINA
ADELA IUGA3
1Pharmaceutical Technology and Biopharmaceutics Department, “Iuliu
Hatieganu” University of Medicine and Pharmacy, Faculty of
Pharmacy,V. Babeş Street, 41, 400012, Cluj-Napoca,
Romania2Analytical Chemistry Department, “Iuliu Hatieganu”
University of Medicine and Pharmacy, Faculty of Pharmacy, 4 Louis
Pasteur Street, 400349, Cluj-Napoca, Romania3Drug Analysis
Department, “Iuliu Hatieganu” University of Medicine and Pharmacy,
Faculty of Pharmacy,6 Louis Pasteur Street, 400349, Cluj-Napoca,
Romania*corresponding author: bodokie@umfcluj.ro
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Abstract:

The main aim in the development of a pharmaceutical system is the achievement of an adequate preparation. The potential physical and chemical interactions between drugs and excipients can affect the chemical nature, the stability and bioavailability of the drugs and, consequently, their therapeutic efficacy and safety.
We present the thermal and spectroscopic study of drug/polymer physical
mixtures containing ibuprofen (IB), clindamycin hydrochloride (CD), metronidazole (MZ), as the active pharmaceutical ingredient (API) and hydroxypropyl methylcellulose (HPMC K100M), Poloxamer 407, polyethylene oxide (PEO 1105) and polycarbophil (Noveon AA1) as excipients, defined as prototype formula. Differential scanning colorimetry (DSC) analysis revealed the deplacement of the characteristic peaks for the prototype formulas of excipients in the case of IB and CD. A Fourier transform infrared spectroscopy (FT-IR) technique was used to confirm and to investigate the type of the possible interactions between the components. In both cases, the spectroscopic data revealed that weak
intermolecular hydrogen-bond type interaction is incriminated, involving the carbonyl moiety of IB and in a lower extent the hydroxyl group of CD. The analysed excipients did not show any effect on the MZ.

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