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COMPATIBILITY STUDIES BETWEEN DRUGS AND EXCIPIENTS IN THE PREFORMULATION PHASE OF BUCCAL MUCOADHESIVE SYSTEMS

ELENA DINTE¹, EDE BODOKI^2*, SORIN LEUCUTA¹, CRISTINA ADELA IUGA³

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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.