COMPATIBILITY OF ITOPRIDE HCL WITH CERTAIN FORMULATION EXCIPIENTS

Itopride HCl (ITO) is a novel prokinetic agent, currently used for the treatment of various gastrointestinal motility disorders. As a step
forward towards the formulation of that drug, the purpose of the present article was to study the compatibility of ITO with some
pharmaceutical excipients that might be utilized during its formulation in specific dosage form. Keeping in mind that a pharmaceutical
formulation is considered appropriate when no interactions, drug-excipient or excipient-excipient, occur. Compatibility screening of
drugs with excipients is recognized as one of the mandatory factors and is at the forefront of drug product science and technology
research. For that purpose thermoanalytical technique (differential scanning calorimetry, DSC) and Fourier transform infrared
spectroscopy (FTIR) were used. The results obtained upon utilizing both techniques, thermal analysis (DSC), and FTIR were found to
be very useful in making decision about selecting the best excipient that is expected not to cause any problem when formulated with
the candidate drug, ITO. Of the excipients tested: hydroxypropyl methylcellulose, ethylcellulose, Eudragit RSpm, Carbopol 934p,
microcrystalline cellulose, citric acid, sodium bicarbonate, magnesium stearate, sodium carboxy methylcellulose and their
corresponding physical mixtures with the drug (1:1 w/w). The drug was found compatible with all excipients investigated.