Preformulation Study of Domperidone: An Insight for Formulation and Development of Nasal Formulation

Abstract

Preformulation is a group of studies that focus on the physicochemical properties of a new drug candidate that could affect the drug performance and the development of a dosage form. This could provide important information for formulation design or support the need for molecular modification. So, in the present study preformulation studies were performed on Domperidone (DM) to assess its suitability for nasal formulation. Domperidone is a peripherally acting dopamine D2 receptor antagonist which has high first pass metabolism after oral administration. The authenticity of DM was established by DSC and FITR spectra. An UV spectrophotometric method and LC-MS method were employed for determination of DM in bulk and blood plasma respectively. Saturation solubility, micromeritical properties, melting point, pH, hygroscopicity, and stability profile were studied. The UV method was linear in the range of 5-50 μg/ml. The low % CV values of intra-day and inter-day variations revealed that the proposed method is robust. The retention time of DM in LC-MS method was found to be 2.6 min. The method was proven robust by obtaining very high regression coefficient value (0.999). The results of the physicochemical study of drug revealed suitability of DM for nasal route. Moreover, the drug was found stable in different conditions.