FORMULATION DEVELOPMENT AND STABILITY STUDY OF FIXED DOSE COMBINATION (FDC) TABLET OF MONTELUKAST AND LORATADINE

Abstract

Fixed-dose combinations (FDC) are drug products that contain more than one active component in a single dosage form. The pharmaceutical industry has shown increased interest in developing FDC drug products to improve patient compliance and extend product life cycles. FDCs offer potential synergistic efficacy and reduced pill burden, with successful applications in areas like diabetes, HIV/AIDS and cardiovascular diseases. Montelukast and loratadine, two well-known drugs used to treat allergy disorders, are combined as a fixed dosage combination (FDC). To provide potential benefits in terms of effectiveness, patient adherence, and convenience, the FDC utilizes complementary modes of action. The main objective of the research study was to formulate a stable fixed dose combination tablet of Loratadine 10mg/ Montelukast 10mg. different formulations of montelukast and loratidine were prepared using wet granulation technique. The samples were tested for different quality control parameters at pre and post compression level. For confirmation of incompatibility, all the samples were evaluated for their FTIR and XRD spectra. The spectra of both FTIR and XRD revealed no extra peaks. Similarly all the pre compression parameters of all formulations like bulk density, tapped density, angle of repose, hausner ratio, carr’s index were within normal limits. The formulated tablets underwent comprehensive post-compression quality control evaluations, with resultant parameters conforming to the specified standards and limits outlined in the United States Pharmacopeia (USP) and British Pharmacopoeia (BP).