Author(s): Rajeev Soni1 and Gali Vidya Sagar2
Loratadine, a piperidine derivative related to azatadine, is a long-acting, non-sedating antihistamine which is widely used for the symptomatic relief of allergic conditions such as runny nose, itchy or watery eyes, sneezing, and nasal or throat itching and chronic urticaria. In such severe allergic cases, quick onset of action is of prime importance. In the present study the direct compression method was adopted to manufacture the quickdissolving tablets, since it is very simple and do not require any sophisticated equipments. This technique has been applied to prepare stable formulation because of the availability of improved patient and eco-friendly excipients Pharmaburst 500®and Flowlac 100®processed in combination by diligently avoiding the usage of deliquescent components reportedly claimed for reference listed drug product Claritin Reditab®. No typical interaction between drug and major (critical and non-critical) excipients wereconfirmed by DSC, XRD and FTIR during preformulation studies. The blend was examined for pre-compression parameters such as Angle of Repose, Loose Bulk Density, Tapped Density, Bulkiness, Carr’s Index and Hauner’s Ratio. The prepared tablets, designed as per 32factorial design layout, were evaluated for almost all significant post-compression test parameters. Uniformity of dosage unit by content uniformity, evaluated by HPLC method, confirmed no evidence of drug content variability. Stability study was conducted at accelerated storage condition and prepared quick dissolving tablets were found to be suitable with respect to morphological characteristics and with in-vitro drug release mechanism & similarity factor (F2) comparison unaffected after 90 days. The present research work could therefore provide the opportunity and form the basis as suitable platform technology to further pursue & own the research in section 505 B (2).