Fast Disintegrating Combination Tablet of Taste Masked Levocetrizine Dihydrochloride and Montelukast Sodium: Formulation Design, Development, and Characterization
The aim of this study was to prepare fast disintegrating combination tablet of taste masked Levocetrizine dihydrochloride and Montelukast sodium by using direct compression method. To prevent bitter taste and unacceptable odour of the Levocetrizine dihydrochloride drug, the drug was taste masked with ion exchange resins like Kyron-T-104 and Tulsion-412. Among the two resins, Kyron-T-104 was selected for further studies because of high drug loading capacity, low cost, and better drug release profile. An ion exchange resin complex was prepared by the batch technique and various parameters; namely, resin activation, drug: resin ratio, pH, temperature, and stirring time, and swelling time were optimized to successfully formulate the tasteless drug resin complex (DRC). The tablets were prepared using microcrystalline cellulose (MCC) PH 102 as diluent along with crospovidone (CP), croscarmellose sodium (CCM), and sodium starch glycolate (SSG) as a superdisintegrants. The tablets were evaluated for weight variation, hardness, friability, wetting time, water absorption ratio, disintegration time (DT), and dissolution study and it was concluded that the tablet formulation prepared with 2% SSG + CCS showed better disintegration time in comparison with other formulation and good drug release. The stability studies were carried out for the optimized batch for three months and it showed acceptable results. 1. Introduction Various physiological and neurological conditions like dysphagia, motion sickness, and hand tremors lead to noncompliance of conventional oral dosage forms. Mouth dissolving drug delivery systems (MDDDS), orally disintegrating system (ODT), and fast disintegrating tablet (FDT) are especially designed for dysphagic, geriatric, pediatric, bed-ridden, travelling, and psychotic patients who are unable to swallow or refuse to swallow conventional oral formulations. As they dissolve/disintegrate very fast when placed in the mouth, FDT are the most convenient dosage forms for dysphagic, pediatric, and geriatric patients with swallowing problem [1–3]. They do not require water for administration and thus are a good alternative for travelers and for bed ridden patients. They simply vanish when placed in the mouth and so cannot be hidden in mouth by psychotic patients. These products not only increase the patient’s compliance but also fetch large revenues to manufacturers due to line extension of the existing formulation [4–6]. FDT or MDDDS display a fast and spontaneous deaggregation in the mouth, soon after it comes in contact with saliva, dissolving the
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