FORMULATION DEVELOPMENT AND EVALUATION OF LORATADINE FAST DISSOLVING TABLETS BY USING DIFFERENT SUPER DISINTEGRATES

Mangesh G. Bhise*, Ashok A. Chopane, Pranali P. Holey, Manisha B. Khandagale, Mahesh P. Gaikwad, Jayram B. Shinde, Keshav R. Sakat and Abhishek P. Yadav

ABSTRACT

This study aimed to develop and evaluate fast dissolving tablets (FDTs) of loratadine to provide rapid onset of action and enhance patient compliance. Loratadine, an antihistamine used for quick relief from allergic reactions such as urticaria and angioedema, was formulated into FDTs using the direct compression method. Three superdisintegrants-croscarmellose sodium, sodium starch glycolate, and crospovidone-were incorporated in varying ratios (5:2, 5:3, and 5:4) to assess their impact on tablet disintegration and drug release profiles. Microcrystalline cellulose and mannitol served as diluents, while a combination of Aerosil and magnesium stearate (2:1) functioned as glidant and lubricant, respectively. The formulations underwent comprehensive evaluation, including assessments of appearance, weight variation, thickness uniformity, hardness, friability, content uniformity, disintegration time, wetting time, water absorption ratio, and in vitro dissolution studies. Among the nine formulations, the one containing crospovidone in a 5:4 ratio (F9) exhibited the most promising results, with a disintegration time of 12 ± 1.67 seconds and a cumulative drug release of 99.10% within 12 minutes. This optimized formulation remained stable under accelerated stability conditions (40°C ± 2°C temperature and 75% ± 5% relative humidity) for three months. The study concludes that loratadine FDTs, particularly the F9 formulation, offer rapid onset of action, quick relief, pleasant taste, and improved patient compliance, making them a viable alternative to conventional oral dosage forms.

Keywords: Loratadine, fast dissolving tablets, superdisintegrants, direct compression, crospovidone, rapid onset, patient compliance.