Original Paper Statistical assessment of in vitro drug release kinetics and quality evaluation of desloratadine orally disintegrating generic tablets available in Bangladesh Madhabi Lata Shuma 1 and Shimul Halder 2 Abstract The objective of the present study was to compare the in vitro equivalence of different orally disintegrating tablets (ODT) of Desloratadine (DES) available in Bangladesh pharmaceutical market with the reference brand. The in vitro dissolution study was carried out using the United States Pharmacopoeia (USP) paddle method and a comparative study were also carried out with the reference brand. Other pharmacopoeial and non-pharmacopoeial quality assessment parameters including hardness, friability, water absorption ratio, and disintegration time etc. were also evaluated. From the results of the dissolution profile of the commer- cially available products, it found majority of the products didn’t exhibited compendial requirements in dissolution behavior to the reference brand with model-independent approach (f 2 > 50, f 1 < 15) and showed statistically significant differences. Additionally, the data of different physical quality parameters revealed that all commercial products complied with the official specifications. From these findings, it could be suggested that the DES-ODT formulations’ available in the Bangladesh market could be prescribed; however additional experiments might require to clarify the interchangeability among the products. Keywords Desloratadine, dissolution, orally disintegrating tablet, similarity factor, difference factor Introduction As Bangladesh is one of the densely populated coun- try, 2030% of the total population is suffering from different types of allergic disorders. 1 The main reasons that trigger the allergic conditions are mainly outdoor, indoor, occupational and food allergens. 2 Antihistamines are the choice of medications to reduce the symptoms and betterment of pathological conditions’ in case of allergic conditions. 3 Among different types of antihistamines, H 1 receptor antagonists remain arguably the highest consumable antihistamine since long ago. 4 However, severe adverse effects such as sedation and impairment of cognitive and psychomotor functions were reported for first-generation antihistamines in the years after their clinical introduction in the 1940s. 2 To overcome these problems, the second generation antihistamines including cetirizine, desloratadine, fexofenadine, levo- cetirizine and loratadine has been introduced and these drugs penetrate the blood-brain barrier to a significantly smaller extent compared with first gen- eration antihistamines. 5,6 Among these second gener- ation antihistamines, desloratadine (DES) (Figure 1); is a selective, non-sedating, antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. 7 DES works by blocking the expression of cell adhesion molecules, inhibits the generation and release of 1 Department of Pharmacy, Stamford University Bangladesh, Dhaka, Bangladesh 2 Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Dhaka, Dhaka, Bangladesh Corresponding author: Shimul Halder, Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Dhaka, Dhaka 1000, Bangladesh. Email: shimulpht@du.ac.bd Journal of Generic Medicines 0(0) 1–7 ! The Author(s) 2020 Article reuse guidelines: sagepub.com/journals-permissions DOI: 10.1177/1741134320947750 journals.sagepub.com/home/jgm