Formulation of Ebastine Fast-Disintegrating Tablet Using Coprocessed Superdisintegrants and Evaluation of Quality Control Parameters.

Autor: Dhakal B; Department of Pharmacy, Kantipur Academy of Health Sciences, Kathmandu 44600, Nepal., Thakur JK; Department of Pharmacy, Kantipur Academy of Health Sciences, Kathmandu 44600, Nepal., Mahato RK; Department of Pharmacy, Kantipur Academy of Health Sciences, Kathmandu 44600, Nepal., Rawat I; Department of Quality Control, Times Pharmaceuticals Private Limited, Chitwan 44200, Nepal., Rabin DC; Department of Research and Development, Asian Pharmaceuticals Private Limited, Rupandehi 32900, Nepal., Chhetri RR; Department of Research and Development, Deurali Janata Pharmaceutical Private Limited, Kathmandu 44600, Nepal., Shah KP; Department of Pharmacy, Kantipur Academy of Health Sciences, Kathmandu 44600, Nepal., Adhikari A; Department of Pharmacy, Kantipur Academy of Health Sciences, Kathmandu 44600, Nepal., Pandey J; Department of Pharmacy, Crimson College of Technology, Affiliated with Pokhara University, Devinagar-11, Butwal 32900, Nepal.
Jazyk: angličtina
Zdroj: TheScientificWorldJournal [ScientificWorldJournal] 2022 May 19; Vol. 2022, pp. 9618344. Date of Electronic Publication: 2022 May 19 (Print Publication: 2022).
DOI: 10.1155/2022/9618344
Abstrakt: Ebastine is a long-acting, nonsedating, second-generation antihistaminic drug that prevents histamine action, mainly in immediate hypersensitivity. This project was aimed to formulate and characterize orodispersible tablets of ebastine, utilizing different proportions of three disintegrants, namely crospovidone, sodium starch glycolate, and coprocessed superdisintegrant. Initially, fifteen trial batches of ebastine orodispersible tablets were outlined using the central composite design of Minitab software. The tablets were formulated by the direct compression method. The compressed tablets were then evaluated for precompression and postcompression physicochemical parameters, such as angle of repose, Carr's index, Hausner's ratio, hardness, thickness, weight variation, drug content, friability, wetting time, disintegration time, dispersion time, and water absorption ratio. The in vitro dissolution test was conducted according to Indian Pharmacopeia 2018, with the help of the rotating paddle method using 0.5% w/v sodium lauryl sulfate buffer in 0.1 N HCl. For the optimized batch (8 th batch), all the physicochemical parameters like angle of repose (33.77°), Carr's index (19.34%), Hausner's ratio (1.24), weight variation (202.5 mg), hardness (4.3 kg/cm 2 ), friability (0.44%), thickness (3.16 mm), dissolution (95.78%), and drug content (101.67%) were within the acceptable limit as per Indian Pharmacopeia 2018. The wetting time, disintegration time, dispersion time, and water absorption ratio were reported to be 25.1 seconds, 16.0 seconds, 38.6 seconds, and 91.92%, respectively. Hence, the results suggested that orodispersible tablets of ebastine can be formulated. Furthermore, the mixing of crospovidone, sodium starch glycolate, and coprocessed super disintegrants can result in excellent desirable properties in the orodispersible tablet.
Competing Interests: The authors declare no conflicts of interest.
(Copyright © 2022 Bhawana Dhakal et al.)
Databáze: MEDLINE
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