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

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...

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Main Authors: Bhawana Dhakal, Jaybir Kumar Thakur, Reema Kumari Mahato, Ishwori Rawat, D. C. Rabin, Rahul Rana Chhetri, Kedar Prasad Shah, Atul Adhikari, Jitendra Pandey
Format: Article
Language:English
Published: Wiley 2022-01-01
Series:The Scientific World Journal
Online Access:http://dx.doi.org/10.1155/2022/9618344
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author Bhawana Dhakal
Jaybir Kumar Thakur
Reema Kumari Mahato
Ishwori Rawat
D. C. Rabin
Rahul Rana Chhetri
Kedar Prasad Shah
Atul Adhikari
Jitendra Pandey
author_facet Bhawana Dhakal
Jaybir Kumar Thakur
Reema Kumari Mahato
Ishwori Rawat
D. C. Rabin
Rahul Rana Chhetri
Kedar Prasad Shah
Atul Adhikari
Jitendra Pandey
author_sort Bhawana Dhakal
collection DOAJ
description 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 (8th 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/cm2), 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.
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publisher Wiley
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spelling doaj-art-e0627e4db12e44079121aa0389c3e77e2025-02-03T06:05:24ZengWileyThe Scientific World Journal1537-744X2022-01-01202210.1155/2022/9618344Formulation of Ebastine Fast-Disintegrating Tablet Using Coprocessed Superdisintegrants and Evaluation of Quality Control ParametersBhawana Dhakal0Jaybir Kumar Thakur1Reema Kumari Mahato2Ishwori Rawat3D. C. Rabin4Rahul Rana Chhetri5Kedar Prasad Shah6Atul Adhikari7Jitendra Pandey8Department of PharmacyDepartment of PharmacyDepartment of PharmacyDepartment of Quality ControlDepartment of Research and DevelopmentDepartment of Research and DevelopmentDepartment of PharmacyDepartment of PharmacyDepartment of PharmacyEbastine 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 (8th 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/cm2), 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.http://dx.doi.org/10.1155/2022/9618344
spellingShingle Bhawana Dhakal
Jaybir Kumar Thakur
Reema Kumari Mahato
Ishwori Rawat
D. C. Rabin
Rahul Rana Chhetri
Kedar Prasad Shah
Atul Adhikari
Jitendra Pandey
Formulation of Ebastine Fast-Disintegrating Tablet Using Coprocessed Superdisintegrants and Evaluation of Quality Control Parameters
The Scientific World Journal
title Formulation of Ebastine Fast-Disintegrating Tablet Using Coprocessed Superdisintegrants and Evaluation of Quality Control Parameters
title_full Formulation of Ebastine Fast-Disintegrating Tablet Using Coprocessed Superdisintegrants and Evaluation of Quality Control Parameters
title_fullStr Formulation of Ebastine Fast-Disintegrating Tablet Using Coprocessed Superdisintegrants and Evaluation of Quality Control Parameters
title_full_unstemmed Formulation of Ebastine Fast-Disintegrating Tablet Using Coprocessed Superdisintegrants and Evaluation of Quality Control Parameters
title_short Formulation of Ebastine Fast-Disintegrating Tablet Using Coprocessed Superdisintegrants and Evaluation of Quality Control Parameters
title_sort formulation of ebastine fast disintegrating tablet using coprocessed superdisintegrants and evaluation of quality control parameters
url http://dx.doi.org/10.1155/2022/9618344
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