Experimental Design Approach for the Formulation of Controlled Release Buccal Bilayer Tablets of Carvedilol

Introduction: The absolute bioavailability of carvedilol is ~25% - 35% even though it rapidly and extensively absorbed following oral administration due to a significant degree of presystemic metabolism. The purpose of this study was to develop controlled release mucoadhesive buccal bilayer tablet o...

Full description

Saved in:
Bibliographic Details
Main Authors: Vinodkumar D. Ramani, Girish U. Sailor, Maulik M. Patel, Ghanshyam R. Parmar, Avinash K. Seth
Format: Article
Language:English
Published: Wolters Kluwer – Medknow Publications 2018-07-01
Series:Journal of Integrated Health Sciences
Subjects:
Online Access:https://journals.lww.com/10.4103/JIHS.JIHS_19_18
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1850150203860975616
author Vinodkumar D. Ramani
Girish U. Sailor
Maulik M. Patel
Ghanshyam R. Parmar
Avinash K. Seth
author_facet Vinodkumar D. Ramani
Girish U. Sailor
Maulik M. Patel
Ghanshyam R. Parmar
Avinash K. Seth
author_sort Vinodkumar D. Ramani
collection DOAJ
description Introduction: The absolute bioavailability of carvedilol is ~25% - 35% even though it rapidly and extensively absorbed following oral administration due to a significant degree of presystemic metabolism. The purpose of this study was to develop controlled release mucoadhesive buccal bilayer tablet of carvedilol using HPMC K4M and carbomer 934 as the mucoadhesive polymer. Method: The formulation optimization was performed using 32 full factorial design to study the effect of independent variables viz. HPMC K4M (X1), carbomer 934 (X2) levels on % drug release in 8 h (Y1), mucoadhesive time (Y2) in buccal cavity and mucoadhesive strength (Y3). The tablets were evaluated for its appearance, thickness, diameter, weight uniformity, content uniformity, surface pH, swelling index and in vitro drug permeation. Results: The optimized formulation evaluated for responses which showed an in vitro drug release of 81.3% in 8 h, mucoadhesive strength 11.2 g with mucoadhesive time of 471.32 min and demonstrated case-II transport mechanism. The results of response variables were found to be very close with the predicted values. These results support the fact that 32 full factorial designs with desirability function could be effectively used in optimization of controlled release mucoadhesive buccal bilayer tablets. Conclusion: It can be concluded that buccal route can be one of the alternatives available to bypass the extensive hepatic first-pass metabolism and to improve the bioavailability of carvedilol.
format Article
id doaj-art-40de110bd13e4838949dc2896cd8948b
institution OA Journals
issn 2347-6486
2347-6494
language English
publishDate 2018-07-01
publisher Wolters Kluwer – Medknow Publications
record_format Article
series Journal of Integrated Health Sciences
spelling doaj-art-40de110bd13e4838949dc2896cd8948b2025-08-20T02:26:37ZengWolters Kluwer – Medknow PublicationsJournal of Integrated Health Sciences2347-64862347-64942018-07-0162535910.4103/JIHS.JIHS_19_18Experimental Design Approach for the Formulation of Controlled Release Buccal Bilayer Tablets of CarvedilolVinodkumar D. RamaniGirish U. SailorMaulik M. PatelGhanshyam R. ParmarAvinash K. SethIntroduction: The absolute bioavailability of carvedilol is ~25% - 35% even though it rapidly and extensively absorbed following oral administration due to a significant degree of presystemic metabolism. The purpose of this study was to develop controlled release mucoadhesive buccal bilayer tablet of carvedilol using HPMC K4M and carbomer 934 as the mucoadhesive polymer. Method: The formulation optimization was performed using 32 full factorial design to study the effect of independent variables viz. HPMC K4M (X1), carbomer 934 (X2) levels on % drug release in 8 h (Y1), mucoadhesive time (Y2) in buccal cavity and mucoadhesive strength (Y3). The tablets were evaluated for its appearance, thickness, diameter, weight uniformity, content uniformity, surface pH, swelling index and in vitro drug permeation. Results: The optimized formulation evaluated for responses which showed an in vitro drug release of 81.3% in 8 h, mucoadhesive strength 11.2 g with mucoadhesive time of 471.32 min and demonstrated case-II transport mechanism. The results of response variables were found to be very close with the predicted values. These results support the fact that 32 full factorial designs with desirability function could be effectively used in optimization of controlled release mucoadhesive buccal bilayer tablets. Conclusion: It can be concluded that buccal route can be one of the alternatives available to bypass the extensive hepatic first-pass metabolism and to improve the bioavailability of carvedilol.https://journals.lww.com/10.4103/JIHS.JIHS_19_18buccal bilayer tabletscarvediloldesirabilityfactorial designmucoadhesivebuccal bilayer tabletscarvediloldesirabilityfactorial designmucoadhesive
spellingShingle Vinodkumar D. Ramani
Girish U. Sailor
Maulik M. Patel
Ghanshyam R. Parmar
Avinash K. Seth
Experimental Design Approach for the Formulation of Controlled Release Buccal Bilayer Tablets of Carvedilol
Journal of Integrated Health Sciences
buccal bilayer tablets
carvedilol
desirability
factorial design
mucoadhesivebuccal bilayer tablets
carvedilol
desirability
factorial design
mucoadhesive
title Experimental Design Approach for the Formulation of Controlled Release Buccal Bilayer Tablets of Carvedilol
title_full Experimental Design Approach for the Formulation of Controlled Release Buccal Bilayer Tablets of Carvedilol
title_fullStr Experimental Design Approach for the Formulation of Controlled Release Buccal Bilayer Tablets of Carvedilol
title_full_unstemmed Experimental Design Approach for the Formulation of Controlled Release Buccal Bilayer Tablets of Carvedilol
title_short Experimental Design Approach for the Formulation of Controlled Release Buccal Bilayer Tablets of Carvedilol
title_sort experimental design approach for the formulation of controlled release buccal bilayer tablets of carvedilol
topic buccal bilayer tablets
carvedilol
desirability
factorial design
mucoadhesivebuccal bilayer tablets
carvedilol
desirability
factorial design
mucoadhesive
url https://journals.lww.com/10.4103/JIHS.JIHS_19_18
work_keys_str_mv AT vinodkumardramani experimentaldesignapproachfortheformulationofcontrolledreleasebuccalbilayertabletsofcarvedilol
AT girishusailor experimentaldesignapproachfortheformulationofcontrolledreleasebuccalbilayertabletsofcarvedilol
AT maulikmpatel experimentaldesignapproachfortheformulationofcontrolledreleasebuccalbilayertabletsofcarvedilol
AT ghanshyamrparmar experimentaldesignapproachfortheformulationofcontrolledreleasebuccalbilayertabletsofcarvedilol
AT avinashkseth experimentaldesignapproachfortheformulationofcontrolledreleasebuccalbilayertabletsofcarvedilol