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28407

FORMULATION, IN-VITRO AND EX-VIVO CHARACTERIZATION OF ROPINIROLE HYDROCHLORIDE BUCCAL MUCOADHESIVE FILMS

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Last updated: 22 Jan 2023

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Abstract

 Ropinirole Hydrochloride (RHCl) is one of the most important highly selective Dopamine agonist drugs for the treatment of Parkinson's disease (PD). The aim of the present study is to develop buccoadhesive films of RHCl to overcome the first pass hepatic metabolism of the drug which is the cause for its low bioavailability (50-55%) and to achieve the greater therapeutic efficacy. Buccal films of RHCl were prepared by the solvent casting method using the hydrophilic mucoadhesive polymer chitosan as the base matrix at different concentrations (1& 1.5 %w/v). Polyvinyl pyrrolidone (PVP) K25 & K30 at different concentrations ( 0.035& 0.07gm) were incorporated into the films to modify RHCl release rate from formulation. Compatibility studies of drug and polymers were performed by DSC and FTIR spectroscopy. In-vitro and ex-vivo characterization was done as well as stability study. A 24 full factorial design was employed to study the effect of independent variables on ex-vivo mucoadhesive strength, ex-vivo residence time and in-vitro drug release. Results showed the absence of incompatability between the drug and chosen polymers. Prepared Mucoadhesive films were clear, flexible, with good folding endurance, uniform in weight, thickness, drug content and stable either in human saliva for 6 hours or at ambient temperature for 1 year. Formula F4 (1 % w/v chitosan, PVP K25, PEG 400) was the optimal bucoadhesive film having the highest percentage drug release (95.25% ) with high stability.    

DOI

10.21608/ajps.2017.28407

Authors

First Name

Rehab

Last Name

Elhadidy

MiddleName

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Affiliation

National Organization for Drug Control and Research, Cairo, Egypt

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Volume

55

Article Issue

1

Related Issue

5065

Issue Date

2017-03-01

Receive Date

2019-03-06

Publish Date

2017-03-01

Page Start

65

Page End

87

Print ISSN

1110-1644

Online ISSN

2535-1958

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https://ajps.journals.ekb.eg/article_28407.html

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https://ajps.journals.ekb.eg/service?article_code=28407

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5

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Original Article

Type Code

518

Publication Type

Journal

Publication Title

Al-Azhar Journal of Pharmaceutical Sciences

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https://ajps.journals.ekb.eg/

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Article

Created At

22 Jan 2023