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67982

EFFECT OF STORAGE ON THE IN-VITRO AND IN-VIVO CHARACTERISTICS OF SOME MARKETED SUSTAINED-RELEASE CARDIOVASCULAR TABLETS

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Last updated: 25 Dec 2024

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Abstract

The in-vitro and in-vivo characteristics of the sustained-release cardiovascular drugs: nifedipine (N) nad procainamide (PA), commercially available as Adalat-Retard and Procainamide durules tablets were evaluated both before and after their storage at ambient condition and under different accelerated conditions of temperature and relative humidity (RH) for twelve months. The effect of storage on the physical properties, the release rate profiles, the chemical stability and the bioavailability of these tablets in beagle dogs was studied. The results showed no or small change in the physical properties or in the drug contents of both drugs under the storage conditions of the study, indicating good physical and chemical stability of these products. In spite of statistically significant difference found in the dissolution results between the prestorage and stored tablets, this difference was not considered to be of practical significant in case of these sustained release products. The in-vivo studies indicated a statistically significant difference in the area under the curve and in the average peak concentration between the prestored tablets and the tablets stored for twelve months under ambient and at 40°C/80% RH in case of PA durules. This is a sign for a possible change in the bioavailability of this product with storage regardless the conditions under which the product is stored. 

DOI

10.21608/bfsa.1998.67982

Authors

First Name

Sayed

Last Name

Khidr

MiddleName

H.

Affiliation

Department of Industrial Pharmacy, Faculty of Pharmacy, Assiut University, Assiut, Egypt

Email

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City

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Orcid

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First Name

Esmail

Last Name

Niazy

MiddleName

M.

Affiliation

Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box: 2457, Riyadh 11451, Saudi Arabia

Email

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City

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Orcid

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First Name

Yousry

Last Name

El-Sayed

MiddleName

M.

Affiliation

Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box: 2457, Riyadh 11451, Saudi Arabia

Email

-

City

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Orcid

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Volume

21

Article Issue

2

Related Issue

10254

Issue Date

1998-12-01

Receive Date

1998-04-30

Publish Date

1998-12-31

Page Start

171

Page End

183

Print ISSN

1110-0052

Online ISSN

3009-7703

Article File

BFSA_Volume 21_Issue 2_Pages 171-183.pdf

PDF . 734.9kB

Link

https://bpsa.journals.ekb.eg/article_67982.html

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https://bpsa.journals.ekb.eg/service?article_code=67982

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8

Type

Original Article

Type Code

1,096

Publication Type

Journal

Publication Title

Bulletin of Pharmaceutical Sciences Assiut University

Publication Link

https://bpsa.journals.ekb.eg/

MainTitle

EFFECT OF STORAGE ON THE IN-VITRO AND IN-VIVO CHARACTERISTICS OF SOME MARKETED SUSTAINED-RELEASE CARDIOVASCULAR TABLETS

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Article

Created At

22 Jan 2023