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70025

SOLID STABILITY TESTING OF IBUPROFEN - EUDRAGIT RESPM SUSTAINED RELEASE TABLETS

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Last updated: 25 Dec 2024

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Abstract

Preformulated ibuprofen-Eudragit RSPM sustained release tablets were subjected to accelerated stability testing at 25, ·37 and 45°C for 6 months. The stored tablets were evaluated for the intact drug in the formula, drug-polymer interaction and compatibility of the drug with the formulated excipients using infra red spectroscopy (I.R.) and differential scanning calorimetry (DSC). The IR spectrum of ibuprofen in the tablets prepared by 15% w/v Eudragit RSPM as a granulating agent and containing 23% w/w Avicel pH 102 as an excipient was similar to the IR of standard ibuprofen. There was no change in the IR spectra of the tablet components before and after storage of those tablets at the different investigated temperatures for 1, 3 and 6 months. The DSC thermograms of ibuprofen stored tablets showed that the drug was still in the highly pure (>98%) crystalline form and there was no significant degradation after storage indicating the stability of the drug on storage. In detecting ibuprofen purity in the stored tablets, plotting of the sample temperature versus the reciprocal of the fraction of ibuprofen melted showed deviation from Van't Hoff linear plot.

DOI

10.21608/bfsa.1993.70025

Authors

First Name

Aly

Last Name

Abdel Rahman

MiddleName

A.

Affiliation

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

Email

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City

-

Orcid

-

First Name

A.

Last Name

Aboutaleb

MiddleName

E.

Affiliation

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

Email

-

City

-

Orcid

-

First Name

A.

Last Name

Stamm

MiddleName

-

Affiliation

Faculty of Pharmacy, Louis Pasteur University, France

Email

-

City

-

Orcid

-

First Name

S.

Last Name

Abdel Rahman

MiddleName

I.

Affiliation

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

Email

-

City

-

Orcid

-

First Name

E.

Last Name

Samy

MiddleName

M.

Affiliation

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

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-

City

-

Orcid

-

Volume

16

Article Issue

1

Related Issue

10639

Issue Date

1993-06-01

Receive Date

1992-07-01

Publish Date

1993-06-30

Page Start

12

Page End

24

Print ISSN

1110-0052

Online ISSN

3009-7703

Link

https://bpsa.journals.ekb.eg/article_70025.html

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https://bpsa.journals.ekb.eg/service?article_code=70025

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2

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

SOLID STABILITY TESTING OF IBUPROFEN - EUDRAGIT RESPM SUSTAINED RELEASE TABLETS

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Article

Created At

22 Jan 2023