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65407

THE UTILIZATION OF A HYDROPHILIC WAXY BINDER IN THE PREPARATION OF ORALLY DISINTEGRATING TABLETS BY MEANS OF TWO DIFFERENT GRANULATION METHODS

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Last updated: 04 Jan 2025

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Abstract

The demand for rapidly disintegrating tablets (RDT) has been growing during the last decade especially for elderly and children who have swallowing difficulties. The problem of certain RDT is their low physical resistance and high friability. This work describes a new approach to prepare RDT with sufficient mechanical integrity, involving the use of a hydrophilic waxy binder (Superpolystate  , PEG-6-stearate). Superpolystate  is a waxy material with a melting point of 33°-37° and an HLB value of 9. So it will not only act as a binder and increase the physical resistance of tablets but it will also help the disintegration of the tablets as it melts in the mouth and solublises rapidly leaving no residues. The incorporation of Superpolystate  in the formulation of RDT was realized by means of two different granulation methods: wet granulation by using an emulsion of this waxy binder as granulating liquid and melt granulation where the molten form of the binder was used. Granule size distributions of both wet and melt granulates of crystallised Paracetamol and D-mannitol were compared using laser light diffractometer. Scanning electron microscopy (SEM) was used to examine their morphological characteristics. The potential of the intragranular addition of croscarmellose as a disintegrating agent was also evaluated. The subsequent step encompassed the preparation and the evaluation of the tablets, including the effect of the extragranular introduction of croscarmellose. An improvement in tablet hardness and friability was observed with both granulation methods where we were able to obtain RDT with a disintegration time of 40  2 s and a hardness of 47.9  2.5 N.

DOI

10.21608/bfsa.2004.65407

Authors

First Name

G.

Last Name

Abdelbary

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Affiliation

Laboratoire de Pharmacie Galénique et Industrielle, Faculté de Pharmacie de Marseille, 13385 Marseille, cedex 5, France

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Orcid

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First Name

P.

Last Name

Prinderre

MiddleName

-

Affiliation

Laboratoire de Pharmacie Galénique et Industrielle, Faculté de Pharmacie de Marseille, 13385 Marseille, cedex 5, France

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-

Orcid

-

First Name

C.

Last Name

Eouani

MiddleName

-

Affiliation

Laboratoire de Pharmacie Galénique et Industrielle, Faculté de Pharmacie de Marseille, 13385 Marseille, cedex 5, France

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-

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-

Orcid

-

First Name

J.

Last Name

Joachim

MiddleName

-

Affiliation

Laboratoire de Pharmacie Galénique et Industrielle, Faculté de Pharmacie de Marseille, 13385 Marseille, cedex 5, France

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-

City

-

Orcid

-

First Name

Ph.

Last Name

Piccerelle

MiddleName

-

Affiliation

Laboratoire de Pharmacie Galénique et Industrielle, Faculté de Pharmacie de Marseille, 13385 Marseille, cedex 5, France

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Volume

27

Article Issue

1

Related Issue

9857

Issue Date

2004-06-01

Receive Date

2004-02-24

Publish Date

2004-06-30

Page Start

41

Page End

51

Print ISSN

1110-0052

Online ISSN

3009-7703

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https://bpsa.journals.ekb.eg/article_65407.html

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https://bpsa.journals.ekb.eg/service?article_code=65407

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Publication Type

Journal

Publication Title

Bulletin of Pharmaceutical Sciences Assiut University

Publication Link

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

MainTitle

THE UTILIZATION OF A HYDROPHILIC WAXY BINDER IN THE PREPARATION OF ORALLY DISINTEGRATING TABLETS BY MEANS OF TWO DIFFERENT GRANULATION METHODS

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Article

Created At

22 Jan 2023