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6892

FORMULATION AND OPTIMIZATION OF VARDENAFIL HYDROCHLORIDE ORAL DISINTEGRATING TABLETS: EFFECT OF SUPERDISINTEGRANTS

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Last updated: 22 Jan 2023

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Abstract

One of the fruitful results of oral technological advancement in dosage forms is the orally disintegrating tablets (ODTs) as they disintegrate rapidly in the mouth and do not require water for administration. This work employed mixture design approach for developing and optimizing oral disintegrating tablets of a slightly water soluble drug, vardenafil hydrochloride. Three component mixture design was used to optimize the type and concentration of superdisntegrants, crosscarmellose sodium (X1), crosspovidone (X2) and sodium starch glycolate (X3) using water soluble dextrates (Emdex®) as a filler. Disintegration time, wetting time and t90 values for all formulations ranged from 33.69 to 208.68 s, 40.42 to 209.83 s and 80.04 to 484.63 s, respectively. According to the results, the selected variables have a strong influence on disintegration time, wetting time and t90 of the ODTs. The lowest disintegration time, wetting time and t90 were showed by ODTs formula composed of 1.72 % of crosscarmellose in combination with 4.28 % of crosspovidone. So, this formula was chosen as the optimized formula. Stability studies also showed that the optimized formula was stable under accelerated conditions. And, by comparing the selected formula with Prosolv® ODT G2 as a ready ODT system, it showed faster disintegration time and higher dissolution rate. Hence, the best superdisintegrants to be used with the water soluble dextrates are crosspovidone in combination with crosscarmellose sodium. 

DOI

10.21608/ajps.2016.6892

Keywords

Oral disintegrating tablets, mixture design, vardenafil hydrochloride, dextrates (Emdex), Prosolv ODT, crosscarmellose sodium, crosspovidone, sodium starch glycolate

Authors

First Name

hamdy

Last Name

Mourad

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Affiliation

The Regional Center for Mycology and Biotechnology, Al-Azhar University, Cairo, Egypt

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First Name

Hossameldin

Last Name

Kadry

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Affiliation

Department of pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Al-Azhar University

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Volume

53

Article Issue

1

Related Issue

1229

Issue Date

2016-03-01

Receive Date

2018-05-12

Publish Date

2016-03-01

Page Start

39

Page End

57

Print ISSN

1110-1644

Online ISSN

2535-1958

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https://ajps.journals.ekb.eg/article_6892.html

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https://ajps.journals.ekb.eg/service?article_code=6892

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7

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Original Article

Type Code

518

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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