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65281

FORMULATION AND EVALUATION OF FAMOTIDINE SUBLINGUAL TABLETS

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Last updated: 25 Dec 2024

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Abstract

Formulation of famotidine, rapidly disintegrated sublingual tablets, by direct compression was carried out. Fifteen tablets formulae were made in order to obtain suitable non-friable formulae, with disintegration time less than one minute and average crushing strength of 2-4 kg/cm2. The excipients used in the different formulae are Avicel pH101, sorbitol, mannitol, lactose anhydrous, Ac-Di-Sol, magnesium strearate and saccharin sodium. The formulae prepared were tested for the effect of certain excipients on the hardness, friability and disintegration time. Tablets of 20 mg famotidine from the formulated and commercial oral dosage forms were administered to five healthy volunteers participated in the study using a balanced cross-over design. Comparison of the mean urinary excretion rate obtained after administration of both dosage forms indicated that in both cases, the time taken to reach peak occurred at a mid point of 1.5 hours. Comparison of the cumulative amounts excreted in the urine after administration of famotidine in the two different dosage forms revealed that about 5.49±1.06 mg of the administered dose (20 mg) was recovered unchanged in the urine during 12 hours following sublingual tablets administration. This value was found to be higher than that excreted after administration of Pepcid® oral tablets (4.61±0.65 mg) during the same period of time. Statistical analysis of the difference at P= 0.05, revealed non-significant difference in the urinary excretion rate obtained of the two different dosage forms. On the other hand, a significant difference was found to exist in the total cumulative amount of famotidine excreted in the urine at 2 and 6 hours from both dosage forms. The results also indicated that there was no significant difference in AUC0-12 between the two dosage forms.

DOI

10.21608/bfsa.2005.65281

Authors

First Name

M.

Last Name

Hassan

MiddleName

A.

Affiliation

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

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Orcid

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First Name

A.

Last Name

Ibrahim

MiddleName

S. A.

Affiliation

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

Email

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City

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Orcid

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First Name

M.

Last Name

Abd El-Mohsen

MiddleName

G.

Affiliation

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

Email

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City

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Orcid

-

First Name

S.

Last Name

El-Shanawany

MiddleName

M.

Affiliation

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

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City

-

Orcid

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Volume

28

Article Issue

2

Related Issue

9840

Issue Date

2005-12-01

Receive Date

2004-09-12

Publish Date

2005-12-31

Page Start

149

Page End

157

Print ISSN

1110-0052

Online ISSN

3009-7703

Link

https://bpsa.journals.ekb.eg/article_65281.html

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https://bpsa.journals.ekb.eg/service?article_code=65281

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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

FORMULATION AND EVALUATION OF FAMOTIDINE SUBLINGUAL TABLETS

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Article

Created At

22 Jan 2023