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Original Research Article | OPEN ACCESS

Formulation of ketotifen child-friendly chewing gums for pediatric administration

Asmaa M Rashid1, Rafid M Hashim2, Hanan J Kassab3, Hussein K Alkufi4 , Hawraa K Khafeef1, Hiba Mohammed Suza1

1Department of Pharmaceutics; 2Department of Pharmaceutical Chemistry, College of Pharmacy, Uruk University; 3Department of Pharmaceutics, College of Pharmacy, University of Baghdad, Baghdad; 4Department of Pharmacognosy, College of Pharmacy, University of Thi-Qar 64001, Iraq.

For correspondence:-  Hussein Alkufi   Email: husseinalkufi21@utq.edu.iq   Tel:+964-7830905105

Received: 29 August 2025        Accepted: 10 January 2026        Published: 31 January 2026

Citation: Rashid AM, Hashim RM, Kassab HJ, Alkufi HK, Khafeef HK, Suza HM. Formulation of ketotifen child-friendly chewing gums for pediatric administration. Trop J Pharm Res 2026; 25(1):15-22 doi: https://dx.doi.org/10.4314/tjpr.v25i1.3

© 2026 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: To formulate ketotifen fumarate (KTF) in the form of an oral chewing gum to enhance patient compliance, particularly among children. Methods: Six KTF gums were prepared using gelatin alone or in combination with sodium carboxymethylcellulose (NaCMC) at 68 ºC and at 75 ºC. The six batches prepared were code-labeled, F1 to F6. The prepared KTF gums were characterized with respect to appearance, thickness, weight variation, moisture loss, and in vitro drug release. Results: Temperature did not significantly affect the properties of the formulated gums (p > 0.05). However, the addition of a second polymer affected the properties of the gums. Two KTF gums (F2 and F4), which had NaCMC as a second polymer, showed maximum release in 2 h (100 % and 87.25 %, respectively). The moisture content for F2 was 15.20 %, suggesting better mechanical properties. Conclusion: Ketotifen fumarate may be formulated into a chewing gum as an alternative method for pediatric administration, aiming to improve compliance.

Keywords: Ketotifen fumarate, Chewing gum, Sodium carboxymethylcellulose

Impact Factor
Thompson Reuters (ISI): 0.6 (2023)
H-5 index (Google Scholar): 49 (2023)

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