Abstract
Background:
Ketotifen is a second-generation antihistamine commonly used in the management of allergic conditions. Conventional oral dosage forms may present administration and compliance challenges, particularly in pediatric and geriatric patients.
Objective:
This study aimed to develop and evaluate ketotifen medicated gummies as a convenient and palatable oral dosage form. The formulation was assessed for its physical properties, drug content uniformity, and in vitro dissolution behavior.
Methods:
Ketotifen gummies were prepared using gelatin, pectin, sucrose, citric acid, and flavoring agents. The prepared gummies were evaluated for physical characteristics, weight variation, content uniformity, and in vitro dissolution using USP Apparatus II, while drug content was quantified spectrophotometrically at 303 nm.
Results:
The gummies exhibited a uniform appearance, smooth texture, good flexibility, and maintained physical integrity for up to 60 days. Weight variation was 1.024 ± 0.05 g, while palatability and physical acceptability were generally favorable; however, content uniformity showed 156% ± 0.06 of the label claim, exceeding the pharmacopeial acceptance range. In vitro dissolution demonstrated rapid drug release, with approximately 80% released within 5 minutes and complete release within 15 minutes.
Conclusion:
Ketotifen gummies demonstrated favorable physical characteristics, palatability, and rapid drug release, supporting their potential as an alternative oral dosage form. However, the observed content-uniformity variation highlights the need for further optimization of the manufacturing and mixing process.
