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Carbamazepine gel formulation as a sustained release epilepsy medication for pediatric use

Mawazi, Saeid Mezail and Abdullah Al-Mahmood, Sinan Mohammed and Chatterjee, Bappaditya and Ab. Hadi, Hazrina and Doolaanea, Abd Almonem (2019) Carbamazepine gel formulation as a sustained release epilepsy medication for pediatric use. Pharmaceutics, 11 (10). pp. 1-13. ISSN 1999-4923

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Abstract

This study aimed to develop a carbamazepine (CBZ) sustained release formulation suitable for pediatric use with a lower risk of precipitation. The CBZ was first prepared as sustained release microparticles, and then the microparticles were embedded in alginate beads, and finally, the beads were suspended in a gel vehicle. The microparticles were prepared by a solvent evaporation method utilizing ethyl cellulose as a sustained release polymer and were evaluated for particle size, encapsulation efficiency, and release profile. The beads were fabricated by the dropwise addition of sodium alginate in calcium chloride solution and characterized for size, shape, and release properties. The gel was prepared using iota carrageenan as the gelling agent and evaluated for appearance, syneresis, drug content uniformity, rheology, release profile, and stability. The microparticles exhibited a particle size of 135.01 ± 0.61 µm with a monodisperse distribution and an encapsulation efficiency of 83.89 ± 3.98%. The beads were monodispersed with an average size of 1.4 ± 0.05 mm and a sphericity factor of less than 0.05. The gel was prepared using a 1:1 ratio (gel vehicle to beads) and exhibited no syneresis, good homogeneity, and good shearthinning properties. The release profile from the beads and from the gel was not significantly affected, maintaining similarity to the tablet form. The gel properties were maintained for one month real time stability, but the accelerated stability showed reduced viscosity and pH with time. In conclusion, CBZ in a gel sustained release dosage form combines the advantages of the suspension form in terms of dosing flexibility, and the advantages of the tablet form in regards to the sustained release profile. This dosage form should be further investigated in vivo in animal models before being considered in clinical trials.

Item Type: Article (Journal)
Additional Information: 7245/76103
Uncontrolled Keywords: gel; sustained release; carbamazepine; epilepsy; pediatric
Subjects: R Medicine > RS Pharmacy and materia medica
R Medicine > RS Pharmacy and materia medica > RS192 Materia Medica-Pharmaceutical Technology
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button): Kulliyyah of Pharmacy > Department of Pharmaceutical Technology
Kulliyyah of Pharmacy
Depositing User: Dr. Abd Almonem Doolaanea
Date Deposited: 13 Nov 2019 11:57
Last Modified: 13 Nov 2019 11:57
URI: http://irep.iium.edu.my/id/eprint/76103

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