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Formulation and Development of Aqueous Film Coating for Moisture Protection of Hygroscopic L. Tablets

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Specialty Pharmacology
Date 2022 May 5
PMID 35509256
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Abstract

Objectives: The present study aims to develop a moisture-protective coating solution and use it to film coat hygroscopic L. tablets.

Materials And Methods: Five coating formulations were developed and applied on core tablets in a fluidized-bed coating. The film-coated tablets were evaluated by appearance, percentage of moisture gain, disintegration time, and percent of drug release. Physicochemical properties and stability during storage of the best obtained coated tablets were studied.

Results: The results of this study showed that the film coating F5 containing 25% hydroxypropyl methyl cellulose (HPMC), 20% shellac, 10% polyethylene glycol (PEG) 1500, 29.6% PEG 4000, 5% tween 80, 10% titanium dioxide, and 0.4% acid red 2 offered good protection for coated tablets against moisture. Coated tablets showed physical and dissolution stability during storage.

Conclusion: A combination of hydrophilic polymer HPMC and hydrophobic polymer shellac is suitable for balancing moisture-protective properties and attaining the fast release of drugs. This study could make it worthwhile to develop a pharmaceutical moisture barrier film coating system for immediate release tablets. However, more studies will be needed to evaluate the moisture-resistant film further.

Citing Articles

Formulation Strategies to Improve the Stability and Handling of Oral Solid Dosage Forms of Highly Hygroscopic Pharmaceuticals and Nutraceuticals.

Ng L, Ling J, Hadinoto K Pharmaceutics. 2022; 14(10).

PMID: 36297450 PMC: 9611293. DOI: 10.3390/pharmaceutics14102015.

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