Abstract
Drug hydrolytic degradation, caused by atmospheric and inherent humidity, significantly reduces the therapeutic effect of pharmaceutical solid dosages. Moisture barrier film coating is one of the most appropriate and effective approaches to protect the active pharmaceutical ingredients (API) from hydrolytic degradation during the manufacturing process and storage. Coating formulation design and process control are the two most commonly used strategies to reduce water vapor permeability to achieve the moisture barrier function. The principles of formulation development include designing a coating formulation with non-hygroscopic/low water activity excipients, and formulating the film-forming polymers with the least amount of inherent moisture. The coating process involves spraying organic or aqueous coating solutions made of natural or synthetic polymers onto the surface of the dosage cores in a drum or a fluid bed coater. However, the aqueous coating process needs to be carefully controlled to prevent hydrolytic degradation of the drug due to the presence of water during the coating process. Recently, different strategies have been designed and developed to effectively decrease water vapor permeability and improve the moisture barrier function of the film. Those strategies include newly designed coating formulations containing polymers with optimized functionality of moisture barrier, and newly developed dry coating processes that eliminate the usage of organic solvent and water, and could potentially replace the current solvent and aqueous coatings. This review aims to summarize the recent advances and updates in moisture barrier coatings.
Highlights
The stability of an active pharmaceutical ingredient (API) in dosage form during its shelf life is essential to guaranteeing its efficacy and safety
The results showed that WVP values of the film were significantly affected by ethyl cellulose (EC) and dibutyl sebacate (DBS) as they increased the water vapor permeability of the membrane
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Summary
The stability of an active pharmaceutical ingredient (API) in dosage form during its shelf life is essential to guaranteeing its efficacy and safety. Several approaches have been developed to minimize water uptake into dosage cores, preventing the hydrolytic degradation of the active ingredients These approaches include formulation designs with appropriate excipients [3] that repel water, avoiding ingredients with high inherent moisture, packaging the dosages with suitable materials and adding desiccants [4,5,6], and coating the dosage cores with polymers to achieve a moisture barrier film [7]. Organic solvent coating is advantageous in producing a faster and more uniform coating film owing to the dissolved nature of the coating polymers. This review details the mechanism of moisture uptake through the coating film, summarizes newly developed coating methods and formulations with their respective advantages and limitations, and provides a brief future perspective for applying those new technologies and formulations in the pharmaceutical industry
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