Abstract
Several nutraceutical products require gastric protection against the hostile environment in the stomach. Currently marketed synthetic and semi-synthetic coatings suffer from major shortcomings such as poor gastric protection, slow-release response to pH change, and the use of artificial ingredients. The challenge of coating natural products is further exacerbated by the relatively high gastric pH in the fed state. In this work, a novel natural enteric coating is presented as a breakthrough alternative to current solutions. Two coating systems were devised: (i) a triple-layer coating that comprises a wax layer embedded between two alginate-based coatings, and (ii) a double-layer coating, where an overcoat of organic acids (fumaric or citric acid) is applied to an alginate-based coating. The multi-layer architecture did not impact the pH-responsive nature of the coating even when more biologically relevant Krebs bicarbonate buffer of lower buffer capacity was used. Interestingly, the gastric protection barrier of organic acid-based coating remained resistant at elevated gastric pH 2, 3, or 4 for 2 h. This is the first report of using an alginate-based coating to provide gastric protection against fed-state stomach conditions (pH 2–4). Being biodegradable, naturally occurring, and with no limit on daily intake, the reported novel coating provides a superior platform to current coating solutions for pharmaceutical and nutraceutical products.
Highlights
The nutraceuticals market has significantly grown in the past decade and $278.96 billion was a benchmark estimate globally of 2021
Several nutraceutical products need gastric protection, e.g., fibres, oils, minerals, vitamins, or probiotics. To meet this market demand, different enteric coatings were developed as commercially available solutions to provide nutraceutical coatings using GRAS grade semi-synthetic (e.g., Nutrateric® and Aquateric® ) and synthetic (e.g., Eudraguard® Biotic and Control) polymers
Shellac has long been presented as a viable natural coating solution [3]
Summary
Drug Discovery, Delivery and Patient Care (DDDPC) Theme, School of Life Sciences, Pharmacy and Chemistry, Kingston University London, Kingston Upon Thames, London KT1 2EE, UK.
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