Abstract
Nutraceuticals provide an additional health or medicinal benefit besides their nutritional value and are therefore marketed for the prevention and treatment of certain conditions. Nutraceuticals contain natural ingredients, usually presented in the form of functional foods or as dietary supplements. Many of the ingredients are susceptible to degradation by gastric acid or can provoke nauseatic feelings or induce vomiting on oral administration. Gastroresistant coatings, widely researched and used in pharmaceuticals, employ enteric polymers which are not regarded as natural ingredients or do not possess GRAS (generally regarded as safe) status by the regulatory bodies, thus cannot be used for nutraceutical products. Consequently, most nutraceuticals are not formulated as gastroresistant and can therefore lack efficacy or are well tolerated. This manuscript provides a critical review of natural substances employed in producing gastroresistant products, their shortcomings, and potential industrial applications. It also identifies current gaps in our knowledge to encourage further research in this area.
Highlights
In recent years, nutraceuticals have been widely adopted in the western world with a market value of over US$50bn in the US and US$30bn in Europe in 2010 (Frost and Sullivan, 2010)
Encap Drug Delivery, a division of Capsugel®, has developed a commercial shellacbased coating formulation, described as containing generally recognized as safe’ (GRAS) materials and suitable for the delivery of pharmaceuticals and nutraceuticals (Fraser and Young, 2010; Young, 2006). This formulation has been shown to be resistant to the acidic pH of the stomach (0.1M HCl, 2h), using different coating thicknesses, yet disintegrating when in more neutral pH values
Apart from the difference between organic and aqueous formulations, this study showed that the choice of plasticiser greatly influences drug release from these dosage forms
Summary
Nutraceuticals have been widely adopted in the western world with a market value of over US$50bn in the US and US$30bn in Europe in 2010 (Frost and Sullivan, 2010). A study by Liu et al (2011) highlighted differences in the release behaviour from these coated formulations when bicarbonate buffer was used to simulate the intestinal phase, instead of conventional phosphate buffer, suggesting the importance of physiological resemblance of the test medium to the GI fluids. This is further supported by evidence from other studies (Goyanes et al, 2015; Merchant et al, 2014; Varum et al, 2014). Coated tablets remain intact in 0.1M HCl (pH≤1.2) for 2 h, coatings are not robust to resist gastric conditions pH >2.0, possibly leading to premature drug release in the stomach
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