Gastro-resistant characteristics of GRAS-grade enteric coatings for pharmaceutical and nutraceutical products

International Journal of Pharmaceutics
Justyna K Czarnocka, Mohamed A Alhnan

Abstract

The use of naturally derived excipients to develop enteric coatings offers significant advantages over conventional synthetic polymers. Unlike synthetic polymers, they are biodegradable, relatively abundant, have no daily intake limits or restrictions on use for dietary and nutraceutical products. However, little information is available on their dissolution properties under different gastrointestinal conditions and in comparison to each other. This work investigated the gastric resistance properties of commercially available GRAS-based coating technologies. Three coating systems were evaluated: ethyl cellulose+carboxymethyl cellulose (EC-CMC), ethyl cellulose+sodium alginate (EC-Alg) and shellac+sodium alginate (Sh-Alg) combinations. The minimum coating levels were optimized to meet USP pharmacopoeial criteria for delayed release formulations (<10% release after 2h in pH 1.2 followed by >80% release after 45 min of pH change). Theophylline 150 mg tablets were coated with 6.5%, 7%, and 2.75% coating levels of formulations EC-CMC, EC-Alg and Sh-Alg, respectively. In vitro dissolution test revealed a fast release in pH 6.8 for ethyl cellulose based coatings: t80% value of 65 and 45 min for EC-CMC and EC-Alg respectively, while a ...Continue Reading

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Citations

Jan 17, 2016·International Journal of Pharmaceutics·Romain CaillardWilfrid Jacques
Aug 25, 2016·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Thawatchai PhaechamudOrn Setthajindalert
Jan 17, 2017·Therapeutic Delivery·Teófilo VasconcelosBruno Sarmento
Dec 5, 2017·Pharmaceutical Development and Technology·Nizar Al-ZoubiAl-Sayed Sallam
Jul 19, 2019·Expert Review of Anti-infective Therapy·Luigi SantacroceLucrezia Bottalico
Oct 5, 2020·International Journal of Pharmaceutics·Rober HabashyMohamed A Alhnan

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