Abstract
Traditional medicines and nutraceuticals contain natural ingredients, usually formulated in the form of functional foods or as dietary supplements. Majority of these ingredients are susceptible to degradation by the gastric acid or provoke nausea or induce vomiting upon oral administration. The gastroresistant coatings, widely researched and used in pharmaceuticals, employs enteric polymers which are not regarded as natural ingredients or do not possess the GRAS (generally regarded as safe) status by the regulatory authorities, therefore, cannot be used for nutraceutical products. Consequently, most of nutraceuticals are not formulated as gastroresistant and therefore either they are not well tolerated or lack efficacy. The subject plant based novel formulation addresses this problem.
The subject technology is based on a plant-origin natural polymeric material which is already considered as safe. The material also has a safe-use history for some food application historically. The novel formulation offers a platform technology with wider applications across pharmaceutical and nutraceutical sector. Apparently, any active ingredient packaged in a standard form (pill, tablet, capsule, granule, particles, pellets) can be simply over-coated with novel natural films using standard industrial equipment. The active ingredients can also be encapsulated in a capsule shell over-coated with current technology. The pKa of the material was measured to be 3.5 suggesting it will fully dissociate around pH ≥ 5.5 confirming its suitability as natural alternate for developing pH responsive dosage forms, in particular gastroresistant products.
The subject technology is based on a plant-origin natural polymeric material which is already considered as safe. The material also has a safe-use history for some food application historically. The novel formulation offers a platform technology with wider applications across pharmaceutical and nutraceutical sector. Apparently, any active ingredient packaged in a standard form (pill, tablet, capsule, granule, particles, pellets) can be simply over-coated with novel natural films using standard industrial equipment. The active ingredients can also be encapsulated in a capsule shell over-coated with current technology. The pKa of the material was measured to be 3.5 suggesting it will fully dissociate around pH ≥ 5.5 confirming its suitability as natural alternate for developing pH responsive dosage forms, in particular gastroresistant products.
Original language | English |
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Patent number | GB2009780.4 |
IPC | UKPTO |
Priority date | 26/06/20 |
Publication status | Published - 30 Dec 2021 |