Definition: An enteric coating is a polymer barrier applied to oral medication that prevents its dissolution or disintegration in the gastric environment.
Source: Tarcha, Peter J. (1990-11-21). Polymers for Controlled Drug Delivery. CRC Press
There are active ingredients (e.g. garlic extracts) that have to be protected from the stomach acids (pH 1-4). Thus, they should not be released before reaching the small intestine (pH 5-7).
Reasons for that can be the sensibility of the active ingredient to the acidic environment in the stomach. Hence, therapeutic effects can be reduced or neutralized by the acid. Also, some active compounds should first be released in the small intestine to yield better adsorption or they should first have an effect there, like intestinal antiseptics that should not be diluted in the stomach. Moreover, some active agents can cause gastric mucos irritations and therefore need enteric protection to prevent irritations.
Enteric film coatings for solid oral dosage forms make this possible. It is a barrier that prevents acids in the stomach from dissolving or degrading any kinds of medication after oral dosage.
Our enteric film coating systems
1. AquaPolish® E for pharmaceutical or food/nutraceutical industries
2. BonuLac® for food and nutraceutical industries.
Pharmaceutical enteric coating
The pharmaceutical film coating system AquaPolish® E consists of the pH-value controlled Methacrylacid / Ethyl Acrylate Copolymer which enables an enteric protection. In addition, it also protects active ingredients against environmental influences such as light decomposition, oxidation and moisture. However, the polymer is not approved for food and nutraceutical products.
Pharmaceutical one-step film coating system
- For of all kinds of solid dosage forms
- Excellent enteric properties
- Superior light, oxygen & moisture protection
- Combination of acrylic acid copolymer, coloring additives & additional excipients
Advantages
- Makes the coating process cost effective
- Easily soluble in water & reproducible high quality film coating
- Clear, white & colored preparations
- Using conventional or modern coating equipment
Regulatory and quality aspects
- All AquaPolish® E formulations are developed to meet the official regulatory requirements of the user’s country for pharmaceutical products.
Pharmacopeia – Criteria
USP 32 + EP 6
- 2 hours pH 1.2 (0.1 N HCl) < 10 % release of API,
- 45 Min. at pH 6.8 > 75 / 80 % release of API.
EP 6
- 2 hours no disintegration at pH 1.0 (0.1 N HCl). Disintegration within one hour at pH 6.8.
- Test is applicable for capsules and limited applicable for tablets.
Nutraceutical enteric coating
BonuLac® is a natural shellac-based coating system, which provides a protective film with moisture sealing and enteric properties. With its taste masking properties it is recommended for the coating of natural extracts, oils and substances with unpleasant taste and odor. Even though shellac is a natural product, it does not comply with some clean label trends as it originates from the female lac bug and thus, is not vegan.
Nutraceutical one-step film coating system
- For of all kinds of solid dosage forms
- Excellent moisture sealing & enteric properties
- Superior taste masking & moisture protection
- Recommended for coating of natural extracts, fatty oils & substances with bad taste / odor
- Combination of natural shellac with plasticizers, coloring additives & additional excipients
Advantages
- Natural shellac is a film forming polymer, which gives enteric propeties for nutritional products
- Easily soluble in water & reproducible high quality film coating
- Clear, white & colored preparations
- Can be applied using conventional or modern coating equipment
Regulatory and quality aspects
- All BonuLac® formulations are developed to meet the official regulatory requirements of the user’s country for pharmaceutical products and for nutritional or dietary supplements.
AquaPolish® E for nutraceuticals is a combination of sodium alginate with plasticizers and additional excipients. It is a ready-to-use, water-soluble film coating compound. Furthermore, it provides a protective film with enteric properties and gives a light glossy effect to the surface of solid oral dosage forms. As an alternative to BonuLac® it is a vegan formulated coating system.
Nutraceutical one-step film coating system
- For of all kinds of solid dosage forms
- Excellent moisture sealing & enteric properties
- Superior taste taste & mositure protection
- Recommended for coating of natural extracts, fatty oils & substances with bad taste / odor
Advantages
- Sodium alginate is thickener, coating & gelling agent
- Easily soluble in water & reproducible high quality film coating
- Clear, white & colored preparations
- Can be applied using conventional or modern coating equipment
- Vegan / non-animal
Regulatory and quality aspects
- All AquaPolish® E formulations are developed to meet the official regulatory requirements of the user’s country for nutritional or dietary supplements.
INFO – Sodium alginate’s enteric function
Sodium alginate, also known under E 401, is the sodium salt of alginic acid, which is a polysaccharide. As Sodium alginate is extracted from the cell wall of brown seaweed it is a natural and plant based polymer. Moreover, sodium alginate is already established in the food industry as a thickener and coating agent. Also, it has a function as a gelling agent and forms with gastric acid a gel foam which floats on the stomach content and forms a protective layer. This protective layer prevents the stomach acid from rising into the esophagus. The undigested mixture is later excreted through the intestines.
Source:
M. Kumpugdee-Vollrath, E. Gögebakan, J Krause, U. Müller, G. Weißmann. “Alginate” in Easy Coating: Grundlagen und Trends beim Coating pharmazeutischer Produkte, Wiesbaden, Vieweg+ Tauber, 2001, p 191-193
https://www.test.de/medikamente/wirkstoff/antazidum-gelbildner-kaliumhydrogencarbonat-natriumalginat-kombination-w274/ 01.07.2020
https://www.gaviscon.de/so-wirkt-gaviscon/natuerlicher-wirkstoff-alginat/ 10.07.2020
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