Enteric Coating

Enteric Coating is Necessary...Why?

When we take a typical supplement, the capsule or table is swallowed and travels down the esophagus to the stomach. In the stomach, the tablet or capsule is churned and gyrated in the highly acidic digestive secretions with pH 1.0-4.0, for 45 minutes to 2 hours. If there is anything left of the table or capsule (and its contents), it will be passed through the duodenum to the small intestine.

The effectiveness of any systemic enzyme is determined by the amount of activity level in the bloodstream after the enzyme has been absorbed from the small intestine. Systemic enzymes, whose activity is significantly reduced in an acidic environment, must be protected from it for their utmost effectiveness.

Some enzymes will begin to lose their activity once introduced into the low pH (1.0-3.0) acids of the stomach. The amount of activity loss is dependent upon the individual enzyme and the amount of time it spends in the stomach.

What happens to uncoated tablets and capsules? Stomach acid breaks down tablets and capsules to prematurely release active ingredients (enzymes). The highly acidic environment of the stomach destroys the majority of the enzymes' activities. If the tablet is of poor quality (contains binders and fillers) the product may pass through both the stomach and intestine with no absorption.

Studies have shown that certain unprotected enzymes can lose up to 100% of their activity in fewer than 30 minutes in pH levels below 3.0. The only reliable method of ensuring that 100% of the enzymes are not destroyed by the stomach acid is to enteric-coat the enzymes.

What benefit does a delivery system serve?

Looking at the delivery system refers to how the enzyme(s) is manufactured, whether it is a powder inside a capsule, a tablet, or as an enterically coated liquid gel, which is the most effective, state of the art delivery system on the market today. Learn more about delivery systems.

Benefits of Enteric Coating:

1. Protects capsule or tablet contents from acidic environments of stomach
2. After passing through the stomach allows capsule or tablet to break down easily in pancreatic juices in the Duodenum*  (pH 6-8)
3. Enables absorption of enzymes, at their highest activity levels, in the small intestine

Note: Not all enzymes are manufactured with enteric coating, and so often a premature release of certain enzymes can cause minimal if any absorption of the ingredients in the blood stream where they belong.

*(approximately 1st 10” of small intestine).

Vitalzym's Enteric Coating

Vitalzym has been reformulated to use an enteric coated gel capsule manufactured under pharmaceutical-grade guidelines.

Though revolutionary to nutritional systemic enzyme blends, this enteric coating process is similar to that used in today’s most advanced products.  The capsule has an all-natural shell barrier that allows it to withstand the extremely low pH levels found in the stomach. Once introduced to the pancreatic juices in the duodenum (upper small intestine), the shell barrier breaks down to release the enzymes it contains.  The enzymes are then absorbed into the bloodstream through the lining of the small intestine.

The new enteric coated gel capsule has been designed to pass both the USP (United States Pharmacopeia) and JP (Japan Pharmacopeia) disintegration tests for enteric coated capsules.  Every batch is tested to ensure it meets the agency guidelines before exportation to the U.S.

Dr. David Getoff talks about the quality and benefits of the new fully enteric coated Vitalzym formulation.

Solubilized Liquid-Filled Gel Capsule

At the center of the advanced delivery system is a new Solubilized Liquid-Filled Gel Capsule used to enhance the absorption of Vitalzym.  The technology of liquid-filled capsules is superior to that of capsules filled with powder because it uses low heat production, provides more uniform dose distribution, and prolongs enzyme activity.

Low Heat Production– Powder enzyme blends are available today that use an enteric coating, but they are typically in tablet form.  The disadvantage of these blends is the amount of heat created with compressing the ingredients into a tablet.  Enzymes are susceptible to high temperatures and may begin to degrade during the manufacturing process.  Solubilized Liquid-Filled Gel Capsules allow for an enteric coated enzyme without activity loss from heat. Throughout all of the processes, Vitalzym is produced under strictly controlled temperature ranges.

Optimal Distribution– Liquid enzyme blends provide a more uniform dose consistency, because the mixing of liquids allows for optimal particle distribution.  In powder formulations, each particle of a different enzyme is different in size, causing greater friction between particles during mixing.  Excipients are introduced to powder formulations to increase the mixability, but liquids still provide far more even distribution of ingredients, allowing for more consistent dosages in each capsule.

Prolonged Enzyme Activity– Enzymes always retain some amount of moisture when they are produced.  Enzymes, as proteins, are more susceptible to denaturation at higher moisture.  Enzyme powders typically have lower (5-10%) moisture.  However, even with lower moisture, enzyme powders will lose some of their activity over time, resulting in a loss of up to 20% of activity over a 12-month period. Vitalzym contains enzymes with a higher degree of purity and less moisture that when combined with Medium-Chain Triglycerides (MCT), then decompressed during the manufacturing process, removes the moisture completely.  As a result, loss of enzyme activity over time due to moisture will not occur after Vitalzym is produced.  Vitalzym is manufactured to have a 5-year shelf life with no loss of activity when properly stored in a cool, dry place with the lid tightly closed.

How Enteric Coating Evolved

Over the years, there have been various methods of enteric coating to help protect the enzymes that can be destroyed by stomach acid and some have been proven to be more effective than others.  As you will see, the latest technology of enteric coating has been used to protect the enzymes in Vitalzym.

Are You Choosing the Right Enzyme Product?

Stomach acid breaks down tablets and capsules to prematurely release the active ingredients of an enzyme formula, such as Vitalzym. The highly acidic environment of the stomach can destroy the majority of the enzymes' activities.

Additionally, if the tablet is of poor quality (contains binders and fillers) the product may pass through both the stomach and intestines with no absorption.  However, the effectiveness of an enzyme is determined by the amount of activity level in the bloodstream after the enzyme has been absorbed from the small intestine.

Enzymes lose activity in low pH (1-3) of the stomach. Studies show unprotected enzymes can lose up to 100% of their activity in 30 minutes or less!  Therefore, the only reliable method is to ensure 100% of the enzymes are not destroyed is to enteric coat the enzymes.

Lab Results and Research Testing

Testing shows how effectiveness of the enzyme is important to understand how the enzyme given the delivery system will interact with your body. This refers to how the enzyme will withstand the different acidic areas of the body as it passes from your mouth, down your esophagus, into your stomach, through your duodenum and small intestine and finally finding its way into the blood stream.

There is misleading information about the effectiveness of many systemic enzyme products in the market today.  In order to demonstrate how the active enzymes in a fully enteric-coated systemic enzyme product are more available to be absorbed into the bloodstream through the small intestine, a number of laboratory tests have been performed.

These tests have been conducted under laboratory conditions by Japan Food Research Laboratories, an independent government laboratory authorized by the Japanese government, and are only intended to show the likely results of the loss of enzyme activity levels on various enzyme products when those products are subjected to simulated common stomach acid conditions. The actual enzyme activity levels of these products, when absorbed into the bloodstream, may vary based on your own body’s metabolism and pH level.

Disintegration & Dissolution Test: To determine the availability of enzyme activity after passing through the stomach acid for the fully enteric-coated systemic enzyme product, Vitalzym®, the “Disintegration Test (Enteric-coated capsule)”, was performed in accordance with the Japanese Pharmacopoeia, Seventh and Fifteenth Editions. This test simulated the acid conditions of the stomach and tested for the disintegration of the sample capsules within a prescribe time period. In the case of Vitalzym®, the test result indicated that the product conformed to acceptable test criteria. For detailed test results, see this link: Vitalzym Disintegration Certificate of Analysis

For products that did not pass the test criteria, the following Protease Activity Loss Tests were performed to determine the actual amount of enzyme loss in the simulated conditions.

1. Neutral Protease Activity Test: A sample of each enzyme product was tested in a neutral state (100% activity) utilizing a standard protease activity assay method.

2. Protease Activity Test: A sample of each enzyme product was then tested utilizing the same test procedure after being exposed to the simulated acid condition of the stomach.

While Vitalzym passed the enteric coating test, the following table illustrates the activity losses for the other systemic enzyme products tested:

Neprinol-AFD® Activity Loss Certificate of Analysis

Exclzyme® Activity Loss Certificate of Analysis

Serracor-NK® Activity Loss Certificate of Analysis

Serracel® Activity Loss Certificate of Analysis

Taking enteric coated Vitalzym can be an effective way to insure that the enzymes in this formula reach the small intestine where they can be absorbed into the bloodstream in order to obtain the utmost effectiveness.

**Neprinol® and Serracel® are registered trademarks of Arthur Andrew Medical;  Exclzyme® and Serracor® are registered trademarks of Specialty Enzymes and Biochemicals Co.; none of whom are affiliated with, nor sponsor or endorse these products or any other product from companies mentioned in this site. The names of all other companies, products and services are the property of their respective owners.