Enzyme Supplements

A Short History

In Germany, it was the biochemist Gaschler who reported the successful treatment of certain forms of cancer by orally adminis­tering individual enzymes as drugs in 1937. The concept of using enzymes to treat cancer was not new. The Mayas and other peo­ple had already done so unwittingly when, for example, they treated malignant ulcers by applying papaya leaves and papaya juice. The enzyme papain contained in the papaya plant is a pow­erfully acting agent which breaks down 'unhealthy' protein. As early as the beginning of the present century, the physician Dr. Beard had injected pancreatic juice from freshly slaughtered calves into his cancer patients, producing such sensational success that he was taken for a charlatan. At the time, other scientists repeated the studies but used older pancreatic juice which no longer contained any active enzymes, because they had denatured due to aging of the solution, improper storage and contamination. Of course, it no longer worked, but unfortunately this lock of effect when denatured sufficed to scientifically refute the effective­ness of enzyme therapy for cancer. 

In the 1950's, Professor Max Wolf,  private physician to some of the greatest politicians and celebrities of the time, and founder of the "Biological Research Insti­tute" in New York , and Dr. Helen Benitez, developed a sophisticated natural enzyme formulation using plant-based enzymes bromelain (pineapple extract) and papain (papaya extract), natural pancreatic enzymes trypsin and chymotrypsin, and the antioxidant flavonoid rutin. After years of research and testing, they developed three enzyme mixtures; one appearing to be more effective on inflammatory, the second more on degenerative disorders, and the third on cancer. These combi­nations of enzymes of animal and plant origin developed in the "Biological Research Institute" were named ‘Wolf-Benitez enzyme mixtures’ (later called Wobenzym).

Together with Professor Haubold, a well-known physician and scientist from Germany, they were able to develop a technology for stable encapsulation of enzymes which then were combined in the proper mixtures and converted to enteric-coated capsules to prevent their premature destruction by stomach acids when taken orally. The capsules then dissolved in the small intestine and their early research confirmed absorption. Together with Professor Wolf, they founded the still existent “Medical Enzyme Research Institute”, dedicated to the research and advancement of enzymes. In 1960, Dr. Max Wolf  launched the original uncoated enzyme capsule 'Wobenzyme' in Germany to help maintain healthy joints, mobility and flexibility as well as healthy inflammation following exertion.

History of Vitalzym

In 1996, inspired by decades of clinical studies, Mr. Hirooka, founder of World Nutrition, hired the most elite team of scientists and medical researchers, and combined a proprietary blend of systemic enzyme complexes with other natural ingredients. 

World Nutrition’s original Vitalzym (Vitalzym Original Hybrid) formula revolutionized the industry and quickly became the most popular vegetarian systemic enzyme supplement in the world. 

In 2008, World Nutrition became the first company to formulate an enteric-coated, liquid filled systemic enzyme gel capsule, and introduced the superior delivery system of Vitalzym Extra Strength.

Developing a Superior Product

In 2008, when the newly developed liquid gel capsule of Vitalzym was put onto the American market, performance was crucial. The goal was to use strict criteria to develop Vitalzym in such a way that the proportion of enzyme activity, stability, active ingredient uniformity, acid resistance, maximum bioavailability, etc., surpassed that of other systemic enzyme supplements products considered to be the best on the market at the time.

Setting higher goals for performance came with drawbacks. For example, increasing the levels of enzyme activity meant that the tablet had to become larger as well. Improving the acid resistance required a thicker tablet coating. Even having better uniformity involved a larger amount of excipients².

Vitalzym's liquid enzyme gel capsule was developed by focusing on achieving the exact opposite. The new capsule became smaller and thinly coated yet 100% acid proof by USP standard³, capable of delivering a more uniform blend of ingredients with much fewer excipients. World Nutrition successfully eliminated as much of everything as possible, leaving only the enzymes.

Purified Proteolytic Enzymes

First, World Nutrition decided to use the highest purified enzymes in order to deliver more activity of enzymes in a smaller capsule. The purified proteolytic enzymes cannot be used under a normal condition of tableting and encapsulation because they are too active and moisture sensitive, and would break down by themselves.

So, they developed a special colloid with MCT⁴ which completely prevents the activation of enzymes from the moisture in the air. It also allowed the capsules to be very small without losing any enzyme activities, as well as drastically increasing the stability of the enzymes.

See Manufacturing

Controlled Production Temperature

Second, they were determined to strictly control temperature during the production. As mentioned, the purified proteolytic enzymes are very active and sensitive to moisture and heat, so heat must be regulated below a certain temperature to avoid loss of any enzymes during production. In tableting enzymes, there are a few necessary processes which require heat: granulation, tablet compression, and drying. Thus, World Nutrition chose a liquid gel capsule to eliminate the need for such potentially harmful processes.

During manufacturing,  humidity and temperature was controlled in the facility with ISO Class 5 clean room⁴ at tight limits, typically ±2%RH and ±1°C, whereas FDA cites a temperature of 72°F (+/-3°F) and a relative humidity of 30-50%RH for manufacturing areas.

The importance of keeping the quality intact, for packaging they choose an aluminum bottle, which has a 100% gas barrier and therefore cannot be permeated by moisture in the air as plastic supplement bottles.

Meticulousness is an integral part of the Japanese culture, and because of this, the most experienced lens crafters have developed the ability to precisely determine the distortion of a sphere in microns through touch alone. They are also capable of recognizing defects by sight far more accurately than machines. Because of our strong desire to deliver only the highest quality products, we added a revolutionary procedure to the end of the process involving a final visual check of every single capsules as a precaution. Two teams of three women alternated every 20 minutes, looking carefully for any defects. If any woman spotted one, she picked it up to confirm the distortion and then removed it from the line. Throughout all of this, only two or three defective capsules were discovered in every batch of a million, but our attention to detail ensured that none of those defective capsules ever left the factory.

Meticulous Quality Control

Meticulousness is an integral part of the Japanese culture, and because of this, the most experienced lens crafters have developed the ability to precisely determine the distortion of a sphere in microns through touch alone. They are also capable of recognizing defects by sight far more accurately than machines. Because of our strong desire to deliver only the highest quality products, we added a revolutionary procedure to the end of the process involving a final visual check of every single capsules as a precaution. Two teams of three women alternated every 20 minutes, looking carefully for any defects. If any woman spotted one, she picked it up to confirm the distortion and then removed it from the line. Throughout all of this, only two or three defective capsules were discovered in every batch of a million, but our attention to detail ensured that none of those defective capsules ever left the factory.

1. An enteric coating is a polymer barrier applied to oral medication that prevents its dissolution or disintegration in the gastric environment.
2. An excipient is a substance formulated alongside the active ingredient of a medication such as glidants, lubricants, binders, anti-adherents, coatings, preservatives, etc.
3. http://www.usp.org/sites/default/files/usp/document/harmonization/gen-method/q02_pf_ira_31_2_2005.pdf
4. https://academic.oup.com/jn/article/132/3/329/4687297
5. ISO Class 5 facility is considered a high-grade cleanroom and is typically required for aseptic applications such as sterile filling of pharmaceutical products into containers, for example. It allows up to 100,000 particles of 0.1µm and up to 3,520 particles of 0.5µm per m3. An ISO Class 5 cleanroom equates to EU GMP class A and B, and BS 5295 Class E and F.