INTENZYME FORTE (Proteolytic Enzymes)

Intenzyme Forte is the primier source of proteolytic enzymes from animal and plant sources. This product is high in Trypsin and Chymotrypsin. It's effective for systemic inflammation, tissue damage with associated inflammation, arthritis, food sensitivity, and poor circulation due to inflammation and poor digestion. These tablets are enteric coated to bypass the stomach and dissolve in the small intestine.

With acute injury to prevent inflammation, use 10 tablets immediately, then 5 tablets every 4 hours on an empty stomach (30 minutes before a meal or 3 hours after a meal) for 3 days until the inflammation and swelling abate. With chronic inflammation or inflammatory arthritis, use three or four tablets, three times a day on an empty stomach.

The only caution with Intenzyme Forte is with blood thinning agents and anemia. If the patient is on a blood thinning medication or is anemic, you must be cautious because Intenzyme Forte will reduce blood viscosity.

I don't think there is a better enzyme formulation than Intenzyme Forte available in the world for inflammation or for breaking down aberrant proteins in the body’s soft tissues. The industry standard has always been A H Robins’ product Viokase. Intenzyme Forte has always exceeded the parameters of that product.

Occasionally, and in addition to HydroZyme, we use Intenzyme Forte 1 to 2 hours after a meal to aid in intestinal or pancreatic digestion. In other words, HydroZyme (HCL) immediately after a meal for the stomach and Intenzyme Forte 2 hours after a meal to aid in pancreatic digestion.

Intenzyme Forte taken near a meal will act to digest food and when taken away from a meal (3 hours after or 30 minutes before) will aid the body by reducing inflammation and swelling.

Intenzyme Forte is another one of the products that my family and I do not travel without. I was in Southern California doing some lectures when I came down with bowel and stomach cramps one hour after eating at a restaurant (food poisoning?). I took 10 Intenzyme Forte tablets every 15 minutes for the first hour, then 10 tablets every hour for the next 3 hours and everything cleared up.

PRODUCT DESCRIPTION

INTENZYME FORTE

**Each tablet supplies:

Pancreatin (4x) 100 mg
Bromelain 50 mg
Papain 50 mg
Lipase 10mg
Amylase 10 mg
Trypsin & Alpha Chymotrypsin 100mg

SUGGESTED USE: One (1) to three (3) tablets each day, or as otherwise directed by a health care professional, to supply enzymes supplementing normal body secretions and to support the digestion of protein, carbohydrates and fats.

Contains: 50 Tablets; 100 Tablets; 500 Tablets
Product #: 1207; 1201; 1202
NDC: 55146-01207; 55146-01201; 55146-01202

ADDENDUM

INTENZYME FORTE

Activity - Pancreatin 4X NF 100 mg:

Pancreatin is a mixture of enzymes obtained from the defatting of pancreas tissues of hogs. The mixture of enzymes includes chymotrypsin, trypsin, amylase and lipase. The USP/NF assay for protease activity from pancreatin is based upon the digestion of casein under test conditions. Pancreatin 1X will contain 25 USP protease units per milligram Pancreatin 4X has four times the activity of pancreatin 1 X (100 USP units per milligram). Pancreatin 4X 100 mg as found in INTENZYME FORTE will have 10,000 USP protease units obtained from pancreatin per tablet.

Pancreatin products can be made to contain higher activity by repeated concentrations. Manufacturers typically make pancreatin products of strengths from 1X to 8X. The lipase activity of pancreatin is also standardized to contain 2.0 units of Lipase USP per milligram pancreatin 1X. The assay for lipase activity involves the measurement of olive oil digestion under test conditions. Lipase digests fats with the liberation of fatty acids, which can be measured by the known addition of sodium hydroxide to neutralize liberated fatty acids. Pancreatin 4X 100 mg contains (4 x 2 x 100) 800 USP lipase units per tablet.

The amylase activity of pancreatin is also standardized to contain 25 units of Amylase activity per milligram pancreatin 1X. The assay for amylase involves the measurement of purified soluble starch digestion under controlled conditions. Amylase digests starch into glucose and other small carbohydrate fractions from starch. Iodine reacts with starch solution to give a blue color. The intensity of blue can be measured spectrophotometrically to determine the concentration of starch under test conditions. Pancreatin 1X will digest 25 times its weight of starch into soluble carbohydrates. The pancreatin in Intenzyme Forte will contain 4X 25 units x 100 (milligrams) = 10,000 USP units of Amylase activity.

Activity - Trypsin:

INTENZYME FORTE contains 100 mg of trypsin that has 80 USP units per milligram. The USP assay for trypsin is based upon the digestion of a synthetic analog of arginine, N-benzoyi-L-arginine ethyl ester hydro-chloride. The digestion is measured spectrophotometrically at 253 nanometers. Crystalline trypsin which is 99% trypsin will contain 2500 units per milligram. Trypsin preparations for oral usage generally have a potency of between 25 and 80 units per milligram. Under the earlier (1 980s) definition of trypsin 80 NF, one NF unit of trypsin activity was that amount of Trypsin that digests 1 mg of casein under test conditions. Trypsin 80 will digest 80 milligrams of casein per milligram trypsin. The trypsin in Intenzyme Forte is such that one tablet contains 80 x 100 = 8000 USP units. USP units have replaced NF and in the case of pancreatic enzymes are equivalent expressions of activity. In the case of trypsin casein digestion was the expression of trypsin units by NF only to be refined by USP via amino acid digestion measurement. The proteolytic activity of pancreatin remains the same, i.e. casein digestion. Since trypsin = the principle protease found in pancreatin, pancreatin which contains 100 USP units per milligrams (as found in Intenzyme Forte) will assay under the conditions for trypsin to contain 100 USP trypsin units per milligram.

Therefore INTENZYME FORTE contains per tablet:

8000 USP Trypsin units from trypsin

10000 USP Trypsin units from pancreatin

18000 USP Trypsin units per tablet

Activity - Chymotrypsin:

Chymotrypsin is an endopeptidase (an enzyme that attacks peptide bonds on the interior of protein chains). Chymotrypsin hydrolyses proteins, peptides, amides and esters, especially at bonds involving the carboxyl groups of aromatic 1 -amino acids. In the commercial production of pancreatic products both trypsin and chymotrypsin are found to naturally occur together.

The USP (United States Pharmacopeia) defines chymotrypsin USP to contain no less than 1000 units of chymotrypsin and contain no more than one (1) per cent trypsin. Because there are substrates that are specific for chymotrypsin and not effected by the presence of trypsin, chymotrypsin can be accurately determined in pancreatic extracts.

Manufacturers of enzymes of pancreatic origin typically found pancreatin extracts to contain 5 USP units of trypsin for each unit of USP chymotrypsin. They do not report the chymotrypsin content in each batch of pancreatic enzymes produced. Vitamin companies often will estimate chymotrypsin values in pancreatin or trypsin tablets based upon theoretical values.

Chymotrypsin USP is available in kilogram amounts. The cost for this purified product is typically $6,000 per kilogram.

INTENZYME FORTE will contain chymotrypsin. The amount of chymotrypsin will vary between 3000 and 1000 USP units per tablet. This range is equal to between three and one milligram USP chymotrypsin per tablet. Label claims for specific values of chymotrypsin are not made because of this variance.

Activity - Papain:

Papain is a proteolytic enzyme derived from the latex of the green fruit and leaves of Carica papaya The first reports of isolated papain occurred in Science 1937 by Balls (vol. 86, p 379). The commercial preparations of Papain were begun in 1954. The enzyme has broad substrate specificity. Papain's commercial applications are very similar to those of bromelain.

The optimum pH range for papain's proteolytic activity is between pH 5 and pH 7. Below pH 3.5 papain is readily inactivated. Similar to bromelain, papain is activated by reducing substances such as cysteine. Papain is inactivated by ascorbic acid. The active site of papain is a sulfhydryl group. Metal ions such as copper, mercury, lead, zinc and iron demonstrate inhibitory effects on the proteolytic enzyme in part due to their interference at the active site.

The physical state of proteins is extremely important with respect to their susceptibility to protease hydrolysis. Native globular proteins are generally resistant to proteolytic attack due primarily to their compact tertiary structure.
Papain is available in a number of different strengths from various manufacturers. Each manufacturer has their own methodology of identifying the strength of their papain preparations. In the 1950s through the 1970s the classic method of assay for both bromelain and papain was to accurately measure the ability of the enzyme to make a known standard solution of milk to clot. Known as milk clotting units (MCU), papain and bromelain were diluted to known MCU units per gram. The dilutant was and is typically lactose (milk sugar). During the 1980s a more sensitive method of assaying those enzymes was developed by the USP (United States Pharmacopeia). The USP specification for papain USP is such that papain when measured will contain not less than 6000 USP units per milligram. One USP unit is the activity of papain that releases the equivalent of one microgram of tyrosine from casein under test conditions.

The papain used in INTENZYME FORTE is obtained from undiluted papain. The papain is standardized to the equivalent of 50 mg USP papain per tablet. The dilutant used is Biotics own vegetable culture rich in antioxidant enzymes. Each tablet contains 300,000 USP papain units from 50 mg USP papain.

Activity - Bromelain:

Bromelain is a proteolytic enzyme derived from the stems and fruit of pineapple (Ananas comosus) by water extraction, precipitation and drying. Bromelain has a broad substrate specificity that allows it to easily digest most soluble proteins. The optimum pH range for its activity is between pH 4 and pH 9. The enzyme is similar to papain in that it has a sulfhydryl active site. As such, it is remarkedly reactivated with reducing agents such as cysteine and inhibited by metal ions such as copper, mercury, lead, zinc and iron.

The first isolation of bromelain was recorded by Marcano (BU1 1.Phar. 5,77) in 1891 from the fruit of pineapple. The discovery of stem bromelain was published in Science (118,753) in 1953. Stem bromelain has a molecular weight of 33,000 and unlike papain, is a glycoprotein (carbohydrate attached to protein). Biochemically, many glycoproteins are found to have a much longer serum half-life once circulating in the plasma. This may explain the dynamic difference between papain and bromelain.

Bromelain is manufactured by a number of suppliers. Pure bromelain is generally diluted with lactose to a known strength. The most widely used unit system for bromelain is the milk-clotting unit (MCU). Bromelain is added to a known solution of milk unit the ability of the enzyme to make the milk solution clot is accurately measured. Highly purified undiluted bromelain will contain more than 4000 MCU per gram. Biotics obtains pure undiluted bromelain and standardizes it with vegetable culture to a desired potency. The vegetable culture is rich in both superoxide dismutase and catalase, which provide antioxidant stability to the enzyme.

INTENZYME FORTE has 50 mg of bromelain (1000 MCU per gram) activity per tablet. In general 50 mg of bromelain of this activity will be very similar in proteolytic action as 50 mg Papain USP. The MCU system of bromelain assay is the official FCC (Food Chemicals Codex) method for bromelain. Other unit systems include:

GDU (gelatin digesting unit) 1 GDU 2 MCU
BTU (bromelain tyrosine unit) 1 BTU 2.06 MCU

The United States Pharmacopeia (USP) and the National Formulary (NF) have not yet established a standard assay for bromelain.

INTENZYME FORTE USP units

Each tablet provides:

Pancreatin (4x) 100 mg 10,000 USP units
Bromelain 50 mg no USP definition
Papain 50 mg 300,000 USP units
Lipase 10 mg 880 USP units
Amylase 10 mg 10,250 USP units
Trypsin 100 mg 18,000 USP units
Chymotrypsin* 1 to 3 mg 1000 to 3000 USP units
Superoxide Dismutase No USP units
Catalase No USP units

*Chymotrypsin occurs with the isolation of trypsin. Trypsin is assayed with respect to its proteolytic activity. The amount of chymotrypsin varies from 1 to 3 mg per 100 mg trypsin.