Why Serratiopeptidase?

Inflammation is the body’s initial response toward injury. It is the first step of the healing process and also serves as a mechanism to protect the body from viruses and bacteria. Usually, once our body recovers, inflammation returns to normal and healthy levels. However, when inflammation persists, it can cause serious pain and damage to the body by limiting joint function and destroying bone, cartilage, and other particular structures. Non-Steroidal Anti Inflammatory Drugs (NSAIDs) including over-the-counter aspirin, ibuprofen, salicylates, and naproxen are the most popular medications for inflammation to treat such disorders (1). However, numerous researches indicate that such treatment is not without serious risk. In fact, some studies specified that naproxen and ibuprofen having lethal effects on cartilage metabolism and inhibited matrix synthesis (2). Another study among patients who had been relying on NSAIDs for a period of six months or longer showed gastroduodenal lesions and ulcers. These patients could no longer continue the use of NSAIDs due to such symptoms. The study suggested that an alternate method without the side effects of NSAID was necessary for treatment (3). Interesting enough, enzymes were actually utilized as an anti-inflammatory in modern medicine in the U.S. as far back as the 1950s (4). Later, Japanese and European research weighed against numerous protein enzymes and found that serratiopeptidase was very effective in reducing inflammation reaction (5, 6).

What is Serratiopeptidase?

Serratiopeptidase, also known as serrapeptase, is a proteolytic enzyme excreted by the nonpathogenic Enterobacteria serratia isolated from the intestine of silkworms. This enzyme is now processed commer-cially through fermentation, and is widely recognized throughout Asia and Europe for treatment related to inflammation. Its minimal side effects and efficacy have drawn much attention in the U.S. as of late. Serratiopeptidase has a distinctive ability to digest the dead tissue of the cocoon of the silkworm so that the moth may emerge. In the same way, this systemic enzyme breaks down protein deposits in human body, known as fibrin, which is believed to be one of the causes of chronic inflammation.

Serratiopeptidase also treats inflammation by thinning the fluids in the body as a result of injury, making fluid drainage smoother. It can digest or break down protein and facilitate fibrinolytic activity in the blood and modify molecules that guide inflammatory cells to their targets (6). This activity includes the digestion of scar tissue, blood clots, cysts, mucus, arterial plaque, and all types of inflammation. Serratiopeptidase reduces internal issue edema and inflammation caused at post-operating handling. Reduction in edema reduces changes of rupture at tissue (7). It can also block the pain-inducing amines from swollen tissues (6). In a double-blind study, patients treated with serratiopeptidase became pain-free more quickly than the other two controlled groups (8).

Benefits of Serratiopeptidase

· Inflammation

Serratiopeptidase acts in three ways to reduce inflammation; it breaks down insoluble protein byproducts of blood coagulation and thins the fluids formed from inflammation and injury as well as facilitating the rate of tissue repair process. Serratiopeptidase eases pain through blocking the release of pain inducing amines (8, 9, 10).

· Natural and safe alternative for NSAIDs Recognized by physicians and successfully used throughout Asia and Europe as anti-inflammatory and pain-blocker, serratiopeptidase is used as a safe alternative with little or no side effects to salicylates, buprofen, and other NSAIDs (11).

The Limitations of Serratiopeptidase

Serratiopeptidase is an enzyme, and thus, is susceptible to degradation. It is particularly vulnerable to acidic pH, i.e. stomach and bile acid. Thus, oral administration of serratiopeptidase without any kind of protection would render the enzyme useless. When consumed in an unpreserved tablet or capsule, the enzyme is damaged by acid in the stomach. In order to obtain an ideal therapeutic outcome, serratiopepti-dase must be protected and delivered to the intestine intact.

©2010 CTC International, LLC. All rights reserved.

World Leader in Coating Delivery System (CDS) Technology

Enteric Coated Serratiopeptidase /mg

Serratiopeptidase 1600U~2600U

Serratiopeptidase Granules Enteric Coated

Recognizing the importance of such release mechanism, CTC has developed an enteric coated serratiopeptidase granule, eSPTM. Due to the fact that the stomach has very acidic pH, enteric coated serra-tiopeptidase granule is formulated to remain stable in such acidic conditions, and then rapidly break down in neutral pH. This grants serratiopeptidase enzymes to be absorbed in the intestine with full efficacy.

eSP™- Enteric Coated Serratiopeptidase Granule

· Enteric Coated Granule

Serratiopeptidase alone easily denatures in gastric acid. However, for full efficacy, it is necessary for serratiopeptidase to be absorbed in the intestine. As such, CTC

has developed enteric coated serratiopepti-dase granules to guarantee the safe delivery of the enzyme to the designated location.

· Flexibility CTC’s serratiopeptidase granules do not require an enteric-coating capsule or tablet

delivery system. Thus, it yields flexibility and optimization for formulation. Also eSPTM free flowing granules are easy to handle and are void of typical safety hazards when dealing with non-enteric coated enzymes during

production.

· High serratiopeptidase activity (>2,220,000u/g) with a long, stable 36-month shelf life

Note: These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease. Legal status of our products may vary from country to country - local applicable regulations should always be considered and assessed prior to use of products.

References

1. Raskin JB. Gastrointestinal effects of nonsteroidal anti-inflammatory therapy. Am J Med. 1999. 106(5B):3S-12S.

2. Dingle JT. The effects of NSAID on the matrix of human articular carti lages. Z. Rheumatol. 1999. 21(7):1131-57.

3. Cheatum DE, Arvanitakis C, Gumpel M, Stead H, Geis GS. An endoscopic study of gastroduodenal lesions induced by nonsteroidal anti-inflammatory drugs. Clin Ther. 1999.21(6):992-1003.

4. Sherry S, Fletcher AP. Proteolytic enzymes: a therapeutic evaluation. Clin Pharmacol Ther 1960.192:202-26.

5. Kakinuma A, Moriya N, Kawahara K, Sugino H. Repression of fibrinolysis in scalded rats by administration of Serra-tiaprotease. Biochem Pharmacol 1982.31(18):2861-6.

6. Mazzone A, Catalani M, Costanzo M, Drusian A, Mandoli A, Russo S, Guarini E, Vesperini G. Evaluation of Serratia-peptidase in acute or chronic inflammation of otorhi-nolaryngology pathology: a multicentre, double-blind, randomized trial versus placebo. J Int Med Res. 1999.18(5):379-88.

7. Abedin E. “Serratiopeptidase: The miracle of microbial enzyme.” Internet Edition The New Nation. Nov.9, 2008. <http://www.ittefaq.com/issues/2008/11/09/news0563.htm>.

8. Esch PM, Gerngross H. Fabian A. Reduction of postopera-tive swell ing. Objective measurement of swell ing of the upper ankle joint in treatment with serrapeptase-a pro-spective study (German). Fortschr. Med. 1989.107(4):67-8, 71-2.

9. A. Rothschild, J. Clinical use of serrapeptase: an alterna-tive to Non-steroidal anti-inflammatory agents, The American Chiropractor. 1991.P17.

10. Yamasaki H, Tsuji H, Saeki k. Anti-inflammatory action of a protease, TSP, produced by Serratia (in Japanese). Nippon Yakurigaku Zasshi. 1967.63(4):302-14.

11. Aso T et al. Breast engorgement and its treatment: Clini-cal effects of Danzen an anti-inflammatory enzyme prepa-ration. The world of Obstetrics and Gynecology (Japanese). 1981.33:371-9.

©2010 CTC International, LLC. All rights reserved.

For more information, please contact us at

(714) 782-7690 or

tomchoi@ctcbio.com

World Leader in Coating Delivery System (CDS) Technology

Serratiopeptidase Granules Enteric Coated

Key Benefits

· Enteric Coated Serratiopeptidase Granule

· Flexibility for Formulation

· Long & Stable Shelf Life

Enzyme Activity Test (after 2 hrs in pH 3.2)

Enzyme Activity Loss in the Stomach

CTC eSPTM Company A

Enzyme Activity (U/mg) 2,500

2,000

1,500

1,000

500

0