Serrapeptase : Mechanism of Action, Recommended Dosing, and Safety Profile

Serrapeptase or serratiopeptidase is a proteolytic enzyme that breaks down proteins into their smaller subunits known as amino acids. It is obtained from the bacteria Serratia marcescens which is present inside the intestine of silkworms. It was first discovered in Japan in the year 1967 for its anti-inflammatory property. It also possesses properties such as fibrinolytic (dissolve fibrin a clotting agent), analgesic, and atherosclerotic properties. It is an enzyme that has a greater affinity towards many substrates due to this it is used in a variety of ways including surgery, orthopaedics, gynaecology, and dentistry.^[1]

Serratiopeptidase is well known for its effectiveness in transforming various target molecules into the right effector due to its properties such as powerful target binding, selectivity, and catalytic action. Due to this, it is useful in a wide range of infections particularly from pediatric to elderly age group patients. The research was conducted in Japan between 1980 and 1990 and the scientist found that it was the best enzymatic preparation that is available now to treat inflammation as compared to other enzymatic preparation.

Serratiopeptidase works in three different ways:

1. It increases the cardiovascular system’s health by dissolving fibrin, a blood clotting agent without harming the other healthy tissue inside the body.
2. It helps in the reduction of inflammation by thinning the fluid that is formed during injury or increasing the drainage of fluid which results in speedy recovery. It also reduces certain inflammatory mediators such as bradykinin, which is essential to inflammation.
3. It also works as an analgesic by reducing the release of certain amines that are responsible for causing pain.^[1]

History: Initially, serratiopeptidase was given parenterally but later the parenteral formulation was replaced by the oral formulation and given in the form of a tablet. It was marketed under the brand name Danzen. When it is used in the form of a tablet a problem emerges that it is degraded by the digestive juices that are present inside the stomach and it fails to reach the intestinal region hence it is very poorly absorbed. To overcome this problem in the 1960s its formulation was replaced with the oral enteric-coated tablet.^[2] The enteric-coated tablet provides the advantage that this formulation is not degraded by the digestive juices that are present inside the stomach instead of this it safely riches to the intestinal region and breakdown there and gets absorbed from there. In this way, its absorption is increased and now its enteric-coated type formulation is used most widely.^[2] Moreover, controlled and sustained-release tablet formulations are gaining more value because they decrease the frequency of dosing and also improve patient compliance.

Dosing: The dosing of serratiopeptidase or any other enzyme depends on a variety of individual factors such as individual health, the severity of the disease, and the physical condition of the body. However, a normal adult dosage of serrapeptase is 10mg tablet 3 times a day taken with water usually after 2 hours of the meal, and for better results, it should be taken on an empty stomach.^[6] The duration of its use is usually dependent on the condition for which it is used, when it is used as an anti-inflammatory agent it is used for 1 week and when it is as used as a mucolytic agent it is used for up to 4 weeks.^[3] Its maximum dose should be 60mg/day. More than this will lead to toxicity of this enzyme. The enzymatic activity is measured in terms of units with 10mg equivalent to 20,000 units of enzyme activity.^[4]

For Reducing Swelling Inside The Cheek: when it is used after sinus surgery to reduce inflammation inside the cheek the dose of 10mg 3 times on the day of surgery, once in the evening after surgery, and then 3 times daily for 5 days following surgery.^[5]

It is well known that orally taken serratiopeptidase tablet gets absorbed from the intestinal region and finally reaches the blood and from blood, it reaches its target site and shows its action. The intestinal absorption was tested in rats and scientists have found that the concentration of serratiopeptidase in plasma and lymph is usually dose dependent. Furthermore, research was conducted by Moriya et al. and they found that the concentration of serrapeptase is more in inflammatory tissue as compared to the other healthy tissue and plasma.^[7]

Serratiopeptidase is a natural molecule and considered safe because there are no severe side effects are reported till now. The safety of this enzyme is supported by many clinical studies that are conducted so far. However, some studies have reported very rare side effects such as stevens-johnson syndrome which occurs only in very few patients so we can say that serratiopeptidase is safe in normal adult however there are no clinical studies are conducted so far that determines its safety in pregnancy and lactating mother. So, it is better to avoid the use of serratiopeptidase in the case of a pregnant mother and a breastfeeding mother.

Various factors affect the dosing of serratiopeptidase such as

The Health Of The Individual: The health of the individual is a deciding factor for the determination of dosing. In the case of a normal individual, the dose is 10mg 3 times a day, or when a person has hepatic failure or any other liver disease this case dose of serrapeptase is reduced to avoid toxicity.

The Medical Condition Of The Patient: The dose may vary according to the disease condition of the patient for example for acute inflammation the dose is different from the dose that is used in case of chronic inflammation.^[4]

The Severity Of The Condition: The dose of serrapeptase also varies according to the severity of the condition for example in the case of a severe condition dose should be higher while in the case of a mild condition, the dose should be lower.^[3]

Other than this the age of the patient, sex of the patient are some other factors on which the dose of the serrapeptase is dependent.

Serrapeptase is an enzymatic preparation used to treat various conditions such as inflammation, pain, and atherosclerosis. The dose of this enzyme may depend on the age and the diseased condition of the patient, so it is necessary to visit the physician for accurate dosing and to avoid any contraindications. However, it is considered a very safe enzymatic preparation for the treatment but very few side effects are associated with it. More clinical trials are recommended to determine its safety in pregnant women and breastfeeding mothers.

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