At your WHO-GMP facility in Mumbai, Serratiopeptidase is a highly popular SKU, often produced as 10 mg or 20 mg enteric-coated tablets, frequently used in combination with NSAIDs like Aceclofenac or Diclofenac.

Common and Serious Side Effects

While generally well-tolerated, Serratiopeptidase can cause the following reactions in some patients:

1. Gastrointestinal Distress

The most frequent side effects involve the digestive tract, as the enzyme interacts with the gastric mucosa.

• Symptoms: Nausea, vomiting, diarrhea, stomach ache, and loss of appetite.

• Technical Note: Because it is an enzyme that breaks down proteins, it can occasionally irritate the intestinal lining if not formulated correctly.

2. Coagulation & Bleeding Risks

Serratiopeptidase has fibrinolytic activity, meaning it helps dissolve fibrin (the protein that forms blood clots).

• Risk: It may increase the risk of bleeding, especially in patients already taking anticoagulants (like Warfarin or Aspirin) or those with bleeding disorders.

• Surgical Alert: It is generally recommended to stop Serratiopeptidase at least two weeks before elective surgery.

3. Hypersensitivity (Allergic Reactions)

• Symptoms: Skin rashes, itching, or in rare cases, respiratory distress (asthma-like symptoms).

4. Rare Systemic Effects

• Joint and Muscle Pain: Some patients report generalized body aches.

• Pneumonitis: In very rare documented cases, it has been linked to eosinophilic pneumonia (lung inflammation).

Mechanism: Proteolytic Action

Serratiopeptidase works by selectively targeting “dead” or inflamed tissue without harming living cells.

Fibrinolysis: It breaks down fibrin, a tough protein that forms a mesh at the site of inflammation, which helps thin the fluids and allows them to drain more easily.

Bradykinin Hydrolysis: It thins the inflammatory exudate and inhibits the release of bradykinin, a chemical that triggers the sensation of pain.

Biofilm Disruption: In infectious cases, it helps break down bacterial biofilms, allowing antibiotics to reach the infection site more effectively.

The Pharmacist’s “Technical Strategy”

• The “Enteric-Coating” Rule: As a manufacturer, this is your most critical quality control point. Serratiopeptidase is acid-labile, meaning it is destroyed by stomach acid. It must be formulated as an enteric-coated tablet to ensure it reaches the small intestine intact for absorption.

• The Empty Stomach Mandate: For maximum efficacy, it should be taken at least 30 minutes before a meal or 2 hours after. Taking it with food causes the enzyme to focus on digesting the proteins in the meal rather than the inflammation in the body.

• The Synergy USP: On your digital platforms, highlight its use as an “Enzyme-NSAID Synergy.” It enhances the penetration of painkillers and antibiotics into the target tissue, reducing the overall dose required.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

• Combination Exports: Your Aceclofenac + Paracetamol + Serratiopeptidase tablets are likely a top-seller. Highlighting this “Triple Action” on your marketplace attracts orthopedic and dental buyers.

• Stability for Export: Serratiopeptidase is sensitive to moisture and high temperatures. Utilizing Alu-Alu blister packaging is essential to maintain a 24-36 month shelf life in Zone IVb tropical regions.

• Dossier Support: Ensure your CTD/eCTD Dossiers emphasize the enzyme’s source and purification standards (measured in Units of activity, e.g., 20,000 IU), as international regulatory bodies are strict about enzyme purity.