Composition and Mechanism of Action
Pancreatin (Pancreatinum) is an extract derived from the bovine pancreas. The drug contains key pancreatic enzymes required for the hydrolysis of nutrients.
Enzyme composition per 1 g of pure substance:
- Amylase and proteases: 25,000 IU.
- Lipase: 200 IU.
Its mechanism of action is replacement enzyme therapy. Upon entering the gastrointestinal tract, these enzymes compensate for the insufficient secretory function of the patient's own pancreas, ensuring the breakdown of proteins, fats, and carbohydrates into absorbable monomers.
Pharmacological Effects and Dosing
The primary clinical effect of the drug is the normalization of digestive processes in exocrine insufficiency.
Key dosing rule: The patient's requirement and daily dose are determined exclusively by the lipase content. There is a direct correlation between the degree of exocrine pancreatic insufficiency and the required lipase dose. The standard daily dose of pure pancreatin is 5–10 g (taken orally as 0.5–1.0 g per dose).
Indications for Use
Single-component pancreatin preparations are prescribed for the following conditions:
- Chronic pancreatitis (as baseline replacement therapy).
- Hepatopancreatic digestive disorders.
- Gastritis with reduced acidity (anacid and hypoacid states), when deficient gastric secretion requires compensation at the intestinal digestion phase.
Side Effects and Contraindications
The drug is generally well-tolerated. In rare cases, allergic reactions may occur since the active substance is an animal-derived protein.
Absolute contraindication — acute pancreatitis (or an exacerbation of destructive chronic pancreatitis). Pathophysiological rationale: In acute conditions, secretion outflow is impaired, and enzymes are activated (such as trypsin converted from proenzymes directly within the pancreatic tissue). This triggers autolysis ("self-digestion") and necrosis. Administering exogenous enzymes in this scenario is contraindicated; instead, protease inhibitors (antienzyme drugs) are administered intravenously by drip to inactivate trypsin and block free kinins.
Analogs and Modern Dosage Forms
The market features numerous pancreatin-based medications, divided into two broad groups: bile-free (pure) and bile-containing.
1. Single-component analogs (bile-free) These include Mezim and Triferment. Their composition matches standard pancreatin. They are typically administered before meals (1–3 dragees 3 times daily).
2. Microgranular formulations Representative example: Creon. This is pancreatin encapsulated in microgranules. Its pharmacokinetic feature is that it dissolves only in the small intestine at pH $\ge$ 5.0, ensuring optimal mixing with the food bolus (chyme). The dosage can reach up to 12 capsules daily, taken with fluid.
3. Combination drugs (containing bile and extracts) Examples: Festal, Digestal, Enzistal, Panzinorm. In addition to pancreatin, they contain:
- Bile components: provide a choleretic effect (true choleretics), promote fat emulsification and absorption, as well as fat-soluble vitamins.
- Hemicellulase (in Festal): breaks down plant fiber, improving enzyme access to food and reducing flatulence.
- Gastric mucosal extract (in Panzinorm): formulated as a dual-layer dragee, where the outer layer dissolves in the stomach and the inner layer (acid-resistant) dissolves in the intestine.
Note: The presence of bile introduces strict contraindications — severe liver disease with hyperbilirubinemia, acute hepatitis, and intestinal/biliary obstruction (obstructive jaundice).
Place Among Other Enzymes
To understand digestive pharmacology, pancreatin must be distinguished from plant- and fungal-derived enzyme preparations:
- Nigedase (from black cumin seeds): possesses only lipolytic activity. Its activity depends on pH (less active at low acidity, requiring administration with gastric juice). Due to the lack of proteases and amylases, it is often combined with pancreatin.
- Solizym (from a mold fungus): also hydrolyzes fats exclusively. Used for isolated reductions in lipolytic activity.