Pancreatin (Pancreatic Enzymes)

Pancreatin is a pharmaceutical‑grade preparation of pancreatic digestive enzymes—principally amylase, lipase, and proteases (trypsin, chymotrypsin, and elastase). It is used to replace or augment the endogenous pancreatic secretions that are deficient or impaired, thereby facilitating the digestion and absorption of nutrients from the gastrointestinal tract.

Pancreatin is not a single molecule but a mixture of protein enzymes with distinct structures:
- Amylase (≈50 kDa), a globular protein with a catalytic (β/α)8‑barrel domain and an active‑site Asp‑Glu‑Asp motif.
- Lipase (≈50 kDa) belongs to the α/β‑hydrolase family, featuring a catalytic triad (Ser‑His‑Asp) and a lid domain that opens in the presence of lipid substrates.
- Trypsin/Chymotrypsin (≈24 kDa) are serine proteases with a conserved catalytic triad (His‑Asp‑Ser) and a substrate‑binding pocket that determines specificity (basic residues for trypsin, aromatic residues for chymotrypsin).
The enzymes are glycoproteins; their molecular formulas are approximated as C≈3000–4000 H≈5000–7000 N≈900–1200 O≈1000–1500 S≈20–30, reflecting the average amino‑acid composition. The preparation is standardized by lipase activity (U), which reflects the number of micromoles of fatty acid released per minute under assay conditions.

Commercial pancreatin is derived primarily from porcine (pig) pancreas, with bovine sources used in some regions. The pancreas is harvested under GMP‑compliant slaughter conditions, then minced, homogenised, and subjected to controlled enzymatic extraction (often using low‑pH buffers) to preserve activity. The extracts are purified by ultrafiltration and lyophilised, often with a protective coating (e.g., enteric polymer) to protect the enzymes from gastric acid. Quality control includes assay of lipase, amylase, and protease activities (U/g), testing for bacterial endotoxins, and verification that no residual viral particles (e.g., porcine circovirus) are present. Some manufacturers produce recombinant human pancreatic enzymes (e.g., recombinant lipase) in yeast or mammalian cell cultures, offering a non‑animal alternative with comparable activity.**