Serratiopeptidase Enteric-Coated Tablets

Serratiopeptidase — INN serrapeptase, accepted enzyme name serralysin, EC 3.4.24.40 — is an extracellular zinc metalloendopeptidase secreted by Serratia marcescens ATCC 21074, formerly designated Serratia sp. E-15, the organism isolated from silkworm intestine in the late 1960s. UniProt entry P23694 records 487 residues and a mass of 52,105 Da, with one catalytic Zn(2+) and seven Ca(2+) ions bound per molecule; the enzyme sits in peptidase family M10. Its specificity is preferential cleavage of peptide bonds with hydrophobic residues in P1', and its pH optimum for digesting protein substrates is about 9 to 10 — alkaline chemistry that explains the dosage form, since the enzyme is acid-labile and would be denatured in the stomach if presented as a plain tablet. That is why Thovek supplies the material as an enteric-coated tablet. The coat resists simulated gastric fluid and releases in the intestinal buffer stage, and both stages are checked on every batch as part of disintegration testing. Batch potency is declared in enzyme units alongside the milligram label strength, and the unit system and assay are written into the approved formula rather than assumed — proteolytic unit systems are assay-defined and do not convert between one another, so a unit figure without its assay is meaningless on a purchase specification. The enzyme is produced by submerged microbial fermentation, so the active itself carries no bovine, porcine, marine or other animal material; excipient selection, including vegetable-source magnesium stearate and lactose-free diluents, is confirmed in writing before compounding. Bulk enzyme powder with declared unit potency is available for buyers who compress and coat in-house. This product needs an honest word on status. Serratiopeptidase does not sit in one regulatory box: India and several Asian markets treat it as a drug substance, with finished tablets made and exported under a drug licence and the associated documentation, while other markets trade it as a supplement ingredient. Published reviews of the clinical literature describe the trial evidence as small in scale and generally poor in methodological quality. Thovek accordingly makes no therapeutic, health or disease claim for this material, supplies no claim language in artwork, and describes it only by its composition and enzymatic function. Confirming the destination market's classification, permitted claims, licensing and import requirements before ordering is the buyer's responsibility, and we will support the dossier with full manufacturing and analytical documentation.