Action and use
Enzyme; treatment of pancreatic exocrine deficiency.
Preparations
Pancreatin Gastro-resistant Capsules
Pancreatin Granules
Pancreatin Gastro-resistant Tablets
DEFINITION
Pancreatin is a preparation of mammalian pancreas containing enzymes having protease, lipase and amylase activity. It may contain Sodium Chloride.
Potency
Pancreatin contains in 1 mg not less than 1.4 Units of free protease activity, not less than 20 Units of lipase activity and not less than 24 Units of amylase activity.
PRODUCTION
Pancreatin is prepared in conditions designed to minimise the degree of microbial contamination.
CHARACTERISTICS
A white or buff amorphous powder.
Soluble or partly soluble in water forming a slightly turbid solution; practically insoluble in ethanol (96%) and in ether.
IDENTIFICATION
A. It demonstrates free protease activity in the Assay for Free protease activity.
B. Triturate 0.25 g with 10 mL of water and adjust to pH 8.0 by the addition of 1M sodium hydroxide using cresol red solution as indicator. Divide the resulting solution into two equal portions. Boil one portion [solution (1)] and leave the other untreated [solution (2)]. Dissolve 0.1 g of soluble starch in 100 mL of boiling water, boil for 2 minutes, cool and dilute to 150 mL with water. Add solution (1) to half the starch mucilage and solution (2) to the remainder and maintain the mixtures at 38° to 40° for 5 minutes. To 1 mL of each mixture add 10 mL of iodinated potassium iodide solution. The liquid containing solution (2) retains the colour of the solution of iodine and the liquid containing solution (1) acquires an intense blue colour.
TESTS
Fat
Extract 1 g with petroleum spirit (boiling range, 40° to 60°) for 3 hours in an apparatus for the continuous extraction of drugs, Appendix XI F, evaporate the extract and dry the residue at 105° for 2 hours. The residue weighs not more than
30 mg.
Loss on drying
When dried at 60° at a pressure not exceeding 0.7 kPa for 4 hours, loses not more than 5.0% of its weight. Use 0.5 g.
Microbial contamination
1 g is free from Escherichia coli; 10 g is free from Salmonella, Appendix XVI B1.
ASSAY
Carry out the Assay of pancreatin, Appendix XIV I.
STORAGE
Pancreatin should be stored at a temperature not exceeding 15°.
LABELLING
The label states (1) the minimum number of Units of activity of free protease, lipase and amylase per mg; (2) the name of any added substance; (3) the date after which the material is not intended to be used; (4) the conditions under which it should be stored.
