US EPA

1316000 

Technical Report 

Production of enteric coated capsules 

Jones, BE 

1970 

SYRACUSE RES CORP 

IPA/71/30184 

Chem 

REF 39 

53-57 

eng 

IPA COPYRIGHT: ASHP The production of enteric coated hard gelatin capsules on a commercial scale is reported. The object of the study was to try and produce an enteric coating which was as clear as possible so that it did not mask either the brilliance of the capsule color or any printing. A literature search revealed that many methods and materials, both natural and synthetic, are available for the bench scale dispensing of enteric coated capsules, and that a suitable technique for their large scale production would be the air suspension method of coating. This survey also indicated that the British Pharmacopoeia in vitro test for enteric coated capsules most closely approximated in vivo conditions and that this test would be most applicable for the study. Pilot scale work was done using a Wurster coater, and final experiments were made on a Glatt fluidized bed spray film coater. The problem of separation during vigorous handling was overcome by using the Lok-Caps locking capsule. The most satisfactory coat both for performance and appearance was obtained using cellulose acetate phthalate in acetone with diethyl phthalate as a plasticizer. The amount of coating solution used was 4 mg./cm.2, which gave a coat approximately 30 microns thick. These capsules withstood mechanical abrasion and showed no increase in disintegration time in an accelerated storage test at 45DGC. 

Capsules; enteric coated; hard gelatin; Coatings; enteric; capsules; Disintegration; time; capsules; Formulations; enteric; Cellulose; acid phthalate; Equipment; enteric