EEK DR capsule composition:
HPMC, gellan gum, alginate, purified water and other exipients.
Structure: One layer
EEK disintegration test:
Dynamic disintegration test with filled capsules
6 x EEK DR caps, HPMC Size 0#
Filled with test mix of peapowder, starch and spirulina blue colorant (as a natural indicator)
Fill weight 350mg
Disintegration apparatus Sotax DT50
Small disks
No sinker used
Observation: average disintegration time is 31:06 min:sec
Capsugel testing methods:
To test the applicability of Vcaps DR as acid resistant capsules, Capsugel uses in vitro dissolution and disintegration tests. Capsugel used both tests on its DR capsules. Although a capsule might not appear to visibly disintegrate it can still release its active ingredients and a dissolution test will document this. Thus using both tests can provide a fuller picture of drug-release mechanism and can ensure batch to batch consistency.
Capsugel has adapted dissolution and disintegration testing method based on available compendia standards (USP) and has defined specifications in line with the proposed functionality of VcapDR capsules.
Capsugel disintegration test:
DR caps are tested based on an adapted method using a Sotax DT2 or equivalent disintegration tester, with USP conformity. They do not use the USP method for disintegration testing of delayed release dosage forms as described in USP 701.
DR caps are tested filled with approx 400mg mixture of lactose and 0,1% B2 blue pigment. The pigment allows early detection of leaks and a better visual evaluation of the disintegration.
The capsules are put in a sinker of the appropriate size in order to avoid opening of the capsules during the test. Note this is not acoording to the USP test. Oscillation of the baskets for 30 minutes. Note this is only half of the time of the USP test.
The test is designed to document by visual observation, that the capsules will remain intact and without any leakage for 30 minutes. (versus 1hr for the USP definition). The test is used for QA release of produced batches by testing 12 capsules.
The specifications for the disintegration time on the capsugel COA are set on "Greater than 30:00 min/sec" (USP states 1hr).