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Rupture Test - A Quick and Easy Test to Avoid Soft Gel Capsule Failure

A free white paper by Brookfield AMETEK Inc

When soft gel capsules rupture during production or handling, no one like it and it is messy. Even worse is if the active ingredients fail to escape the capsule, as designed, at an appropriate time (by rupture, dissolution, or melting), due to Although the FDA has yet to endorse the rupture test as an alternative to dissolution or disintegration testing, it has gained fast popularity among manufacturers of soft gel capsules. The rupture test, a form of hardness testing, is a quick and easy way for qualifying and quantifying the film strength, which is also the bursting strength of a soft gelatin capsule. A recent study to investigate differences between the rupture test and the disintegration test using soft-shell capsules revealed that the results from the rupture and the disintegration tests proved that both tests are comparable and equally sensitive in detecting simulated production deficiencies or storage conditions of soft-shell capsules (1).

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