Comparison of the rupture and disintegration tests for soft-shell capsules

May Almukainzi, Mahnor Salehi, Nadia A.B. Chacra, Raimar Löbenberg

Research output: Contribution to journalArticleResearchpeer-review

9 Citations (Scopus)

Abstract

The USP General Chapter <2040> Disintegration and Dissolution of Dietary Supplements introduced a rupture test as a performance test of soft-shell capsules. Traditionally, the disintegration test was used for determining the disintegration time of all solid oral dosage forms. The aim of this investigation was to investigate differences between the rupture test and the disintegration test using soft-shell capsules. Five different soft-shell capsule products were chosen based on their filling contents and treated to simulate a production deficiency. The study design compared capsules as received with capsules that were treated by coating them with the liquid contents of another capsule. The capsules were incubated at room temperature and at 40 °C. The tests were repeated after two weeks, and at each time point, twelve capsules of each product were tested using the rupture and the disintegration tests. Six capsules were tested untreated, while the other six capsules were treated. Rupture and disintegration times were recorded as dependent variables in each experiment. The data were analyzed using ANOVA. According to the USP definition for disintegration, the rupture of a soft-shell capsule can be seen as fulfilling the disintegration criterion if the capsule contents is a semisolid or liquid. Statistical analysis showed no advantage of the rupture test over the disintegration test. On a product-by-product basis, both tests were sensitive to certain investigated parameters. A noticeable difference between both tests was that in most cases, the rupture test reached the defined endpoint faster than the disintegration test. Soft-shell capsules that are subject to a Quality by Design approach should be tested with both methods to determine which performance test is the most appropriate test for a specific product.

Original languageEnglish
Pages (from-to)21-25
Number of pages5
JournalDissolution Technologies
Volume18
Issue number1
DOIs
Publication statusPublished - 1 Jan 2011

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Capsules
Rupture
Dosage Forms
Dietary Supplements
Analysis of Variance
Temperature

Cite this

Almukainzi, May ; Salehi, Mahnor ; Chacra, Nadia A.B. ; Löbenberg, Raimar. / Comparison of the rupture and disintegration tests for soft-shell capsules. In: Dissolution Technologies. 2011 ; Vol. 18, No. 1. pp. 21-25.
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Comparison of the rupture and disintegration tests for soft-shell capsules. / Almukainzi, May; Salehi, Mahnor; Chacra, Nadia A.B.; Löbenberg, Raimar.

In: Dissolution Technologies, Vol. 18, No. 1, 01.01.2011, p. 21-25.

Research output: Contribution to journalArticleResearchpeer-review

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