When soft gel capsules rupture during production, packaging or subsequent handling, the damage is oftentimes more extensive than just the single capsule that fails. When consumed by patients, if the active ingredients in soft gel capsules fail to escape as designed at the appropriate time (by rupture, dissolution, or melting), then the product is a failure. Both types of problems are due to non-conforming capsule film strength. How can you predict these types of problems before they occur? Performing a simple rupture test is the quickest way to avoid these potential disasters. Although the FDA has yet to endorse the rupture test as an alternative to dissolution or disintegration testing, it has gained 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 both tests are comparable and equally sensitive in detecting simulated production deficiencies that cause non-conforming film strength. As the product-to-market timeline for new pharmaceutical formulations becomes tighter, it is essential to efficiently quantify the critical properties of soft gel capsules that affect product performance. There are several ways to perform a rupture test on soft gel capsule with a Texture Analyzer, an instrument that can cause materials to deform in compression or tension. (Figure 1) One such method uses a 2 mm cylinder probe (Figure 2) to penetrate into the test sample until rupture. The TA-CJ Fixture (Figure 3) is used to secure the soft gel capsule in place for the rupture test. A single compression test on the soft gel capsule detects and measures the weakness in a gelatin film or seal; this test therefore simulates circumstances whereby a capsule may burst during manufacturing, packaging or handling. It can also quantify the elasticity of the gel capsule shell by measuring its deformation at peak load. The Texture Analyzer gives quality control the necessary tool to guarantee compliance with R&D performance specifications. Most Texture Analyzers are complemented with an array of fixtures, probes and accessories to accommodate test requirements for the varied shapes and sizes used in capsule design. Rupture test methods involve choice of probe type and penetration speed. Applying a fixed sustained load is another method for conducting a rupture test. Overall the testing must produce quantifiable results that guarantee the gelatin capsule will behave correctly during processing and use by consumer. VISCOMETERS RHEOMETERS TEXTURE ANALYZERS POWDER FLOW TESTERS ISO 9001 CERTIFIED T: 800.628.8139 / 508.946.6200 www.brookfieldengineering.com Figure 1: Brookfield CT3 Texture Ana- lyzer Figure 2: Performing rupture test on soft gel capsule Figure 3: TA-CJ Fixture fpr holding down test sample Rupture Test a quick and easy test to avoid soft gel capsule failure
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
-
When soft gel capsules rupture during production, packaging or subsequent handling, the damage is oftentimes more extensive than just the single capsule that fails. When consumed by patients, if the active ingredients in soft gel capsules fail to escape as designed at the appropriate time (by rupture, dissolution, or melting), then the product is a failure. Both types of problems are due to non-conforming capsule film strength. How can you predict these types of problems before they occur? Performing a simple rupture test is the quickest way to avoid these potential disasters.
Although the FDA has yet to endorse the rupture test as an alternative to dissolution or disintegration testing, it has gained 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 both tests are comparable and equally sensitive in detecting simulated production deficiencies that cause non-conforming film strength.
As the product-to-market timeline for new pharmaceutical formulations becomes tighter, it is essential to efficiently quantify the critical properties of soft gel capsules that affect product performance. There are several ways to perform a rupture test on soft gel capsule with a Texture Analyzer, an instrument that can cause materials to deform in compression or tension. (Figure 1) One such method uses a 2 mm cylinder probe (Figure 2) to penetrate into the test sample until rupture. The TA-CJ Fixture (Figure 3) is used to secure the soft gel capsule in place for the rupture test. A single compression test on the soft gel capsule detects and measures the weakness in a gelatin film or seal; this test therefore simulates circumstances whereby a capsule may burst during manufacturing, packaging or handling. It can also quantify the elasticity of the gel capsule shell by measuring its deformation at peak load. The Texture Analyzer gives quality control the necessary tool to guarantee compliance with R&D performance specifications.
Most Texture Analyzers are complemented with an array of fixtures, probes and accessories to accommodate test requirements for the varied shapes and sizes used in capsule design. Rupture test methods involve choice of probe type and penetration speed. Applying a fixed sustained load is another method for conducting a rupture test. Overall the testing must produce quantifiable results that guarantee the gelatin capsule will behave correctly during processing and use by consumer.
VISCOMETERS RHEOMETERS TEXTURE ANALYZERS POWDER FLOW TESTERSISO 9001 CERTIFIED
T: 800.628.8139 / 508.946.6200www.brook�eldengineering.com
Figure 1: Brookfield CT3 Texture Ana-lyzer
Figure 2: Performing rupture test on soft gel capsule
Figure 3: TA-CJ Fixture fpr holding down test sample
Rupture Testa quick and easy test to avoid soft gel capsule failure
-
The rupture test is performed by positioning the soft gel capsule with its seal perpendicular to the direction of travel for the cylinder probe, which penetrates and ruptures the sample at a constant speed. The Texture Analyzer, working in either standalone or computer-controlled mode, measures the force needed to rupture the tablet. The force values obtained will depend on the construction and size of the soft gel capsule. Using a dedicated software program to run the test, Fig. 4 shows a typical plot of force load (g) vs. time (s) as the test progresses. The highest force value on the graph is described as the soft gel capsule maximum strength before rupturing (Figure 4). Harder samples will give a higher peak load and a higher hardness work done (energy required to deform sample to the defined deformation distance).
The rupture test is a quick and easy way for qualifying and quantifyng the film strength of soft gel capsules. It is a straightforward, destructive test designed to measure critical points of physical failure in the sample. Meaningful test data collected can be used for new product development, quality control, and production efficiency. It ultimately ensures soft gel capsule consistency between different batches, shifts, and plants, thus guaranteeing a consistent product no matter where it is manufactured.
References:1. May Almukainzi, Mahnor Salehi, Nadia A. B. Chacra, and Raimar Löbenberg, “Comparison of the Rupture and Disintegration Tests for Soft-Shell capsules” in Dissolution Technologies Feb 2011.
VISCOMETERS RHEOMETERS TEXTURE ANALYZERS POWDER FLOW TESTERSISO 9001 CERTIFIED
T: 800.628.8139 / 508.946.6200www.brook�eldengineering.com
Figure 4: Graph shows the rapture force and elasticity of a soft gel capsule
Author: Eric Chiang (Product Manager - Texture Analyzers) Brookfield Engineering Laboratories, Inc., 11 Commerce Blvd., Middleboro, MA 02346 Tel: (800) 628.8139 Fax: (508) 946.6262 Email: [email protected] Website: http://www.brookfieldengineering.com VertMarkets - Pharmaceutical Online - Reprint Permission - July 2013
edeleLab Unlimited
Related Documents
![¨ íð GJ aJ#SS 8 1 7 #1 1#8 N · The Quickest & Easiest Way To [desired result] ex: The Quickest & Easiest Way to Organize Your Closet, The Quickest and Easiest Way to Manifest](https://static.cupdf.com/doc/110x72/5f81e3c9ba2c4407db7bc952/-gj-ajss-8-1-7-1-18-n-the-quickest-easiest-way-to-desired-result.jpg)
