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STABLE MICRO SYSTEMS LAUNCHES NEW TEST FOR HARD GELS

AUGUST 2007

Capsule Loop Tensile Rig

Stable Micro Systems, expert in the physical characterisation of medical products, has developed an innovative new test method for the pharmaceutical industry. The Capsule Tensile Rig measures the force required to split one half of a hard gel capsule. This allows manufacturers to investigate the effects of certain fillings on the capsule shell and identify changes that may impact their stability and long-term performance.

The simplified manufacture process of hard gelatine capsules and their ability to withstand higher filling temperatures is attractive to many manufacturers. Yet, the introduction of certain types of liquid, such as hydrophilic solvents, to hard capsules can often affect the mechanical properties of the shell, causing them to become brittle or soften. If the texture of a capsule is compromised, it may not be able to withstand handling and storage, resulting in fillings leaking from the capsule.

As effects are likely to be progressive, only displaying very small changes initially, compressive tests are often limited in their ability to adequately distinguish the anomalies. Stable Micro Systems' Capsule Tensile Rig is designed to help manufacturers identify subtle degradation, providing valuable information which can be used to avoid subsequent capsule failure. For example, manufacturers can identify the effect of liquid filling on the strength and stability of capsules and therefore reformulate liquid type or capsule accordingly.

Prior to testing, the filling of the capsule is removed and the empty shell is mounted to a separating rod fixture on the TA.XTplus texture analyser. Vertical movement of the upper rod is then applied until the capsule is split apart, while Exponent software records the force required to do so. This test highlights three important parameters; elastic stiffness (if a linear region on the graph is present), tensile force and elongation at break point. A reduction in elastic stiffness and tensile strength occurs when capsules become softer and therefore show a tendency to fail.

Stable Micro Systems' unique Capsule Tensile Rig is the latest addition to its extensive range of precision-engineered fixtures for the pharmaceutical sector. Other test methods include the assessment of tablet and gel strength, tablet coating adhesion force and blister pack integrity. All products can be tailor-made according to individual specification.

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