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STABLE MICRO SYSTEMS' SHEAR INITIATIVE

DECEMBER 2007

Bilayer tablet shear rig

Stable Micro Systems, expert in the physical characterisation of pharmaceutical and medical products, has announced the launch of its innovative Bilayer Tablet Shear rig. A unique new attachment for the company's industry-leading TA.XTplus texture analyser, the Community Registered Design has been developed to help manufacturers gauge and optimise the stability of tablets which contain isolated immediate and controlled release component layers. Such formulations are popular as they provide efficacy for consumers as well as ease of production for manufacturers.

Ensuring that one tablet layer does not impact on the other is instrumental to the remedial benefits of bi-layer medication, and to the safety of the consumer. But isolating two release components in separate layer formations can prove complex for manufacturers. The characteristics of each active pharmaceutical ingredient in a bi-layer tablet often differ, leading to problems in tablet composition which may in turn result in cross-contamination. Common issues include layer separation, insufficient hardness and inaccurate individual layer weight control. By testing the strength of bi-layer tablets, pharmaceutical manufacturers are able to identify weaknesses and improve the quality and stability of their products.

The Bilayer Tablet Shear Rig is attached to the TA.XTplus texture analyser, which uses Exponent software to analyse layer separation. The tablet sample is placed in the central cavity of a guillotine-type blade, which is then compressed until the two components of the tablet are sheared apart. The force taken to shear the tablet, as well as the distance to failure, is calculated. The lower the force required to shear the tablet, the more likely it is that the layers will fail during manufacture, packing or consumption. Visual characterisation of the fracture surface enables quantification of the percentage of each fracture failure, which is important in enabling manufacturers to optimise adhesion between the two tablet components.

Stable Micro Systems' new rig is just one of a wide range of precision-engineered fixtures that guarantee accurate and repeatable analysis of pharmaceutical products and materials. Additional test methods assess characteristics such as mucoadhesion, tablet and gel strength and granule compressibility. All Stable Micro Systems' products can be custom-made according to individual specification. 

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