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Secondary Manufacturing

Once, the active ingredient is manufactured, it needs to be presented in a convenient way to the patient, e.g. as tablet, capsule or injection.

The solid dosage covers the majority of produced drugs today. Well established powder handling batch processes are commonly used by many pharmaceutical companies. After verifying the identity of the substances, blending, sieving, granulation and drying are the main steps prior to the final tableting or capsulation.

Blending, Granulation & Drying

Powder mixing is a pharmaceutical unit operation required for the production of all solid pharmaceutical products. In the blending process, blend uniformity analysis is an important aspect that needs to be controlled during the manufacturing of solid dosage forms, since only a homogeneous mixture can be subdivided into individual doses, which provide the correct proportion of the active pharmaceutical ingredient (API). FT-NIR offers a number of possibilities for the contact or non-contact measurements of solid products.

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During wet granulation processes a continuous monitoring of the water content allows the operator to generate the correct particle sizes and to avoid too wet or too dry products.

Tabletting & Capsulation

To control a tablet press, data about the weight, thickness and hardness of the produced tablets are necessary. Normally external tablet tester offers these kinds of analysis. The TANDEM FT-NIR online system allows the operator besides the mentioned parameters to get chemical information about the tablets, very often requested the content uniformity (CU) of the produced batch.

For the detailed analysis of the API distribution inside the tablet, the HYPERION 3000 FT-IR microscope is a perfect solution. The HYPERION combines FT-IR imaging and single point spectroscopy in one microscope. Two separated optics inside the microscope guarantee a highly accurate, distortion-free image of the sample on the FPA (Focal Plane Array)-detector when performing chemical imaging.

Coating

Monitoring of tablet coating processes especially in drum coaters are a task for FT-NIR spectroscopy. A fiber optic solid probe is installed into the drum coater in contact to the tablets and allows the continuous measurement of the tablet thickness.