Taking the guesswork out of tablet manufacturing assessments

Most tablet formulations are developed and manufactured on a large scale without any objective assessment of their ability to form tablets, or whether they are adequately lubricated.

With the latest tablet presses measuring both of these parameters, as well as a third critical quality attribute (CQA) – punch sticking (or take-off ) force – taking measurements on small amounts of material may start to offer improved process understanding and control.

Main Methods 

The principal production methods for tablets are direct compression, dry granulation (DG) and wet granulation. The product control strategy (PCS) is based on understanding the links between the formula and process, CQAs and the certificate of a pharmaceutical product. Generating the data to support the PCS is therefore key to meeting the regulatory expectations of Quality by Design (QbD).

The development of the formulation and process is usually an iterative one, in which it is adjusted based on evaluation of intermediates and products. All of these are carefully evaluated to understand the impact of formulation and process changes on product quality, in addition to supporting QbD. The manufacturing scale used during formulation development largely depends on the amount of drug substance and the equipment available.

 

Download full paper: Taking the guesswork out of tablet manufacturing assessments
(Scroll down document list to date of post: 7 August 2017)

 

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