The unmistakable trend towards the Conti process in pharmaceutical solid dosage production requires intelligent approaches. Continuous direct compression with Glatt’s Modcos system fulfills every wish for an economic and stable process. Continuous Direct Compression is a lean, effective and economic process.
Continuous technologies have started to gain widespread acceptance in pharmaceutical production since the FDA published their GMP Initiative for the 21st century in 2003.
The approaches for improving quality in pharmaceutical production propagated by both the FDA and the EMA encourage continuous manufacturing, particularly of solid dosage forms, where the advantages of this approach become clearly visible: reproducible quality, great versatility, high throughput and compact design. Pharmaceutical companies embarking on a journey towards continuous production are currently faced with a choice between three technological processes:
- continuous direct compression
- continuous roll compacting, and
- continuous wet granulation.
Glatt’s experience also shows a definite trend towards this production method: pharmaceutical companies currently favor continuous process solutions, particularly for new active substances. However, the suitability of a formulation must be precisely assessed before the choice for one of the three technical solutions is made. None of the listed processes can be seen as a panacea which prevents the manufacturer from encountering any of the possible difficulties of classical batch processing.
Continuous direct compression — lean, effective and economic process
However, the continuous process does offer verifiable advantages over the batch process in many cases. One particularly good example is the production of MUPS (Multiple Unit Pellet System) tablets — an innovative, controlled-release dosage form in which active substance pellets are mixed with excipients and compressed into tablets. Producing MUPS tablets in a conventional batch process is often fraught with problems, since the concentrations of premixes fluctuate due to the differing particle sizes of powder and pellets.
Trials carried out by Glatt prove that continuous direct compression has become a stable alternative to batch processing. Furthermore, continuous direct compression is considered to be a lean, effective and economic process, since it requires fewer steps than the often-used continuous wet granulation, which, for instance, requires an energy-intensive drying step.
This article is protected by copyright. You want to use it for your own purpose? Infos can be found under www.mycontentfactory.de (ID: 44622429 / Pharma & Food)