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Postado por NEITEC em 04/Fev/2014
Freeman Technology, a global provider of powder testing instruments, and GEA Pharma Systems, a company that specialises in the design and development of processing solutions for the pharmaceutical industry, are collaborating to advance the application of continuous wet granulation and drying technology in the pharmaceutical industry.
The work involves Freeman Technology’s FT4 Powder Rheometer and GEA Pharma Systems’ ConsiGma 1 continuous granulation unit. Data from the FT4 are being used to quantify the influence of the operating conditions of the ConsiGma1 on the bulk characteristics of the granules being manufactured. These data are then correlated to attributes of the tablets, providing the link between granule and tablet properties. An application note detailing the study can be can be accessed by clicking here.
Pharmaceutical manufacturers frequently utilise wet granulation as a precursor to tableting, with the current trend moving from traditional batch manufacturing towards integrated continuous processing. Consequently there is a requirement for continuous wet granulation technology. The ConsiGma 1 is a laboratory-scale version of GEA Pharma Systems’ ConsiGma concept, which incorporates a patented continuous high shear granulator and small batch dryer, and has been developed specifically to meet this continuous wet granulation need.
The FT4 Powder Rheometer enables the measurement of bulk, shear and dynamic powder properties that can be correlated directly with process performance and product quality. It is therefore a powerful tool for scoping the design space for powder processes, as advocated by QbD. Identification of the operating envelope that results in product with the defined critical quality attributes (CQAs) is a central strategy for ensuring consistent clinical efficacy. This operating envelope is the design space for the process.
In this study, dynamic properties were measured to quantify the impact of granulation process variables on the quality of granules produced. Paracetamol (APAP) and dicalcium phosphate (DCP) blends were used in the work. These dynamic properties were also successfully correlated with the CQAs of finished tablets, such as hardness.
The study rigorously investigated the impact of changes in water addition level, granulator screw speed, and powder feed rate. The results show how it is possible to produce granules of closely defined quality using a series of different operating conditions, and demonstrate how the design space for the ConsiGma can be mapped efficiently for a given tableting blend. Dynamic powder measurements provide the information needed to effectively specify optimal operating conditions. Within a commercial manufacturing environment they would also provide the information needed for operational decision making, within the design space.