Here you will find all technical articles that cover the technology 'Granulation and Drying' for solid dosage production, including high shear granulation, fluid bed processing, single pot processing, batch granulation and drying process and continuous granulation and drying.
The authors describe the in-line moisture measurement of a pharmaceutical granulation of lactose, microcrystalline cellulose and crospovidone in a fluid bed granulator dryer using top sprayed granulating liquid.
Effervescent tablets are an interesting pharmaceutical dosage form, offering some unique advantages when compared with simple tablets. However, the manufacturing process involves some critical steps that need to be addressed carefully during formulation and factory design.
Granulation is one of the most important unit operations in the production of pharmaceutical oral dosage forms. However, there are many different technologies each having different strengths and weaknesses. Most companies choose which one to use simply based on their own experience. This article introduces different processes, compares them objectively and offers unbiased advice on the merits of each system. It then looks at the implications of selection on two different applications.
Fluid Bed Granulation and High Shear Granulation are presently the most important wet granulation techniques employed in the pharmaceutical industry. Precision-Granulation™, a new bottom spray method, is evaluated for comparison with the conventional granulation methods.
Installing a new granulation suite is littered with technological and legislative obstacles and often has to be undertaken in existing production facilities. This article looks at how SmithKline overcame the problems associated with this task.
This study compares different processing methods to prepare a melt granulation with polyethylene glycol (PEG) in a high shear mixer / Single pot processor. For melting the PEG, either the heated jacket or heated jacket supplemented with microwaves was used to supply the necessary energy. For cooling the mass after granulation, 3 methods were compared: cooling with the jacket, cooling with pressurized air and cooling with liquid nitrogen. The results of the comparison show a significant time reduction in the process when using microwave energy for heating the product, and liquid nitrogen for cooling. No differences in granule particle size distribution could be observed.
This paper reviews single-pot systems for the production of solid dosage drugs in the pharmaceutical industry. A discussion of the underlying physics is followed by a detailed review of the drying processes. The paper concludes by a comparison of the different techniques based on published data.
As a result of the FDA PAT initiative an increased interest in process understanding is seen in the pharmaceutical industry. Also a rising interest in “consistent” processes is noticed. Aim is that during pharmaceutical processing each particle should undergo the same experience independent of equipment or scale of operation. This paper reviews the consequences of transferring a fluid bed process from scale 1 to a larger scale 2.
GEA Pharma Systems (formerly known as Niro Pharma Systems) in conjunction with FSA, the safety specialist centre in Germany, have carried out an extensive test program involving over 100 test explosions. This research has shown conclusively that should an explosion occur during the transfer operation in an integrated system where a granulator is connected directly to a fluid bed dryer without an explosion isolation valve then, the secondary explosion pressures in the granulator can be significantly higher than in the fluid bed.
These tests have enabled GEA Pharma Systems to gain full EC type approval for a range of pressure shock resistant integrated systems and 16 bar pressure shock resistant high shear granulators.