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.