Last year, Rottendorf inaugurated a new development and upscaling center for all kinds of solid dosage forms. After the starting, Rottendorf notes a positive feedback from the customers.
Conform to GMP and FDA standards, the pilot plant provides technical equipment for laboratory lots less than 1 kg and for stability and clinical batches of 15 to 150 kgs.
Bruno Buss, Head of Pharmaceutical Technology: "All the machinery was put into operation, GMP and clinical batches have already been produced successfully." Beyond that, the twin screw extruder from Leistritz (hot melt extrusion) was used to realize trials and small scale batches, both with positive results.
With its development and upscaling center, Rottendorf Pharma GmbH does not only offer the common solid technologies but also special ones such as hot melt extrusion, hot melt granulation and pellet production. Furthermore, the range of services includes process optimization, analytical method development and validation, ICH stability studies, batch release and the compilation of registrations dossiers and expertises.
Conform to GMP and FDA standards, the pilot plant provides technical equipment for laboratory lots less than 1 kg and for stability and clinical batches of 15 to 150 kgs.
Bruno Buss, Head of Pharmaceutical Technology: "All the machinery was put into operation, GMP and clinical batches have already been produced successfully." Beyond that, the twin screw extruder from Leistritz (hot melt extrusion) was used to realize trials and small scale batches, both with positive results.
With its development and upscaling center, Rottendorf Pharma GmbH does not only offer the common solid technologies but also special ones such as hot melt extrusion, hot melt granulation and pellet production. Furthermore, the range of services includes process optimization, analytical method development and validation, ICH stability studies, batch release and the compilation of registrations dossiers and expertises.
