Contract Development Solid Dosage Forms (CDMO)
Glatt Pharmaceutical Services contract develops and manufactures solid pharmaceutical dosage forms. Our focus is on multiparticulate systems such as pellets, micropellets and granules. Whether you are looking for optimal bioavailablity or taste masking, improved solubility or stabilization of the dosage form, we have the right solution for every challenge.
Glatt Pharmaceutical Services as a CDMO brings together fundamentals, experience and innovative technology expertise. With our comprehensive services, we support you from product idea to market launch.
Formulation & Process Development
For clinical studies and market supply, we contract manufacture medicines in bulk and efficiently bring your products to market. Our technical capabilities facilitate a seamless scale-up from the lab to commercial production scale, for which we conduct all requisite analytical studies and stability tests. For optimal processes and a secure investment.
Process and contract development is conducted in our technology centers in Binzen in Southern Germany and in Ramsey, New Jersey in the United States. These sites give you access to innovative laboratory and production facilities for pilot projects and contract manufacturing. Both centers use technologies in compliance with GMP norms approved by the FDA, the EMA (Binzen) and the DEA (Ramsey).
Special Technologies with Glatt Pharmaceutical Services (CDMO)
The Glatt MicroPX™ technology (micro pelletizing technology) is a continuous fluidized bed agglomeration procedure for the manufacture of pellets and micropellets with a very high active ingredient content. Functional excipients – for example to control the release of the active ingredient or to optimize bioavailability – can be integrated into the pellet matrix. Unlike the traditional Wurster fluidized bed process, in which starter cores or pellets are coated with the active substance or functional coats, the MicroPX™ technology works without a product template. This new technology allows contract manufacturing of micropellets in sizes of 100 to 400 micrometers with very narrow particle size distribution and consistent active ingredients contents of 90 to 95 percent. Pharmaceutical substances are sprayed in liquid form together with the excipients into the MicroPx™ fluidized bed system. Initial spray drying creates product dust at first, which is agglomerated in a controlled manner in the start phase of the process. Subsequently, these primary particles are built up to micropellets in layers to the desired size.A fundamental component of the MicroPX™ technology is a classifying zig-zag sorter. Micropellets of proper size are continuously discharged from the process via air separation, while particles that are still too small are returned to the processing chamber where they are built up further. The MicroPX™ technology is the perfect procedure to obtain micropellets for subsequent coating for taste masking. Plan now your contract development with Glatt Pharmaceutical Services!
ProCell – Spouted bed technology
The Glatt spray coating technology is our innovative solution for the effective and efficient treatment of difficult-to-fluidize products. Thanks to this technology, very small, very large, or irregular products can be contract manufactured just the same. The adjustable energy input also makes the processes very economical.
Unlike the fluidized bed technology, air does not exit through a screen bottom in the spray coating process, but through a longitudinal gap in the processing chamber. The air speed can be adjusted by changing the size of the gap. High air speeds at the air inlet gap make sure that large or irregular particles are fluidized too. The high material speed at the nozzle also prevents agglomeration. A dual expansion inside and above the process chamber ensures a strong drop of the process-air speed. This ensures that fine particles are not removed from the process either. Due to the high flow speed in the center of the process chamber, even coarse or irregular particles can be fluidized.
The process is also stable with sticky and lumpy products. High spraying performances are possible in the process chamber even with little material present. Assuming an equal throughput, the median retention time of the product is thus lowered compared to the fluidized bed. The precise adjustment of airflow also allows for excellent energy balance. This results in very economical processes – either in contract development or contract manufacturing!
The Glatt CPS™ technology (Complex Perfect Spheres Technology) is a further development of the rotor fluidized bed process. It allows for the (contract) manufacture of functionalized pellets and micropellets with perfect roundness and surface. Direct pelletizing allows for a variety of drug formulations to be realized in extremely low or very high doses. Unlike traditional rotor systems, the CPS ™ technology works with a conically tilted rotating disc that allows for a directional particle motion. It is possible to clearly define the end point of the pelletization. No starter pellets are required for direct pelletizing with the Glatt CPS ™ technology. The concentrations of the active ingredients in the pellet matrix can vary from less than 0.1 percent up to a drug load of 90 percent. Round and evenly shaped pellets are achieved, with precisely defined pellet sizes between 100 and 1,500 micrometers with an extremely narrow size distribution.
Microcrystalline cellulose is often used as an important excipient. The pellet matrix can contain other pharmaceutical excipients, such as polymers, and disintegrating or solubilizing agents. CPS™ pellets and micropellets are especially suitable as carrier cores for coating applications for an optimized active ingredient release or for taste masking. Optimally defined film qualities can be achieved.
*CDMO = Contract Manufacturing Organization