The Renaissance of Pellets is Promoting Innovative Technologies

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A word from Klaus Möller, the Head of Business Development

“A TECHNICAL PLAYGROUND FOR THE PHARMACEUTICAL INDUSTRY”

? The new Innovation Center in Binzen was inaugurated last Fall. What can you offer customers there?

Klaus Möller: We offer the customers a technical playground of 7000 m² with state-of-the-art machine technology. The customer can perform batch and continuous processes in a non-GMP environment. The highly flexible machines can be configured as needed for granulation, pelletization and coating processes, from laboratory to production scale with batch sizes of up to 150 kg. A Glatt Modcos process machine is available, in which powder can be processed up to the finished tablet in a fully-automated process. A whole range of modular processing equipment is available that can be arranged into a fully-automated process line. Up to 6 processes can be performed in parallel.

? What do you think is the most important unique feature?

Möller: The combination of Pharmaceutical Services’ competences in the development of formulations, processes and technology, the Innovation Center and the possibility to manufacture clinical samples under GMP conditions is, as far as we know, a range of services which only we can provide. Our technical capacities allow us to scale up from laboratory to commercial production scale seamlessly under GMP conditions. This means we accompany the customer from the initial product idea to market launch.

? In which specific problems can you offer assistance?

Möller: The development of processes and formulations is a massive playing field and places the customer before a huge range of challenges. Our specialty is the development of solid dosage forms with a focus on complex formulations and we have great expertise in multiparticular systems. This is why customers frequently come to us with matters such as product and process development or even the registration of a product.

MicropelIets and More

Glatt’s development team demonstrated how to refine an established process with the fluidized bed agglomeration technique known as MicroPx. The trick is to use the Conti process, which was conceived in Pharmaceutical Services’ laboratories in Binzen: first, the active ingredient/excipient liquid is spray-dried to a very fine product dust in a fluidized bed and agglomerated into tiny primary particles. The micropellets then build up, layer by layer, until the desired size is reached.

The heart of this technology is a zigzag classifier which continuously ejects particles of sufficient size from the process, while simultaneously allowing smaller particles to reenter the process chamber where they continue to grow.

Möller explains that the result of this method are high dosage active ingredient pellets in the size range of 100 to 400 µm with a narrow particle size distribution and content uniformity of a consistent 90 to 95 percent. This means that one significant limitation of former times is now no longer an issue: for many years, the volume of a pellet-filled capsule was larger — and therefore much harder to swallow — than the equivalent tablet with the same dose and composition.

The use of microencapsulation, which changes bitter-tasting active ingredients into tasteless microparticles, means the taste is much improved now, too. Micropellets can be also pressed into tablets or MUPS tablets which already begin disintegration in the mouth. But the reason pharmaceutical companies find the MicroPx process so exciting is that it makes completely new formulations possible and therefore allows the legal circumvention of property rights.

The technology experts have long known the secret to the perfect pellet, too, an answer provided by Complex Perfect Spheres Technology (CPS). CPS is a souped-up rotor process for fluidized bed machines that uses direct pelletization to yield functionalized pellets and micropellets which are perfectly round and smooth.

Unlike classic rotor technology, the modified technique uses a tapered rotating disc which allows the movement of particles to be directed and pelletization to be performed to a defined endpoint. The results are perfectly spherical pellets of exactly defined sizes of between 100 and 1500 µm and extremely narrow size distribution. This is how Glatt’s own Cellets of microcrystalline cellulose are created, which are used as starter cores for pellets and in the Wurster process, for example — thus completing the formulation cycle.

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Pelletttechnology

The Renaissance of Pellets is Promoting Innovative Technologies

MicropelIets and More