From the lab to continuous production

At Achema 2018, Bosch Pack­ag­ing Tech­nol­o­gy unveiled its lat­est R&D device for the con­tin­u­ous pro­duc­tion of oral sol­id dosage (OSD) forms. The plat­form ensures a short time to mar­ket and opti­mum dos­ing of APIs. “The new lab­o­ra­to­ry device is based on our Xelum pro­duc­tion plat­form that we pre­sent­ed last year,” says Fritz-Mar­tin Scholz, prod­uct man­ag­er at the Bosch sub­sidiary Hüt­tlin. “The sep­a­rat­ed process steps of batch pro­duc­tion take place one after the oth­er and with­out inter­rup­tion. This leads to short­er cycle times, low­er pro­duc­tion costs and high flex­i­bil­i­ty.” With the Xelum R&D, the com­pa­ny offers a plat­form that offers an ide­al start to con­tin­u­ous manufacturing.

Precise and reliable dosing

As opposed to the com­mon com­plex mass flow rate, excip­i­ents and active ingre­di­ents are dosed as a dis­crete mass in the Xelum R&D. This makes it pos­si­ble to dose even small­est amounts of APIs of less than one per­cent. The sys­tem dos­es, mix­es and gran­u­lates indi­vid­ual pack­ages, so-called X‑keys, which con­tin­u­ous­ly run through the process chain and are removed suc­ces­sive­ly from the machine as pack­ages into bins. “This way we reduce not only process com­plex­i­ty, but also the system’s fail­ure sus­cep­ti­bil­i­ty, while increas­ing both accu­ra­cy and qual­i­ty of the end prod­uct. More­over, the prod­uct is trace­able at all times,” says Scholz. Depend­ing on require­ments, up to four loss-in-weight feed­ers can be used.

The benefits of the fluid bed

Cur­rent con­tin­u­ous pro­duc­tion sys­tems for wet gran­u­la­tion most­ly use twin screw gran­u­la­tors. The Xelum sys­tem relies on flu­id bed proces­sors – based on a proven tech­nol­o­gy devel­oped by Hüt­tlin. In the flu­id bed, gran­u­la­tion and dry­ing take place in the same process cham­ber. “This elim­i­nates the need to trans­fer wet gran­ules, which in turn has a pos­i­tive effect on the system’s reli­a­bil­i­ty,” Scholz empha­sizes. Phar­ma­ceu­ti­cal man­u­fac­tur­ers obtain gran­u­lates with the desired char­ac­ter­is­tics – includ­ing uni­modal par­ti­cle size dis­tri­b­u­tion, as well as excel­lent flow and tablet­ing prop­er­ties com­bined with high pro­duc­tion yields.