The Spain-based contract improvement and manufacturing group (CDMO) has been running its contract improvement and manufacturing spray-drying service for barely over a yr. At the middle of the operation is a GEA Niro Mobile Minor spray dryer, designed to fabricate smaller volumes of powder samples.
Manuel Leal, Idifarma enterprise improvement director, advised Outsourcing-Pharma the spray-drying facility will assist his firm help purchasers in coping with a very vexing problem drug builders regularly face.
“Poor solubility is one of the key problems for drug development. It is estimated that as much as 90% of drugs in the pipeline have poorly soluble APIs,” Leal advised us.
“Spray-dried solid dispersion is one to the most suitable solutions to this challenge,” he added. “Idifarma is focused in providing our clients with the best technological solutions to the problems in their pipelines, so investing in GMP spray drying capabilities was the perfect fit for us.”
Additionally, Leal mentioned, spray drying is efficient of enhancing solubility of BCS class II and IV molecules. Also, he advised us, the expertise will be harnessed to course of thermo labile APIs and permits course of management in reaching fascinating traits by way of movement property, particle measurement distribution, and different attributes.
Leal added that within the months for the reason that spray-drying capabilities have been put into service, the response amongst Idifarma clients has been “very positive.”
“There are just a handful of companies able to handle OEB4 drugs with this technology, and we are probably the most nimble partner, so we are catering to a variety of customers, from start-ups all the way up to Big Pharma companies,” he mentioned. “We are developing and manufacturing mostly innovative and hybrid drugs -505 (b)(2)-, although we are also collaborating with this technology for generic drugs.”
In addition to bringing on spray drying capabilities, Idifarma lately has expanded its serialization and capsule-filling capabilities. Leal advised OSP the corporate plans within the close to future to extend its contract manufacturing enterprise, develop specialised capabilities for small-scale and extremely potent medicine, and make different strategic investments to extend its market presence.