Japan and EU to promote block-copolymer-micelle medicines
These drugs deliver active ingredients via coated spherical nano-structures
The Japanese government and the European Union (EU) have joined forces to help promote the development of nanotechnology-based block-copolymer-micelle medicines.
These drugs deliver active ingredients via coated spherical nano-structures that can deliver more punch from medical chemicals that can otherwise be unstable or have poor solubility. They can also be designed for targeted distribution within a patient and ‘contribute to an improved benefit-risk balance of the encapsulated product’ said a joint communiqué from the European Medicines Agency (EMA) and Japan’s ministry of health labour and welfare.
‘In particular, block copolymer micelles have been shown to preferentially accumulate in solid tumours,’ it added.
Welcoming this potential, EMA and the ministry have now released a reflection paper designed to support innovation in the field. The communiqué said it aimed to achieve this by ‘providing guidance at very early stages of development’ and discussing ‘the general principles for assessing block-copolymer-micelle products’.
Also included is basic information for pharmaceutical development, non-clinical and early clinical studies of such products ‘designed to modify the pharmacokinetics, stability and distribution or incorporated or conjugated active substances in vivo’.
For instance, EMA says that functional features may be added to micelle systems. One way is adding another homopolymer to stabilise the micelle or active substance, modify its release rate and increase the loading of an active substance.
As for the interior nano-structure of these medicines, it stressed how the ‘inner core typically serves as a container for [the] active substance and that is surrounded by an outer shell of hydrophilic polymers’. It added that the chemistry of block copolymer micelles could be designed to ensure high stability after dilution on administration, to optimise targeting and to control the drug release.
It added that because block copolymer micelle products contain highly functional polymers, it is highly recommended that appropriate quality control of intermediates and the manufacturing process is undertaken through the Quality by Design (QbD) concept.
