Capsugel Zephyr is a new portfolio dry-powder inhalation (DPI) capsules of different polymers and compositions. EPM editor Reece Armstrong caught up with Frederique Bordes-Picard, business development for innovative products, capsule delivery solutions at Lonza to learn more.
Inhalation Illustration
Why did Lonza choose to develop a new DPI capsule portfolio?
The Capsugel Zephyr portfolio responds to the marketplace needs for comprehensive inhalation solutions that seek end-product efficacy with consistent and optimal release performance regardless of formulation characteristics or DPI device principles. With the launch of the Capsugel Zephyr portfolio, Lonza now offers full end-to-end solutions for capsule-based DPI products. Our specialised capsule technology provides to our customers with the right solution to deliver optimal product performance for the pulmonary route to patients; a testament to how patient-centricity and customer focus are at the heart of Lonza’s healthcare continuum.
Can the portfolio help increase compliance rates for respiratory patients?
Addressing patient compliance issues in the inhalation field is indeed essential as clearly stated during the recent RDD conferences in Lisboa. This should be done through patient-centric drug product development combined with deep patient education. For capsule-based DPI products, it is essential to ensure optimal performance of the DPI capsule with the selected device and the specific formulation. Thus, the importance of a complete portfolio of solutions as there is no “standard DPI” capsule: the critical parameters impacting the end performance should be customised to maximise emitted dose and fine particle fraction as well as finished product stability. Moreover, DPI capsule visual appearance including colour combination, transparency and printing can also be used to increase patient compliance.
What barriers do inhalation drug product manufacturers currently face and how does Lonza’s new portfolio address them?
Drug product manufacturers working in the inhalation field have to develop efficient and safe treatments with increasingly complex formulations while ensuring cost effectiveness and access to essential treatments for highly prevalent respiratory diseases. In addition, there are now calls to develop connected solutions to improve patient compliance as well as a more “green” device selection with lower environmental impact.
In this regards, capsule-based DPI products can accommodate different formulations (from standard carried base to innovative engineered particles), from small to larger doses for combination products or new systemic indications, using standard high speed capsule filling machine equipment widely available. There is a large offer of re-usable, off the shelf capsule-based devices, now including connectivity options as well. In this respect, Capsugel’s Zephyr DPI capsule portfolio addresses the need of tailored high quality DPI capsules that can offer optimal performance of the final inhalation product.
What does the current market look like for inhalation solutions and why does it need customisable services like Lonza’s DPI portfolio.
There is an increasing interest in the inhalation route looking at respiratory diseases primarily with COPD, now third leading cause of death worldwide (65 million people with moderate to severe COPD according to WHO) but also looking at new systemic indications (antibiotherapies, CNS and cardiovascular diseases). The pulmonary route not only represents a non-invasive needle-free alternative to the oral route but the lungs also offer an enormous absorption surface area, highly permeable with slow clearance that can be utilised for delivery of small molecules to peptides and larger proteins as well as long lasting formulations.
Is the new portfolio in any way a response to the way drug delivery devices are becoming more intuitive and advanced?
Absolutely yes, again, the ability to customise critical parameters of the DPI capsule allows Lonza to achieve optimal performance of DPI capsule in combination with capsule-based devices currently on the market as well as the new connected device solutions like the RS01x developed by Plastiape –RPC.
Could you outline the particle engineering approach used throughout encapsulation and the benefits this brings?
The primary consideration in pulmonary drug delivery is the ability for DPI to create stable fine particles of APIs in the range of one to five microns that can be deposited into the lungs. A number of particle size reduction and particle engineering technologies can be used to generate particles in aerodynamic sizes within this specific range. Conventional particle size reduction techniques, such as jet milling works for most of the asthma/COPD drug substances on the market but other particle engineering approaches such as spray drying allow for drug substance that cannot be treated by micronising to be converted into respirable particles. The latest approach can be utilised to develop the higher doses products (beyond 5mg API) or biotech type product where drug-alone formulations are the preferred path forward. Spray drying approach can also help address bioavailability challenges in case of low soluble compounds.
As such these techniques may impact material characteristics, morphology, surface properties, stability of the API, the quality of the final formulation in terms of aerolisation performance, physical and chemical stability, delivery and absorption in the lungs will be impacted by all these contributing factors including process, DPI capsule and selected device.