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Press Clipping / Sep 13, 2019

Kiel University and Hovione to develop high-dose inhalation formulations

in-PharmaTechnologist, September 3, 2019

Portugal-based Hovione Technology, a company developing inhalation devices, announced it has entered a collaboration agreement with the Kiel University’s Institute of Pharmacy in Germany.

The agreement will see scientists from the institution utilize Hovione’s portfolio of large dose dry-powder inhalers (DPIs) to conduct research on advanced formulation approaches for high-dose inhalation applications.

João Ventura Fernandes, Hovione’s director of technology, development and licensing, told us that the collaboration started in July 2019 and will continue during the course of the next three years.

Specifically, researchers will use Hovione’s TwinMax and 8Shot inhalation devices, which enable administration of powder doses of up to 400mg to patients lungs through multiple inhalations manoeuvres. The devices are suitable for inhaled delivery of antibiotics, peptides, anti-virals, vaccines, pain or rescue treatments.

Using Hovione’s devices, the researchers will work on formulations containing softpellets and nanocrystals for high-dose administration via dry powder inhalation, and with antibiotics including clarithromycin and rifampicin as model drugs.

"In high dose drug delivery, the key in inhaled formulation development is to create an active pharmaceutical ingredient (API)-rich formulation, i.e. with as little as possible excipients, to deliver the required therapeutic dose with the smallest amount of material as possible,"​ Regina Scherließ, director of the Institute of Pharmacy, told us.

Scherließ added that, in order to achieve this goal, while concurrently maintaining handling and dispersion properties, the Institute develops two advanced formulation approaches:

  • Softpellets, which can be produced from pure API, i.e. 100% API in the formulation, and provide improved powder handling and aerodynamic dispersion properties when compared to the traditional approach of micronizing the material​
  • Nanoparticles, which may decrease the dose needed due to higher dissolution rate, and can be formulated to API rich microparticles for inhalation by particle engineering technologies, such as spray drying. This combination is called Trojan particle and also provides improved powder handling and dispersion properties.​

Fernandes said that Hovione aims to answer market needs, after the introduction of new drugs requiring delivery of large lung doses, often within the range of 50 to 150mg. Indications of such drugs include cystic fibrosis, pulmonary arterial hypertension, idiopathic pulmonary fibrosis or lung infections.

Earlier this year​, Hovione acquired from Med & Tec the rights to the design of Papillon, a reusable, cost-effective, dry powder inhaler suitable for administration of treatments for chronic or acute pulmonary conditions.

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Integrated approach simplifies development, reduces risk, and supports scalable manufacturing. Hovione and Industrial Design Consultancy Ltd.’s (IDC) lead single-use nasal dry powder device is now available for commercial partnerships. Hovione and IDC have completed the device design and established initial device manufacturing and supply capability, enabling pharmaceutical partners to leverage existing capsule filling infrastructure. This approach simplifies development, reduces cost and risk, and helps shorten timelines to the clinic and commercialization. “This milestone marks an important step in the evolution of our collaboration with IDC — from device innovation to a fully integrated intranasal drug delivery platform,” said Márcio Temtem, Ph.D., Vice President, Strategic Business Management, Hovione. “As the industry looks for faster, more reliable ways to bring complex therapies to patients, integration becomes critical. By bringing together nasal particle engineering science, formulation manufacturing and filling, and device technologies into a single offering, we enable a more seamless and predictable development journey, accelerating the path to market for intranasal therapies.” The nasal delivery device enables broad and targeted nasal deposition flexibility while delivering maximum usability and reliability. With a patented design and manufacturing process established, the platform is available for partnering with pharmaceutical companies on an exclusive basis as part of Hovione’s integrated offering for inhalation and nasal drug development and manufacturing. Additionally, IDC’s Managing Director, Stephen Knowles Ph.D., said the companies are now “well-advanced” with the development of a multi-use device to support an even wider range of therapies and patient needs. Read the full article at ContractPharma.com    

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