Press Room

10th Global DDF Summit - Drug Delivery Formulation

Start
Monday, March 11, 2019 - 00:00
End
Monday, March 11, 2019 - 00:00
Location: Berlin, Germany

HOVIONE PRESENTATION

Title: The Perks of a One Stop Shop: From Low Solubility APIs to High Performance Formulations

Speaker: Mafalda Paiva 

Date: Monday, March 11th, 2019

Time: 2:30 - 3:05 PM

Close to 90% of drugs coming out of the drug discovery pipeline, have solubility limitations translating to poor bioavailability, which may ultimately result in clinical failures. Amorphous solid dispersions (ASDs) are an established platform to address bioavailability challenges due to low aqueous solubility. The complexity of ASD development, added to the concerns on physical stability, pose as perceived risks, however, the clinical and commercial success of ASD-based formulations stands as driving force: to date, 24 FDA-approved therapies are commercially available

This presentation will address the main challenges in the formulation of ASDs, and highlighting the importance of integrated development and the synergies between pre-formulation and commercial manufacturing expertise. The science-based development platform for ASDs will be presented. This platform relies on the integration between formulation and analytical development, from API to drug product, coupled with the use of computational models, formulation databases and miniaturized high-throughput in vitro techniques.

If you would like to find more about Hovione's full range of inhalation development servicesparticle engineering and development by design schedule a meeting with us

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Our colleague, Paul Dunne will be pleased to meet you.

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Paul Dunne

Business Development Manager

 

 

 

 

 

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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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