Discuss Development at DDL 2021 - Drug Delivery to the Lungs Conference

The Drug Delivery to the Lungs (DDL) 2021 Conference will be virtual this year. Connect with our team in the networking lounge and access our resource library for best practice on tackling OINDP development challenges

We are excited to be DDL2021 sponsors once again. This year's virtual event will focus on recent developments in the field of inhalation therapy with live presentations, on-demand talks and a discussion forum. Our team of experts will be available on our virtual booth to discuss your inhalation product developmentinhalation product testingdrug repurposing for inhaled or intranasal deliveryformulation development or stability testing or stability storage outsourcing challenges. Contact our team now to arrange a meeting during the virtual event.

DDL Presentation:

Plume Front Velocity and Force to Actuation Characterisation of Pressurised Metered Dose Inhalers and Soft Mist Inhalers

Joshua Houlden, Miles Jeanneret Davide Cunha & Mervin Ramjeeawon
Intertek Melbourn, Saxon Way, Melbourn, Herts, SG8 6DN, UK

Summary

There has been increased focus on the generic pharmaceutical industry when embarking on in-vitro only bio-equivalence testing of inhaled products, using a weight of evidence based approach to submission. In the draft product specific guidance document for beclomethasone dipropionate issued in May 2019, the FDA proposed additional supportive in-vitro studies. These included the characterisation of Plume Front Velocity (PFV) profiles of the test and reference product to support the weight of evidence approach to negate the need for resource consuming comparative clinical endpoint bioequivalence studies.

Plume Velocity analysis is a technique that permits the movement of the plume generated from the inhalers to be visually captured over time from which data can be extracted and extrapolated to determine the velocity of the plume emitted.

Two different commercially available metered dose inhalers (pMDI) and one commercially available soft mist inhaler (SMI) were selected to demonstrate this novel approach to device characterisation. The differences in the plume velocity between the two different device types (pMDI/SMI) was investigated and the comparison of plume velocities between a generic pMDI device and its reference listed drug (RLD). The force to actuate, and plume duration times, for both pMDIs were also investigated

REQUEST A COPY OF OUR DDL 2021 PRESENTATION
‘Plume Front Velocity & Force to Actuation Characterisation of pMDI and Soft Mist Inhalers’

We would be delighted to send this to you after DDL2021. Find out more about DDL 2021 

RESOURCES

 

Our OINDP Development Expertise

Our experts provide integrated OINDP development and testing services for both small molecules and biologics through its centres of excellence across Europe. We provide critical performance and quality testing such as laser particle sizing, aerodynamic particle size distribution (APSD) by impaction (ACI, NGI) and spray pattern/plume geometry. Intertek’s integrated formulation and analytical teams carry out early stage pre-formulation support, solubility screening, drug-excipient compatibility, stability testing and device selection support. For large molecule development, comprehensive protein characterisation services supported by forced degradation and stability monitoring for the protein’s structure and bioactivity throughout formulation and storage can also be provided. Interaction with the device and closure systems are evaluated through comprehensive extractable and leachable testing and toxicological assessments. With 30 years of experience in supporting our clients’ inhaled and nasal product developments, we deliver world-class support to help you meet the challenges of your demanding development programs. The laboratory is inspected and approved by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for GMP compliance. The Laboratory has also been inspected by the US Food and Drug Administration (FDA) against GMP as part of clients’ pre-approval inspections. 

Need help or have a question? +44 1763 261648
 

Need help or have a question?

+44 1763 261648
UK:
+44 1763 261648