Accelerating the development process of a generic pMDI
Sponsored by: Proveris & H&T Presspart
Date: 27 October
Time: 10 AM EST/ 2 PM LONDON/ 7:30 PM IST
Pressurized metered dose inhalers (pMDIs) are complex products, especially when compared with standard dosage forms such as oral tablets or injectable formulations. At their core, they consist of the drug formulation (solution or a suspension) combined with propellants and excipients in a pressurized canister. The can is seated into an actuator and connected to a valve which delivers the formulation. The delivery method is extremely attractive due to the direct delivery to the target site, rapid onset of action, high and long-term pulmonary efficacy, reduced risk of systemic side effects and has been accepted by patients across the world mainly for its portability.
The FDA has classified pMDI’s as a combination product due its uniqueness of drug device combination. Genericizing a pMDI’s has been a major challenge especially for the US market where the regulatory hurdles make it even more difficult for the generic companies to achieve approval. Although this past year, we have seen several new key approvals that seem to be paving the way for others. Also, the present Covid 19 situation has led to a number of generic pMDIdi’s having their approvals fast tracked by the FDA and other regulators around the world which could lead to quicker approvals of pMDI applications in the future. in order to have more metered dose inhaler supplies available to treat respiratory disease.
In this webinar H&T Presspart and Proveris will focus on two important arms of the pMDI system; namely the canister and the actuator with built in dose counter indicator. H&T Presspart will highlight key learnings in the areas of design, development, manufacturing of generic pMDI products while Proveris will focus on analytical tools (specifically the SprayVIEW® Measurement System) and applying the technology to accelerate development from early R&D stages straight through to manufacturing QC.
Ameet Sule will present the suitability of the plasma treated canister and the development process of a generic actuator with a dose counter. Ian Flaherty will continue on presenting the use of the SprayVIEW Measurement System and the use of spray pattern and plume geometry measurements combined with the importance of employing automated shaking and actuation in testing to achieve a suitable device design for generic products. Please join us on October 27th to learn strategies geared towards ensuring the timely success of your pMDI development projects.
Senior Product Manager, Proveris Scientific Corporation
Ian Flaherty is a Senior Product Manager for Proveris Scientific Corporation, an instrument and laboratory service company that creates advanced testing solutions for OINDP drug development and manufacturing. Ian is responsible for technical communication, managing product development, applications support, and is familiar with the regulatory requirements and common challenges pertaining to OINDP product development.
Ian has a bachelor’s degree in biomedical engineering from Boston University. He has worked in academia and in the pharmaceutical industry for almost 10 years. In addition to his current role at Proveris he has past experience in electrophysiology, automation for early stage drug discovery, compound management, and biobanking.
Director, Inhalation Product Technology Centre (IPTC) H&T Presspart
Ameet Sule is the Director of H&T Presspart’s Inhalation Technology Product Centre (IPTC) set up in 2013 at their Blackburn site (UK) in a purpose-built laboratory. As well as heading up the IPTC team, Ameet plays a strategic role in the development of current and new innovative products at H&T Presspart.
Ameet has a Master’s Degree in Analytical Chemistry and has worked in the pharmaceutical industry for over 20 years with his previous experience including developing drug device combination products essentially pMDI’s, primary packaging components and analytical test methods as per market needs and regulatory requirements.
At H&T Presspart, in addition to developing new devices, Ameet and his team work closely with customers around the globe understanding and mitigating the front end development challenges of new and generic products for inhalation drug delivery.
Key Learning Objectives
- Develop a greater understanding of the pMDI development process and an overview of the regulatory landscape surrounding generic pMDI’s across the globe.
- Arriving at a suitable combination of can valve actuator and dose counter for a generic pMDI.
- Utilize spray characterization tools to evaluate the overall performance of pMDIs
- The fundamentals of spray pattern and plume geometry and how to apply them in early development for identifying critical quality attributes (CQAs)
- Academic Researchers
- Drug Delivery Scientist
- Formulation Development
- Formulation Scientist
- Formulation Specialist
- Head of Formulation Development
- Head of Manufacturing Support
- Head of Manufacturing
- Head of Pre-formulation Development
- Head of Process Development
- Head of Quality Control
- Heads of R&D
- Principle Scientist
- Process Development Scientist
- Product Managers
- Project Managers
- Quality Control Scientist
- Quality Operation Manager
- R&D Managers
- Research Scientist
- Senior Research Investigator
- Senior Research Scientist
- Senior Scientist
- Drug Delivery Scientist Manager
- Innovation Manager
- Head of Packaging development
- Head of Analytical development