With many products coming off patent the interest in developing generic Metered Dose Inhalers (pMDI) is increasing. Unlike DPIs where access to the device technology may be limited MDIs are based on container closure systems which are available off the shelf. The size of the market with relatively few competitors can make this route of delivery attractive.
However pMDIs are nonetheless a complex dosage form comprised formulation, container closure and actuator/dose-counter all of which influence product performance. The US regulatory expectations have been articulated through a series of guidance documents starting with the general CMC guidance still in draft first published in 1998. More recently the FDA has issued more specific guidance such as the Albuterol guidance in 2013. However the regulatory guidance’s can be challenging against a backdrop of evolving regulatory expectations.
In this webinar, experts in inhalation development will provide an overview of the generic development process with emphasis on pulmonary and nasal products. The speakers will review the key aspects of product performance which must be met when developing a generic pMDI.
The speakers will focus on the particular challenges encountered early in the development with respect to API selection and controls including review of considerations for the development of a well-controlled micronization process and the subsequent API characterization will be provided. Additionally the challenges of designing a suitable in-vitro characterization study will be reviewed. Catalent will provide a view of some essential elements to be considered in the planning stages, execution and data analysis and reporting.
Through expert content and case study examples this webinar will highlight strategies and capabilities required to reliably develop a generic MDI.
Craig Davies-Cutting, Ph.D
Director, Inhaled Products & Technologies, Catalent Pharma Solutions
Dr. Craig Davies-Cutting is the Director of Inhaled Products & Technologies at Catalent. He joined Catalent in 2003 where he led analytical, formulation, and process development for pMDI, DPI, nasal sprays, and liquids for inhalation, as well as sterile product development and analytical research and development. Previously, he worked for seventeen years at GlaxoSmithKline where, in various roles, he focused on the development of pMDIs and DPIs, inhalation product testing, pMDI scale-up and marketed product support, and inhalation technology development. He earned his Ph.D. from the University of Bristol, UK on "The Effects of Suspension Stability on Metered Dose Inhaler Performance." Dr. Davies-Cutting has almost 30 years of pharmaceutical industry experience, over 20 of which have been in the development of pulmonary and nasal products. He has actively promoted scientific research in the inhalation field both through his own research and through management of various doctoral and post-doctoral research programs. He has led teams through early and late stage development programs in addition to research and development of inhalation delivery systems/technologies. In 2010 he moved from Operations into a strategic R&D functional role and currently serves as the Catalent Global Inhalation Platform Director. His research contributions are evidenced by various publications in scientific journals, conference proceedings, and patents. Dr. Davies-Cutting was the 2008 Chair for the North Carolina Pharmaceutical Discussion Group. He is an editorial advisory board member for Inhalation magazine, he represents Catalent on the International Pharmaceutical Aerosols Consortium on Regulation and Science (IPAC-RS) Board of Directors and was Co-Chair of the 2014 Orlando Inhalation Conference organizing committee.
Carole Evans, Ph.D,
Director Inhalation Business Operations, Catalent Pharma Solutions
Dr. Carole Evans is the Director Inhalation Business Operations at Catalent. She joined Catalent in 1997 where she has had various roles including heading up analytical and formulation, development for pMDI, DPI, nasal sprays, and liquids for inhalation, as well as the analytical research and development team. She has experience in both large and small pharma and in generic product development. Before joining Catalent she worked for Delphi Pharmaceuticals in Boston supporting new product and generic development of pMDIs. She later joined SmithKline Beecham where she supported the development of MDIs and the evaluation of new technologies for DPI and solution delivery. She also worked at Inspire as the CMC regulatory lead for inhaled and ophthalmic product developments.
Dr. Evans earned her Ph.D. in microbiology from the University of Wales Institute of Science and Technology. Dr. Evans has 25 years of pharmaceutical industry experience, chiefly in the development of pulmonary and nasal products. During this time she has led teams in both early and later stage development programs and has actively participated in Industry Groups. She served as the secretary, vice chair and chair of the AAPS Inhalation Technology Forum, leading the team in the development of commentary on the FDA 1998 draft guidance Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing and Controls Documentation. More recently she has served as vice chair of the ISAM regulatory group and co-chaired a ISAM/IPAC European conference on equivalence considerations for orally inhaled products for local action.
- Increase understanding of key elements of MDI product performance to must be met for a generic MDI
- Review of relevant FDA guidance’s
- Understanding of micronization process development and API characteristics
- Key factors in IVBE study design
- C-levels
- Head of Research and Development
- Senior Analytical leads
- Compliance
- Regulation
- Operations
- Outsourcing
- Project Managers
