Overcoming challenges in generic Metered Dose Inhaler development
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.
Presented by
Lei Mao, PhD,
Scientific Manager, Pulmonary and Nasal Development
Dr Lei Mao is Scientific Manager, Pulmonary and Nasal Development of Catalent Pharma Solutions at the Research Triangle Park (RTP) facility where he oversees technical elements of the product development within the inhalation department.
Prior to the current assignment, Lei has led an inhalation product development group since joining Catalent in early 2008. Lei head an Inhalation development team at Vectura plc, UK where he held positions of increasing responsibility between 1998 and 2007. Prior to that he was employed as a section leader at IVAX, UK between 1996 and 1998 and earlier held a number of senior positions at IVAX's joint venture in China.
Lei has twenty year experience in the inhalation industry, with substantial expertise and knowledge in dry powder inhaler, metered dose inhaler, nebulizer and nasal product development. He is a named inventor on fourteen patents granted worldwide, has authored one book, contributed to one book chapter and thirty publications in the peer reviewed journals and conference proceedings.
Lei is a faculty member for the annual Aerosol School organized by the MacMaster University and ISAM.
Lei received his PhD in Pharmaceutical Sciences from Shenyang Pharmaceutical University and BSc Pharm from China Pharmaceutical University, China.
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.
