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Inhalation Asia © 2015

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The Inhalation Asia Autumn School 2015

at the Shenyang Pharmaceutical University

Monday 7 September 2015 to Saturday 12 September 2015

Shenyang Pharmaceutical University 103 Wenhua Road, Shenhe District

Shenyang, Liaoning Province, China

www.inhalationasia.org


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Introduction The Inhalation Asia autumn school is designed for graduate students and new comers to the inhalation drug delivery field. It will provide attendees with sound knowledge of the tenets of inhalation drug delivery to support their research or development work, from molecules to commercialisation. Attendance of the Autumn School is free for students of the University of Shenyang, and for bona fide registered attendees of Inhalation Asia 2015 (www.inahaltionasia.org). For more information and registration, you may contact [email protected]. Students from Shenyang Pharmaceutical University must contact Prof. Mao to register ([email protected]). Content Pulmonary function and respiratory diseases Pulmonary physiology and inhalation of aerosols Dry powder inhalers (DPIs) formulations Micronization and particle engineering for DPI formulations Powder characteristics and DPI performance DPI devices Dry powder inhaler testing Pressure Metered Dose Inhalers Electrostatics of pharmaceutical aerosols

Nebulizer formulations and devices Drug delivery to the nose Aerosol measurement techniques in inhaled product development Clinical Development of Inhaler products Patient-device interactions as barriers to portable inhalation therapies From R&D to commercial manufacture of inhalation product Faculty Prof. Murray Ducharme, Universite de Montreal Canada Dr. Philip Kwok, Hong Kong University Prof. Shirui Mao, Shenyang Pharmaceutical University China Dr. Darragh Murnane, Hertfordshire University UK Dr. Philippe Rogueda, Aedestra Ltd Hong Kong Dr. Daniela Traini, Woolcock institute Sydney Australia Mr. Frank Zheng Haaro Hoeflinger China Dr. Tony Qi Zhou, Purdue University USA Venue old research building, 501 Shenyang Pharmaceutical University 103 Wenhua Road, Shenhe District Shenyang, Liaoning Province, China


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Course Synopsis Anatomy and physiology of the respiratory tract

• Pulmonary anatomy and epithelia

• Respiratory mechanics and airflow in the lungs

• Overview of disease states

• Barriers to drug absorption in different pulmonary regions

Respiratory drug delivery and aerosols as medicines

• Advantages and rationale for topical and systemic pulmonary drug delivery

• Aerosol deposition mechanisms in the respiratory tract

• Targeting regional drug delivery through controlling aerosol properties

• An overview of inhalation products and how to choose the device platform

Drug delivery to the nose: formulation, deposition, permeation and in vitro models

• Nasal formulations and devices in commercial products

• Formulation approaches, factor affecting deposition and absorption

• In vitro models used to assess aerosol performance for nasal delivery systems

• Critical evaluation of principles involved in the formulation of nasal medicine

Dry powder inhalers (DPIs)

• DPI formulations and performance

• DPI therapies efficacy

• Devices designs and merits

• Devices to increase patient adherence

Characterization of powder bulk behavior and influence on DPI performance

• Physico-chemial properties of DPI powders

• Characterization techniques for DPI products

• Powder densities definitions and measurements

• Powder rheology and aerosolisation

Micronization and particle engineering for DPI formulations

• Micronization of APIs

• Particle engineering for enhanced aerosol performance.


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• Spray drying, lyophilisaiton, sono-crystalisation, nanonisation

• Comparison of merits of different particle engineering techniques

Emerging DPIs

• Review of new applications of inhaled antimicrobials

• Inhaled biopharmaceuticals and herbal medicines

• Dose regimen and formulation design of emerging therapies

Pressure metered dose inhalers: formulation, devices and product testing

• Fundamentals of pressurized metered dose inhalers (pMDIs)

• pMDI hardware and formulations (solutions vs. suspensions), including add-on

devices

• aerosol science and compendia testing required for marketing approval

• pMDI technology in patient care

Electrostatics of pharmaceutical aerosols I

• Introduction to the electrification of solids and liquids

• Principles and techniques of aerosol charge measurement

• Relevance of electrostatics in pulmonary drug delivery

• Computational simulation of the effect of charges on lung deposition

Electrostatics of pharmaceutical aerosols II

• Electrostatics of dry powder inhalers

• Electrostatics of metered dose inhalers and spacers

• Electrostatics of nebulised aerosols

• Future directions in electrostatics of pharmaceutical aerosols

Clinical development of inhaler products

• In vivo PK and PD requirements for inhaled products

• Statistical tools for in vivo studies

• Current and potential future clinical requirements for inhaled products in highly

regulated markets: US, EU and Canada

• Case studies on clinical development from brand and generic products


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Aerosol measurement techniques in inhaled product development

• Pre-formulation characterisation of inhalation product components

• Understanding and measurements of particle size distributions

• Principles of laser diffraction (wet and dry dispersion) analysis

• Inertial impaction analysis

• Optical counters, laser time-of-flight and aerosolization studies

Nebulizer Formulations and Devices

• Nebulizers in secondary care settings and treatment of severe lung disease

• Formulations for nebulized products

• Understanding of droplet formation, evaporation and growth in jet nebulisers

• Hardware design: vibrating mesh devices and smart nebuliser devices

Dry powder inhaler devices: aerosolization and product testing

• Mechanisms of drug particles dispersion into inhalable aerosols

• Dose metering, actuation and emission processes

• Review of reservoir, single unit dose and multiple unit dose device

• Characterization of emitted dose and particle size distribution for DPIs

• In fluence of device design on aerosolization mechanisms in passive inhaler devices

Patient-device interactions as barriers to portable inhalation therapies

• Influence of patients errors on treatment outcomes

• Issues of co-ordination of actuation and inhalation with pMDIs

• Flow rate dependency of DPIs

• Case study: choosing devices for children to improve patient therapy

From R&D to Commercial Manufacture of Inhalation Product

• Introduction to inhalation markets

• The product development strategy

• Device development

• Filling technology on the develop inhalation products

• Assembly and Packaging technology


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Timetable

Monday 7 September Morning 8:00-12:00 Anatomy and Physiology of the Respiratory Tract Dr. Philip Kwok Respiratory Drug Delivery and Aerosols as Medicines Dr. Philip Kwok Drug delivery to the nose 1 Dr. Daniela Traini Drug delivery to the nose 2 Dr. Daniela Traini Afternoon 14:00-18:00 Dry powder inhalers (DPIs) Dr. Tony Qi Zhou Characterization of powder bulk behavior and influence on DPI performance

Dr. Tony Qi Zhou

Micronization and particle engineering for DPI formulations Dr. Tony Qi Zhou Emerging DPIs Dr. Tony Qi Zhou Tuesday 8 September Morning 8:00-12:00 Pressure Metered Dose Inhalers 1 Dr. Daniela Traini Pressure Metered Dose Inhalers 2 Dr. Daniela Traini Electrostatics of pharmaceutical aerosols 1 Dr. Philip Kwok Electrostatics of pharmaceutical aerosols 2 Dr. Philip Kwok Afternoon 14:00-18:00 Clinical Development of Inhaler products 1 Prof. Murray Ducharme Clinical Development of Inhaler products 2 Prof. Murray Ducharme Clinical Development of Inhaler products 3 Prof. Murray Ducharme Clinical Development of Inhaler products 4 Prof. Murray Ducharme Wednesday 9 September – Friday 11 September – Inhalation Asia 2015 Saturday 12 September Morning 8:00-12:00 Aerosol measurement techniques in inhaled product development Dr. Darragh Murnane Nebulizer formulations and devices Dr. Darragh Murnane Dry powder devices and product testing Dr. Darragh Murnane Patient-device interactions as barriers to portable inhalation therapies Dr. Darragh Murnane Afternoon 14:00-18:00 From R&D to commercial manufacture of inhalation product 1 Mr. Frank Zheng From R&D to commercial manufacture of inhalation product 2 Mr. Frank Zheng From R&D to commercial manufacture of inhalation product 3 Mr. Frank Zheng From R&D to commercial manufacture of inhalation product 4 Mr. Frank Zheng


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Faculty

Prof. Murray Ducharme

Universite de Montreal Canada

Prof. Ducharme is president and CEO of Learn Confirm Inc. Professeur Associé, Faculté de Pharmacie, University of Montreal, Canada, Visiting Professor, Faculty of Pharmacy, Rhodes University, South Africa. He has more than 20 years of academic and industrial experience in the Drug Development field and in pharmacometrics, infectious diseases and drug metabolism. Dr. Ducharme has an undergraduate Pharmacy degree and a graduate diploma in Hospital Pharmacy from the University of Montreal, Canada, and a graduate Pharm. D from the College of Pharmacy and Allied Health Canada. Professor Ducharme has directed the work of 6 PhD Candidates, 5 post-doctoral fellows, and 11 MSc candidates. He has trained more than a thousand pharmacy students in PK/PD and infectious diseases, and has given special workshops and training sessions to regulatory agencies and pharmaceutical companies in Canada, USA, Asia, Israel and Europe. Dr. Ducharme was elected as a Fellow of the American College of Clinical Pharmacy in 2000 and nominated as a Fellow of the American College of Clinical Pharmacology in 2001. Since 2012, Professor Ducharme also serves as a Core Member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology. https://www.linkedin.com/pub/murray-ducharme/10/776/689

Dr. Philip Kwok

Hong Kong University

Dr Philip Chi Lip Kwok is an assistant professor at the Department of Pharmacology and Pharmacy, The University of Hong Kong. He obtained his Bachelor of Pharmacy degree with First Class Honours in 2002 at the Faculty of Pharmacy, The University of Sydney, Australia. He became a registered pharmacist after one year of full-time training in a community pharmacy. He then undertook his PhD studies on pharmaceutical aerosol electrostatics in the Advanced Drug Delivery Group at The University of Sydney and graduated in 2007. Dr Kwok was a research associate in the same group until August 2011 and took up his current position at The University of Hong Kong in September 2011. He has collaborated with academic and industrial researchers, both locally and internationally, on formulation-focused as well as cross-disciplinary projects. http://www.pharma.hku.hk/pharma/staffweb/DrPhilipKwok/index.php


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Prof. Shirui Mao

Shenyang Pharmaceutical University China

Course director

Dr. Shirui Mao is Professor of Pharmaceutics in School of Pharmacy, Shenyang Pharmaceutical University, China. She obtained her Master degree from Shenyang Pharmaceutical University (SPU) in 1994 and then joined the SPU faculty. In 2004, she earned her Ph.D. degree from Philipps University Marburg, Germany, and then worked as a post-doc in Prof. Kissel’s group until 2006. She was the recipient of CRS/Nagai innovation award in 2009. She was elected as the follow of controlled release society in 2010. Her research interests include mucosal drug delivery (pulmonary, intranasal, ocular….), micro-and nanotechnology based drug delivery system, and sustained drug delivery system. She is collaborating with academic researchers and pharmaceutical industries, both locally and internationally. http://www.omicsgroup.org/editor-biography/Shirui_Mao/

Dr. Darragh Murnane

University of Hertfordshire, UK

Course director

Dr. Darragh Murnane is Associate Dean (Enterprise) and Principal Lecturer in Airways Pharmaceutics at University of Hertfordshire. He is an early-career researcher who has established a research group which has worked on national (Cambridge, Leeds, King’s College London) and international (Teva Pharmaceuticals, Pfizer, GSK, IPRC Jordan) collaborations dedicated to cross-disciplinary research involving chemical engineering, physical and analytical chemistry to understand the link between patient physiology and pulmonary drug delivery. The research group has secured project funding in excess of £1.5M (NC3Rs, BBSRC CASE, ERDF and pharmaceutical industry) in the last five years for research in pulmonary aerosol therapies and bioanalysis. He is President of The Aerosol Society and a Steering Group Member of the Academy of Pharmaceutical Sciences Inhalation Focus Group. As Associate Dean, Darragh provides strategic leadership for academic-industrial and academic-health service liaisons including consultancy, knowledge transfer, and collaborative research activities with a value in excess of £1M per annum. Darragh Murnane graduated with a BSc. (Pharm.) from Trinity College Dublin (Ireland) and PhD in Pharmaceutical Technology from the University of London (UK). www.go.herts.ac.uk/Darragh_Murnane


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Dr. Philippe Rogueda

Aedestra Ltd Hong Kong

Course chair

Dr. Rogueda Pharma industry executive with a track record of driving business growth within the inhalation technology sector underpinned by a strong scientific background in physical chemistry. Key strengths include: a deep knowledge of developing markets particularly EU, US, China, the Far East and Latin America; driving drug development from initial concept through to clinical studies and registration on oral inhaled and nasal technologies; providing regulatory affairs advice to optimize strategies within various legislative frameworks; and defining milestones and targets to translate research aspirations into deliverable projects. https://hk.linkedin.com/in/philipperogueda

Dr. Daniela Traini

Woolcock institute Sydney Australia

Dr. Daniela Traini is an Associate Professor of the University of Sydney and ARC Future Fellow. herresearch portfolio covers all areas of respiratory research, from bench to bedside. Dr Trainihas completed her PhD in June 2005 under the primary supervision of Dr. Robert Price, at the University of Bath, UK.Dr Traini is part of the Respiratory Technology group at the Woolcock Institute for Medical Research and works in collaboration with Associate Professor Young. Associate Professor Traini is an emerging international leader in pulmonary drug delivery. Over the last 9 years since joining the University of Sydney, and before during her 5 years in industry, she had developed a leading research program on aerosol drug delivery, ranging from powder engineering, aerosol generation and characterisation in vitro to in vivo lung deposition and clinical outcomes. She has extensive experience in both academic and industrial pharmaceutics, and still retains strong link with the pharmaceutical industry. She has published over 100 full peer reviewed manuscripts, has 5 patents and has attracted more than $9 Millions in competitive funding. http://sydney.edu.au/medicine/people/academics/profiles/daniela.traini.php


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Mr. Frank Zheng

Haaro Hoeflinger China

Mr. Frank Zheng is Senior business manager of Harro Hoefliger Company in China region. He is responsible for company’s business development, technical support and strategy in China market. He has over couple of years of combined business and science experiences. He is well-experienced in the areas of new drug R&D, technology transfer, licensing and business development. Before he joined Harro Hoefliger, Dr. Zheng was division manager of Drug delivery System Division at 3M China, responsible for drug development and business development activities in China on inhalation and transdermal drug product. Prior to 3M, he worked at Novartis China R&D (CNIBR) as the Sr. scientist. He received a BS, master and Ph. D from Shenyang Pharmaceutical University. Dr. Zheng has authored/co-authored about 10 research publications. https://www.linkedin.com/pub/dir/Frank/Zheng

Dr. Tony Qi Zhou

Purdue University USA

Dr. Qi (Tony) Zhou is an Australian Biomedical Early Career Fellow at the Faculty of Pharmacy, The University of Sydney. He obtained B.Eng. from Shenyang Pharmaceutical University, M.Sc. from National University of Singapore and Ph.D. from Monash University. During his PhD and postdoctoral training, he has won several major international prizes from IPEC, AAPS and Australian Governments. His research has attracted funding of AU$800k in the past five years. Dr. Zhou will join the College of Pharmacy, Purdue University as an Assistant Professor from August of 2015. https://au.linkedin.com/pub/qi-tony-zhou/13/88b/b26


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