MVIC Workshop September 2020

Two days course – CMC for Inhalation Products  will be run digitally during the 23–24th of September 2020.
Note: The program is subject to change

Digitally the 23–24th of September 2020.

All presentations are in English.

Day 1 

09.00–09.30 Registration Workshop

09.30–10.15 General about Aerosol Physics and Lung Deposition, Lars Asking

  • Aerosol particle behavior
  • Deposition mechanisms and lung dimensions
  • Other particle properties as e.g. evaporation and hygroscopic growth

10.15–11.00 Inhalation Products – DPIs, Dr Orest Lastow

  • DPIs on current and future market
  • Technical principles
  • Technical features

11.00–11.15 Coffee

11.15–11.40 Inhalation Products – pMDIs, Dr Orest Lastow

  • pMDIs on current and future market
  • Technical principles including cans, driving gases and valves
  • Technical features including breath trig and spacers

11.40–12.00 Inhalation Products – Nebulized Products, Lars Asking

  • Nebulization technologies including jet, ultrasonic and mesh
  • Nebulizers and products for nebulization
  • Soft mist inhalers

12.00–13.00 Lunch

13.00–14.00 Inhalation Products – Liquid Formulations and Nasal Products, Dr Martin Lindsjö

  • Liquid formulations
  • Solutions and suspensions
  • Nasal products

14.00–15.45 DPI Formulations, Dr Ann-Marie Lyberg

  • Particle size reduction methods incl. micronization and spray drying
  • Excipients
  • Formulation alternatives

15.00–15.15 Coffee (break in above presentation)

15.45–17.15 Powder Solid State, Dr Lars-Erik Briggner

  • Crystalline vs amorphous
  • Solid state analytical techniques
  • Conditioning and relaxation

17.15 End of Day

19.00 Dinner, Lund City

Day 2 

08.30–09.00 Regulatory Specifics of Inhalation Products, Lars Asking

  • Key requirements for inhalation products
  • Requirements to show equivalence
  • EU & US

09.00–09.45 Inhalation Statistics, Dr Dennis Sandell

  • Setting specifications for DDU
  • Strategy to show equivalence EU & US
  • Stability data and setting shelf-life

09.45–11.15 Inhaler Testing – Impactors, Dr Mårten Svensson

  • Impactor types and principles
  • Pharmacopeial aspects
  • In vivo predicting in vitro methods

10.15–10.30 Coffee (break in above presentation)

11.15–12.00 Inhaler testing – Continue, Dr Mårten Svensson and Peter Elfman

  • Delivered dose testing (and waste dosing)
  • LALLS methods
  • Spray pattern and plume geometry

12.00–13.00 Lunch

13.00–13.30 Automated Testing and Equipment Demo, Kjell Fransson

  • What can be automated and why
  • Automation solutions
  • Demo of equipment used at impactor and DD testing

13.30–15.15 Lung Deposition Modelling, Dr Per Bäckman

  • Modelling of lung deposition
  • Modelling of PK-profiles
  • Demo of Mimetikos PreludiumTM software

14.15–14.30 Coffee (break in above presentation)

15.15–15.30 Final Q&As and Summary of Workshop, Lars Asking

15.30 End of Day