A focus on freeze-drying. APS Parenteral Focus Group meeting; January 28 2015; Loughborough. UK

Abstract

Cite as:Smith, G. (2015) A focus on freeze-drying. Podium presentation at APS Parenteral Focus Group meeting; January 28; Burleigh Court, Loughborough, UKPresentation Overview1. Freeze-drying – Process steps and questions?2. QbD in Freeze-Drying3. Freezing Stage – Critical process parameters : solidification end point, eutectic formation, glass formation – PAT in the freezing Stage (development & production)4. Primary Drying Stage – Critical process parameters : collapse temperature, drying rate, drying end point – PAT in the 1ry drying Stage (development & production)5. LyoDEA – A new PAT – Equivalent circuit modelling – Determination of the ice nucleation onset, the ice solidification time and the thermal equilibration time – Impact of sucrose on mannitol crystallization – Annealing times and the prediction of primary drying duration – In-vial determination of the glass transition temperature, Tg' – Strength/fragility of glass forming liquids – Primary drying rates and end point determination – Product collapse