The authors evaluate the thermal properties of gentamicin sulfate as a small-molecule drug model in optimizing the freeze-drying cycle.
Jun 2, 2012
By:
Henning Gieseler, PhD, Susanne Hibler
The authors evaluate the thermal properties of gentamicin sulfate as a small-molecule drug model in optimizing the freeze-drying cycle.
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Jun 1, 2012
By:
Henning Gieseler, PhD, Susanne Hibler
For true freeze-drying cycle optimisation, information on the maximum allowable product temperature during primary drying is required.
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Lyophilisation is often necessary for pharmaceutical products to improve stability or shelf-life. However, the process can present difficulties, particularly when scaling up from the laboratory to commercial production. We bring experts together to discuss best practices for developing a lyophilisation process, including quality by design (QbD) and design space.
Apr 1, 2012
By:
Henning Gieseler, PhD, Yves Mayeresse, Steven Nail, Trevor Page, Michael J. Pikal, Manfred Steiner
Lyophilisation is often necessary for pharmaceutical products to improve stability or shelf-life. However, the process can present difficulties, particularly when scaling up from the laboratory to commercial production. We bring experts together to discuss best practices for developing a lyophilisation process, including quality by design (QbD) and design space.
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Cycle design and robustness testing using advanced process analytical technology.
Oct 2, 2008
By:
Henning Gieseler, PhD, Tony Kramer, Stefan Schneid
Cycle design and robustness testing using advanced process analytical technology.
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Mar 2, 2008
By:
Stefan Schneid, Xenia Riegger, Henning Gieseler, PhD
Mannitol is the most commonly used bulking agent in freeze-drying formulation design. The benefit of using mannitol is that it crystallizes during freezing and permits drying processes at higher product temperatures, and thus with higher sublimation rates relative to purely amorphous systems (1). Mannitol, however, is known to form different crystalline modifications which compromises reproducibility of product characteristics and storage stability due to phase transformations (2, 3).
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