Articles by Henning Gieseler, PhD - Pharmaceutical Technology

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Articles by Henning Gieseler, PhD

Freeze-Drying Process Optimization for a Small Molecule

The authors evaluate the thermal properties of gentamicin sulfate as a small-molecule drug model in optimizing the freeze-drying cycle.
Jun 2, 2012

The authors evaluate the thermal properties of gentamicin sulfate as a small-molecule drug model in optimizing the freeze-drying cycle.

Freeze-Drying Process Optimisation for a Small Molecule

Jun 1, 2012

For true freeze-drying cycle optimisation, information on the maximum allowable product temperature during primary drying is required.

Freeze Drying: The Experts' View

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

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.

Peer-Reviewed Technical Note: Quality by Design in Freeze-Drying

Cycle design and robustness testing using advanced process analytical technology.
Oct 2, 2008

Cycle design and robustness testing using advanced process analytical technology.

Peer-Reviewed Technical Note: Influence of Common Excipients on the Crystalline Modification of Freeze-Dried Mannitol

Mar 2, 2008

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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