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A Guided Materials Screening Approach for Developing Quantitative Sol-gel Derived Protein Microarrays

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Towards effective solid form screening.

Morten Allesø¹, Fang Tian, Claus Cornett

¹Faculty of Pharmaceutical Sciences, Department of Pharmaceutics and Analytical Chemistry, University of Copenhagen, Universitetsparken 2, DK-2100 Copenhagen, Denmark.

Journal of Pharmaceutical Sciences

|October 3, 2009

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This study introduces a novel solid form screening method using miniaturized equipment to simulate manufacturing processes. It effectively identifies new active pharmaceutical ingredient (API) solid forms by applying process-induced stresses.

Area of Science:

Pharmaceutical Sciences
Materials Science
Chemical Engineering

Background:

Traditional solid form screening often overlooks secondary manufacturing steps.
Process-induced transformations during manufacturing can lead to the discovery of new active pharmaceutical ingredient (API) solid forms.
Existing methods may not fully capture the impact of manufacturing stresses on API solid-state properties.

Purpose of the Study:

To present a new, effective approach for solid form screening.
To integrate well-plate-based crystallizations with miniaturized processing equipment.
To investigate process-induced transformations of APIs under simulated manufacturing conditions.

Main Methods:

Utilized well-plate-based crystallizations combined with miniaturized processing equipment.

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Applied process-induced stresses (heat, solvent, shear, pressure) directly to well-plate units.

Employed theophylline and nifedipine as model compounds for screening.

Main Results:

Observed theophylline anhydrate-to-monohydrate transformation and subsequent dehydration.
Detected a metastable polymorph (beta form) of nifedipine during kinetic milling profiling.
Achieved complete conversion to the stable nifedipine polymorph (alpha form) via compaction.

Conclusions:

The developed approach enhances solid form screening outcomes.
Miniaturized processing effectively mimics unit operations to induce solid-state transformations.
This method maximizes solid form discovery while minimizing compound consumption.