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The solid-state continuum: a perspective on the interrelationships between different solid-state forms in drug
David P Elder1, James E Patterson2, René Holm3
1GlaxoSmithKline Pharmaceuticals, Hertfordshire, UK.
The Journal of Pharmacy and Pharmacology
|August 16, 2014
Summary
Understanding solid-state nomenclature is crucial for selecting optimal drug substance forms. Rational selection ensures effective drug development, considering both substance and product needs for improved processing and stability.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Chemical Engineering
Background:
- The solid-state continuum encompasses diverse crystalline and non-crystalline forms, including amorphous systems.
- Effective drug development necessitates a comprehensive understanding of solid-state properties and their implications.
Purpose of the Study:
- To review the nomenclature of solid-state forms relevant to drug substances and products.
- To explore the relationship between solid-state form selection and drug development processes.
- To discuss the role of the drug substance's physicochemical properties in solid oral dosage forms.
Main Methods:
- Literature review of solid-state nomenclature and drug development principles.
- Analysis of the interplay between drug substance solid-state form and secondary processing.
- Examination of crystal engineering applications for optimizing drug properties.
Main Results:
- A rational approach to solid-state form selection, integrating drug substance and product requirements, is vital for drug candidate development.
- Secondary processing considerations significantly influence the choice of drug substance solid-state form and formulation.
- Crystal engineering offers potential for optimizing drug stability, purity, and optical resolution, alongside regulatory compliance.
Conclusions:
- The nomenclature of the solid-state continuum, including amorphous systems, was reviewed.
- The physicochemical significance of the drug substance in solid oral dosage forms was highlighted.
- Integrated decision-making in solid-state form selection is essential for successful drug development.
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