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A survey of solid form landscape: Trends in occurrence and distribution of various solid forms and challenges in
Z Jane Li1, Yue Lu1, Ruiping Wang1
1Material Sciences Department, Pharmaron, 6 Taihe Road, Beijing 100176, China.
Journal of Pharmaceutical Sciences
|November 4, 2024
Summary
This study analyzed solid form screening for 476 new chemical entities (NCEs). Key trends in polymorphism, salt formation, and molecular weight (MW) distribution were identified, highlighting evolving challenges in pharmaceutical development.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Chemical Engineering
Background:
- Solid form screening is critical for selecting optimal drug candidates.
- Understanding polymorphism, salt formation, and crystallization is essential for drug development.
- Historical data provides context for current trends in solid form selection.
Purpose of the Study:
- To analyze trends in solid form screening for new chemical entities (NCEs) from 2016-2023.
- To identify changes in polymorphism, salt formation, crystallization, and molecular weight (MW) distribution over time.
- To discuss the complexities and challenges in selecting development forms for pharmaceutical applications.
Main Methods:
- Comprehensive analysis of solid form screening data for 476 NCEs.
- Evaluation of polymorphism, salt formation, crystallization behavior, and MW distribution.
- Comparison of current data with historical trends in solid form selection.
Main Results:
- Identified notable trends in polymorphism, salt formation, and MW distribution of NCEs.
- Observed increased complexity in the solid-form landscape and challenges in crystallization.
- Documented the occurrence of emerging and disappearing polymorphs over the study period.
Conclusions:
- Solid form screening and selection present evolving challenges in pharmaceutical development.
- Insights into crystallization and form selection strategies are crucial for future drug development.
- The study provides valuable data for optimizing solid form selection processes.
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