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Indicator-based assessment of potential supply risks for pharmaceutical excipients: Method and application
Kosuke Nemoto1, Yusuke Hayashi1, Hirokazu Sugiyama1
1Department of Chemical System Engineering, The University of Tokyo, Tokyo, Japan.
International Journal of Pharmaceutics
|August 26, 2024
Summary
This study assessed pharmaceutical excipient supply risks in Japan using the Herfindahl-Hirschman index (HHI). Magnesium stearate, tablets, and capsules pose the highest risks, necessitating mitigation strategies like diversification.
Area of Science:
- Pharmaceutical Sciences
- Supply Chain Management
- Risk Assessment
Background:
- Pharmaceutical excipients are critical for drug formulation and delivery.
- Ensuring a stable supply chain for excipients is vital for public health.
- Market concentration can lead to significant supply risks.
Purpose of the Study:
- To develop and apply an indicator-based system for assessing pharmaceutical excipient supply risks.
- To identify high-risk excipients, dosage forms, and disease categories in the Japanese market.
- To provide actionable recommendations for mitigating identified supply risks.
Main Methods:
- Systematic survey, data collection, and indicator value calculation.
- Adaptation of the Herfindahl-Hirschman index (HHI) for market concentration analysis.
- Case studies at compound, dosage form, and disease levels for risk assessment.
Main Results:
- Magnesium stearate identified as a high-risk compound due to its widespread use and market concentration.
- Tablets and capsules indicated higher supply risks compared to granules, highlighting the need for dosage form diversification.
- Adult disease drug supply chains may be vulnerable due to reliance on tablet formulations.
Conclusions:
- The indicator-based assessment effectively identifies pharmaceutical excipient supply vulnerabilities.
- Diversification of excipients and dosage forms is crucial for supply chain resilience.
- Strategic shifts away from high-risk formulations, like tablets for adult diseases, are recommended.
Keywords:
Dosage formHerfindahl-Hirschman indexPeriodic tablePharmaceutical manufacturingSupply chainWorldwide governance indicatorsMore Related Videos
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