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Published on: August 3, 2013
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Pharmaceutical patent applications in freeze-drying
Edmond Ekenlebie1, Tomaž Einfalt2, Arianna Irò Karytinos3
1School of Pharmacy, Aston University, Birmingham, UK.
Pharmaceutical Patent Analyst
|November 3, 2016
Summary
Freeze-drying (lyophilization) enhances pharmaceutical product stability by reducing water content. Patent analysis reveals stabilized freeze-drying technology, indicating maturity in its application within the biotechnology sector.
Area of Science:
- Pharmaceutical Science
- Biotechnology
- Chemical Engineering
Background:
- Injectable therapeutics often face degradation in liquid formulations due to hydrolysis.
- Freeze-drying (lyophilization) is a key pharmaceutical manufacturing technique to mitigate this by lowering water activity.
- Understanding the patent landscape of freeze-drying is crucial for assessing its current state and future potential.
Purpose of the Study:
- To analyze the international patent landscape and identify trends in freeze-drying technology.
- To evaluate the contribution of freeze-drying to the 'state of the art' in pharmaceutical formulation.
- To explore future potential applications of freeze-drying.
Main Methods:
- A comprehensive search of patent databases was performed, covering 1992-2014.
- 914 disclosures related to freeze-drying, lyophilization, or equivalent drying methods were analyzed.
- Patent activity was contrasted between early (1992-1993) and later periods.
Main Results:
- Freeze-drying technology patent filings have stabilized after a peak in biotechnology activity in 2011-2012.
- While patent submissions show an increasing trend overall, freeze-drying specific submissions have slowed since 2002.
- This trend suggests a level of maturity in the freeze-drying field.
Conclusions:
- Freeze-drying remains a vital technology for enhancing the stability of pharmaceutical products, particularly injectables.
- The patent landscape indicates a mature but evolving field with ongoing innovation.
- Future research and development may focus on optimizing existing freeze-drying processes and exploring novel applications.
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