Blogmaster
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Nov 12, 2024
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1
min read
Small volume dissolution studies are conducted by drug developers for several important reasons:
- Limited Material Availability: In the early stages of drug development, there may be limited quantities of the drug available, especially for investigational new drugs. Small volume dissolution studies allow researchers to obtain necessary dissolution data without requiring large amounts of the drug substance or formulation.
- Rapid Screening: Small volume methods are conducive to high-throughput screening of multiple formulations. This is particularly useful during the formulation development phase, enabling quick assessment of different excipients, manufacturing processes, and formulation approaches.
- Cost-Effectiveness: Smaller volumes of solvents and reagents reduce costs associated with laboratory resources and waste disposal, making it a more economical approach during early development versus using larger volumes.
- Minimizing Waste: The drug development process often involves many iterations and modifications. Using a smaller volume minimizes the waste of drug substances, especially if formulations do not succeed in earlier testing phases.
- Better Mimicking of Physiological Conditions: Small volume dissolution studies can emulate the conditions in specific areas of the gastrointestinal tract more closely, which can be beneficial in characterizing the behavior of the drug in physiological environments.
- Regulatory Compliance: Regulatory agencies acknowledge small volume methods as valuable tools for understanding the formulation's performance characteristics. They can provide necessary data for Investigational New Drug (IND) applications.
- Innovative Technologies: Advances in analytical instruments and technologies allow for effective dissolution testing using smaller volumes, which can integrate with other assays and provide more comprehensive data.
Small volume dissolution studies play an important role in the drug development landscape, enabling efficient and cost-effective assessments while accommodating the limitations of material availability typical in early-stage research. Pion offers a range of small volume dissolution apparatuses that may be used with our Rainbow Dynamic Dissolution Monitor that utilizes UV fiber optic probes for in situ, small volume concentration testing. We also offer several related flux technologies to help researchers understand membrane permeability at small yet biorelevant volumes. Contact us today to learn more.
