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Related Concept Videos

Non-ohmic Devices00:51

Non-ohmic Devices

In most substances, the current flow is proportional to the voltage applied to it. A simple relationship between the values of current, voltage, and resistance is known as Ohm's law. Nonohmic devices do not exhibit a linear relationship between voltage and current. One such device is the semiconducting circuit element known as a diode. A diode is a circuit device that allows current flow in only one direction.
Consider a simple circuit consisting of a battery, a diode, and a resistor. A diode...

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Solid-state compatibility studies using a high-throughput and automated forced degradation system.

Tatsuyoshi Wakasawa1, Kyoko Sano, Yutaka Hirakura

  • 1Pharmaceutical Analysis, Pharmaceutical Research and Technology Laboratories, Astellas Pharma Inc., 180 Ozumi, Yaizu, Shizuoka 425-0072, Japan.

International Journal of Pharmaceutics
|January 25, 2008
PubMed
Summary
This summary is machine-generated.

A new automated powder compatibility testing system uses robotics and ultra-performance liquid chromatography (UPLC) for faster pharmaceutical development. This high-throughput system accurately assesses drug-excipient interactions, reducing manual labor and costs.

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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Process Automation

Background:

  • Increasing pharmaceutical candidate numbers necessitate faster development workflows.
  • Traditional powder compatibility testing is time-consuming and labor-intensive.

Purpose of the Study:

  • To establish a high-throughput automated powder compatibility testing system.
  • To validate the system's accuracy and precision in assessing drug-excipient interactions.
  • To demonstrate the system's applicability in evaluating powder mixture homogeneity.

Main Methods:

  • An integrated robotic system for automated dispensing, weighing, and storage of powder samples.
  • Ultra-performance liquid chromatography (UPLC) for drug substance extraction and analysis.
  • Mass tracking at each unit operation for system validation.
  • Testing of aspirin and magnesium stearate (Mg-St) mixtures under varying conditions.

Main Results:

  • The automated system accurately discriminated between incompatible powder mixtures (aspirin and Mg-St) with different homogeneity levels.
  • Differential scanning calorimetry (DSC) was less sensitive than the automated system in distinguishing powder conditions.
  • The system's results for aspirin and Mg-St incompatibility were comparable to previous studies, confirming reliability.
  • Manual labor was reduced sixfold, and outsourcing costs were decreased.

Conclusions:

  • The automated powder compatibility testing system is reliable and efficient for pharmaceutical development.
  • The system offers significant advantages over traditional methods, including reduced manual work and costs.
  • The technology is applicable to both compatibility testing and analytical method development for drug products.