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Related Concept Videos

Raman Spectroscopy Instrumentation: Overview01:26

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A conventional Raman spectrophotometer includes a laser source, a sample holding system, a wavelength selector, and a detector.
The monochromatic laser source, typically using visible or near-infrared radiation, generates a highly focused beam of light. This light interacts with the molecules of the sample, scattering some of the light. Liquid and gaseous samples are usually tested in ordinary glass capillaries, while solids can be analyzed as powders packed in capillaries or as potassium...
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Quantitative Macro-Raman Spectroscopy on Microparticle-Based Pharmaceutical Dosage Forms.

Hui Wang1, Lisa Williams, Susan Hoe

  • 1University of Alberta, Department of Mechanical Engineering, 5-1G Mechanical Engineering Building, Edmonton, AB T6G 2G8, Canada.

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|June 4, 2015
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Summary
This summary is machine-generated.

Quantitative macro-Raman spectroscopy accurately analyzes pharmaceutical powders. It determined the minimum sample volume needed for representative analysis of both carrier-based and carrier-free inhaler formulations, ensuring accurate drug composition assessment.

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Sciences
  • Spectroscopy

Background:

  • Accurate quantitative analysis of pharmaceutical powders is crucial for drug product quality control.
  • Dry-powder inhalers (DPIs) and metered-dose inhalers (MDIs) contain complex multi-component formulations.
  • Sample heterogeneity in pharmaceutical powders can lead to significant analytical errors.

Purpose of the Study:

  • To apply quantitative macro-Raman spectroscopy for analyzing the bulk composition of pharmaceutical drug powders.
  • To determine the minimum sample volume required for representative sampling of heterogeneous DPI and MDI formulations.
  • To assess the applicability of a custom-designed macro-Raman instrument for multicomponent powder analysis.

Main Methods:

  • Quantitative macro-Raman spectroscopy was performed on commercial DPIs (Flixotide, Seretide) and an MDI.
  • A custom-designed dispersive macro-Raman instrument with a 0.16 μL sample volume was utilized.
  • A Monte Carlo model was developed to predict the minimum sample volume for representative sampling based on heterogeneity.

Main Results:

  • Macro-Raman spectroscopy successfully analyzed the bulk composition of pharmaceutical drug powders.
  • Carrier-free respirable powders required a minimum sample volume of approximately 10(-4) μL for <3% relative error.
  • Lactose-carrier-based dosage forms required a larger sample volume (approx. 0.1 μL) for representative measurements.
  • Experimental error analysis showed good agreement with the Monte Carlo model predictions.

Conclusions:

  • Quantitative macro-Raman spectroscopy is a viable technique for analyzing pharmaceutical powder composition.
  • The study established critical sample volume requirements for representative analysis of different inhaler formulations.
  • The findings provide valuable insights for optimizing analytical methods for inhaled drug products.