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Pharmaceutical Equivalents

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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.

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Visualizing and Quantifying Pharmaceutical Compounds within Skin using Coherent Raman Scattering Imaging

Visualizing and Quantifying Pharmaceutical Compounds within Skin using Coherent Raman Scattering Imaging

Published on: November 24, 2021

Raman mapping of pharmaceuticals.

Keith C Gordon¹, Cushla M McGoverin

¹MacDiarmid Institute for Advanced Materials and Nanotechnology, Chemistry Department, University of Otago, Dunedin 9054, New Zealand.

International Journal of Pharmaceutics

|January 4, 2011

Summary

Raman spectroscopy with microscopy creates detailed chemical maps of pharmaceuticals. This technique analyzes drug distribution and behavior in various systems, offering new insights for drug development.

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Area of Science:

Analytical Chemistry
Pharmaceutical Sciences
Spectroscopy

Background:

Raman spectroscopy is suitable for analyzing pharmaceutical systems due to drug molecular structures.
Current chemometric methods often overlook spatial information in Raman mapping data.
Limited studies utilize the inherent spatial data of Raman maps for chemical mapping.

Purpose of the Study:

To highlight the application of Raman mapping in pharmaceutical analysis.
To emphasize the use of spatial information in Raman datasets for chemical mapping.
To discuss the potential of Raman mapping for pharmaceutical systems.

Main Methods:

Raman spectroscopy implemented through microscopy for fine-scale chemical mapping.
Application of univariate and multivariate chemometric methods to Raman mapping data.
Axial (depth) profiling using Raman mapping.

Main Results:

Raman mapping determines the distribution of active pharmaceutical ingredients (APIs) in tablets, solid dispersions, and controlled release devices.
Axial profiling reveals API penetration through membranes, cellular uptake of liposomes, and elution from medical device coatings.
Demonstrated the utility of spatial information for creating chemical maps.

Conclusions:

Raman mapping provides detailed chemical and spatial information crucial for pharmaceutical analysis.
The technique is valuable for studying drug distribution, release, and interaction within complex systems.
Advancements in instrumentation will enhance the efficiency and application of Raman mapping in pharmaceuticals.