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Related Experiment Videos

Evaluation of solid-state forms present in tablets by Raman spectroscopy.

L S Taylor1, F W Langkilde

  • 1Solid State Analysis, Pharmaceutical and Analytical R&D, AstraZeneca R&D Mölndal, S-431 83 Mölndal, Sweden. lynne.taylor@astrazeneca.com

Journal of Pharmaceutical Sciences
|September 12, 2000
PubMed
Summary
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Fourier transform (FT)-Raman spectroscopy can identify active pharmaceutical ingredients in intact tablets and capsules. This technique also reveals the solid-state form of drugs within dosage forms, even at low concentrations.

Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Sciences
  • Solid-State Chemistry

Background:

  • Solid-state characterization is crucial for drug efficacy and stability.
  • Traditional methods for analyzing drug forms in dosage forms can be destructive or require sample preparation.
  • Non-destructive techniques are needed for efficient quality control of pharmaceutical products.

Purpose of the Study:

  • To evaluate Fourier transform (FT)-Raman spectroscopy for analyzing active pharmaceutical ingredients (APIs) in intact solid dosage forms.
  • To determine the capability of FT-Raman spectroscopy in identifying APIs and their solid-state forms within tablets and capsules.
  • To assess the sensitivity of FT-Raman spectroscopy for detecting APIs at low concentrations in pharmaceutical formulations.

Main Methods:

Related Experiment Videos

  • Acquisition of Raman spectra from intact tablets and capsules containing various APIs (enalapril maleate, prednisolone, ranitidine polymorphs, theophylline anhydrous/monohydrate, warfarin sodium clathrate).
  • Comparison of spectra from intact dosage forms with spectra of the pure drug substances.
  • Analysis of spectral data to identify APIs and assess their solid-state forms, including mixtures of polymorphs.

Main Results:

  • FT-Raman spectroscopy successfully detected APIs in intact tablets and capsules, even when comprising less than 1% of the total mass.
  • The technique demonstrated the ability to differentiate between different solid-state forms (polymorphs, hydrates) of the APIs within the dosage forms.
  • Identification of drug substances and their solid-state forms was achievable without sample destruction or extensive preparation.

Conclusions:

  • FT-Raman spectroscopy is a powerful, non-destructive tool for analyzing APIs in intact pharmaceutical dosage forms.
  • The method offers high sensitivity for detecting low-concentration APIs.
  • FT-Raman spectroscopy can provide valuable information on the solid-state characteristics of drugs within their final product form, aiding in quality control and formulation development.