Application Note: Verification of three different Opadry whites using a handheld Raman analyser

Pharmaceutical companies that manufacture tablets, capsules, and other solid dosage forms use film coatings on their products to differentiate appearance and to improve palatability by masking unpleasant tastes or odors.

Film coatings also protect tablets from light, moisture, and environmental gases, reduce breakage and chipping, and prevent cross contamination.

In choosing a film coating, pharma-ceutical manufacturers consider the active pharmaceutical ingredients (API) and excipients’ attributes (e.g. solubility, stability, particle size) and the API’s intended delivery profile (e.g. immediate release, controlled release, sustained release, enteric release).

Colorcon^® produces a range of Opadry^® film coatings that are widely used by pharmaceutical manufacturers and available in diverse formulations suitable for various API and excipient characteristics and release profiles. A dry mix concentrate, different Opadry formulas appear identical and share a similar chemical compound structure making discrimination between them challenging. Traditional material identity verification uses wet chemistry or Fourier transform infrared (FT-IR) spectrometry and necessitates opening of secondary packaging, sampling the raw materials, transporting samples to a central laboratory, and expert sample preparation and analysis of results.