Pharmaceuticals

The development of a pharmaceutical drug product requires - an extraordinary amount of time and effort to ultimately develop the final drug product. During its entire lifecycle, the quality of the pharmaceuticals is one of the most critical steps, as it continually faces challenges from government and regulatory agencies to ensure the quality and efficacy.

From drug discovery to post-marketed products, the scientific fields and technologies involved require fast and innovative characterization tools. Today, many techniques are used in pharmaceutical laboratories to ensure the quality of a product. Several tests, such as dissolution profiles, stability studies or control of active content are required to follow the pharmaceutical guidelines and authorities, ensuring that the analyzed product  adheres to pre-determined specifications. In a quality control laboratory, most of the analytical tools are based on chemical analyses (liquid chromatography, dissolution apparatus…) which generally damage the sample, require solvent and a lot of time and important human resources. Accordingly, analytical methods based on optical technologies are increasingly appreciated. Therefore, the use of vibrational spectroscopy has grown quickly and has appeared as an alternative analytical tool to the usual techniques. By allowing fast and non-destructive analysis, without needing sample preparation in most cases, these analytical tools are particularly appreciated by the analysts.

Since its discovery, Raman spectroscopy, which is based on  inelastic scattering of light, has attracted increasing attention due to its numerous advantages, such as not needing to use organic solvents, the reduced sample preparation step, and the ability to perform qualitative, as well as quantitative analyses with relatively short data acquisition times. It has been combined with optical microscopy, giving rise to Raman hyperspectral imaging. The use of the latter has expanded in the pharmaceutical and biomedical fields since microspectroscopic techniques present several advantages by combining the acquisition of spatial and spectral information from a sample. Raman hyperspectral imaging characterizes the sample in terms of chemical (actives and excipients identification, distribution and content, for example), and physical properties (solid state/polymorphism, particle size, etc.) by adding information on the spatial distribution.

Raman spectroscopy can be very helpful throughout the entire lifecycle of a drug, and especially during the steps below:

 

Stage

Main objectives

Why use Raman?

Drug discovery (lead compound search and characterization)

  • Identification and validation of biological mechanisms behind a disease (i.e. the target)
  • Identification of active molecules on the target
  • Selection of candidate drugs (optimized properties for future developments)
  • High-throughput screening
  • Studying interactions of drug-like molecules with a target
  • Determination of the absolute configuration of new molecules (lead compound)
  • Better understanding of the activity of lead compounds and their optimization
  • Crystalline behavior of the lead compound

From preclinical to Pharmaceutical development

  • Preclinical trials to document that the compound is safe for entry into human trials
  • Science of formulation, development and manufacturing of the final drug product
  • Raw material identification
  • Solid state studies, polymorphism
  • Characterization of actives and excipients
  • Compound distribution
  • In-process controls
  • Trouble shooting

Quality control

  • Ensures the drug product quality and reduces the ‘out-of-specifications’ products
  • Polymorphism
  • Characterization of actives and excipients
  • Monitoring of physical and chemical attributes (coating thicknesses, distribution of compounds, content uniformity…)
  • Trouble shooting

Counterfeit detection and patent protection

  • Defense of intellectual property
  • Fight against counterfeit marketing
  • Study of generics
  • Counterfeit detection
  • Identification of actives and excipients
  • Distribution of compounds
  • Content uniformity
  • Polymorphism
  • “Reverse engineering”

 

HORIBA Scientific supports the research, development and quality control of the product with various analytical instruments. HORIBA Scientific’s analytical tools contribute to the reduction of time in research, provide information on the product during development, and ensure product quality of the post-marketed products. 

 

 

Application Notes

Pharmaceuticals -  application notes
  • RA26 : Raman Analysis and Characterization of Pharmaceuticals.
  • RA27 : Polymorphy in Pharmaceuticals.
  • RA28 : Characterization and Mapping of active pharmaceutical ingredients and excipients in a tablet by Raman and infrared spectroscopy on the same microspectrometer.
  • RA29 : Raman Microscopy in Pharmaceutical Salt Analysis.
  • Pharmaceutics05 : XploRA - Smart Microscopy.
  • RA55 : Transmission Raman Spectroscopy: review of applications.
  • RA58 : Statistical, morphological and chemical characterization of particles on cellulose nitrate filters for quality control
  • RA61 : Raman spectroscopy of pharmaceutical ingredients under humidity controlled atmosphere
  • RA66 : Raman Hyperspectral Imaging: An essential tool in the pharmaceutical field

For a list of all available application notes please click here.