Editorial Feature

The Benefits of Surface Analysis Techniques to the Pharmaceuticals Industry

Surface technologies play an important role in accelerating the development of pharmaceutical products and in the optimisation of manufacturing processes so that ‘pipeline’ products reach the market place quickly.

Critical interactions continually take place between surfaces of product, plant and packaging throughout the manufacturing process and indeed the entire pharmaceutical product life cycle. Consequently the need for reliable and highly chemically specific methods for surface analysis is paramount in this industry.

Benefits of Surface Analysis to the Pharmaceuticals Industry

Techniques including XPS (X-ray Photoelectron Spectroscopy) and ToFSIMS (Time-of-Flight Secondary Ion Mass Spectrometry) provide the following benefits to pharmaceutical manufacturers:

  • Cleanliness validation of products, process equipment and materials, and product packaging
  • Rapid identification of contamination, its source and cause
  • Evaluation of product and packaging stability (and product - packaging compatibility)
  • Assessment of sterilisation effects on products and packaging
  • Optimisation and acceleration of new product development
  • Reverse engineering of products taken directly from the pharmacy shelf.

In addition, two new techniques have greatly enhanced the characterisation of pharmaceutical products:

  1. 3DP technique provides detailed surface topography with sub micron resolution - both spatially and depth wise. An understanding of the spatial roughness of excipients is invaluable for pharmaceutical coating technologies.
  2. Powerful SIMS imaging techniques enable the surface chemistry to be mapped at high spatial resolution (e.g. complex active drug species on excipient species). Detailed mapping of this kind is invaluable in the development of drug delivery systems.

Pharmaceuticals-Related Surface Analysis Studies Performed by CERAM

  • ToFSIMS Analysis of Brown/Yellow Staining on Pharmaceutical Ovule Blister Packaging Material
  • Investigation into Spot Defects in Metallised Pharmaceutical Packaging Film using Dynamic Secondary Ion Mass Spectrometry
  • Investigation of the Interaction of a Steroid-Based Drug with Rubber Gasket Material
  • Investigation of a Drug Elution from Coated Stents by DSIMS
  • Investigation of Drug Distribution in Coated Stents
  • Characterisation of Stents Coated with Drug-Loaded PCL
  • LSOM and DSIMS Characterisation of Coating on Stents with Different Drug Elution Rates.
  • Surface Analysis of Drug Powders Demonstrating Variable Solubility
  • An XPS Investigation of Active Loading on Drug Powders for Dry Powder Inhalers (DPIs)
  • High Resolution SIMS Imaging of the Distribution of Drug Active Agent on Lactose Granules
  • An XPS investigation of heat seal strength reduction on drug foil packaging.
  • Characterisation of Monodisperse Polystyrene Beads by XPS, ToFSIMS and SEM
  • Investigation of Antibody (IgG) Immobilisation on PolyEthylene and PolyStyrene Beads by XPS and ToFSIMS
  • Surface Characterisation of Polystyrene Beads and Silica Hybrid Polymers using XPS and ToFSIMS
  • XPS Analysis of Magnetite Beads
  • Investigation of the Efficacy of Cleaning Procedures to Remove Drug and Other Residues from Used YTZ Beads
  • Surface Analysis of Micro-Milling Beads After Conditioning
  • Investigation into the Variable Adhesion of X Film Bonding to Glass Beads using X-ray Photoelectron Spectroscopy (XPS)
  • LIMA analysis of coaxial cable foam and raw polymer beads
  • Investigation of the Surface and Depth Distribution of a Lubricant on Drug X Tablets
  • Investigation of the Surface Composition of Drug X Blends and Tablet Cores
  • Further Topographical Characterisation of Tablet Samples
  • Investigation of Tablet Hydration using 3D Non-Contact Profiling
  • Further Investigation of Sulfoxide in Tablets using ToFSIMS
  • ToFSIMS Investigation into the Loss of Potency of Drug X Tablets for Veterinary Medicine
  • Investigation into the Appearance of Brown Spots on Antibiotic Tablets using ToFSIMS and XPS
  • ToFSIMS Investigation into the Cause of the Yellow Discolouration of a Drug Tablet
  • Surface Analysis of Tablets and Excipient Powders using ToFSIMS & XPS
  • Analysis of Model Tablet Formulations using Surface Analysis Techniques
  • Analysis of a Paracetamol Tablet using Surface Analysis

Source: CERAM

For more information on this source please visit CERAM

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