Workshop: Powder Analysis of Pharmaceutical Products, Munich, 18. June, 2013

  • When: June 18. 2013. 13.00-16.30.
  • Where: Munich, Germany

We are happy to invite you to this 4th Workshop held by Particle Analytical. Product properties both during manufacturing and in vivo are determined by the particles/powder making up the pharmaceutical product. This workshop will take you through the regulatory requirements within this scientific discipline – and explain the background for the requirements. Further, a general introduction to physical characterisation of pharmaceutical drugs will be given,  including a discussion of the importance of crystalline properties and particle size.

Participation is free – but a fee of Euro 100 will be charged to cover the expenses in case of no-show. Sign up at info@particle.dk. Please read the abstracts below.

 

Pills on Drug Information Sheet

 

Program

  • 13.00-13.45: Welcome and light lunch. Presentation of Particle Analytical
  • 13.45-14.15: Particle analysis: Why should I car – and what do the guidelines say?
  • 14.15-14.30: Coffee break
  • 14.30-15.00: Polymorph screening – searching for new crystalline structures – which approach to use
  • 15.00-15.30: Examples of pitfalls in determination of particle size and shape
  • 15.00-15.30: Questions, discussion
  • 15.30-16.30: Networking over a cocktail

 

Abstracts:

  • Powder/particle analysis is essential in order to understand and control a compound during development. This analysis  includes information about size, shape and crystalline structure. Lack of control of the particles increases the risk of sudden transformations, leading to changes in the stability and properties of the compound. Such changes might have large consequences for the behavior of the compound during manufacturing and -ultimately- in vivo. I.e. the potential risk, if these analyses are not performed, is that the analytical program and the clinical studies have to be repeated, which of course is quite costly. Some of the requirements from the regulatory guidelines will be presented and discussed.
  • Most solid materials are capable of forming different crystalline structures, known as polymorphic forms. These polymorphic forms have different physicochemical properties that might have significant impact on the intended use of the material. It is of immense importance to determine the crystalline structure in order to minimize the risk of transformation into other structures during development or, even worse, after introduction to the market. We present a rational approach to meet this risk. Further, methods for determination of the “degree of crystallinity” will be presented,
  • Particle size and shape are often critical parameters in the manufacture of many products. The goal of all particle-sizing techniques is to provide a single number that is indicative of the particle size. However, particles are three-dimensional objects for which at least three parameters (length, breadth and height) are required in order to provide a complete description.  Thus, measurement of particle size is not an exact technique and a “true” value does not exist. A range of analytical techniques is available; these all have their strengths and weaknesses. Some examples of pitfalls in particle analysis will be given.