Regulatory guidelines on polymorphy and particle size determinations. Zürich, 12. Sep. 2013

Patient safety

We are happy to invite you to this 5.th Workshop held by Particle Analytical.

  • Why: To learn more about the regulatory requirements on powder/particle analysis.
  • When: September 12. 2013. 13.00-16.30.
  • Where: Zürich, Schwitzerland,  Continental Zurich-Mgallery Collection Hotel, Stampfenbachstrasse 60

Health authorities are becoming increasingly aware of the importance of particle properties for the quality and safety of pharmaceutical products. The primary risk for a patient in relation to intake of a tablet is lack of  “release control”, leading to either too low or too high plasma levels. Lack of control could be due to variation in particle sizes or to changes in crystallinity (i.e. changes in polymorphic form). This workshop will take you through the regulatory requirements. Further, a practical interpretation will be given: How much experimental work is required to fulfill the guidelines in relation to polymorph screening and particle size control.

Participation €200. Sign up at info@particle.dk. Please read the abstracts below.

Program

  • 13.00-13.45: Welcome and light lunch.
  • 13.45-14.15: Patient safety, guidelines and cases from “real life”
  • 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

Speakers

  • Karin Liltorp, Principal Scientist. Ph.D.(physical chemistry). 8 years experience from pharmaceutical industry within the area of physical characterisation.
  • Søren Lund Kristensen, CEO at Particle Analytical. +15 years experience in particle characterisation.

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. 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.