Particle Analytical is a GMP-certified and FDA registered contract laboratory with 20 years experience in physical characterization of pharmaceutical products. Based on our 20 years experience, we offer this 1-day course free of charge to share knowledge with professionals in the pharmaceutical industry.
Background for the course
By far the most important physical property of particulate samples is particle size. Particle size determinations are routinely carried out across a wide range of industries and is a critical parameter in the manufacture of pharmaceutical products. Particle size has a direct influence on material properties such as reactivity, dissolution rate, stability, flowability and handling.
Particle size distribution should be known – and controlled! Ultimately, to protect patients, but also to avoid unpleasant surprises during manufacture. Measurement of particle size is not an exact technique and a “true” value does not exist. A range of analytical techniques are available for determination of particle size; these all have their strengths and weaknesses. In order to develop and validate analytical methods for determination of particle size, it is necessary to correlate several methods.
In this course we will give you an overview of methods and regulatory requirements. Based on real life examples, we will go through commonly observed pitfalls in particle size determination that should avoided.
The primary purpose of this course is to review the various properties of powdered solids in relation to development and manufacture of the products of the pharmaceutical industry. In particular, experimental techniques and equipment for evaluating important properties of powders will be discussed and related to both the underlying principles and common industrial problems.
This course identifies the studies needed to characterise the physico-chemical properties of drug substances in tablet development, with special focus on particle sizes, including the following topics:
- Regulatory requirements for powder characterisation
- Linking material properties to formulation/processing behaviour, stability and bioavailability.
- Identifying potential Critical Product Attributes related to the drug substance: Real life examples
- Established techniques for powder characterisation
- Development of analytical methods for powder characterisation
- Validation of analytical methods for powder characterization
The course is designed for everyone involved with physical characterization of pharmaceutical products, including:
- Technologists: Introduction to various methods used for characterisation
- Regulatory and quality personnel, who need to understand the development process.
Time and place
This 1-day course will be held on the 24th March 2020 in Frankfurt, Germany.
Pre-registration for this event is now open. To register, please send an e-mail to firstname.lastname@example.org, stating your name, company name, your position and the country where you wish to participate in the event (i.e. either Italy or Germany)
An e-mail with the final details of the course will be send on the 29th of February 2020
Participation in this course is FREE OF CHARGE.