13AM 500x150R2 

Symposium

From Particle Engineering to Powder Processing

Wednesday, November 13, 2013
8:30 am–11:00 am
 

Overview | Hotel/Travel | Program 

ACPE Number: 0073-9999-13-541-L04-P
CE Credit Hours—2.5 hours; 0.25 CEUs

Overview

Almost all pharmaceutical products are handled in powder form at some point during manufacture, and therefore, efficient and effective powder manufacture and processing is vital for creating successful dosage forms. Additionally more than 70% of the value of pharmaceutical sales worldwide is from solid dosage forms as it is still the preferred vehicle for the administration of active pharmaceutical ingredients, either as tablet/capsule or as an inhalable powder. The formulation of each solid dosage form has many, often conflicting, requirements which can be broadly divided into three areas. The first area is particle engineering, getting the right molecules into a form where they can be effective within the body. Some important properties are activity/potency, stability, solubility, dispersibility, and bioavailability. The second area is scale up from the laboratory; can the particles be manufactured at production scale whilst retaining their fundamental properties? Some evolving technologies include coprocessing, modern surface treatments, and advanced spray drying techniques for very high surface area material. The third area is particle manufacture and powder processing, ensuring that particles can be manufactured efficiently and developed into a product. Some important areas are processability, blendability, and tabletability. All of these areas require an understanding of what properties of the particles and assemblies of the particles are required to ensure that a suitable solid dosage form can be manufactured efficiently and that the final product is safe, consistent, and effective. To optimize the formulation, compromises must be made, but without suitable measurement techniques, such compromises must be determined by uninformed and risky extrapolation or by extensive (and by implication costly and time-consuming) pilot scale test programs. This symposium will present recent improvements to particle engineering and powder processing that have also required novel ways of measuring particle and powder characteristics (PAT) and how this information can be used to design better particles which can be processed more easily (QbD).

Upon completion of the symposium participants should be able to 1) identify the primary API particle engineering techniques used commonly in the pharmaceutical industry to facilitate downstream processing, 2) explain the need to modify API powder properties, 3) discuss the key powder properties that affect in-process performance, and 4) describe the role of material property characteristics during process scale-up.

Hotel/Travel

Housing is now open for the 2013 AAPS Annual Meeting and Exposition!

Back to top 

Program

Moderators
Arya Jayatilaka, Ph.D.
Senior Principal Scientist/API Process Technology
Pfizer Inc., Kalamazoo, Mich.

Preetanshu Pandey, Ph.D.
Senior Research Investigator/ R&D
Bristol-Myers Squibb Company, New Brunswick, N.J.

8:30 am–9:00 am
Crystallization Control at the API-DP Interface
Al Schwartz, Ph.D.
Senior Manager, Global Technical Services, API Technical Operations
Pfizer Inc., Peapack, N.J.

9:00 am–9:30 am
Material Characterization, and Relevance to In-Process Performance
Tim Freeman
Managing Director
Freeman Technology, Tewkesbury, UK

9:30 am–10:00 am
Inline Monitoring and Control of Granulation Unit Operations
Kevin Macias, Ph.D., R.Ph.
Research Investigator II/ Analytical R&D
Bristol-Myers Squibb Company, New Brunswick, N.J.

10:00 am–10:30 am
Material Property Characteristics Considerations during Drug Product Scale-up and Commercialization
Stephen Closs, Ph.D.
Director, Global Technical Affairs
Patheon Inc., Whitby, ON, Canada

10:30 am–11:00 am
Panel Discussion

11:00 am
Adjourn
 

Back to top