An outline for the Tablets & Capsules Hands-On Short Course held October 20-24, 2014, at the University of Maryland School of Pharmacy is provided below for your convenience.

For details about the lab experiences noted in this outline, please visit the Laboratory Content webpage.

Monday, October 20:

TimeTopic
7:30-8:00 a.m. Continental Breakfast
8:00-8:40 a.m. Introduction
Steve Hoag, PhD
Director, Good Manufacturing Practice Facility
Professor of Pharmaceutical Sciences
University of Maryland School of Pharmacy
  • Course Objectives and Outline
  • Design Criteria from QTPP to QbD
  • Formulation Strategies
  • Excipient Function
  • Factors that Influence Choice of Excipients
8:40-9:30 a.m. Micromeritics and Bulk Powder Properties
Myke Scoggins, PhD
MAS/MPS Lab Manager and Pharmaceutical Scientist
Micromeritics
  • Sampling
  • Particle size and distribution
  • Surface area and shape
  • Bulk properties, densities, porosity, particle-particle interactions and flow
9:30-10:20 a.m. Milling and Mixing
Steve Hoag, PhD
Director, Good Manufacturing Practice Facility
Professor of Pharmaceutical Sciences
University of Maryland School of Pharmacy
  • Size reduction and material properties
  • Particle fracture
  • Mill types and selection
  • Mixing mechanisms
  • Mixing Equipment
  • Segregation prevention
  • Verification of mixedness in the blender
10:20-10:40 a.m. Break
10:40-11:30 a.m. Drying
Gary Hollenbeck, PhD
Chief Scientific Officer, UPM Pharmaceuticals
Adjunct Professor of Pharmaceutical Sciences
University of Maryland School of Pharmacy
  • Expressions for moisture content
  • Factors that determine drying rate
  • Mass transfer of water soluble components during drying
11:30-12:00 p.m. Particle Engineering I
Steve Hoag, PhD
Director, Good Manufacturing Practice Facility
Professor of Pharmaceutical Sciences
University of Maryland School of Pharmacy
  • Introduction to granulation
  • Comparison of methods
  • Theory of particle-particle interactions
  • Fluid bed granulation
  • Granule properties
12:00-1:00 p.m. Lunch
1:00-2:50 p.m. Monday Lab M1
2:50-3:10 p.m. Break
3:10-5:00 p.m. Monday Lab M2
7:00 p.m. Opening Reception at Frank and Nic's West End Grille
Meet in Pharmacy Hall at 6:30 p.m. to walk to restaurant

Tuesday, October 21:

TimeTopic
7:30-8:00 a.m. Continental Breakfast
8:00-9:15 a.m. Particle Engineering 2
Timothy J. Smith, MS
Senior Process Development Scientist
Freund-Vector Corporation
  • Dry Granulation - Roll Compaction
    • Equipment Design
    • Process Control
    • Formulation Considerations
    • Scale-Up Principles
  • Wet Granulation - High Shear Mixers
    • Equipment Design
    • Process Control - Endpoint Considerations
    • Scale-Up Principles
9:15-10:00 a.m. Particle Engineering 3
Debra Repko
Product Specialist, Spray Drying Segment
Buchi Corporation
  • Spray drying history
  • What is spray drying?
  • Types of dryers
  • Dryer hardware
  • What the interest?
  • Process parameters
  • Case studies
10:00-10:20 a.m. Break
10:20-11:00 a.m. Thermal Analysis
Steven R. Aubuchon, PhD
Senior Territory Manager
TA Instruments-Waters, LLC
  • Thermal analysis instrumentation
  • Principles of thermal measurements
  • Data interpretation
11:00-11:40 a.m. Excipients Functionality and Selection
Carmen Popescu, PhD
Senior Project Coordinator
Roquette America, Inc.
  • Filler-Binders
11:40-12:15 p.m. Table Compaction I
Stephen Hoag, PhD
Professor of Pharmaceutical Sciences
Director, Good Manufacturing Practice Facility
University of Maryland School of Pharmacy
  • Introduction to tablet compaction
12:15-1:00 p.m. Lunch
1:00-2:50 p.m. Tuesday Lab T1
2:50-3:10 p.m. Break
3:10-5:00 p.m. Tuesday Lab T2

Wednesday, October 22:

TimeTopic
7:30-8:00 a.m. Continental Breakfast
8:00-9:50 a.m. Wednesday Morning Lab W1
9:50-10:10 a.m. Break
10:10-12:00 p.m. Wednesday Morning Lab W2
12:00-1:00 p.m. Lunch
1:00-2:50 p.m. Wednesday Afternoon Lab W3
2:50-3:10 p.m. Break
3:10-5:00 p.m. Wednesday Afternoon Lab W4

Thursday, October 23:

TimeTopic
7:30-8:00 a.m. Continental Breakfast
8:00-8:50 a.m. Excipients Functionality and Selection
Larry Augsburger, PhD
Professor Emeritus
University of Maryland School of Pharmacy
  • Disintegrants
9:00-9:50 a.m. Excipients Functionality and Selection
Larry Augsburger, PhD
Professor Emeritus
University of Maryland School of Pharmacy
  • Lubricants
9:50-10:10 a.m. Break
10:10-11:30 a.m. Capsule Filling
Dennis Murachanian, RPh, MS
Regional Sales Manager
MG America
  • Formulation principles
  • Filling mechanisms and operating variables
  • Formulation design
11:30-12:10 p.m. Tablet Compaction II
Steve Hoag, PhD
Director, Good Manufacturing Practice Facility
Professor of Pharmaceutical Sciences
University of Maryland School of Pharmacy
  • Powder compression
  • Tablet press operation
  • Test methods for formulation development
  • Compaction simulators
12:10-1:00 p.m. Lunch
1:00-2:50 p.m. Thursday Lab R1
2:50-3:10 p.m. Break
3:10-5:00 p.m. Thursday Lab R2

Friday, October 24:

TimeTopic
7:30-8:00 a.m. Continental Breakfast
8:00-8:50 a.m. Fluid Bed Spray System for Coating Process
Christoph Riedel, PE
Sales Manager
BOSCH-Hüttlin
  • Coating equipment
  • Theory of coating
  • Coating of multiparticulate beads
9:00-9:50 a.m. Excipient Risk Analysis in QbD
Brian Carlin, PhD
Director, Open Innovation
FMC Corporation
  • Avoiding excipient-related surprises on your product quality
  • Incorporation of excipients into your Control Strategy
  • Demonstration of due diligence of excipient risk analysis to regulatory authorities
9:50-10:10 a.m. Break
10:10-11:00 a.m. Continuous Manufacturing in the Pharmaceutical Industry
Andrew Birkmire
Process Development Manager
GEA Process Engineering, Inc.
  • Overview of continuous tableting line from granulation to compression
  • Continuous manufacturing process development
  • Continuous wet granulation -- process development case study
  • Continuous manufacturing process control
  • Portable/modular continuous manufacturing line
11:00-11:50 p.m. Tablet Evaluation USP and PAT Methods
Darvin L. Martin
Technical Sales Manager
Sotax Corporation
  • Tablet and capsule evaluation
  • USP QC methods, dissolution, content uniformity, etc.
  • Stability testing and ICH guidelines
11:50-12:20 p.m. Course Wrap-Up And Review of Lab Results
Steve Hoag, PhD
Director, Good Manufacturing Practice Facility
Professor of Pharmaceutical Sciences
University of Maryland School of Pharmacy

Ahmed Ibrahim, PhD
Post-Doctoral Fellow
Department of Pharmaceutical Sciences
University of Maryland School of Pharmacy
  • Discussion of lab results
  • Course wrap-up
  • Course evaluation
12:20 p.m. Bag Lunch for Departure