An outline for the Tablets & Capsules Hands-On Short Course held October 21-25, 2013, at the University of Maryland School of Pharmacy has been provided below for your convenience.

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

Sunday, October 20:

TimeTopic
6:00-8:00 p.m. Reception, registration, and introductions
Mingle and get acquainted with instructors and fellow classmates

Monday, October 21:

TimeTopic
7:30-8:00 a.m. Continental Breakfast
8:00-8:50 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
8:50-9:40 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
9:40-10:50 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
  • Chewable tablet case study
10:50-11:20 a.m. Break
11:10-12:00 p.m. Drying
Gary Hollenbeck, PhD
Chief Scientific Officer, UPM Pharmaceuticals
Adjunct Professor of Pharmaceutical Sciences
University of Maryland School of Pharmacy
  • Relationship between RH and moisture content for solids
  • Moisture content determination
  • Identify factors that determine drying rate
  • Mathematically model the drying process
  • Define critical moisture content and equilibrium moisture content
  • Determine the amount of time required to dry from a given initial moisture content to a stipulated final moisture content
12:00-1:00 p.m. Lunch
1:00-2:50 p.m. Monday Lab (Part 1)
2:50-3:10 p.m. Break
3:10-5:00 p.m. Monday Lab (Part 2)

Tuesday, October 22:

TimeTopic
7:30-8:00 a.m. Continental Breakfast
8:00-8:30 a.m. Particle Engineering 1
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
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
10:20-11:10 a.m. Tablet Compaction
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
11:10-12:00 p.m. Excipients Functionality and Selection
Carmen Popescu, PhD
Senior Project Coordinator
Roquette America, Inc.
  • Filler-Binders
12:00-1:00 p.m. Lunch
1:00-2:50 p.m. Tuesday Lab (Part 1)
2:50-3:10 p.m. Break
3:10-5:00 p.m. Tuesday Lab (Part 2)

Wednesday, October 23:

TimeTopic
7:30-8:00 a.m. Continental Breakfast
8:00-9:50 a.m. Wednesday Morning Lab (Part 1)
9:50-10:10 a.m. Break
10:10-12:00 p.m. Wednesday Morning Lab (Part 2)
12:00-1:00 p.m. Lunch
1:00-2:50 p.m. Wednesday Afternoon Lab (Part 1)
2:50-3:10 p.m. Break
3:10-5:00 p.m. Wednesday Afternoon Lab (Part 2)

Thursday, October 24:

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
10:10-11:00 a.m. Capsule Filling
Vikas Moolchandani
Amway, Inc.
  • Formulation principles
  • Filling mechanisms and operating variables
  • Formulation design
11:00-12:00 p.m. Tablet Coating
Steve Hoag, PhD
Director, Good Manufacturing Practice Facility
Professor of Pharmaceutical Sciences
University of Maryland School of Pharmacy
  • Latex film formation process
  • Coating equipment
  • Coating formulation components
12:00-1:00 p.m. Lunch
1:00-2:50 p.m. Thursday Lab (Part 1)
2:50-3:10 p.m. Break
3:10-5:00 p.m. Thursday Lab (Part 2)

Friday, October 25:

TimeTopic
7:30-8:00 a.m. Continental Breakfast
8:00-8:50 a.m. Process Development in the Laboratory and the Implications on Scale-Up for Fluidized Bed Processing
David M. Jones
President
OWI-Consulting, Inc.
  • Identify set-up and process variables in fluidized bed processing and their possible interacts
  • Process simplification, using DoE to narrow the list of parameters targeted for evaluation during development.
  • Understanding critical process parameters and the strength of these ‘levers’ for insight into pilot & production scale-up.
  • Case study for process optimization and scale-up
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. Tablet Evaluation USP and PAT Methods
Ahmed Ibrahim, PhD
Post-Doctoral Fellow
Department of Pharmaceutical Sciences
University of Maryland School of Pharmacy
  • Tablet and capsule evaluation
  • USP QC methods, dissolution, content uniformity, etc.
  • Stability Testing and ICH guidelines
  • PAT methods
11:10-12:00 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