A tentative outline for the next Tablets & Capsules Hands-On Short Course 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:

TimeTopic
7:15-8:00 a.m. Registration and Continental Breakfast
8:00-8:30 a.m. Introduction & Formulation and Process Design
Speaker: Steve Hoag/University of Maryland School of Pharmacy

  • Course objectives and outline
  • Design criteria from QTPP to QbD
  • Formulation strategies
  • Excipient function
  • Factors influencing choice of excipients
8:30-9:20 a.m. Micromeritics and Bulk Powder Properties
Speaker: Myke Scoggins/Osmotica Pharmaceutical

  • Sampling
  • Particle size and distribution
  • Surface area and shape
  • Bulk properties, densities, particle-particle interactions and flow
9:20-10:20 a.m. Milling and Mixing
Speaker: Steve Hoag/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
Speaker: Gary Hollenbeck/UPM Pharmaceuticals, Inc.

  • Expressions for moisture content
  • Factors that determine drying rate
  • Mass transfer of water soluble components during drying
11:30-12:10 p.m. Thermal Analysis
Speaker: Steve Aubuchon/TA Instruments, Inc.

  • Thermal analysis instrumentation
  • Principles of thermal measurements
  • Data interpretation
12:10-1:00 p.m. Lunch
1:00-2:50 p.m. Monday Lab Session M1
2:50-3:10 p.m. Break
3:10-5:00 p.m. Monday Lab Session M2
5:30 p.m. (Meet)
6:00 p.m. (Dinner)
Opening Reception at Frank and Nic's West End Grille

Tuesday:

TimeTopic
7:30-8:00 a.m. Continental Breakfast
8:00-9:15 a.m. Particle Engineering 1
Speaker: Timothy J. Smith/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 2: Extrusion Spheronization
Speaker: Lauren Petraglia/LCI Corp.

  • Pellitization
  • Extrusion spheronization process
  • Formulation of beads
  • Equipment
10:00-10:20 a.m. Break
10:20-11:10 a.m. Excipients Functionality and Selection 1
Speaker: Carmen Popescu/Roquette America, Inc.

  • Overview of formulation development
  • Filler-binders
  • Granulation binders
11:10-12:00 p.m. Excipients Functionality and Selection 2
Speaker: Carmen Popescu/Roquette America, Inc.

  • Disintegrants
  • Lubricants
12:00-12:15 p.m. Group Picture (Atrium)
12:15-1:00 p.m. Lunch
1:00-2:50 p.m. Tuesday Lab Session T1
2:50-3:10 p.m. Break
3:10-5:00 p.m. Tuesday Lab Session T2

Wednesday:

TimeTopic
7:30-8:00 a.m. Continental Breakfast
8:00-9:50 a.m. Wednesday Morning Lab Session W1
9:50-10:10 a.m. Break
10:10-12:00 p.m. Wednesday Morning Lab Session W2
12:00-12:50 p.m. Lunch
12:50-2:20 p.m. Wednesday Afternoon Lab Session W3
2:20-2:30 p.m. Break
2:30-4:00 p.m. Wednesday Afternoon Lab Session W4
4:00-4:10 p.m. Break
4:10-5:40 p.m. Wednesday Afternoon Lab Session W5

Thursday:

TimeTopic
7:30-8:00 a.m. Continental Breakfast
8:00-8:35 a.m. Particle Engineering 3
Speaker: Debra Repko/Buchi Corp.

  • Spray drying history
  • What is spray drying?
  • Types of dryers
  • Dryer hardware
  • Why the interest?
  • Process parameters
  • Case studies
8:35-10:10 a.m. Tablet Compaction
Speaker: Robert Sedlock/Natoli, Inc.

  • Powder compression
  • Tablet press operation
  • Test methods for formulation development
  • Compaction simulators
10:10-10:20 a.m. Break
10:20-12:00 p.m. Capsule Filling
Speaker: Larry Augsburger/University of Maryland School of Pharmacy

  • Formulation principles
  • Filling mechanisms and operating variables
  • Formulation design
12:10-12:50 p.m. Lunch
12:50-2:20 p.m. Thursday Afternoon Lab Session R1
2:20-2:30 p.m. Break
2:30-4:00 p.m. Thursday Afternoon Lab Session R2
4:00-4:10 p.m. Break
4:10-5:40 p.m. Thursday Afternoon Lab Session R3

Friday:

TimeTopic
7:30-8:00 a.m. Continental Breakfast
8:00-8:50 a.m. Tablet and Bead Coating
Speaker: Simon Cashmore/Bosch Packaging

  • Coating equipment
  • Theory of coating
  • Coating of multiparticulate beads
8:50-9:40 a.m. Use of Compaction Simulator in Tablet Development
Speaker: Susana N. Bobadilla/Medelpharm

  • Compaction simulation
  • Compression scale up and speed dependence
  • Layered tablets
9:40-10:00 a.m. Break
10:00-10:50 a.m. Continuous Manufacturing in the Pharmaceutical Industry
Speaker: Andrew P. Birkmire/GEA Process Eng., 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
10:50-11:40 p.m. Excipient Risk Analysis in QbD
Speaker: Brian Carlin/FMC Corp.
Sotax Corporation

  • Avoiding excipient-related surprises on your product quality
  • Incorporation of excipients into your Control Strategy
11:40-12:10 p.m. Course Wrap-Up And Review of Lab Results
Speakers: Steve Hoag and Ahmed Ibrahim/University of Maryland School of Pharmacy

  • Discussion of lab results
  • Course wrap-up
  • Course evaluation
11:50 p.m. Box Lunch for Departure