A tentative outline for the next Tablets and 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, Nov. 11:

Time Topic
7:15-8 a.m. Registration and Continental Breakfast
8-8:30 a.m. Introduction and 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
8:30-9:20 a.m. Micromeritics and Bulk Powder Properties
Speaker: Myke Scoggins/Syner-G BioPharma Group
  • Sampling
  • Particle size and distribution
  • Surface area and shape
  • Bulk properties, densities, particle-particle interactions and flow

9:20-10:10 a.m.

Excipients Functionality and Selection 1
Speaker: Carmen Popescu/Roquette America, Inc.

  • Overview of formulation development
  • Filler-Binders
  • Granulation binders
10:10-10:25 a.m.

Break

10:25-11:15 a.m.

Excipients Functionality and Selection 2

Speaker: Carmen Popescu/Roquette America, Inc.

  • Disintegrants
  • Lubricants

11:15 a.m.-Noon

 3D Drug Printing for Clinical Trials and Personalized Medicine and Mark
Speaker: Alvaro Goyanes Goyanes/FabRx
  • How does 3D drug printing work?
  • Dosage forms
  • Release control
  • Formulation insights and managing quality
Noon- 1 p.m. Lunch
1-2:50 p.m. Monday Lab Session M1
2:50-3:10 p.m. Break
3:10-5 p.m. Monday Lab Session M2
5:30 p.m. (Meet)
6 p.m. (Dinner)		 Opening Reception

Tuesday, Nov. 12:

Time Topic
7:30-8 a.m. Continental Breakfast
8-9:15 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 a.m. Particle Engineering 2: Extrusion Spheronization
Speaker: Alva Godfrey/LCI Corp.
  • Pellitization
  • Extrusion spheronization process
  • Formulation of beads
  • Equipment
10-10:20 a.m. Break
10:20-11:20 a.m. Milling and Mixing
Speaker: Stephen 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

11:20 a.m.-Noon

 Drying
Speaker: Gary Hollenbeck/University of Maryland School of Pharmacy
  • Expressions for moisture content
  • Factors that determine drying rate
  • Mass transfer of water soluble components during drying
Noon-12:15 p.m. Group Picture (Atrium)
12:15-1 p.m. Lunch
1-2:50 p.m. Tuesday Lab Session T1
2:50-3:10 p.m. Break
3:10-5 p.m. Tuesday Lab Session T2

Wednesday, Nov. 13:

Time Topic
7:30-8 a.m. Continental Breakfast
8-8:40 a.m.

Particle Engineering 3

Speaker: Debra Repko/Buchi Corp.

  • Spray drying history
  • What is spray drying
  • Types of dryers and dryer hardware
  • Why the interest?
  • Process parameters
  • Case studies
8:40-10:15 a.m.

Tablet Compaction

Speaker: Robert Sedlock/Natoli Inc.

  • Powder compression
  • Tablet press operation
  • Test methods for formulation development
  • Compaction simulators
10:15-10:25 a.m. Break
10:25 -11:10 a.m.

Use of Compaction Simulator in Tablet Development

Speaker: Sixtine Caquant/Medelpharm

  • Compaction simulation
  • Compression scale up and speed dependence
  • Layered tablet
11:10 a.m.-Noon

Tablet and Bead Coating
Speaker: Alex Trombley/Syntegon

  • Coating equipment
  • Theory of coating
  • Coating of multiparticulate beads
Noon-12:50 p.m. Lunch
12:50-2:20 p.m. Wednesday PM Lab Session R1
2:20-2:30 p.m. Break
2:30-4 p.m. Wednesday PM Lab Session R2
4-4:10 p.m. Break
4:10-5:40 p.m. Wednesday PM Lab Session R3

Thursday, Nov. 14:

Time Topic
7:30-8 a.m. Continental Breakfast
8-9:50 a.m.

Thursday AM Lab Session W1
9:50-10:10 a.m.

Break
10:10 a.m.-Noon Thursday AM Lab Session W2
Noon-12:50 p.m.

Lunch
12:50-2:20 p.m.

Thursday PM Lab Session W3
2:20-2:30 p.m. Break
2:30-4 p.m. Thursday PM Lab Session W4
4-4:10 p.m. Break
4:10-5:40 p.m. Thursday PM Lab Session W5

Friday, Nov. 15:

Time Topic
7:30-8 a.m. Continental Breakfast
8-9:40 a.m. Capsule Filling
Speaker: Stephen Hoag/University of Maryland School of Pharmacy
  • Formulation principles
  • Filling mechanisms and operating variables
  • Formulation design tablet and bead coating
9:40-10 a.m. Break
10-10:50 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 a.m. Excipient Risk Analysis in QbD
Speaker: Brian Carlin/DFE Pharma
  • 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
11:40 a.m.-Noon Course Wrap-Up And Review of Lab Results
Speakers: Stephen Hoag and Gary Hollenbeck/University of Maryland School of Pharmacy
  • Discussion of lab results
  • Course wrap-up
  • Course evaluation
Noon-1 p.m. Box Lunch