Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.
Solid dosage forms are the most common commercial drug delivery system in use today. This short course covers the “a to z” of solid dosage form design and development, from pre-clinical excipient selection to commercial manufacturing.
Concepts covered in this course include:
Patient-centric drug product design
Development of a target product profile (QTPP)
Importance of physicochemical properties of drug molecules
Basics of biopharmaceutics and gastrointestinal physiology
Solid-state properties of salts, co-crystals, polymorphs & hydrates
Challenges associated with low/high doses & low solubility
Amorphous solid dispersions
Controlled release platform technologies
Excipient selection for immediate and controlled release dosage forms
Common manufacturing processes (such as blending, granulation tableting, film coating, encapsulation)
Continuous vs batch manufacturing
Drug product manufacturing process optimization & troubleshooting
Quality-by-Design principles
Solid state stability testing
Regulatory guidelines for solid dosage forms
Course participants will be provided with up-to-date research-based information taught by industry leaders with over 100-years of collective experience. They will learn this material through lectures, classroom discussions (with opportunities for information sharing), and case-studies based on real-life examples.
This course is part of the Drug Product Development Certificate. It fulfills one elective. Take the course ‘as-is’ or as part of the certificate.
Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.
Pyle Center
University of Wisconsin-Madison Campus
702 Langdon Street
Room 227
Madison, WI
Course fee:
$2300 (please contact us for group rates)
$1150 Academic and non-profit (contact us for registration code)
$575 Graduate student (contact us for registration code)
Tuition includes a reception on Monday evening and lunch on Monday, Tuesday and Wednesday.
Refund Policy: All requests for refunds, less a $75 administrative fee, will be honored if received prior to May 19, 2025. No refunds will be provided after that date.
Course Objectives
This short course provides the learner with current, research-based information covering (but not limited to) crystalline and amorphous properties of molecular solids, fundamental properties of powders, and the relationships between solubility, permeability, partitioning, diffusion rates of dissolution and release mechanisms.
Upon completion of this course, the learner should be able to:
Understand the most important physicochemical and solid-state properties of drug substances in the context of solid dosage form design;
Describe the relationships between solubility, permeability, dissolution, and release mechanisms, and the biopharmaceutical and clinical performance of solid dosage forms;
Select the best excipients for use in immediate and controlled release tablets and capsules;
Relate fundamental properties of powders (such as particle size morphology, flow, compaction, and hygroscopicity) to solid dosage form design, manufacturing, and performance;
Articulate the principles underlying solid-state instability at elevated temperature and relative humidity conditions;
Discuss regulatory principles (such as Quality by Design) and refer to current international regulatory guidelines.
Who Should Attend
Scientists who are working on the design, development or manufacture of solid dosage forms for small molecule drugs in all stages of development. Also, individuals who wish to expand their general understanding of solid dosage forms, how they are made, and associated regulatory aspects should take this course.
Course Outline
Monday, June 2, 2025
8:30 am
Welcome Eric Buxton, PhD
Clinical Professor, Department Chair, School of Pharmacy, University of Wisconsin-Madison
Speaker: Paul Luner, PhD, Principal Consultant, Triform Sciences, LLC
Basic Biopharmaceutics
GI physiology and physiologic variables
Dissolution, solubility and permeability
ADME
Pharmacokinetics and bioavailability
Formulation objectives
12:00 pm
Lunch
1:00 pm
Speaker: Paul Luner, PhD
General Pharmaceutics
What makes a good drug molecule?
Rule of 5 (Ro5) and “Drugability”
Physicochemical categories of small drug molecules
Neutral, acids, bases, zwitterions
pH-solubility profile for acids & bases
Maximum Absorbable Dose (MAD) (single compartment)
Biopharmaceutics Classification System (BCS/DCS)
Factors affecting drug absorption from the gastrointestinal (GI) tract
2:30 pm
Break
2:45 pm
Speaker: Paul Luner, PhD
Solid State Phenomena (Part 1)
Solids, their properties, impact and measurement/characterization
Thermal properties
Particulate properties
Morphology
Particle size
Surface area
Density
Solution state
Solid state
Preformulation
4:30 pm
Adjourn and Reception at the Wisconsin Union Terrace
Tuesday, June 3, 2025
8:30 am
Speakers: Paul Luner, PhD and Sheri Shamblin, PhD
Solid State Phenomena (Part 2)
Overview of crystalline forms
Thermodynamics of Solid Forms
Polymorphs, hydrates and solvates
Amorphous solids
Solid form selection
Why form matters in pharmaceutical development
10:00 am
Break
10:15 am
Speaker: Paul Luner, PhD
Solid State Part (Part 3)
Solid form phase transformations
Solid phase purity of drug substances
Disproportionation in salts and co-crystals
12:00 pm
Lunch
1:00 pm
Speaker: Bruno Hancock, PhD, Vice-President, Aleurites, LLC
Drug Product Design (Basics)
General principles - bulk & deformation props of powders
Importance of powder flow & compact mechanical properties
Excipients & their uses & functionality
Excipient selection
Regulatory guidelines
4:30 pm
Adjourn
Evening free to explore Madison
Wednesday, June 4, 2025
8:30 am
Speaker: Bruno Hancock, PhD
DP Design (Intermediate)
Process design & selection
Continuous vs batch processes
Review of common DP unit operations(dispensing, blending, granulation, milling, tableting, encapsulation, film coating, etc)
Process optimization
Processing modeling basics
In-process controls
What can go wrong during manufacturing...
12:00
Lunch
1:00 pm
Speaker: Sheri Shamblin, PhD
DP Design (Advanced)
Low & high drug loading challenges
Formulation solutions for low solubility APIs
Modified release approaches (with examples)
Prodrugs & drug product intermediates
4:30 pm
Adjourn
Evening free to explore Madison
Thursday, June 5, 2025
8:30 am
Speakers: Bruno Hancock, Paul Luner, PhD and PhD, Sheri Shamblin, PhD
Bringing it all together
Hot topics in the industry
Participant's requested topics
Case studies from word of consulting (blinded)
Quizzes from the faculty
Open Q&A
Wrap up
11:30 am
Course adjourned
Instructors
Bruno Hancock, PhD Vice President
Aleurites LLC
Westerly, RI
Paul Luner, PhD Principal Consultant Triform Sciences, LLC
Waterford, CT
Sheri Shamblin, PhD President
Aleurites, LLC
Westerly, RI
Accommodations
Accommodations are the responsibility of the registrant.
The Graduate (1 block from the course site) 601 Langdon Street
Madison, WI 5373
608.257.4391 Price: $169.00
Arrival/Departure Dates: 6/1/25 – 6/5/25
Room release: 5/19/2025 Booking link
Program Coordinator
Eric Buxton, PhD
Division of Pharmacy Professional Development 777 Highland Avenue Madison, WI 53705 (608) 262-2431 FAX (608) 265-2259 eric.buxton@wisc.edu
