Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.
Two key traits of solid dosage forms of drugs are solubility and stability. Insoluble or unstable drugs slow down the approval of drugs. This course covers the “a to z” of solid dosage forms from screening and selection to manufacturing. You will go over specific examples to learn the importance of various concepts.
Some of the concepts covered in this course are
particle size and morphology
mixing and blending
flow and compaction
hygroscopicity and dissolution rates
biopharmaceutics
release mechanisms
The course also addresses specific issues in the manufacturing of tablets and capsules. To keep up with latest updates, there will also be a discussion on emerging and standard formulations.
The tools and concepts in this course will help you and your team optimize solid dosage forms. 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. Scientists who plan to expand their understanding of solid dosage forms should take this course.
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 232
Madison, WI
Course fee:
$1950 (please contact us for group rates)
$975 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, Tuesday and Wednesday.
Refund Policy: All requests for refunds, less a $75 administrative fee, will be honored if received prior to May 20, 2024. 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:
Characterize the crystalline and amorphous properties of molecular solids and recognize the factors that give rise to solid-state transformations and interactions;
Relate fundamental properties of powders, such as particle size morphology, flow, compaction, hygroscopicity and mixing, to solid dosage form design, manufacture and performance;
Describe the relationships between solubility, permeability, partitioning, diffusion rates of dissolution and release mechanisms, and biopharmaceutical and clinical performance of solid dosage forms; and
Analyze the important principles underlying solid-state instability under accelerated temperature and relative humidity conditions.
Who Should Attend
Scientists who are working on creating formulations for small molecule drugs in all stages of development.
Course Outline
Monday, June 3, 2024
12:45 pm
Welcome Eric Buxton, PhD
Clinical Associate Professor, Department Chair, School of Pharmacy, University of Wisconsin-Madison
Adjourn and Reception at the Wisconsin Union Terrace
Tuesday, June 4, 2024
8:30 am
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
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
MAD (single compartment)
BCS/DCS
Factors affecting drug absorption from the GI tract
Solid State (Part 1)
Solids, their properties, impact and measurement/characterization
Thermal properties
Particulate properties
Morphology
Particle size
Surface area
Density
Solution state
Solid state
Preformulation
12:00
Lunch
1:00 pm
Speakers: Paul Luner, PhD and Sheri Shamblin, PhD
Solid State (Part 2)
Overview of crystalline forms
Impact of crystalline vs amorphous form
Thermodynamics of Solid Forms
Polymorphs, hydrates and solvates
Amorphous solids
Solid form selection
Why form matters in pharmaceutical development
Solid State Part (Part 3)
Solid form transformation
API solid phase purity
Disproportionation in salts/co-crystals
4:30 pm
Adjourn
Evening free to explore Madison
Wednesday, June 5, 2024
8:30 am
Speaker: Bruno Hancock, PhD, Global Head of Materials Science, Pfizer
DP Design (Basics)
General principles - bulk & deformation props of powders
Importance of powder flow & compact mechanical properties
Excipients & their uses & functionality
Excipient selection
Regulatory guidelines
12:00
Lunch
1:00 pm
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 - QbD/RFT/DoE
Processing modeling basics
In-process controls
What can go wrong during manufacturing...
4:30 pm
Adjourn
Evening free to explore Madison
Thursday, June 6, 2024
8:30 am
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
11:30 am
Wrap up and Course adjourned
Instructors
Bruno Hancock, PhD Global Head of Materials Science
Pfizer
Groton, CT
Paul Luner, PhD Principal Consultant Triform Sciences, LLC
Waterford, CT
Sheri Shamblin, PhD Director
Pfizer
Groton, CT
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: $179.00
Arrival/Departure Dates: 6/2/24 – 6/5/24
Room release: 5/13/2024 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
