University of Wisconsin–Madison

Fundamentals of Solid Dosage Form Development

Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.

a graduated flask and cylindrical flask for solid dosage forms

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.

Registration Information

Register

Refund Policy

Course date:Jun 3, 2024 - Jun 6, 2024
Location:

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:

  1. Characterize the crystalline and amorphous properties of molecular solids and recognize the factors that give rise to solid-state transformations and interactions;
  2. Relate fundamental properties of powders, such as particle size morphology, flow, compaction, hygroscopicity and mixing, to solid dosage form design, manufacture and performance;
  3. Describe the relationships between solubility, permeability, partitioning, diffusion rates of dissolution and release mechanisms, and biopharmaceutical and clinical performance of solid dosage forms; and
  4. 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

1:00 pm

21st Century Oral Drug Delivery (SLS)

  • Challenges/benefits associated with oral delivery (taste masking, rapid-onset, colonic delivery, food effect, light protection, etc)
  • Target patient populations (pediatrics, geriatrics, oncology, etc)
  • Tablets vs capsules (types and pros/cons of each)
  • The critical role of excipients
  • Quality Target Product Profile (QTPP)

4:30 pm

Adjourn and Reception at the Wisconsin Union Terrace

Tuesday, June 4, 2024

8:30 am

Critical Material Attributes (PL)

  • Key drug properties (rule-of-5, aqueous solubility, permeability, crystallinity and melting point, water sorption, physical and chemical stability)
  • Particle and bulk powder properties (density, particle size and shape, surface area, dissolution rate, powder flow, etc)
  • Biopharm basics (IV vs IR oral delivery, relative bioavailability, half-life, 1st pass metabolism, BCS/DCS classes, formulation decision tress, modeling, etc)

12:00

Lunch

1:00 pm

Critical Material Attributes (PL) - continues

  • Solid phases (crystalline/amorphous/liquid crystal phases, polymorphism and phase purity)
  • Solid form design (salts, co-crystals, hydrates, solvates, etc)
  • Solid state physical stability (ICHQ6A, dehydration, disproportionating, deliquescence, etc)
  • Solid state computational approaches (informatics & CSP)
4:30 pm

Adjourn

 

Evening free to explore Madison

Wednesday, June 5, 2024

8:30 am

Designing the Optimal Formulation (SLS)

  • Formulating to address low solubility compounds (milling, salts, ASDs, etc)
  • Formulating to address instability (prodrugs, excipient compatibility, etc)
  • Formulating to control drug release rate (short T 1/2, once-a-day dosing, colonic absorption, etc)
  • Modified release drug delivery platforms (matrix, osmotic, multi-particulates, mini tablets, etc)
  • More about excipients (IR and MR)
  • Low/high drug loading challenges

 

12:00

Lunch

1:00 pm

Solids Manufacturing Processes (BCH)

  • Amorphous dispersion manufacturing processes (spray-drying, hot melt extrusion, co-precipitation, milling)
  • Common unit operations (blending, granulation, milling, lubrication)
  • Tablet compression
  • Encapsulation
  • Coating processes (tablets, microspheres, etc)
  • Batch vs continuous approaches
  • Process modeling overview
  • Common manufacturing problems
  • Scale-up and technology transfer
4:30 pm

Adjourn

 

Evening free to explore Madison

Thursday, June 6, 2024

8:30 am

Analysis and Integration

  • Chemical analysis (potency, content uniformity, dissolution, etc)
  • Physical analysis (solid fraction, hardness/crushing strength, friability, disintegration time, etc)
  • Overview of "API-in-DP" analysis (ICHQ6A, etc)
  • Accelerated (ASAP) vs long-term real-time stability
  • Databases, expert systems and artificial intelligence applied to solid dosage form development 
  • Regulatory filings (INDs, IMPDs, CTDs, etc)
11:30 am 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

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