University of Wisconsin–Madison

Principles of Solid Dosage Forms

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

The 2022 Principles of Solid Dosage Forms short course is an online course with live and recorded components.  There are 6 live weekly sessions designed for the student/faculty interaction.  Prior to the first session, and in between the remaining sessions the students will be assigned recorded lectures that will provide the basis of the live discussion for that session.

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:Apr 12, 2022 - May 16, 2022
Location:
Course fee:

This course will be held via weekly webinar as well as asynchronous presentations. 

Live webinar sessions: April 12, 19, 26, May 3, 10 & 16

$1400
$1150 two or more from same company

In a cancellation is requested, a fee of $75 will be applied.

Please contact Eric Buxton to qualify for an academic and graduate student rate.

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

Pre-course lectures

 

Crystalline & Amorphous Solids
Speaker: Sheri Shamblin, PhD, Director, Pfizer

Module 1: Crystalline Solids
Module 2: Polymorphism in Pharmaceutical Solids
Module 3: Interactions of Pharmaceutical Solids in Water
Module 4: Pharmaceutical Salts and Cocrtytals
Module 5: Molecular Disorder in Solids: Liquid crystal, mesophase and amorphous materials
Module 6: Opportunities and Challenges with Pharmaceutical Amorphous Solids
Module 7: Interactions of Amorphous Solids with Water

This provides a brief overview of important solid state properties that can change the bioavailability, manufacturability, and stability of solid dosage forms.

These presentations will define and highlight the important pharmaceutical properties of crystal polymorphs and amorphous forms of drugs.

April 12

Opening Live Webinar - April 12 , 2022 (approximately 2.0 hours)

Time: 11:00 am - 1:00 pm CDT

Discuss pre-course modules, Q&A, Problem sets

Asynchronous presentations

Watch following lectures prior to the April 19 webinar

 

Particle Properties & Performance

Speaker: Daniel P. McNamara, PhD, Principal Scientist, Bristol-Myers Squibb

Module 8: Particle Size
Module 9: Particle Morphology
Module 10: Powder Mixing and Sampling
Module 11: Dissolution
Module 12: Dissolution Particle

These modules will define mixing a quality and uniformity. In particular sampling form mixtures and methods to measure content uniformity will be discussed. These modules will also highlight the effect of shape on the formulation of solid dosage forms, methods to determine the shape of particles, and models to predict the influence of particle shape on formulation.

April 19

Live Webinar - April 19 , 2022 (approximately 2.0 hours)

Time: 11:00 am - 1:00 pm CDT

Discussion of previous content and homework

Asynchronous presentations

Watch following lectures prior to the April 26 webinar

 

Solid Dosage Formulation & Process Design

Speaker: Bruno Hancock, PhD, Research Fellow, Pharmaceutical R & D, Pfizer Central Research

Module 13: Introduction to Pharmaceutical Solids
Module 14: Powder Compaction and Compact Properties

This session will define mixing a quality and uniformity. In particular sampling form mixtures and methods to measure content uniformity will be discussed.

April 26 

Live Webinar - April 26, 2022 (approximately 2.0 hours)

Time: 11:00 am - 1:00 pm CDT

Discussion of previous content and homework

Asynchronous presentations

Watch following lectures prior to May 3 webinar

 

Solid Dosage Forms
Speaker: Bruno Hancock, PhD, Research Fellow, Pharmaceutical R & D, Pfizer Central Research

Module 15: Solid Dosage Form Manufacturing  – Part 1 (Excipient and process selection, materials transfer, blending, dry granulation, wet granulation)
Module 16: Solid Dosage Form Manufacturing  – Part 2 (Milling, Lubrication, Tableting)
Module 17: Solid Dosage Form Manufacturing  – Part 3 (Encapsulation, Coating, In-process testing and common problems, hot melt extrusion, spray drying, continuous vs. batch processing)

Several systems used to prepare controlled release dosage forms will be discussed. The advantages and disadvantages of the systems will be demonstrated by a series of examples.

May 3

Live Webinar - May 3, 2022 (approximately 2.0 hours)

Time: 11:00 am - 1:00 pm CDT

Discussion of previous content and homework

Asynchronous presentations

Watch following lectures prior to May 10 webinar

 

Drug Delivery

Speaker: James L. Wright, PhD, Adjunct Professor, School of Pharmacy, University of Wisconsin Madison

Module 18: Biopharmaceutical Properties (Barriers to Oral Delivery and classification, Solubility and Salts)
Module 19: Delivery of Poorly Soluble Drugs (Amorphous Dispersions, Cyclodextrin and solid dosage forms, self-emulsifying systems)
Module 20: Hydrophilic Polymer Systems (mechanism and models, application to nevirapine, in-vitro and in vivo correlation and modeling)

May 10

Live Webinar - May 10, 2022 (approximately 2.0 hours)

Time: 11:00 am - 1:00 pm CDT

Discussion of previous content and homework

Asynchronous presentations

Watch following lectures prior to May 16 webinar

 

Drug Delivery

Speaker: James L. Wright, PhD, Adjunct Professor, School of Pharmacy, University of Wisconsin Madison

Module 21: Hydrophobic Polymer Systems
Module 22: Osmotic Based Systems
Module 23: Nanoparticles in drug delivery

May 16

Final Live Webinar - May 16, 2022 (approximately 2.0 hours)

Time: 11:00 am - 1:00 pm CDT

- Discussion of previous lectures

-  PANEL Q&A

- Wrap up for the course

Instructors

Bruno Hancock, PhD
Research Fellow, Pharmaceutical R & D
Pfizer Central Research

Daniel P. McNamara, PhD
Principal Scientist
Bristol-Myers Squibb

Sheri Shamblin, PhD
Director
Pfizer

James L. Wright, PhD
Adjunct Professor
School of Pharmacy
University of Wisconsin Madison

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