University of Wisconsin–Madison

Principles of Solid Dosage Forms

a graduated flask and cylindrical flask for solid dosage formsTwo 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 Applied Drug 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

Register by: May 13, 2019
Course date:May 13, 2019 - May 17, 2019
Location:

Pyle Center
Room 204
702 Langdon Street
Madison, WI

Course fee:

$1600/$1300 each two or more from same company
$800Academic/$475 Graduate Student

*$75 Cancellation fee prior to April 30, 2019
No refund after April 30, 2019

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 Requirements

Laptops Required

Slide presentations will be downloadable one week prior to the start of the course.

Course Outline

Monday, May 13, 2019

8:15 am

Welcome
Eric Buxton, PhD
Clinical Associate Professor, School of Pharmacy, University of Wisconsin-Madison

8:30 am

Introduction: Overview of Solid State Properties of Drug
This session will give a brief overview of important solid state properties that can change the bioavailability, manufacturability, and stability of solid dosage forms.

Selecting Appropriate Solid Forms: Crystalline and Amorphous States
This session will define and highlight the important pharmaceutical properties of crystal polymorphs and amorphous forms of drugs.

12:00

Lunch

1:00 pm

Characterizing Solids: Particle Size Properties

This session will describe methods to measure the particle size of drugs, important issues related to the effect of particle size on pharmaceutical processing, and the effect of size on the bioavailability of drugs

Characterizing Solids: Morphology

This session will 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.

 

Evening free to explore Madison

Tuesday, May 14, 2019

8:30 am

Assessing the Solid State Stability of Drugs

This session will identify those processing and environmental factors that determine the solid state and chemical stability of drugs.

The Importance of Water (Hygroscopicity)

Following up on the issues identified with solid state stability in the previous session this session will concentrate on the effect of moisture, from processing and the environment, on the stability of drugs, in particular changes in the amorphous and polymorphic state of drugs.

12:00

Lunch

1:00 pm

Assessing the Quality of Powder Mixtures

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

Assessing the Solubility and Dissolution of Solids

This session will define dissolution and discuss models to describe the dissolution of drugs. It will also discuss factors that can change the dissolution of solids.

 

Evening free to explore Madison

Wednesday, May 15, 2019

8:30 am

Assessing Solubility and Making Appropriate Choices
This session will look at structure solubility relationships for drug molecules.

Estimating Bioavailability and Addressing Biopharmaceutical Issues

Current methods to assess bioavailability, such as BCS, will be discussed and examples shown on these methods can be used in the formulation of drug products.

12:00

Lunch

1:00 pm

Developing Controlled Release Solid Dosage Forms

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.

 

Evening free to explore Madison

Thursday, May 16, 2019

8:30 am

Developing Tablets and Capsules: Mechanical Properties I

12:00

Lunch

1:00 pm

Developing Tablets and Capsules: Mechanical Properties II

Both session on this day will deal with processing, evaluation and manufacturing of tablets and capsules. Issues such as powder mixing, compression, excipient choice and others will be discussed.

 

Evening free to explore Madison

Friday, May 17, 2019

8:30 am

New Developments in the Design of Solid Dosage Forms: Nanoparticles and Combination Products

In the first part a brief overview of current methods to generate nanoparticles for drug delivery will be given. The second part will discuss issues and concerns related to combining two or more drugs in the same tablet or capsule

Instructors

Melgardt M. de Villiers, PhD, DTE
Professor
School of Pharmacy
University of Wisconsin Madison

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

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

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

Accommodations

Accommodations are the responsibility of the registrant

Lowell Center
610 Langdon St Madison, WI 53703
608-256-2621 Ext 1133

Event Title:  Solid Dosage
Group Code: SOLIDDOS

Price: $115 per night
Arrival/Departure Dates:  5/12/19 – 5/17/19
Booking link
Room release: 4/12/2019

Graduate Madison
601 Landon Street, Madison, WI  53703
608.257.4391

Group Name: Solid Dosage

Price: $159.00 per night
Arrival/Departure Dates:  5/12/19 – 5/17/19
Booking link
Room release: 4/12/2019

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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