Advance your expertise in early-stage pharmaceutical development with our Developing Oral Drug Formulations: Practical Strategies for Preclinical and Phase 1 course, offered by the University of Wisconsin–Madison’s Division of Pharmacy Professional Development.
Course Overview:
Navigating the complexities of preclinical drug development requires efficient and effective formulation strategies. This self-paced, online course provides a comprehensive guide to developing oral drug formulations tailored for preclinical and Phase 1 studies.
Moreover, you’ll gain practical insights into solubilization techniques, bioavailability enhancement, and formulation optimization, enabling you to accelerate your drug development projects.
Key Learning Objectives:
Solubilization Techniques: Master approaches for enhancing the solubility of poorly soluble compounds to improve bioavailability.
Preclinical Formulation Strategies: Develop formulations suitable for various animal models, considering species-specific requirements.
Phase 1 Dosage Form Development: Design and evaluate oral dosage forms, including powders for reconstitution, capsules, and tablets, with a focus on lab and pilot-scale processing.
Bioenhanced Formulations: Explore advanced strategies such as particle size reduction, solid dispersions, and liquid-filled capsules to enhance drug absorption.
Stability Assessment: Implement stability evaluation protocols in line with ICH guidelines, addressing excipient compatibility and common stability challenges.
Course Format:
This 100% online, self-paced course allows you to enroll at any time and progress through the material at your convenience until June 1, 2026. In addition, the curriculum combines theoretical knowledge with practical applications, thus ensuring you can apply learned concepts directly to your projects.
Who Should Attend?
This course is designed for scientists and technical managers involved in early drug development, particularly those responsible for preclinical and Phase 1 clinical formulations. Ideal participants include BS, MS, and PhD graduates with less than five years of experience in formulation science. Professionals in analytical, preformulation, and biological sciences will also find this course beneficial.
Why Enroll?
By completing this course, you’ll acquire practical skills and knowledge essential for developing effective oral drug formulations in the critical early stages of drug development. Hence, this expertise will enable you to streamline your formulation processes, reduce development timelines, and enhance the success rate of your drug candidates.
This course is part of the Drug Product Development Certificate. It fulfills one of three required courses. You may take this course as is or as part of the certificate. Students interested in mastering drug development should complete the certificate program.
Join us to elevate your proficiency in oral drug formulation and make a significant impact on your pharmaceutical development projects.
Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.
$1500 (please contact us for group rates)
$750 Academic/$375 Graduate Student
Please contact Eric Buxton to qualify for the academic and graduate student rates.
This course is online and self-paced. You may register at any time and complete the curriculum at your own pace by June 30, 2026.
Course Objectives
Goals and Objectives
This course covers practical aspects of dosage form development for preclinical and phase 1 formulations. The formulation approaches include solubilization and disperse phase systems (suspensions, emulsions, microemulsions, liposomes and micelles) for preclinical as well as powders for reconstitution, capsules and tablets for phase 1.
The course is a practical guide in that its focus is on major considerations in selecting and evaluating oral dosage forms for preclinical and phase 1 studies by examining the excipients used, their typical level ranges and various preparation/processing procedures on small laboratory and pilot scales. The challenges in developing oral dosage forms at this early stage will be examined in detail, including the major problems encountered and the common strategies that are used to overcome them.
In addition to its focus as a formulation guide, the course content includes key points in stability evaluation, such as excipient compatibility approaches and the ICH guidelines. The major physical tests used to assess formulations are an integral part of the course material and are covered in terms of their application to problem solving and in setting the product specification.
Upon completion of the course, the attendees should be able to describe:
Solubilization approaches used for poorly soluble compounds
Preclinical animal species considerations for testing formulations
Strategies and major issues to consider in oral dosage form development for phase 1, including lab and pilot scale processing factors, excipient compatibility for capsules and tablets, common problems encountered and problem solving approaches
Bioenhanced formulation strategies for phase 1 capsules and tablets, including particle size reduction techniques, solid dispersions and liquid-filled capsules
Stability assessment of solid oral dosage forms for phase 1, including common problems encountered and problem solving approaches
Who Should Attend
Scientists and technical managers who work in early drug development and who are responsible for preclinical and/or phase 1 clinical formulations. Attendees should include BS, MS and PhD graduates with less than 5 years of experience in the formulation discipline.
Additional scientists and managers who would benefit from the course include those working in analytical, preformulation, various biological sciences (toxicologists, pharmacokineticists, pharmacologists), and other groups interested in gaining a better understanding of principles and practices in early formulation development.
Other individuals who would be well-suited to attend this short course are those who have previously completed the other core Applied Drug Development short courses.
Course Outline
Module 1
Introduction and overview of course
Module 2
Preclinical Formulation
pH adjustment, cosolvents, complexation and oil/lipid-based formulations; small scale processing considerations; dosing small volumes; filling and dosing small capsules; comparing solution and suspension results
Module 3
Preclinical Formulation Problem Set
Given a compound with certain properties, provide a formulation strategy, including details of excipients used, their levels and dosing limitations for the animal species
Module 4
Drug Substance Considerations
Salt forms; role of drug substance crystal form and particle size in capsule and tablet formulations
Module 5
Dosage Form Selection for Phase 1 and Placebo Considerations
Drug-in-bottle approach, reconstitution (solutions and suspensions), advantages and disadvantages, when and when not to use; time, resource and drug substance requirement comparison with capsules and tablets; excipient compatibility and stability considerations; matching; controls for stability
Module 6
Excipient Compatibility
Traditional and statistical design approaches vs. the miniformulation strategy
Module 7
Excipient Compatibility Problem Set
Given a compound with certain properties, design an excipient compatibility study; a dataset will be provided and groups will review results to determine next steps and select the optimum ingredients for a formulation
Module 8
Physical Property Tests
Physical characterization of powders and granules: size, morphology, density, porosity, flowability, water content Physical characterization of tablets: hardness/tensile strength, friability, water content, disintegration, dissolution
Module 9
Tablet Formulation Development
Advantages and when to use tablets; excipients used, functionality and levels; tablet compaction process, manual vs. automated; direct compression, wet granulation, dry granulation, film coating; processing formulations at lab and pilot scales; ICH guideline; stability protocols for tablets (e.g., decrease in dissolution)
Module 10
Capsule Formulation Development
Advantages and when to use capsules; excipients used, functionality and levels; capsule filling process, manual vs. automated; gelatin and nongelatin capsules, gelatin specific issues; processing formulations at lab and pilot scales; ICH guideline; stability protocols for capsules (e.g., decrease in dissolution)
Module 11
Capsule/Tablet Problem Set
Given a drug with certain properties, anticipate potential problems and devise a formulation strategy, including excipients and processing details
Module 12
Milling and Solid Dispersions to Enhance Oral Bioavailability
Assessing dissolution rate limited oral bioavailability; milling, micronization and wet milling at lab and pilot scales; key methods for physicochemical characterization of processed drug substance and small particles
When to and not to consider solid dispersions; eutectics and amorphous solid dispersions; excipients used; methods of manufacture at lab and pilot scales; importance of physicochemical characterization; physical and chemical stability
Module 13
Solid Dispersion Formulation Problem Set
Given a compound with certain properties, devise a formulation strategy, including excipient choices, levels considered and stability assessment
Module 14
Liquid Filled Capsule Formulations to Enhance Oral Bioavailability
Assessing solubility limited absorption; when to and not to consider liquid filled capsules; excipients used and their functionality; excipient levels and capsule shell compatibility; liquid fill process considerations for hard shell capsules (e.g., temperature and banding); soft gel capsule filling process
Module 15
Liquid Filled Capsule Formulation Problem Set
Given a compound with certain properties, devise a formulation strategy, including excipient choices, levels considered and stability assessment
Instructors
Edmund (Ed) Elder, Jr., RPh, PhD
Director, Zeeh Pharmaceutical Experiment Station
School of Pharmacy, University of Wisconsin–Madison
Madison, WI
Mark Sacchetti, PhD
Scientific Director, Zeeh Pharmaceutical Experiment Station
School of Pharmacy, University of Wisconsin–Madison
Madison, WI
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
