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  1. Courses
  2. eCourse: Formulation

eCourse: Formulation


WELCOME
The dissolution behavior of drugs remains one of the most challenging aspects in formulation development for BCS II and IV APIs. With the advent of combinatorial chemistry and high throughput screening, the number of poorly water soluble drug candidates dramatically increased. Solubility enhancement is an important enabling strategy to enhance drugability of NCEs as well as life cycle management for marketed pharmaceutical products.

This course provides an overview of formulation strategies of poorly soluble drugs for drug dissolution enhancement. The presentations, delivered by key thought leaders, highlight fundamental principles, as well as enabling technologies, for solubility enhancement.

This course covers an introduction to the topic as well as takes a deeper dive into three key areas:
  1. Solid Formulations
  2. Liquid Formulations
  3. Regulatory Aspects

COURSE OBJECTIVES

Upon completion of this course, participants will be able to:
  • Review solubility, permeability, and dissolution and explore the details of BCS and its applications and discuss formulation strategies based on BCS.
  • Analyze the need and drivers for particle size reduction, its role on dissolution and bioavailability, link to BCS classification of drugs, and its place among other BA improving technologies.
  • Explore the physical principles of spray drying and discuss polymer selection, process development, and the controls of spray drying. 
  • Review Hot Melt Extrusion (HME) as a pharmaceutical technology and provide a brief historical overview of HME as a pharmaceutical technology and review recent applications.
  • Discuss lipid chemistry, nomenclature, and physical behavior and explore how lipids improve solubility and bioavailability.
  • Analyze the design, evaluation, and development of lipid formulations.
  • Review scale up & QbD aspects in manufacturing of amorphous solid dispersions and describe how the QbD principles may be applied to the development of enabled formulations of poorly soluble drugs.
  • Discuss the impact of BCS classification into II/IV categories on regulatory submission and/or review and which areas of the submission become more involved or focused.
  • Discuss the regulatory aspects of setting dissolution specifications, IVIVC, post-approval changes, bioequivalence evaluation, and polymorphic stability.
AAPS members, students, and academicians enjoy special pricing. Previews of each of the lectures are available. Participants have access to the course content for a 6 month period following purchase.


PURCHASE NOW

Purchase the entire series at an even greater discount by clicking a button below. Interested in just a lecture or two? Scroll down to add lectures to your cart individually.

AAPS members get this course at a discounted rate! Join today!


 ($600.00-$1,100.00)


$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 1: Solubility: General Principles and Practical Considerations

Presentation: Rodolfo Pinal, Ph.D., 75 min 38 sec

Assessment - Lecture 1

Assessment: 9 questions 5 retakes

Evaluation - Lecture 1

Survey: 13 questions

Solubility: General Principles and Practical Considerations

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 2: Dissolution and its Role in Solid Oral Dosage Form Development

Presentation: Gregory E. Amidon, Ph.D., 61 min 9 sec

Assessment - Lecture 2

Assessment: 8 questions 5 retakes

Evaluation - Lecture 2

Survey: 13 questions

Dissolution and its Role in Solid Oral Dosage Form Development

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 3: Overview and Selection of Solubilization Techniques

Presentation: Robert O. (Bill) Williams III, Ph.D., Editor-in-Chief, AAPS PharmSciTech, Scott V. Jermain, Pharm.D., 58 min 30 sec

Assessment - Lecture 3

Assessment: 10 questions 5 retakes

Evaluation - Lecture 3

Survey: 13 questions

Overview and Selection of Solubilization Techniques

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 4: Particle Size Reduction (Micronization)

Presentation: Stephan Tindal, 32 min 7 sec

Assessment - Lecture 4

Assessment: 9 questions 5 retakes

Evaluation - Lecture 4

Survey: 13 questions

Particle Size Reduction (Micronization)

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 5: Spray Drying

Presentation: Márcio Temtem, Ph.D., Filipe Gaspar, Ph.D., 36 min 37 sec

Assessment - Lecture 5

Assessment: 7 questions 5 retakes

Evaluation - Lecture 5

Survey: 13 questions

Spray Drying

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 6: Pharmaceutical Hot Melt Extrusion

Presentation: Dr. Justin YW Tian, BEng (Honour), MSc, PhD, 62 min 38 sec

Assessment - Lecture 6

Assessment: 8 questions 5 retakes

Evaluation - Lecture 6

Survey: 13 questions

Pharmaceutical Hot Melt Extrusion

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 7: Complexation for the Delivery of Poorly Soluble Drugs

Presentation: Ajit Narang, Ph.D., 80 min 44 sec

Assessment - Lecture 7

Assessment: 10 questions 5 retakes

Evaluation - Lecture 7

Survey: 13 questions

Complexation for the Delivery of Poorly Soluble Drugs

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 8: Lipid Formulations

Presentation: Colin W. Pouton, 61 min 18 sec

Assessment - Lecture 8

Assessment: 9 questions 5 retakes

Evaluation - Lecture 8

Survey: 13 questions

Lipid Formulations

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 9: Self-Emulsifying Formulations for Oral Delivery of Poorly Soluble Drugs

Presentation: Anette Müllertz, Ph.D., 44 min 12 sec

Assessment - Lecture 9

Assessment: 10 questions 5 retakes

Evaluation - Lecture 9

Survey: 13 questions

Self-Emulsifying Formulations for Oral Delivery of Poorly Soluble Drugs

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 10: Case Study: First-in-Human Formulations for Poorly Soluble APIs

Presentation: M. Sherry Ku, Ph.D., R.Ph., 38 min 11 sec

Assessment - Lecture 10

Assessment: 7 questions 5 retakes

Evaluation - Lecture 10

Survey: 13 questions

Case Study: First-in-Human Formulations for Poorly Soluble APIs

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 11: QbD and Scalable Manufacturing of Poorly Soluble Products

Presentation: Michael Lowinger, 84 min 45 sec

Assessment - Lecture 11

Assessment: 5 questions 5 retakes

Evaluation - Lecture 11

Survey: 13 questions

QbD and Scalable Manufacturing of Poorly Soluble Products

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 12: Regulatory Aspects for Poorly Soluble Drugs

Presentation: Zhigang Sun, Ph.D., Yue (Helen) Teng, Ph.D., 31 min 15 sec

Assessment - Lecture 12

Assessment: 7 questions 5 retakes

Evaluation - Lecture 12

Survey: 13 questions

Regulatory Aspects for Poorly Soluble Drugs

Certificate: 0/3 Course items completed

Formulation 101 Certificate

Certificate: 0/13 Course items completed
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