Pre-formulation
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Pre-formulation
This course is part of Drug Hunting: The Science of Making New Medicines Specialization
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14 assignments
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There are 3 modules in this course
In this course we will focus on how active compounds are developed into a formulation suitable for dosing in animal studies and early human clinical trials.β― Factors such as the route of administration, enhancing the solubility of the drug substance, the crystalline form of the drug substance, drug substance vs. drug product, storage requirements, and how special requirements of the patient population play a role in the design of an ideal formulation will be covered.β― Finally, some of the differences encountered when formulating a biologic vs. a small molecule will be discussed.
Target audience: This course is suitable for life scientists, clinicians, and individuals from fields that support drug discovery (e.g., patents, finance, licensing, etc.) interested in learning more about the pharmaceutical/biotechnology sector. Advanced undergraduate coursework or practical familiarity/working knowledge in biological sciences and organic chemistry is recommended.
Welcome, by the end of the course students will be able to: Define the concepts of formulation, drug substance, and drug product. Describe the role of pre-formulation in drug discovery and its impact on route of administration selection. List and explain the importance of physicochemical properties in drug discovery and development. Compare and contrast the pre-formulation considerations for small molecule drugs and biologics.
What's included
4 videos1 reading3 assignments
4 videosβ’Total 21 minutes
- Course Welcomeβ’1 minute
- Interview with Stephanie Dodd, TRDβ’11 minutes
- Introductionβ’4 minutes
- Physicochemical Propertiesβ’5 minutes
1 readingβ’Total 10 minutes
- Physicochemical propertiesβ’10 minutes
3 assignmentsβ’Total 75 minutes
- Knowledge Checkβ’30 minutes
- Knowledge Checkβ’30 minutes
- Untitledβ’15 minutes
What's included
5 videos6 assignments
5 videosβ’Total 25 minutes
- Routes of Administrationβ’4 minutes
- Drug Productβ’5 minutes
- Classification Systemsβ’5 minutes
- Crystallizationβ’6 minutes
- Drug Substance Stabilityβ’5 minutes
6 assignmentsβ’Total 180 minutes
- Knowledge Checkβ’30 minutes
- Knowledge Checkβ’30 minutes
- Knowledge Checkβ’30 minutes
- Knowledge Checkβ’30 minutes
- Knowledge Checkβ’30 minutes
- Assessmentβ’30 minutes
What's included
5 videos5 assignments
5 videosβ’Total 20 minutes
- Drug Product Stabilityβ’4 minutes
- Impuritiesβ’5 minutes
- Clinical Formulation Developmentβ’6 minutes
- Biologicsβ’4 minutes
- Course Farewellβ’1 minute
5 assignmentsβ’Total 160 minutes
- Knowledge Checkβ’30 minutes
- Knowledge Checkβ’30 minutes
- Knowledge Checkβ’30 minutes
- Knowledge Checkβ’30 minutes
- Assessmentβ’40 minutes
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Reviewed on Jul 2, 2025
This course is well-structured to help people understand the drug development process
Frequently asked questions
To access the course materials, assignments and to earn a Certificate, you will need to purchase the Certificate experience when you enroll in a course. You can try a Free Trial instead, or apply for Financial Aid. The course may offer 'Full Course, No Certificate' instead. This option lets you see all course materials, submit required assessments, and get a final grade. This also means that you will not be able to purchase a Certificate experience.
When you enroll in the course, you get access to all of the courses in the Specialization, and you earn a certificate when you complete the work. Your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile.
Yes. In select learning programs, you can apply for financial aid or a scholarship if you canβt afford the enrollment fee. If fin aid or scholarship is available for your learning program selection, youβll find a link to apply on the description page.
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Financial aid available,
