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. 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. Finally, some of the differences encountered when formulating a biologic vs. a small molecule will be discussed.
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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. 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. Finally, some of the differences encountered when formulating a biologic vs. a small molecule will be discussed.
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. 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. 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.
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Syllabus
Pre-formulation, part 1
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.
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Syllabus
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Activities
Review Pre-formulation Techniques
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Reviewing pre-formulation techniques will help you prepare for the Pre-formulation section of the course by refreshing your understanding of foundational concepts.
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Review the physicochemical properties of drug substances.
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Summarize the key steps involved in pre-formulation studies.
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Create a table comparing and contrasting pre-formulation considerations for small molecule drugs and biologics.
Practice Solubility Calculations
Show steps
Solving solubility calculations will help you solidify your understanding of the role of solubility in drug formulation.
Show steps
-
Use the Henderson-Hasselbalch equation to calculate the pH at which a drug has a solubility of 1 mg/mL.
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Calculate the solubility of a drug in a given solvent using the octanol-water partition coefficient.
Explore Crystal Forms of Drug Substances
Show steps
Investigating the different crystal forms of drug substances will enhance your comprehension of their impact on drug formulation.
Show steps
-
Use online databases such as the Cambridge Structural Database to search for crystal structures of drug substances.
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Attend a webinar or workshop on the role of crystal form in drug development.
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Read scientific articles and review papers on the topic.
Five other activities
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Attend a Conference on Drug Formulation
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Attending a conference will expose you to the latest research and industry trends in drug formulation.
Browse courses on
Drug Formulation
Show steps
-
Identify a relevant conference and register for attendance.
-
Attend presentations and workshops on topics related to drug formulation.
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Network with other attendees, including researchers, industry professionals, and potential mentors.
Mentor a Junior Student in Pre-formulation
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Mentoring a junior student will reinforce your understanding of pre-formulation concepts while also helping others learn.
Show steps
-
Identify a junior student who is interested in pre-formulation.
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Set up regular meetings to discuss pre-formulation concepts and provide guidance.
-
Review the student's work and provide constructive feedback.
Design an Ideal Drug Formulation
Show steps
Designing an ideal drug formulation will challenge you to apply the concepts learned in the course to a real-world scenario.
Browse courses on
Drug Formulation
Show steps
-
Select a target drug and identify its physicochemical properties.
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Research different formulation strategies and select the most appropriate one.
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Design the formulation, including the excipients, manufacturing process, and storage conditions.
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Create a presentation or report summarizing your design and explaining your rationale.
Volunteer at a Pharmaceutical Company
Show steps
Volunteering at a pharmaceutical company will provide you with hands-on experience and insights into the drug formulation process.
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Pharmaceutical Industry
Show steps
-
Identify a pharmaceutical company that offers volunteer opportunities.
-
Apply for a volunteer position and complete any required training.
-
Assist with tasks related to drug formulation, such as data collection, sample preparation, or laboratory experiments.
Contribute to Open-Source Drug Formulation Projects
Show steps
Contributing to open-source drug formulation projects will allow you to apply your skills, collaborate with others, and gain valuable experience.
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Open Source
Show steps
-
Identify a suitable open-source drug formulation project on platforms such as GitHub or GitLab.
-
Review the project documentation and codebase.
-
Identify a specific area where you can contribute, such as bug fixing, feature development, or documentation improvement.
-
Submit a pull request with your contributions.
Review Pre-formulation Techniques
Show steps
Reviewing pre-formulation techniques will help you prepare for the Pre-formulation section of the course by refreshing your understanding of foundational concepts.
Show steps
- Review the physicochemical properties of drug substances.
- Summarize the key steps involved in pre-formulation studies.
- Create a table comparing and contrasting pre-formulation considerations for small molecule drugs and biologics.
Practice Solubility Calculations
Show steps
Solving solubility calculations will help you solidify your understanding of the role of solubility in drug formulation.
Show steps
- Use the Henderson-Hasselbalch equation to calculate the pH at which a drug has a solubility of 1 mg/mL.
- Calculate the solubility of a drug in a given solvent using the octanol-water partition coefficient.
Explore Crystal Forms of Drug Substances
Show steps
Investigating the different crystal forms of drug substances will enhance your comprehension of their impact on drug formulation.
Show steps
- Use online databases such as the Cambridge Structural Database to search for crystal structures of drug substances.
- Attend a webinar or workshop on the role of crystal form in drug development.
- Read scientific articles and review papers on the topic.
Attend a Conference on Drug Formulation
Show steps
Attending a conference will expose you to the latest research and industry trends in drug formulation.
Browse courses on
Drug Formulation
Show steps
- Identify a relevant conference and register for attendance.
- Attend presentations and workshops on topics related to drug formulation.
- Network with other attendees, including researchers, industry professionals, and potential mentors.
Mentor a Junior Student in Pre-formulation
Show steps
Mentoring a junior student will reinforce your understanding of pre-formulation concepts while also helping others learn.
Show steps
- Identify a junior student who is interested in pre-formulation.
- Set up regular meetings to discuss pre-formulation concepts and provide guidance.
- Review the student's work and provide constructive feedback.
Design an Ideal Drug Formulation
Show steps
Designing an ideal drug formulation will challenge you to apply the concepts learned in the course to a real-world scenario.
Browse courses on
Drug Formulation
Show steps
- Select a target drug and identify its physicochemical properties.
- Research different formulation strategies and select the most appropriate one.
- Design the formulation, including the excipients, manufacturing process, and storage conditions.
- Create a presentation or report summarizing your design and explaining your rationale.
Volunteer at a Pharmaceutical Company
Show steps
Volunteering at a pharmaceutical company will provide you with hands-on experience and insights into the drug formulation process.
Browse courses on
Pharmaceutical Industry
Show steps
- Identify a pharmaceutical company that offers volunteer opportunities.
- Apply for a volunteer position and complete any required training.
- Assist with tasks related to drug formulation, such as data collection, sample preparation, or laboratory experiments.
Contribute to Open-Source Drug Formulation Projects
Show steps
Contributing to open-source drug formulation projects will allow you to apply your skills, collaborate with others, and gain valuable experience.
Browse courses on
Open Source
Show steps
- Identify a suitable open-source drug formulation project on platforms such as GitHub or GitLab.
- Review the project documentation and codebase.
- Identify a specific area where you can contribute, such as bug fixing, feature development, or documentation improvement.
- Submit a pull request with your contributions.
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