CHEM ENG 4060 - Pharmaceutical Formulation and Manufacturing

North Terrace Campus - Semester 1 - 2020

The course addresses the whole process pathway of pharmaceutical manufacturing from discovery, hit to lead, and lead optimization towards their legislative approval and commercial production (as API), including the formulation to the final product, which might be the pill (or other dosage designs). This will include modern approaches of biopharmaceutical API and formulation manufacture, e.g. relying on fermentation, cell growth and culturing, cell disruption, sterilization, modern bioreactors and their scale-up. The first half of the course centres on the drug (API) development, by chemical and biological means. This demands for giving a holistic, multi-disciplinary view at the intersection of synthetic organic chemistry, molecular & structural biology, and pharmacology. Key pillars for modern medicinal chemistry will be given, such as green chemistry, flow chemistry, homogeneous catalysis, process intensification, and compact, modular container production platforms as well as their sustainability assessment (LCA & costs). For biopharmaceutical synthesis, a section on enzymes as major biocatalyst completes this modern process methodology. The second half of the course will give dosage design principles for pharmaceutical formulation. Manifold common types of formulations currently used industrial manufacturing practices will be presented. Separate lectures will detail three major classes of dosage designs: liquid formulations, emulsions & suspensions, and tablets. This includes an outline on their manufacture, respective equipment, and theoretical framework (eg mechanisms, stability). Sections on drug absorption, bioavailability, coatings, and drug delivery systems will detail the targeted pathway of drug uptake in the human body. Main types of industrial formulation equipment is introduced such as for liquid mixing, powder technologies, granulation, and drying. This section will provide extended assessment of the series of process steps within one technology chain, choice of process mechanisms for one single step, respective equipment, their pros & cons. The course is delivered through a combination of lectures, and tutorials/self-directed learning activities.

  • General Course Information
    Course Details
    Course Code CHEM ENG 4060
    Course Pharmaceutical Formulation and Manufacturing
    Coordinating Unit School of Chemical Engineering
    Term Semester 1
    Level Undergraduate
    Location/s North Terrace Campus
    Units 3
    Contact Up to 4 hours per week
    Available for Study Abroad and Exchange N
    Prerequisites Chemical engineering skills are mandatory throughout the course, and basics in chemistry are helpful for a smaller part of the course
    Corequisites Desirable, yet not mandatory are basic knowledge in catalysis, biology, (soft) matter/materials, medicine, and technical process equipment and design
    Assumed Knowledge Solid understanding of fundamentals in chemical engineering and basic types of equipment and underlying operational principles (mass and heat transfer); including basics on reaction engineering and process design
    Course Description The course addresses the whole process pathway of pharmaceutical manufacturing from discovery, hit to lead, and lead optimization towards their legislative approval and commercial production (as API), including the formulation to the final product, which might be the pill (or other dosage designs). This will include modern approaches of biopharmaceutical API and formulation manufacture, e.g. relying on fermentation, cell growth and culturing, cell disruption, sterilization, modern bioreactors and their scale-up.
    The first half of the course centres on the drug (API) development, by chemical and biological means. This demands for giving a holistic, multi-disciplinary view at the intersection of synthetic organic chemistry, molecular & structural biology, and pharmacology. Key pillars for modern medicinal chemistry will be given, such as green chemistry, flow chemistry, homogeneous catalysis, process intensification, and compact, modular container production platforms as well as their sustainability assessment (LCA & costs). For biopharmaceutical synthesis, a section on enzymes as major biocatalyst completes this modern process methodology.
    The second half of the course will give dosage design principles for pharmaceutical formulation. Manifold common types of formulations currently used industrial manufacturing practices will be presented. Separate lectures will detail three major classes of dosage designs: liquid formulations, emulsions & suspensions, and tablets. This includes an outline on their manufacture, respective equipment, and theoretical framework (eg mechanisms, stability). Sections on drug absorption, bioavailability, coatings, and drug delivery systems will detail the targeted pathway of drug uptake in the human body. Main types of industrial formulation equipment is introduced such as for liquid mixing, powder technologies, granulation, and drying. This section will provide extended assessment of the series of process steps within one technology chain, choice of process mechanisms for one single step, respective equipment, their pros & cons.
    The course is delivered through a combination of lectures, and tutorials/self-directed learning activities.
    Course Staff

    Course Coordinator: Professor Volker Hessel

    Course Timetable

    The full timetable of all activities for this course can be accessed from Course Planner.

  • Learning Outcomes
    Course Learning Outcomes
    On successful completion of this course students will be able to:

     
    1 Discuss the fundamental principles for dosage form design, drug release and drug delivery
    2 Apply the engineering principles for formulation of solutions, suspensions and emulsions, granules and tablets
    3 Formulate the dosage forms for a given API based on its properties
    4 Develop a formulation process for a given API
    5 Take regulatory requirements into consideration for each unit operation
    6 Demonstrate awareness of contemporary issues related to each unit operation

     
    The above course learning outcomes are aligned with the Engineers Australia Stage 1 Competency Standard for the Professional Engineer.
    The course is designed to develop the following Elements of Competency: 1.3   1.4   1.5   2.1   3.4   

    University Graduate Attributes

    This course will provide students with an opportunity to develop the Graduate Attribute(s) specified below:

    University Graduate Attribute Course Learning Outcome(s)
    Deep discipline knowledge
    • informed and infused by cutting edge research, scaffolded throughout their program of studies
    • acquired from personal interaction with research active educators, from year 1
    • accredited or validated against national or international standards (for relevant programs)
    1,2
    Critical thinking and problem solving
    • steeped in research methods and rigor
    • based on empirical evidence and the scientific approach to knowledge development
    • demonstrated through appropriate and relevant assessment
    3-4
    Teamwork and communication skills
    • developed from, with, and via the SGDE
    • honed through assessment and practice throughout the program of studies
    • encouraged and valued in all aspects of learning
    3-6
    Career and leadership readiness
    • technology savvy
    • professional and, where relevant, fully accredited
    • forward thinking and well informed
    • tested and validated by work based experiences
    3-6
    Intercultural and ethical competency
    • adept at operating in other cultures
    • comfortable with different nationalities and social contexts
    • Able to determine and contribute to desirable social outcomes
    • demonstrated by study abroad or with an understanding of indigenous knowledges
    5
    Self-awareness and emotional intelligence
    • a capacity for self-reflection and a willingness to engage in self-appraisal
    • open to objective and constructive feedback from supervisors and peers
    • able to negotiate difficult social situations, defuse conflict and engage positively in purposeful debate
    3-6
  • Learning & Teaching Activities
    Learning & Teaching Modes

    No information currently available.

    Workload

    No information currently available.

    Learning Activities Summary

    No information currently available.

  • Assessment

    The University's policy on Assessment for Coursework Programs is based on the following four principles:

    1. Assessment must encourage and reinforce learning.
    2. Assessment must enable robust and fair judgements about student performance.
    3. Assessment practices must be fair and equitable to students and give them the opportunity to demonstrate what they have learned.
    4. Assessment must maintain academic standards.

    Assessment Summary
    Assessment Task Weighting (%) Individual/ Group Formative/ Summative
    Due (week)*
    Hurdle criteria Learning outcomes
    Tutorial Assignments 20 Group Summative Weeks 2-12 1. 2. 3. 4. 5. 6.
    Quizzes 10 individual Summative Week 2-12 1. 2. 5. 6.
    Final exam 70 individual formative 1. 2. 3. 4.
    if more than eight tasks try to bundle tasks
    Total 100
    * The specific due date for each assessment task will be available on MyUni.
     
    This assessment breakdown complies with the University's Assessment for Coursework Programs Policy.

    Due to the current COVID-19 situation modified arrangements have been made to assessments to facilitate remote learning and teaching. Assessment details provided here reflect recent updates.

    To support the changes to teaching, the following revisions to assessment have been made:-

    Assignments: will be held remotely. Otherwise nothing will change to the way we approached it, when we still meet (team answer, document file with questions, document file with answers). The scheduling is not planned to change.

    Quiz: I plant to hold this remotely and need to check for the right technology (let you know). The scheduling is not planned to change.

    Exam: will be done remotely (as to the last information). There may be changes to the contents: concerning the way the questions are given and the way answers are provided. That obviously needs right technology. I will update you hereabout. Clear is that the exam will and have to be open book, and you will have to answer from remote location. The scheduling is not planned to change.

    Adjusted shares in the final mark: due to the need for remote assessment, a change of the shares of the individual marks to the final mark has been decided, as follows: assignments (30%), quiz (20%), and exam (50%).
    Assessment Detail

    No information currently available.

    Submission

    No information currently available.

    Course Grading

    Grades for your performance in this course will be awarded in accordance with the following scheme:

    M10 (Coursework Mark Scheme)
    Grade Mark Description
    FNS   Fail No Submission
    F 1-49 Fail
    P 50-64 Pass
    C 65-74 Credit
    D 75-84 Distinction
    HD 85-100 High Distinction
    CN   Continuing
    NFE   No Formal Examination
    RP   Result Pending

    Further details of the grades/results can be obtained from Examinations.

    Grade Descriptors are available which provide a general guide to the standard of work that is expected at each grade level. More information at Assessment for Coursework Programs.

    Final results for this course will be made available through Access Adelaide.

  • Student Feedback

    The University places a high priority on approaches to learning and teaching that enhance the student experience. Feedback is sought from students in a variety of ways including on-going engagement with staff, the use of online discussion boards and the use of Student Experience of Learning and Teaching (SELT) surveys as well as GOS surveys and Program reviews.

    SELTs are an important source of information to inform individual teaching practice, decisions about teaching duties, and course and program curriculum design. They enable the University to assess how effectively its learning environments and teaching practices facilitate student engagement and learning outcomes. Under the current SELT Policy (http://www.adelaide.edu.au/policies/101/) course SELTs are mandated and must be conducted at the conclusion of each term/semester/trimester for every course offering. Feedback on issues raised through course SELT surveys is made available to enrolled students through various resources (e.g. MyUni). In addition aggregated course SELT data is available.

  • Student Support
  • Policies & Guidelines
  • Fraud Awareness

    Students are reminded that in order to maintain the academic integrity of all programs and courses, the university has a zero-tolerance approach to students offering money or significant value goods or services to any staff member who is involved in their teaching or assessment. Students offering lecturers or tutors or professional staff anything more than a small token of appreciation is totally unacceptable, in any circumstances. Staff members are obliged to report all such incidents to their supervisor/manager, who will refer them for action under the university's student’s disciplinary procedures.

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