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CHEM ENG 4060 - Pharmaceutical Formulation and Manufacturing

North Terrace Campus - Semester 1 - 2019

The course addresses the whole process pathway of pharmaceutical manufacturing from the identification of suited candidates for drugs until their formulation to the final product, the pill (or other forms of dosage). Seen from industrial and process-design view, the integrated chain from molecule to pharmacy shop's product is given - from discovery, hit to lead, lead optimization towards process development to pilot and production. First, the biochemical pathway will be outlined, relying on fermentation, cell growth and culturing, cell disruption, sterilization, modern bioreactors and their scale-up. Second, the chemical pathway will be detailed, relying on medicinal chemistry which forms the intersection of synthetic organic chemistry, molecular & structural biology, and pharmacology. Modern pharma processing approaches will be included such green chemistry, flow chemistry, process intensification, and compact, modular container production platforms as well as their sustainability assessment (LCA & costs). In a third and final part, the course will give design principles of pharmaceutical formulation, dosage forms and current industrial manufacturing practices for common dosage forms. Important downstream operations include precipitation, membrane operation, and chromatography. The course is delivered through a combination of lecture, tutorials, self-directed learning activities. You should obtain, upon successful completion of the course, a holistic, multi-disciplinary view on the different single reaction and downstream processes and their interplay from idea to market entry.

  • General Course Information
    Course Details
    Course Code CHEM ENG 4060
    Course Pharmaceutical Formulation and Manufacturing
    Coordinating Unit School of Chemical Eng and Advanced Materials(Ina)
    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
    Assessment Tutorials, Final Examination,
    Course Staff

    Course Coordinator: Professor Volker Hessel

    Course Timetable

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

  • 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 .
    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.
     
    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 .

  • 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鈥檚 disciplinary procedures.

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