CHEM ENG 4060 - Pharmaceutical Formulation and Manufacturing

North Terrace Campus - Semester 1 - 2023

The course informs about the dosage form design (formulation) of drugs. For this, an understanding of the biopharmaceutical pathway of the formulation and drug in the human body will be provided, from the entry (administration) to the exit (elimination); which governs drug absorption and bioavailability. This involves physical disintegration and dissolution processes in the gastrointestinal tract and the 'systemic transport' (blood circular system) up to membrane and cellular media transport. The course will provide detailed insight on the different classes of formulations, starting from how they are build up and finally how they are industrially manufactured. This involves explanation on the underlying fundamental physical and matter processes, with major focus on powder technology (e.g. flow, gliding, compression, granulation, drying, tabletting, coating). The manufacturing of tablets, as most common formulation product is described all the way up from the powders to the final product. This involves the principles of particle breaking, merging, dosing, mixing, flow, and more; as well as outlining the respective industrial equipment. Further, liquid formulations are presented, comprising (including lyophilisation for biopharmaceuticals), suspensions, and emulsions (supramolecular aggregates) as well as their preparation by mixing. The course presents various drug-delivery systems (e.g. coating, matrix, erosion, depot). The pre-formulation stage conducts analytical tests for essential functions, which formulations need to fulfil to be manufactured. Drug development will be described, including the stages from discovery (hit), to optimisation (lead), and testing (clinical phases) and legislation. Sustainability is achieved herein by the concepts of green chemistry, flow chemistry (continuous-flow), process intensification, and compact, modular container production platforms; the first being listed as Australia's frontier technology. The course is delivered through a combination of lectures (divided in a set of mini-lectures), training and exercises in a workshop, two assessments, and a quiz.

  • 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
    Assumed Knowledge Underlying operational principles (mass and heat transfer); including basics on reaction engineering and process design
    Course Description The course informs about the dosage form design (formulation) of drugs. For this, an understanding of the biopharmaceutical pathway of the formulation and drug in the human body will be provided, from the entry (administration) to the exit (elimination); which governs drug absorption and bioavailability. This involves physical disintegration and dissolution processes in the gastrointestinal tract and the 'systemic transport' (blood circular system) up to membrane and cellular media transport. The course will provide detailed insight on the different classes of formulations, starting from how they are build up and finally how they are industrially manufactured. This involves explanation on the underlying fundamental physical and matter processes, with major focus on powder technology (e.g. flow, gliding, compression, granulation, drying, tabletting, coating). The manufacturing of tablets, as most common formulation product is described all the way up from the powders to the final product. This involves the principles of particle breaking, merging, dosing, mixing, flow, and more; as well as outlining the respective industrial equipment. Further, liquid formulations are presented, comprising (including lyophilisation for biopharmaceuticals), suspensions, and emulsions (supramolecular aggregates) as well as their preparation by mixing. The course presents various drug-delivery systems (e.g. coating, matrix, erosion, depot). The pre-formulation stage conducts analytical tests for essential functions, which formulations need to fulfil to be manufactured. Drug development will be described, including the stages from discovery (hit), to optimisation (lead), and testing (clinical phases) and legislation. Sustainability is achieved herein by the concepts of green chemistry, flow chemistry (continuous-flow), process intensification, and compact, modular container production platforms; the first being listed as Australia's frontier technology.

    The course is delivered through a combination of lectures (divided in a set of mini-lectures), training and exercises in a workshop, two assessments, and a quiz.
    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)

    Attribute 1: Deep discipline knowledge and intellectual breadth

    Graduates have comprehensive knowledge and understanding of their subject area, the ability to engage with different traditions of thought, and the ability to apply their knowledge in practice including in multi-disciplinary or multi-professional contexts.

    1,2

    Attribute 2: Creative and critical thinking, and problem solving

    Graduates are effective problems-solvers, able to apply critical, creative and evidence-based thinking to conceive innovative responses to future challenges.

    3-4

    Attribute 3: Teamwork and communication skills

    Graduates convey ideas and information effectively to a range of audiences for a variety of purposes and contribute in a positive and collaborative manner to achieving common goals.

    3-6

    Attribute 4: Professionalism and leadership readiness

    Graduates engage in professional behaviour and have the potential to be entrepreneurial and take leadership roles in their chosen occupations or careers and communities.

    3-6

    Attribute 5: Intercultural and ethical competency

    Graduates are responsible and effective global citizens whose personal values and practices are consistent with their roles as responsible members of society.

    5

    Attribute 8: Self-awareness and emotional intelligence

    Graduates are self-aware and reflective; they are flexible and resilient and have the capacity to accept and give constructive feedback; they act with integrity and take responsibility for their actions.

    3-6
  • Learning & Teaching Activities
    Learning & Teaching Modes
    Each (weekly) lecture is split in several mini-lectures (videos) which are prerecorded. Each lasts typically not longer than 15 min at typically 5-15 slides. Those lectures are every year updated for better learning. The mini-lectures will be provided several days before the tutorial. There will be no physical presentation of the lecture material.

    The lectures will be provided as slide documents on MyUni.

    The lectures are supported by problem-solving tutorials developing material covered in lectures. The tutorials will be given physically in a 2-hours workshop every week. The tutorials repeat the core information of the course, in discussion with the students to allow questions and active learning. Core of the tutorials are exercises that will support the learning and understanding. They will be solved in the tutorial with guidance on the correct solution, giving the students enough time to explore themselves solving the questions.

    The tutorials will also provide, at small share and with focus, additional information to the lecture, which has the purpose to exemplify and detail the lecture contents. This will not, however, add contents to the lectures. For this reason, this information is not obligatory and needed for the examination, will its understanding can help in a better overall learning of the courses. The additional information will be provided as slide documents on MyUni as well as the exercise documents. The latter are obligatory material needed for the examination.

    The tutorials are recorded to allow students to experience, while not being able to make the meeting physically.

    The tutorials provide also relevant information on the course administration and management, for example, about announcements and about coming assignments, quiz, and exam. This includes questions to administration and managements. Essential information will be provided in parallel by emails to all course students to ensure everyone is informed.

    Weekly uploads of documents will be announced per email to permit students maximal time for studying.
    Workload

    The information below is provided as a guide to assist students in engaging appropriately with the course requirements.

    - Lectures (videos): ca. 1.5 hours per week (excluding repeated watch of videos); totalling in 21 hours for the course; 12 lectures
    - Tutorials: 2 hours per week; totalling in 24 hours for the course; 12 lectures
    - Assignments: each assignment might need 6 hours per team member, totalling in 12 hours for two assignements
    - Quiz: ca. 1 hour (excluding learning for quiz)
    - Exam: 2 hours (excluding learning for exam)
    - Study, research, reading and writing time: 6 hours per week, totalling in 72 hours for the course
    - Preparation for examination. 20 hours

    TOTAL Workload: ca. 152 hours
    Learning Activities Summary
    Lecture Schedule

    Week    Topic of Lecture                                  Resources           Formative Activities      Summative Activities

             Dosage form design                              Slides, videos           Lecture/Tutorial
    2           Drug absorption and bioavailability         Slides, videos           Lecture/Tutorial
    3           Drug delivery design                             Slides, videos           Lecture/Tutorial              Assignment 1
    4           Drug discovery & development               Slides, videos           Lecture/Tutorial
             Preformulation                                      Slides, videos           Lecture/Tutorial
    6           Liquid solutions                                     Slides, videos           Lecture/Tutorial
             Colloids, suspensions and emulsions       Slides, videos           Lecture/Tutorial              Quiz
    8           Liquid mixing                                        Slides, videos           Lecture/Tutorial
             Particle science and powder technology   Slides, videos           Lecture/Tutorial
    10         Granulation                                           Slides, videos           Lecture/Tutorial              Assignment 2
    11         Drying                                                  Slides, videos           Lecture/Tutorial
    12         Tabletting/Coating                                 Slides, videos           Lecture/Tutorial
    15 or 16                                                                                                                                Exam

    Specific Course Requirements
    None
  • 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 Summative 1. 2. 3. 4.
    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 Related Requirements
    It is compulsory to take part in the two assessments and quiz as well as in the final exam

    Attendance at tutorials is not compulsory but strongly recommended. It provides learning and training for the above compulsory requirements and to get best capability for the examination.

    The assessments and quiz have no minimum results required, yet contribute, together with the exam to the total mark for the course, which has the general minimum requirement, as given for all courses.
    Assessment Detail
    The assessments and quiz will be done according to recommendations for their classes of questions. Those are explained in the Course's Workshop and the Workshops train for best answering along those recommendations. The assessments comprises four classes of questions, being essays, mini-questions, calculations, and quiz-format questions.

    An essay is an extended answer which typically asks for demonstration of the multi-disciplinary understanding needed for the course. It typically requires connecting contents from more than one slide and has to comprise multiple contents within one lecture (or even spanningaccross the lectures). An essay is typically given as a narrative with a top-down information style, alike abstracts are made for a scientific paper.

    A mini-question asks typically for "naming" or "describing" of a detailed course content. "Compounding" would be an example for naming of manual, human-made formulation. Describing is a short answer of 1-3 short sentences; for example, how cutting as particle size reduction mechanims works.

    Calculations are widely exercised in the Course's Workshop. Goal is to use an equation provided by the Course and to apply it to solve mathematically a pharmaceutical formulation issue. When answering, it is essential to comment on the calculation, as typically it means to calculate parameters (e.g. particle density) before coming to the main calculation asked for. Answers help to make evident the complex, multi-step process of these calculations.

    Quiz-format questions have the format of multiple-choice, yes/no-questions, etc. and are trained in the Workshops.
    Submission
    Submission due dates and times generally follow the schedule given in the Learning Activities Summary and also in the Syllabus (document on MyUni), yet might be slightly varied to adjust to needs. Any update or change in dates and times will be announced on time in the Tutorial by the course coordinator and by email so that all are informed ahead of the duty.

    Electronic submission of assignments and the quiz will be done through the respective features in MyUni. 

    The assignment will be marked and oral feedback will be given to each group in one tutorial, with each group separate. There will be room for discussion. Feedback on the quiz will be given in the tutorial to all attendees together.

    Assignments will be returned within one week. As the quiz is automatically marked ("correct answer/incorrect"), the outcome is quasi immediately communicated.

    Late submission of assessment will not given penalty, if that is announced on due time with a reason followed by approval. Otherwise, a penalty of 5 scores (out of 100) will apply. Extensions have to be submitted to the course coordinator for granting approval.

    Submitting the quiz too late will result in a zero result. It is therefore highly recommended to submit a few minutes before the deadline. In case of any web transfer issue when submitting the quiz (wifi breakdown), this shall be documented, e.g. by photo, and immediately communicated to the course coordinator, by email. Then the quiz might be transferred by email directly after the official deadline, if the web transfer failure has been approved by the course coordinator.
    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.

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    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.

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