CHEM ENG 3021 - Pharmaceutical Dosage Form & Manufacturing

North Terrace Campus - Semester 2 - 2014

This course examines methodologies, both applied and fundamental, to analyze and scale up manufacturing pharmaceutical processes involving centrifugation, membrane separation, crystallization, adsorption, moving bed processes chromatography, electrophoresis, liquid and dispersed-phase systems e.g. liquid and multiphase mixing, sterilization and sanitation, lyophilisation drying. Also processes involving solids processing, such as solids characterization, blending, milling, granulation, tableting, coating, etc.

  • General Course Information
    Course Details
    Course Code CHEM ENG 3021
    Course Pharmaceutical Dosage Form & Manufacturing
    Coordinating Unit School of Chemical Eng and Advanced Materials(Ina)
    Term Semester 2
    Level Undergraduate
    Location/s North Terrace Campus
    Units 3
    Contact Up to 4 hours per week
    Course Description This course examines methodologies, both applied and fundamental, to analyze and scale up manufacturing pharmaceutical processes involving centrifugation, membrane separation, crystallization, adsorption, moving bed processes chromatography, electrophoresis, liquid and dispersed-phase systems e.g. liquid and multiphase mixing, sterilization and sanitation, lyophilisation drying. Also processes involving solids processing, such as solids characterization, blending, milling, granulation, tableting, coating, etc.
    Course Staff

    Course Coordinator: Dr Hu Zhang

    Course Timetable

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

  • Learning Outcomes
    Course Learning Outcomes
    Upon successful completion of this course, students will be able to:
    1. Select the correct dosage forms for a given API;
    2. Design of production, isolation and purification processes for APIs;
    3. Apply the engineering principles to unit operations, such as centrifuge, membrane operation, extraction, chromatography, crystallization, drying, mixing, granulation, tabletting and coating;
    4. Calculate and design the process conditions or equipment size for a unit operation;
    5. Scale up each unit operation;
    6. Analyze the target product and identify rational sequence of unit operations;
    7. Take regulatory requirements into consideration for each unit operation;
    8. Demonstrate awareness of contemporary issues related to each unit operation.
    University Graduate Attributes

    No information currently available.

  • Learning Resources
    Recommended Resources
    Reference books:
    1. Levin, M 2006, Pharmaceutical process scale up, Taylor & Francis
    2. Hickey, AJ, & Ganderton, D 2001, Pharmaceutical process engineering, Marcel Dekker
    3. Aulton, ME 2007, Aulton’s Pharmaceutics, 3rd edition, Elsevier
    4. Mccabe, Smith, Harriott, 2001, Unit Operations of Chemical Engineering, 6th, McGraw Hill
    5. Richardson, Harker and Backhurst, 2002, Coulson and Richardson’s Chemical Engineering, Volume 2, 5th, Butterworth-Heinemann, 2002
    Online Learning
    Resources are available on MyUni.
  • Learning & Teaching Activities
    Learning & Teaching Modes
    The course is delivered through a combination of lectures, tutorials, self-directed learning and small group discovery activities.
    Workload

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



    Activity  Contact hours Workload hours
    Lectures  30 50
    Tutorials  15 45
    Quizzes 0 10
    TOTALS 45 105
    Learning Activities Summary
    Topic 1: Dosage form design
    A range of dosage forms will be reviewed including solid, semi-solid, suspension, cream, and liquid forms and the design principles will be discussed. 
    Topic 2: API production, isolation and purification
    Methods for producing APIs via chemical and biochemical approaches will be analyzed and unit operations for API isolation and purification will be detailedly discussed. Scale up of unit opearations will be included in the discussion
    Topic 3: Solid dosage form manufacturing
    Unit operations for solid dosage form manufacturing process are introduced including solid mixing, drying, granulation and tabeletting. Scale up of the processes will be briefly discussed.
    Small Group Discovery Experience
    Topic 1 and 3 will be discussed in small group discovery activities. Challanges will be raised for small groups during the lecture and tutorial sessions.
  • 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

    No information currently available.

    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

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