Units

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Sample subject outline - Semester 2 2013

Note: Subject outlines often change before the semester begins. Below is a sample outline.

Rationale

This unit is designed to extend the knowledge of the design and formulation of advanced pharmaceutical dosage forms. The unit will focus on the application of the physicochemical properties of drugs and excipients in dosage form design, drug formulation, product stability and drug delivery systems.

Aims

The aims of this unit are to:

1. Provide knowledge of the physical properties that determine how active products can be formulated into solid dosage formulations such as powders, tablets and capsules formulations.

2. Demonstrate the mechanics of controlled release formulations and other advanced drug delivery systems.

3. Provide knowledge of the advanced pharmaceutical products (novel drug delivery systems).

4. Examine the stability of drugs in various formulations and provide an understanding of degradation mechanisms of common active ingredients used in the teaching of this unit.

Objectives

1. Demonstrate the knowledge of preformulation studies and dosage form design in the manufacturing of tablets, capsules and powder formulations and various quality assurance methods used to control the content of the active product in these formulations.

2. Demonstrate an understanding of the physical processes involved in oral controlled release formulations and the influence of these products on patients dosing regimens.

3. Understand the biopharmaceutical properties of advanced drug delivery systems and formulations and their advantages in allowing the administration of drugs with poor bioavailability and stability.

4. Understand the drug and dosage form stability, drug interactions and degradation.

5. Demonstrate a sound knowledge in drug discovery and regulations, quality control and GMP, radiopharmaceuticals and dental products.

Content

Solid Dosage Form Design: the concept of pre-formulation, preformulation studies (solubility, melting point, polymorphism, dissolution, partition-coefficient, pKa and dissociation constant), particle size and size reduction, characteristics of crystals (like purity, size, shape, and geometry), moisture content and granulation, mechanism of drying, rate and time of drying. Pharmaceutical excipients (fillers, binders, disintegrates, etc); theory of mixing, mixing equipments, manufacturing and quality control (uniformity of weight, uniformity of content, hardness, friability and disintegration & dissolution) of tablets and capsules.

Biopharmaceutical principles of drug delivery: physiology of GIT and drug absorption and dosage form factors in bioavailability.

Product stability and quality control: drug and drug product stability, mechanism of degradation, kinetics of drug degradation, shelf-life, rate and order of drug degradation, accelerated stability testing.

Controlled release and other novel drug delivery systems: Physical characteristics and properties of a variety of controlled or sustained release formulations. Examples of the different pharmaceutical technologies used in controlled release formulation and novel drug delivery systems including lipid, pulmonary, transdermal, implantable and polymer.

Approaches to Teaching and Learning

The teaching content of this unit will be presented as lectures (2 hours/week) and practical sessions (3 hours/week) will provide a forum to perform pharmaceutical practical and problem solving exercises. A one-day visit to a pharmaceutical manufacturing company (Alphapharm) will demonstrate the use of pharmaceutical techniques to formulate a wide variety of medications in an industrial environment.

Assessment

Successful completion of the unit requires that students must obtain above 50% marks in each component of the assessment item in order to achieve a pass grade (i.e., 4-7) in this unit.Students will receive feedback on formative summative assessment including their progress exam and practical reports.

Assessment name: Examination (written)
Description: Progress exam (summative): This is a closed book mid semester written exam (1 hour), which will be a combination of multiple choice/short answer questions and relevant calculations. It will cover materials presented in weeks 1-5.
Relates to objectives: 1, 2, 3 and 4.
Weight: 20%
Internal or external: Internal
Group or individual: Individual
Due date: Week 7

Assessment name: Practical Report
Description: Students must attend all practical classes and submit weekly practical reports. Students who are unable to attend should notify to the unit coordinator at least 24 hours before the scheduled date with a valid medical reason. Students are to submit a report (in pairs/small groups) based on their practical experience on the industry visit (date and time to be advised).
Relates to objectives: 5
Weight: 25%
Internal or external: Internal
Group or individual: Individual
Due date: See Blackboard site

Assessment name: Demonstration
Description: Demonstration of competencies in pharmaceutical formulations and associated calculations.
Relates to objectives: 1,2,3 & 4
Weight: 15%
Internal or external: Internal
Group or individual: Individual
Due date: See Blackboard site

Assessment name: Examination (written)
Description: End of semester exam (summative). This is a closed book written exam (2 hours) comprising of materials presented in lectures/practicals during the whole semester. This will be a combination of multiple choice, relevant calculations and short/broad answer questions.
Relates to objectives: 1,2,3 & 4
Weight: 40%
Internal or external: Internal
Group or individual: Individual
Due date: End of Semester

Academic Honesty

QUT is committed to maintaining high academic standards to protect the value of its qualifications. To assist you in assuring the academic integrity of your assessment you are encouraged to make use of the support materials and services available to help you consider and check your assessment items. Important information about the university's approach to academic integrity of assessment is on your unit Blackboard site.

A breach of academic integrity is regarded as Student Misconduct and can lead to the imposition of penalties.

Resource materials

Required texts:

Aulton's Pharmaceutics: The design and manufacture of medicines, 3rd Edition, Edited by Aulton, ME, Churchill Livingstone, 2007.

Further readings:

Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems. 9th Edition, Loyd. V. Allen, Nicholas G. Popovich & Howard C. Ansel, 2010. Lippincott Williams & Wilkins.

Sinko, PJ, Martin's Physical Pharmacy and Pharmaceutical Sciences, 6th edition, Lippincott Williams and Wilkins, 2011.

Remington, The Science and Practice of Pharmacy, 21st edition, Lippincott-Williams and Wilkins, 2005.

Risk assessment statement

You will be made aware of evacuation procedures and assembly areas in the first few lectures. In the event of a fire alarm sounding, or on a lecturer's instruction, you should leave the room and assemble in the designated area which will be indicated to you.

This unit includes a laboratory component. In order that you become proficient in necessary practical skills, you will be trained in the handling of equipment, materials and specimens normally associated with this discipline. You will be provided with the latest edition of a comprehensive safety booklet pertinent to the laboratory and specifically to this discipline, and you will be required to adhere to the safety procedures detailed in it.

More information on health and safety can be obtained from

If you have an underlying health condition you are encouraged to consult the lecturer in charge of the unit, as you may be required to take additional precautions on occasions.

Disclaimer - Offer of some units is subject to viability, and information in these Unit Outlines is subject to change prior to commencement of semester.

Last modified: 14-Nov-2012