PAC4261 - Drug delivery and development

This aim of this unit is to expand the student's knowledge of biopharmaceutics, pharmacokinetics and formulation considerations for a range of non-oral drug delivery routes, advanced oral drug delivery technologies and targeted drug delivery systems.

The unit will also provide students with an overview of the drug development process from pre-clinical stages through to product registration. Additionally, this unit aims to develop students' generic skills in evaluation of scientific literature, critical thinking, problem-solving, report writing, leadership and working in teams.

In this unit students will develop an appreciation of:

1. The role of the Therapeutic Goods Administration and its responsibilities in ensuring the safe, efficacy, and quality of medicines available in Australia;
2. The process of clinical drug development ;
3. The importance of Good Manufacturing Practices in the pharmaceutical industry.

In this unit, students will develop an understanding of:

1. The biopharmaceutical barriers to effective drug delivery various routes of drug delivery;
2. The formulation approaches that can be employed to overcome the biopharmaceutical barriers to effective drug delivery via various routes of drug delivery;
3. The advantages and disadvantages of various routes of delivery;
4. Situations when one route of delivery is preferred over another route of drug delivery;
5. The need for a quality system in the manufacturing of pharmaceuticals;
6. The process for drug registration for a generic formulation compared to a novel therapeutic drug;
7. Phase I, II and III clinical trials.

In this unit students will develop skills in:

1. Analysis of pharmaceutical formulations and identification of key excipients;
2. Locating and evaluating scientific literature on pharmaceutical drug formulations;
3. Working effectively in teams;
4. Time management and meeting deadlines;
5. Writing scientific reports that reflect an understanding of the pharmaceutical and biopharmaceutical rationale behind a specific pharmaceutical formulation;
6. Preparing high quality, well formatted and presented written documents.

Upon completion of this unit students will be able to:

• Describe the biopharmaceutical barriers to effective drug delivery various routes of drug delivery
• Discuss the formulation approaches that can be employed to overcome the biopharmaceutical barriers to effective drug delivery via various routes of drug delivery
• Analyse pharmaceutical formulations and identify key excipients and describe the potential functions of the excipients in the formulation
• Compare and contrast the advantages and disadvantages of various routes of delivery
• Identify situations when one route of delivery is preferential to another route of delivery for a drug
• Discuss the need for a quality system in the manufacturing of pharmaceuticals and the role of Good Manufacturing Practices
• Explain why the process for drug registration for a generic formulation can be different to a novel therapeutic drug
• Summarise the purpose of Phase I, II and III clinical trials
• Describe the role of the TGA and its responsibilities in ensuring the safe, efficacy, and quality of medicines available in Australia
• Explain the process of clinical drug development
• Propose a rationale behind a specific pharmaceutical formulation
• Prepare a high quality, well formatted and presented written document.