module specification

This module will equip students with a fundamental understanding of drug preformulation/formulation and different routes of administration. Throughout the module students will develop an ability to simulate data important to the subject matter.

This module aims to equip students with information on how to (a) preformulate drugs – medicines (b) explain kinetic processes involving medicines (c) understand how various pharmaceutical formulations can exert different biological outcomes. Understanding and appreciating the physiological aspects of the human body and physicochemical properties of drugs are essential to explaining how these processes affect the behaviour of different medicines.

BE4053 & BE4055.

Available for Study Abroad? YES

Principles of Pharmacokinetics (LO 1 – 2)

• Absorption and bioavailability
• Metabolism
• Volume of distribution
• Clearance
• Elimination
• Steady state and therapeutic window
• Use of pharmacokinetic software to investigate drug disposition

Biopharmaceutical principles of drug delivery (LO 1 – 3)

• Biopharmaceutical classification system
• Routes of drug administration and absorption (physiological factors)
• Intravenous
• Gastrointestinal
• Transdermal/dermal
• Inhalation
• Ocular, nasal
• CNS

Formulation factors affecting different routes of administration (LO 2 – 4)

• Parenteral
• Oral
• Topical/transdermal
• Aerosols
• Eye formulations
• Nasal formulations
• Bioavailability & bioequivalence

Introduction to preformulation studies (LO 5)

• Solubility
• Partition coefficients
• pH and pKa
• Osmolarity
• Polymorphism, salt forms
• Particle size
• Stability

Students will be provided with a range of activities to accommodate different learning styles. The module delivery will consist of lectures (26.5 hours) and tutorials (11 hours).

Lecture and tutorial sessions will include ‘punctuated lectures’ and ‘minute papers’ thus providing opportunities for ‘active engagement’ and to reflect on what has or has not been understood during the sessions. In-class verbal feedback will be provided and students encouraged and directed towards relevant subject matter material. The tutorial sessions will include various types as well descriptive/discussion elements. Students will be expected to prepare in advance for these sessions (11 hours – directed).

Pharmacokinetic data manipulation will stress the importance of organisational proficiency by reflective work and will augment dry practical skills to produce reliable experimental data. Peer – peer interactions will be encouraged via group reflection thus developing communication, data handling and interpretation skills. This will culminate in the submission of a summative assessment consisting of an individual piece of data handling coursework which will include a discussion section to encourage critical thinking.

On successful completion of this module, a student will be able to:

1. Understand the quantitative methods with which drug actions are measured.
2. Predict the fate of specified drugs and routes of delivery using knowledge of pharmacokinetics.
3. Recognize the physiological factors and formulation characteristics that affect drug bioavailability.
4. Critically assess the rationale when choosing specific dosage forms for different routes of administration.
5. To display an understanding of the importance of preformulation studies for successful delivery of drugs.

The module will be assessed in the following order: a data handling exercise (40%) and one unseen written exam (60%).

A data handling exercise (coursework, 40%) will summative assess the student ability to interpret and manipulate computer simulated pharmacokinetic data. This will be preceded by exercises designed to provide formative feedback.

A written exam (60%) will examine the material covered during a particular part of the semester (e.g. will cover materials between TW 4 – 11). The exam will be comprised of SAQs and LAQs.

To pass the module, students need to achieve a minimum aggregate mark of 40%. If the module is passed on reassessment, then the maximum mark awarded will be 40%.

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