module specification

This module will equip students with a fundamental understanding of the actions and fate of drugs in the human body, linking this with drug formulations and different routes of administration.  Throughout the module students will develop an ability to collect, manipulate and interpret experimental and simulation data important to the subject matter.

CH4003 Cell and Molecular Biology

The aims of this module are aligned with the qualification descriptors within the Quality Assurance Agency’s, Framework for Higher Education Qualifications.

This module aims to equip students with information on how formulated drugs – medicines, (a) get into the body (b) get around the body (c) how they act on the body and (d) how they get out of the body. 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.

Pharmacodynamics

• Receptor theory
• Sites of drug action
• G-proteins and downstream signalling cascades
• Ion channels and transporters
• Quantitative pharmacology
• Autonomic pharmacology
• CNS pharmacology
• Key receptor families
• Local mediators

Principles of Pharmacokinetics

• 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

• 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

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

Introduction to preformulation studies

• 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, workshops, practicals  and tutorials.

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 numerical problems with emphasis on the principles to solve problems of various types as well descriptive/discussion elements.  Students will be expected to prepare in advance for these sessions (30 hours - directed).

Workshops will utilise computer aided simulations to contextualise and enhance understanding of the action of drugs in the human body over a period of time, including the processes of absorption, distribution, localization in tissues, biotransformation and excretion.  Peer – peer interactions will be encouraged via group working 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.  Students will be directed towards a resource centre within Weblearn with the expectation that this will be utilised for completion of the coursework (30 hours - directed).

Practical sessions will stress the importance of organisational proficiency by group working and will augment practical skills in order to produce reliable experimental data.  Students will be expected to interpret the experimental data within context.  These sessions will be summatively assessed via submission of two practical reports using proforma and will be directed towards relevant literature in order to complete the assignments (10 hours – directed).

To develop and enhance student engagement a series of progress tests (quizzes) will be provided with a mixture of both formative and summative assessments.  Quizzes designed for formative assessment will be provided with ‘instantaneous’ feedback and the time constrained summative assessments will only be available once the formative elements have been completed.  Background links and literature linked to quizzes will be provided via Weblearn (resource centre) and the students will be expected to utilise this when completing the on-line (formative) quizzes (20 hours - directed).

PDP: on completion of this module students’ provide an on-line evaluation of how the module allowed them to develop skills such as information technology, organisational skills, team building, communication, time management, and working under pressure.

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

1. Demonstrate an appreciation of receptor biology.
2. Understand the molecular mechanisms involved in receptor signalling pathways
3. Describe different chemical mediators and their functions.
4. Understand the quantitative methods with which drug actions are measured
5. Show an understanding of the principles of autonomic nervous system physiology.
6. Predict the fate of specified drugs and routes of delivery using knowledge of pharmacokinetics.
7. Recognize the physiological factors and formulation characteristics that affect drug bioavailability.
8. Critically assess the rationale when choosing specific dosage forms for different routes of administration.
9. To display an understanding of the importance of preformulation studies for successful delivery of drugs.

The module will be summatively assessed by 2 unseen written exams (one at the end of each semester – 25% each), 1 data handling coursework (20%), 2 x practical reports (20%) and 2 in-class progress tests that aim to facilitate student learning at the mid-semester stage (10%). 

Both the unseen written exams at the end of each semester will examine the specific material covered during that particular semester (e.g. exam 1 will cover material between TW 2-13 and exam 2 will cover material between TW 16-27). The end of semester exams will be comprised of MCQs, SAQs and LAQs and will last for 1.5 hours.

The two in-class progress tests will take place halfway through each semester (TWs 10 and 23) and will comprise of a short, 30 minute test containing a mixture of MCQs and SAQs. Although these tests are summative (10% of the overall assessment), students are expected to use these progress tests as a way to consolidate the teaching material covered at the halfway point of the semester. For semester 1, this will be the material covered between TWs 2-8 and for semester 2, the material covered between TWs 16-22.

A data handling exercise (coursework, 20%) will summatively assess the student ability to interpret and manipulate computer simulated pharmacokinetic data.  This will be preceded by exercises designed to provide formative feedback.

Two practical reports on pharmacology and biopharmaceutics, respectively (Total 20%) will be submitted to assess the ability to acquire, manipulate and interpret experimental data. This element will provide a summative assessment.

To pass the module, students need to achieve a minimum aggregate mark of 40%.  There will be an attendance requirement for the practical sessions. If the module is passed on reassessment, then the maximum mark awarded will be 40%.

Assignment                                  Learning Outcomes
Semester 1 exam (1.5 hours)  1, 2, 3, 4, 5
1 x data handling coursework  4, 6
2 x progress tests                       1, 2, 3, 4, 5, 6, 7, 8, 9
2 x practical reports                    3, 4, 6, 7, 8
Semester 2 exam (1.5 hours)   6, 7, 8, 9

Core Texts
• Rang, H.P., Dale, M.M., Ritter, J.M., Rod J. Flower, and Henderson, G (2012). Rang & Dale's Pharmacology , 7th Edition. London: Churchill Livingstone.
• Washington, N., Washington, C. and Wilson, C.G. (2001).  Physiological Pharmaceutics: Barriers to Drug Absorption, 2nd Edition. London: Taylor Francis.
• Ritschel, W.A. and Kearns, G.L. (2009). Handbook of Basic Pharmacokinetics including Clinical Applications, 7th Edition. Washington D.C.: American Pharmacists Association.
• Florence, A.T. and Attwood, D. (2006).  Physico-chemical Principles of Pharmacy, 4th Edition. London: Pharmaceutical Press.
• Aulton, M.E. (2007). Aulton's Pharmaceutics: The Design and Manufacture of Medicines, 3rd Edition. London: Churchill Livingston.

Review Articles
• Fiese, E. F. (2003). General Pharmaceutics--the New Physical Pharmacy.  Journal of Pharmaceutical Sciences,. 92 (7), pp.1331 - 1342.
• Thomson, A. (2004).  Back to basics: Pharmacokinetics.   The Pharmaceutical Journal, 272, pp.769 – 771.

Online resources
• http://www.pharmacalogy.com/
• http://copnt13.cop.ufl.edu/safezone/pat/pha5127/simulatn.htm (Pharmacokinetic Simulations)
• www.pubmed.com (literature data base)