Model Industry Concept (MIC)

MEDICINES DEVELOPMENT PROJECT

AIMS AND PROTOCOL

This exercise is designed to apply the theoretical and practical knowledge of

pharmaceutical sciences, gained in the pharmacy degree programme, to
design, formulate and evaluate a medicine for site-specific delivery. It
should result in a proposed formulation which can be manufactured in batch
quantities for trials of a new drug or on an industrial scale rather than
extemporaneous dispensing. Note that a detailed pharmacological review
is unnecessary. The type of information required is illustrated below but
note that different formulations will require a different emphasis. For
example, a controlled release solid dose product for oral administration may
require

more

detailed

consideration

of

pharmacokinetic

pharmacodynamic behaviour than would an eye drop preparation.

EXAMPLES OF FORMULATIONS PRESENTED
1.

A cream containing betamethasone-17-valerate (0.1%)

2.

An eye ointment containing acyclovir (3%)

3.

Sustained release capsule formulation of salbutamol (4mg)

4.

Fentanyl transdermal patch

5.

Liposomal formulation of doxorubicin.

and

INFORMATION TO BE CONSIDERED AND COLLECTED

1. Health
condition
treated,
pharmacological/therapeutic effect.
2.

site

of

drug

action,

What are the physico-chemical properties of the drug?

a) Structure, solubility, salt forms, polymorphism, pKa
b) How do these properties influence the selected formulation approach?

3. Consider the required biopharmaceutical,

pharmacodynamic behaviour of the drug.

pharmacokinetic

and

a) Are there any known bioavailability problems?

b) How may the formulation affect the bioavailability/pharmacokinetics
of the drug?
4. Consider the advantages of the pharmaceutical product regarding
patient use or administration, therapeutic activity, manufacturing process.
a) What advantages are offered by alternative delivery systems eg oral vs
transdermal?
5. Consider the excipients required eg diluents in tablets, flavours in oral
liquids, colouring agents, surfactants in semi-solid preparations,
preservatives.
a) Function and amount of each excipient
b) Alternatives
6.

Consider how you would manufacture the product.

a) Production method
b) Type of equipment
c) Possible manufacturing problems and prevention eg uniformity,
viscosity, chemical and/or microbiological contamination
d) Alternative processes

7.

Packaging
a) Pack selection.
b) Incompatibility testing: drug/excipient/pack interactions

8.

Consider aspects of characterisation and performance testing.

a) How you would evaluate the stability of the pharmaceutical?
b) Analysis of drug activity, degradation pathways and degradation
products
c) Excipient/drug interaction
d) Evaluation of key properties such as preservation
e) What tests would be carried out during production?
f) What tests would be carried out on the product?
g) Frequency of testing

9. Provide advice that a pharmacist should give to a patient before taking

your product e.g. take before or after food, do you crush a controlled release
formulation?
10. Give references to published literature for commercial and compendial
products.
ORGANISATION AND CONDUCT

Students will work in Groups of four (4) to collect and analyse a range
of data in order to design, manufacture and characterise a specific
pharmaceutical product for trials of a new drug or on an industrial
scale.

The product will be provided at random to each Group (some examples

are shown above).

Each Group should collect data and evidence to support the design and

development of the selected product and present specific details of physicochemical properties, formulation and test methods. If information is

unavailable, you should report data from a similar system eg a related steroid
formulation.
Students are not expected to approach Pharmaceutical Companies for
information.

Assessment criteria for Oral Presentation

1. Presentation skills: Flow, verbal and non-verbal communication skills,
time keeping.
2. Content: Accuracy, relevance and originality
3. English: Grammar and articulation
4. Q and A handling skills: Professionalism, confidence and accuracy