Exam papers all question 1's

Question 1

What is the name of the Irish agency, which regulatory functions include human and
veterinary medicines? What is the decentralised agency of the European Union (EU)
responsible for the scientific evaluation, supervision and safety monitoring of
medicines in the EU? 2x

Answer 1

HPRA and EMA

Question 2

What is the aim of drug pre-formulation?

Answer 2

To optimise the process of developing a drug candidate into a drug product

Question 3

Give two types of aerosol inhalers.

Answer 3

Metered dose inhaler and Dry powder inhaler

Question 4

List two types of pharmaceutical dosage forms based on physical classification

Answer 4

Liquid and solids

Question 5

What are the two components that typically form a pharmaceutical drug?2x

Answer 5

The API and the excipient

Question 6

Cite two causes for the loss of drug stability.

Answer 6

Heat and light

Question 7

What do O/W and W/O refer to in cream formulations?

Answer 7

Oil in water, water in oil

Question 8

What is the role of a preservative in a pharmaceutical drug?
Give an example.

Answer 8

The role is to prevent microbial spoilage, it should possess a broad spectrum of activity, an example sodium benzoate

Question 9

What is the difference between the sublingual and the buccal route of
administration?

Answer 9

Sublingual is when the tablet is placed under the tongue whereas buccal is when is when the tablet is placed between the gums and the cheek

Question 10

Give the main function of a buffer, which may be found in a solution and give an example.

Answer 10

Buffer maintains a specific pH to ensure API solubility an example being phosphate buffers

Question 11

What do the acronyms EMA and HPRA stand for?

Answer 11

EMA stands for European medicines agency. HPRA stands for Health products regulatory authority

Question 12

List two routes of drug administration.

Answer 12

Oral and topical

Question 13

What is defined as the process in which different chemical substances, including the
active drug, are combined to produce a final medicinal product?

Answer 13

Pharmaceutical formulation

Question 14

What is an OTC? What are the two categories of OTCs listed by the regulatory
agency in Ireland?

Answer 14

OTC stands for over the counter and the two categories are subject to prescription and not subject to prescription.

Question 15

N-acetyl-para-amino-phenol is an analgesic discovered over a century ago. What is
the common name used for this API?

Answer 15

Paracetamol

Question 16

What is sucrose and what is its role in syrup?

Answer 16

Sucrose is a type of sugar made from glucose and fructose, in syrup it acts as a sweetening agent

Question 17

What can be added to the formulation of a drug to prevent oxidation of the API?

Answer 17

Reducing agents

Question 18

Give an example of two artificial sweeteners authorised in the EU

Answer 18

Sucralose and aspartamine

Question 19

Define pharmaceutics

Answer 19

Pharmaceutics is the art and applied science of dosage form design that converts drugs into medicine

Question 20

What is defined as ‘any man-made, natural, or endogenous molecule, which exerts a
biochemical and/or physiological effect on the cell, tissue, organ, or organism

Answer 20

A drug

Question 21

What is ‘pharmaceutics’ concerned with?

Answer 21

Pharmaceutics is concerned with the art and applied science of dosage form design

Question 22

Define pharmaceutical formulation.

Answer 22

The process of combining various chemicals with the API to form a medicinal product.

Question 23

Cite two properties of a drug substance likely to be important considerations in dosage
form design.

Answer 23

Particle size and solubility

Question 24

Give two functions of a dosage form.2x

Answer 24

To achieve a predictable therapeutic response to a drug that is chemically and physically stable and is capable of large-scale manufacturing

Question 25

Define ‘Time of onset of action’.
Give an example of a dosage form for which the onset of action is in seconds.

Answer 25

Time of onset action is the length of time it takes for a medicine to start to work. IV injections work within seconds as they’re entered straight into the blood stream

Question 26

Which route is the most widely used for the administration of a drug?
Give an advantage and an inconvenience of that route.

Answer 26

The oral route, its easy to administer however it can demonstrate low and unpredictable absorption

Question 27

Contrast the terms solution and suspension.

Answer 27

Solutions are homogeneous mixtures of two or more components. A suspension is a heterogeneous mixture of insoluble solid particles in a liquid medium

Question 28

What is the role of a wetting agent in a suspension?
Give an example of such an excipient.

Answer 28

The role of a wetting agent is to reduce the surface tension of the liquid an example being pectin

Question 29

Which type of drying method is used for biopharmaceuticals such as vaccines,
serums, protein, and peptide drugs? Briefly explain the principle of the method.

Answer 29

Freeze drying is a specialised drying method used for heat liable products which involves freezing the product and then sublimating the ice under reduced pressure

Question 30

Contrast these two dosage forms for veterinary products: a drench and a bolus.

Answer 30

A drench is a liquid dosage form that is poured down an animals throat.
Boluses are large elongated tablets with large amounts of API that can be chewed or swallowed

Question 31

List four types of pharmaceutical dosage forms

Answer 31

Tablets, capsules, creams and liquids

Question 32

Explain briefly what is meant by the term ‘direct compression’ in the manufacture of a
pharmaceutical product.

Answer 32

It compresses a blend of API and excipients without additional substances

Question 33

What do the following acronyms SC and IM stand for?

Answer 33

Subcutaneous and intramuscular

Question 34

List two dosage forms that may be used in Hormone Replacement Therapy such as
in Estrogen Replacement Therapy

Answer 34

Tablets and Gels

Question 35

What is the role of a chelating agent in parenteral formulation? Give an example of
such excipients.

Answer 35

Chelating agents remove metal ions that catalyse degradation i.e. EDTA

Question 36

How can you tell if an ingredient is an API?

Answer 36

The active ingredient always contains the mg of the drug i.e. 500mg paracetamol

Question 37

How can you tell if an ingredient is a colourant?

Answer 37

The colourants often have a number after them i.e. titanium dioxide (E171)

Question 38

What are typical examples of binders?

Answer 38

Cellulose, lactose and starch

Question 39

Name two disintegrant’s?

Answer 39

Starch and crospovidone

Question 40

What ingredient is a dissolution enhancer?

Answer 40

Povidone

Question 41

Name two ingredients that can be a lubricant

Answer 41

Magnesium stearate and Talc