Exam papers all question 1's Flashcards
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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
HPRA and EMA
What is the aim of drug pre-formulation?
To optimise the process of developing a drug candidate into a drug product
Give two types of aerosol inhalers.
Metered dose inhaler and Dry powder inhaler
List two types of pharmaceutical dosage forms based on physical classification
Liquid and solids
What are the two components that typically form a pharmaceutical drug?2x
The API and the excipient
Cite two causes for the loss of drug stability.
Heat and light
What do O/W and W/O refer to in cream formulations?
Oil in water, water in oil
What is the role of a preservative in a pharmaceutical drug?
Give an example.
The role is to prevent microbial spoilage, it should possess a broad spectrum of activity, an example sodium benzoate
What is the difference between the sublingual and the buccal route of
administration?
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
Give the main function of a buffer, which may be found in a solution and give an example.
Buffer maintains a specific pH to ensure API solubility an example being phosphate buffers
What do the acronyms EMA and HPRA stand for?
EMA stands for European medicines agency. HPRA stands for Health products regulatory authority
List two routes of drug administration.
Oral and topical
What is defined as the process in which different chemical substances, including the
active drug, are combined to produce a final medicinal product?
Pharmaceutical formulation
What is an OTC? What are the two categories of OTCs listed by the regulatory
agency in Ireland?
OTC stands for over the counter and the two categories are subject to prescription and not subject to prescription.
N-acetyl-para-amino-phenol is an analgesic discovered over a century ago. What is
the common name used for this API?
Paracetamol
What is sucrose and what is its role in syrup?
Sucrose is a type of sugar made from glucose and fructose, in syrup it acts as a sweetening agent
What can be added to the formulation of a drug to prevent oxidation of the API?
Reducing agents
Give an example of two artificial sweeteners authorised in the EU
Sucralose and aspartamine
Define pharmaceutics
Pharmaceutics is the art and applied science of dosage form design that converts drugs into medicine
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
A drug
What is ‘pharmaceutics’ concerned with?
Pharmaceutics is concerned with the art and applied science of dosage form design
Define pharmaceutical formulation.
The process of combining various chemicals with the API to form a medicinal product.
Cite two properties of a drug substance likely to be important considerations in dosage
form design.
Particle size and solubility
Give two functions of a dosage form.2x
To achieve a predictable therapeutic response to a drug that is chemically and physically stable and is capable of large-scale manufacturing
Define ‘Time of onset of action’.
Give an example of a dosage form for which the onset of action is in seconds.
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
Which route is the most widely used for the administration of a drug?
Give an advantage and an inconvenience of that route.
The oral route, its easy to administer however it can demonstrate low and unpredictable absorption
Contrast the terms solution and suspension.
Solutions are homogeneous mixtures of two or more components. A suspension is a heterogeneous mixture of insoluble solid particles in a liquid medium
What is the role of a wetting agent in a suspension?
Give an example of such an excipient.
The role of a wetting agent is to reduce the surface tension of the liquid an example being pectin
Which type of drying method is used for biopharmaceuticals such as vaccines,
serums, protein, and peptide drugs? Briefly explain the principle of the method.
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
Contrast these two dosage forms for veterinary products: a drench and a bolus.
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
List four types of pharmaceutical dosage forms
Tablets, capsules, creams and liquids
Explain briefly what is meant by the term ‘direct compression’ in the manufacture of a
pharmaceutical product.
It compresses a blend of API and excipients without additional substances
What do the following acronyms SC and IM stand for?
Subcutaneous and intramuscular
List two dosage forms that may be used in Hormone Replacement Therapy such as
in Estrogen Replacement Therapy
Tablets and Gels
What is the role of a chelating agent in parenteral formulation? Give an example of
such excipients.
Chelating agents remove metal ions that catalyse degradation i.e. EDTA
How can you tell if an ingredient is an API?
The active ingredient always contains the mg of the drug i.e. 500mg paracetamol
How can you tell if an ingredient is a colourant?
The colourants often have a number after them i.e. titanium dioxide (E171)
What are typical examples of binders?
Cellulose, lactose and starch
Name two disintegrant’s?
Starch and crospovidone
What ingredient is a dissolution enhancer?
Povidone
Name two ingredients that can be a lubricant
Magnesium stearate and Talc
