introduction to medicinal products part 1 Flashcards
what are medicines made of?
drug and excipient
what is an excipient
something added to a drug to ensure its safe, efficient and convenient
what is a drug
Active Pharmaceutical Ingredient (API)
what three features do medicine have to have?
safe
effective
high quality
why are medicines designed?
they need to be effective and accepted by the patient
what are the different routes of administration of medicines?
oral, rectum, topic (applied on the surface), parenteral (injections), pulmonary route (into lungs), nasal, ocular, otic (via ear)
definition of local delivery?
has an effect on the site its applied on
definition of systemic delivery?
has an effect from the route of administration
how are medicines classified?
by route of administration or by physical type
what is a medicine?
a way of delivering a drug to the body safely, conveniently and efficiently.
what act did Thalidomide trigger?
Medicines Act 1968
What is an FDA requirement and what does that mean?
Quality by design includes:
efficacy- how effective the drug is
safety- is it safe to be used by the patient
quality- dose uniformity (same dose made every time)
product uniformity (‘each batch made need to have the same characteristics’)
stability (long lasting shelf life)
patient acceptability
medical information (includes labelling, ancillaries)
what are regulatory agencies responsible for?
licensing new medicines for use (license number given)
what is the definition of Pharmacopoeia?
‘Books of official standards for medicines. Published by regulatory agencies as legal standards for the quality of common drugs and excipients ‘
