L3 - concept of medicine and dosage forms, brands & generics
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what is a medicine?
a drug in a dosage form. any product used to diagnose, treat, mitigate, cure or prevent disease.
what is a drug?
the active pharmaceutical ingredient (API)
what is an excipient?
other components of the formulation excluding the API
what is a formulation?
mixture of API and excipient
what are the 2 types of medication names?
• brand name • chemical/ generic name
what is the brand name?
registered ®. given by pharmaceutical company
what is the generic name?
the API
examples of things which can be trademarked
medicinal devices, packaging, shape, colour, brand and generic name
what are new medicines marketed as?
branded drugs
when a big pharma company discovers a new drug what do they do?
take out a patent (which lasts 20 years but you can have additional 5 years added on) to earn money
outline process of discovering new drug and introducing it to the market
• 15-20 yrs to create drug • file a new drug application • obtain marketing authorisation • 6+ yrs for discovery & preclinical studies • 5+ yrs for clinical development & regulatory • 10-15 years for marketing to make a profit before patent expires
role of pharmaceutical research
to convert any synthesised compounds into candidate drugs for development
what is product development?
involves converting the candidate drugs into dosage forms for registration and sale
do drugs cost the same in different countries?
no drugs cost different amounts in different countries
what is a blockbuster drug?
sales reach 1 billion US dollars per year (1/3 of pharma market)
when do generic drug companies kick in and start making drugs?
• when leading band loses patent • they usually make lower profits • can become blockbusters
if a disease is large enough what may happen to a blockbuster drug?
blockbuster drug loses patent protection (E.g for cardiovascular disease and respiratory disease)
what are generic drugs?
• identical in dose, route of administration, same safety and efficacy as “innovator”
prescribing generic medicines
• expected to prescribe these as they are generally cheaper
word of caution surrounding generics
rare cases where branded + generic are diff E.g epilepsy, modified release preparations, lithium, biological medicines