Lecture 3- Concept of medicine and dosage form, brands and generics Flashcards
What are excipients?
Components which are added to the drug to keep it active, allow it to be absorbed, etc.
Formulation
A process in which APIs and excipient are combined to produce a medicinal product.
Every medicinal product has a brand name and a generic name. What is the difference.
- brand name= given by a pharmaceutical research and development company. It is a registered name.
- a chemical name is the name for the active ingredient.
Medications have trademarks. What are trademarks?
Could be a word, name, symbol or design used to identify and distinguish the goods of one manufacturer/seller from those of another.
How long does a trademark last?
Lasts as long as it is used in commerce and defended against infringement.
Companies will take out patents on each new product they discover. Why?
By taking out a patent only the company can produce/sell the meds. They can regain the money they spent on R&D and make a profit.
How long does a patent last?
A patent lasts 20 years but can be extended by 5 years. So in total 25 years.
What is the objective of R&D?
- to convert synthesised chemical compounds into candidate drugs for development.
- Candidate drugs can be converted into dosage forms for registration and sale.
Why must pharmaceutical companies ensure new discoveries are frequently brought out?
- new discoveries are needed to fund the next generation of compounds, therefore companies need a pipeline of new chemical entities.
What is a blockbuster drug?
drugs which generate a lot of income (US $1 billion per annum), which is used for the development of new drugs. For example, Ozempic.
When does generic business kick in?
When a brand loses patent protection. Copies of the branded patent drug are made.
What is a generic drug?
Bioequivalent to a branded drug. They have the same pharmacokinetic and pharmacodynamic properties.
They are identical in dose, route of administration, safety and efficacy as the branded drug.
Within the pharmacy they are usually interchangeable.
Pros of generics
- more affordable.
- loved by health ministers.
- population is getting older so there is a higher demand for drugs, these are cheaper and more readily available.
- Good for the NHS
- Several blockbuster drugs have lost patent protection due to being in such high demand.
- just as effective.
- save 80% of cost.
- Allow pharmacists the widest choice of products to dispense.
- Important if there is a shortage of a particular brand of drug.
Cons of generics
- loathed by R&D. The profits are lower.
- sometimes branded and generic are different. eg.
Epilepsy - slight difference in the rate of absorption between the branded and generic drug. This creates a big difference in the therapeutic effect.
MR- generics absorb differently
Lithium- brands may vary widely in the absorption. - Sometimes prescribers prescribe specific brands.