Drug Development Process 1 Flashcards
Define a drug
A chemical compound of defined structure that upon administration to a living organism produces a biological effect.
What can a chemical compound be?
- A natural product which is isolated and purified
- Synthetic i.e. made by a chemical process
- Semi - synthetic
What is a medicine?
A chemical preparation which contains a drug and other substances.
What can be prescribed for waterborne parasites?
Pomegranate as it contains a powerful antihelminthic.
When did the Royal Pharmaceutical Society form and what did they do?
In 1841
They began legislating for higher standards
What did the Venereal diseases act of 1917 lead to?
The control of unsubstantiated claims for medicines
- Thought as one of the forbears of evidence based medicine
What happened in 1956 for the development of legal framework?
Previous legislation was rationalised and the control of both the sale and manufacture of medicines was combined into a single piece of legislation.
What is extemporaneous dispensing?
The preparation of a medicinal product for an individual patient by the instruction from a doctor.
State the standards for the following elements of extemporaneous dispensing.
- Personal hygiene
- Personal protective equipment
- Work area and equipment
- Label preparation
- Avoidance of contamination
- Suitable record keeping and processes
Why were galenicals made?
- To separate active compounds from inactive from plants
How were galenicals made?
- By macerating a crude drug with a solvent
Why were pills good to make?
- Easy to make
- Compact
- Could mask foul tastes
What are the problems with pills?
- Were often coated in insoluble materials and too dense
- This meant they often went through the GI tract unchanged and unabsorbed.
What is aromatic water?
- An aqueous solution of a volatile substance
What is aromatic water used for?
- Flavouring agent
- Some do have mild therapeutic actions usually carminative
How are waters now prepared?
- From their concentrates; must be diluted with 39 times its volume of potable water to make a single strength water
How do you make money on a drug?
- Stop other people selling it who don’t have the cost of developing it
- Market it
- Develop a patentable formulation
What must you show to patent an entity (not just a drug)?
- Must be novel
- Must involve an inventive step
- Must have utility
What is the lifespan of patents?
20 years
Describe discovery of a target selection/assay development.
- Starts with research into disease mechanisms to identify potential targets that a drug could work on
What is the next stage of drug discovery?
Finding a chemical agent that will act specifically on the target - which is called a lead
Describe the sources of leads.
- Originally relied on natural sources
- Now we are able to ‘design’ leads
State the 5 sources of leads.
- ‘Design’
- Plant
- Marine
- Microorganism
- Semi - synthetic
Describe lead selection - SAR
- Develop an assay that displays interaction of your molecule with the
target plate based/cell based - This identifies ‘drug like’ chemistry that is active against the target
- Possible to start at this stage if you have a chemical you know has an effect
