Lecture 1 Flashcards
What is Pharmaceutics?
The art and applied science of dosage form design. Pharmaceutics converts a drug into a medicine.
What is Pharmacology?
The branch that studies drug action and the interaction between living organisms and chemicals. Derived from Greek words meaning “drug” and “to study.”
How is a drug defined?
Any molecule that exerts a biochemical or physiological effect on the cell, tissue, organ, or organism. Used in treatment, cure, prevention, or diagnosis of a disease.
What is pharmaceutical manufacturing?
The preparation of drugs according to pharmacy rules or formulas. It includes substances that can affect the mind and body, sometimes blurring the line between food and drugs.
Why is patient acceptability important in medicine?
It affects the safety and effectiveness of treatments. New formulations must be tested for acceptability in target age groups. Factors like taste, texture, shape, and chewability affect oral medicine acceptability.
How are drug products classified in Ireland?
They can be prescription-based (non-renewable/renewable) or non-prescription (pharmacy-only/general sale). The HPRA regulates legal supply, and new medicines must be prescribed until supply category changes.
When did the pharmaceutical industry start in Ireland?
It started in the late 1950s. In 1958, Leo Laboratories opened a factory in Dublin. Today, 9 of the top 10 pharma companies operate in Ireland, with 50 FDA-approved plants.
What are the key steps in drug development?
Drug discovery, pre-clinical research, IND application, clinical trials, regulatory approval, manufacture, and post-marketing surveillance. Average length: 10 years. Average cost: €2.5b.
What are the stages of pharmaceutical manufacturing?
- Research and development.
- Primary manufacture (making the active ingredient).
- Secondary manufacture (formulating the medicine).
What is primary manufacturing, and why is it often outsourced?
It involves making the active pharmaceutical ingredient (API) and is outsourced to reduce costs. There are concerns about API quality and shortages. The EMA monitors medicine shortages across the EU.
What is secondary manufacturing?
The process of formulating a medicine. The excipient is chosen based on the API’s properties, such as dose, particle size, flow properties, and moisture content.
Name some pharmaceutical labs operating in Ireland.
Leo Laboratories, Allergan, Johnson & Johnson, and Pfizer.
