Lecture 1 Flashcards
What is pharmaceutics?
The science of dosage form design
What are the key objectives of pharmaceutics?
Ensuring optimal delivery, stability, and patient acceptability of a drug
What does pharmacology study?
The interactions between a living organism and chemicals that affect its biochemical function.
How are drugs broadly defined?
Any man-made, natural, or endogenous molecule that has a biochemical and/or physiological effect on cells, tissues, organs, or organisms.
What factors influence patient acceptability?
Taste, smell, texture, shape, size, and ease of administration
How long does drug development typically take?
An average of 10 years.
What are the main steps in the drug development process?
Discovery, pre-clinical research, investigatonal new drug (IND) application, clinical trials, regulatory approval, manufacturing, and post-marketing surveillance.
What are the three main stages of pharmaceutical manufacturing?
Research and development (R&D), primary manufacture, and secondary manufacture.
What is primary manufacture?
The process of making the active pharmaceutical ingredient (API).
What is secondary manufacture?
Formulating the medicine by adding excipients.
What are excipients?
Chemically inactive substances that help deliver the active ingredient (API).
What factors are considered when choosing excipients?
Dose, particle size, flow properties, and compatibility with the API.
What is the role of the European Medicines Agency?
Regulating medicines in the European Union and monitoring safety.
What are biopharmaceuticals?
Substances with medicinal properties.
How are dosage forms classified?
Classified based on route of administration or physical form.
