Lecture 2 Flashcards
What is pharmaceutics ?
Takes into account the physiochemical, dosage form design, manufacturing, product testing, avoidance of microbial contamination and pathophysiology.
What is the process of pharmaceutics ?
The process of turning a new chemical entity (NCE) into a medication to be used safely and effectively by patients, also known as the science of dosage form design.
Process of producing medicine
Drug discovery - pharmacological active compound (or NCE) - medicine - patient.
What are medicines ?
Drug delivery systems, they administer drug(s) into the body in a safe, accurate, reproducible and convenient way.
What is an excipient ?
A substance formulated alongside the active ingredient of a medicine.
Purpose of an excipient
Long-term stabilisation and bulking up solid formulations that contain potent active ingredient in small amounts.
Factors that impact dosage form design
Physiochemical properties - how the drug molecule is charged, pKa
Biopharmaceutical considerations - how the administration route of dosage form design affects the rate and extent of drug absorption in the body.
Therapeutic considerations - disease state, patient population.
Patient populations…
… around the world have very different needs and so require different treatments.
Dosage forms available for different administration routes
Oral, rectal, topical, parental, respiratory, nasal, eye, ear.
Factors that affect the exact location of where the drug enters the body
The type of dosage form that is designed.
The type of drug molecule (the physiochemical properties of the chemical will dictate which route will be favoured).
In the circulatory system, the drug can be ?
Lost, excreted or metabolised - it depends on the drug candidate what will happen to the drug in the body and what type of administration route is suitable.
Onset of action
The drug must enter the systemic circulation to be pumped around the body and get to the target location (as fast as possible).
What is the limiting factor ?
The time is takes for the drug to enter the circulatory system - once the drug reaches its target location, the pharmacological effect can be very fast.
What are enteric coated formulations ?
Tablets which have a specific coat so the tablet does not release its drug until it reaches its correct destination within the GI tract, this can take a couple hours.
What act controls the sale and supply of medicines ?
The Medicines Act 1968 and Council Directive 2001/83/EC.