L2 - Introduction into medicinal products Flashcards
pharmaceutics
- process of turning a new chemical entity (NCE) into a medication to be used safely and effectively by patients
- aka science of dosage form design
for pharmaceutics we need an understnaqding of:
- basic physical chemistry
- necessary for the effective design of dosage forms
- relevant body systems
- how drugs arrive there following administration
- dsign and formulation of medicines
- dosage from desing
- manufacture
- avoidance and elimination of microorganisms in medicine
- product performance testing
medicines
- drug delivery system
- administartion of drug(s) into body in a safe, efficient, accurate, reproducible, and convenient way
when do medicines = drugs
- when there are no ‘excipients’ present
excipient
- substance formulated alonside the active ingredient of a medication
- many purposes, e.g.
- stability
- bulking agents
- theraputic enhancement etc
major factors that impact dosage from design
- physiochemical properties of the drug
- e.g. pKa
- biopharmaceutical considerations
- e.g. how adminsstration route of dosage affects rate and extent of drug absorbtion in the body
- therapeutic considerations
- e.g. patient popuilation, disease state
suspension
- medicine mixed with a liquid, usually water, in which it can not dissolve and therefore remains intact in the form of small particles
topical
- applied directly to part of the body
transdermal
- route of administration wherein active ingredients are delivered across the skin for systematic distribution
buccal
- relating to mouth
Variation of onset of action for different dosage forms:
seconds
intravenous injection
Variation of onset of action for different dosage forms:
minutes
- intramascular and subcutaneous injection
- buccal tablets
- aerosols
- gases
Variation of onset of action for different dosage forms:
minutes to hours
- solutions
- suspensions
- powders
- granules
- capsules
- tablets
Variation of onset of action for different dosage forms:
several hours
- enteric coated formulations
Variation of onset of action for different dosage forms:
days to weeks
- implants
- depot injections
subcutaneous injection
- subcutaneous - under the skin
- short needle used to inject a drug into the tissue layer between the skin and the muscle
granules
- primary powder particles are made to adhere to form larger multiparticle entities called granules
- forms bonds between them
enteric coating
- polymer barrier applied on oral medication
- prevents its dissolution or disintegrations in the gastric environment
- e.g. prevents drug being released in stomach due to acidic condtions
- some are unstable at gastric pH
- used in targeting
depot injection
- slow-release, slow-acting form of medication
Medicines Act 1968 mand Council Direction 2001/83/EC
- control sale and supply of medisicines
- legal status of medicinal products is part of the marketing authorisation
what are the different availabilities of products?
- POMs
- prescription only medicines
- P
- in a pharmacy, w/o prescription, under pharmacist supervision
- GSL
- General Sale (lisence) can be sold in general retail outlets
who can isssue prescriptions
- doctors
- dentists
- nurse independant prescribers
- pharmacist independant prescribers
- supplementary prescribers
how can same medicine have differnet legal classifications?
- different strength
- different pack size
