Formulation of Advanced or Complex Medicines 1 Flashcards
Give four examples of sterile products
Parenteral products
- injections
- infusions
Ophthalmic products
- eye drops
- eye ointments
- contact lens solutions
Sterile fluids
- water for irrigation
- haemodialysis
- peritoneal dialysis solutions
Medical devices
- artificial heart pumps
- dressings
What is a parenteral preparation?
Sterile preparations intended for administration by injection, infusion, implantation into the human or animal body
What considerations need to be made with parenteral preparations?
Formulation
- drug and excipient stability
- pH
Sterility
- terminal sterilisation vs aseptic manufacture/dispensing
Contamination
- endotoxins
- pyrogens
- particulates
Container/usage
Action
- route
- adsorption from site of injection
Storage and Delivery
- hospital
- home
Why might parenteral preparations require the use of excipients?
To make isotonic with blood/cells etc
To adjust the pH
To increase the solubility of active drug
To prevent deterioration of the active ingredients
To provide adequate antimicrobial properties
Describe the containers used for parenteral preparations
Manufactured in containers made, as far as possible, from materials that are sufficiently transparent to permit the visual inspection of the contents, except for implants and in other justified and authorised cases
Give examples of materials that can be used for containers of parenteral preparations
Glass
Plastic
Coated glass
Give examples of containers that are used for parenteral preparations
Ampoules
Vials
Infusion bottles
Infusion bags
Give examples of different drug systems that can be given parenterally
Aqueous solutions
Aqueous suspensions
Oily injections
Oily suspensions
Emulsions
Colloidal solutions
Mixed solvent systems
Concentrated solutions
Powders for injection
Implant
Give examples of routes of parenteral drug delivery
Intravenous (I/V)
Intramuscular (I/M)
Subcutanous (S/C)
Intraspinal
- Intrathecal (I/T)
- Sub-arachnoid
- Intracisternal
- Epidural
- Peridural
Interdermal (I/D)
Intra-arterial (I/A)
Intracardiac
Intra-articular
Ophthalmic injections
- subconjunctival
- intracameral
- intravitreous
- retrobulbar
Veterinary injections
- intramammary
What is a Luer slip?
Attachment type- needle hub is pushed into the end of a syringe with a quarter turn, held in place by friction
What is a Luer lock?
An adapter to connect administration set to the IV catheter
What is the difference between a needle and a cannula?
A needle is sharp whereas a cannula is blunt
What is a syringe driver?
A device for delivering a set volume of drug at a set rate via an injection
What is an infusion pump?
A device for delivering fluids and nutrients at a preselected, constant flow rate
Give three examples of regulatory bodies that cover parenteral products
EMA - Human Medicines Regulatory Information
MHRA - Regulation of Medicines
MHRA - Regulation of Devices
