Week 1 - Sterile Products: Injection & Ophthalmic Products Flashcards
What makes a product sterile
- Free from micro-organisms
- Free from particulates (contains minimum no. of particles)
- Is isotonic with bodily fluids
- Has excipients to eliminate contaminants
- Prepared under aseptic / sterile conditions
NOTE: to be sterile needs to meet pharmacopeial requirements
What are the “pharmacopeial requirements”
- Sterility
- Excipients (that:)
- keep product isotonic
- have same osmotic pressure as fluid its injected into or cells could swell OR shrivel
- use 0.9% NaCl or 5% dextrose
- acts as perservative
- antimicrobial prevents microbial growth + preserves product
- adjust pH (as close to physiological pH)
- IV = pH 5-8
- IM = pH 2-12
- SC = PH 2-7.9
- ↑ drug stability
- ↑ drug solubility
- changing drug salt, alter pH with buffer, co-solvents, surfactants, W/O, emulsion, suspension - Containers
- can be glass or plastic
- transparent, to visually inspect for particles
- tightly sealed prevents contamination, degredation
- robust
- no interaction between container + drug - FREE from Endotoxins and Pyrogens
- released from bacteria
- if present can cause fever, shock - FREE from Particulates
- free or contain low no. of visible particles
OTHER:
- No phase separtion in emulsions
- Perservative NOT used if injected into eye, infusion use, epidurally or intracthecal
- O/W used for infusions (as it is IV)
- Concentrates for injection / infusion need to be diluted with water or saline
What are parenteral products
parenteral = NON-oral (route that doesn’t pass through GI tract)
- Opthamalic / eye
- eye products need to be sterile as eye can be easily contaminated
- Dressings
- Injections
- Irrigating products
- needs to be sterile as its used to wash wounds, open cuts, cleaning chemicals from eyes - Implants
What excipients are used for parenteral products
- Vehicles
- water = most common
- ethanol
- glycerol
- Preservatives
- antimicrobial ~ inhibits microbial growth + preserves product
- e.g. benzoic acid, benxyl alcohol
- Antioxidants
- reduce drug degradation by oxidation
- e.g. vitamin C, nitrogen
- Suspending agents
- Tonicity-adjusting agents
- pH adjustment agents and buffers
List the 5 types of injections
- Liquid Injection
- Dry Solid Injection
- Injection Emulsion
- Injection Suspension
- Injectable Suspension
NOTE:
- Water-in-Oil (W/O) AND Suspension injections should NOT be admisntered IV = will block blood capilarries
- particles in suspension = physical block
- oil = form fat embolism
What is Liquid injections
A liquid preparation containing drug
What is Dry solid injections
Dry solid that forms a soultion when ADD suitable vehicle
What is Injection Emulsion
Drug substance dissolved or dispersed in emulsion medium
What is Injection Suspension
Drug substance suspended in liquid medium
What is Injectable Suspension
A dry solid which becomes a solution when ADD liquid vehicle
What are the potential advantages of Injections
- Rapid onset of action (IV injections)
- Prolonged / delayed onset of action (IM injection)
- Avoids 1st pass metabolism
- Rapid rehydration, replacement of vitamins, nutrients and fluids
- Can adminster to unconcious patients
- Provide localised effects (e.g. into joint, intraocular, CSF)
What are the disadvantages of Injections
- Pain
- Infection
- wear PPE, wash hands before and after etc. - Reactions (at site)
- Patient has to come in to clinic / hospital (most arent adminstered at home)
- Expensive
- Needlestick injury
- Administration error
- Not easy to prepare / adminster
What are the routes of injection (ROI)
- Intravenous (IV)
- into vein
- can be solutions, emulsions / dispersion
- Intramuscular (IM)
- into muscle
- solutions, suspenin, O/W
- Subcutaneous (SC)
- into connective and adipose tissue below dermal skin layer
- solutions, suspension, O/W
- Intrathecal (IA)
- into spinal canal
- solutions, suspensions
- Intrademral
- into skin
How are injectables manufactered
- Terminally sterilised
- Produced using aseptic processes
How are injectables manufactered: Using aseptic processes
More common
Process of making product under clean conditions
- Product, container and container closure are sterilsed separetly then combined
- Combination is perfomed in a sterile environmen using sepcial equipment
