Parental products Flashcards
What dosage forms do parental productsa come in?
(1) Solution
(2) Emulsion
(3) Suspension
(4) Concentrate
(5) Powder
(6) Gel
(7) Implant
What are parental products administrated via?
(1) Injection
(2) Infusion
(3) Implantation
Where in the body are parental products admistrated?
(1) Vascular system (Veins)
(2) Soft tissue
(3) Muscle
Under what circumstances are parental products used?
(1) When 100% bioavailability is required
(2) Oral route is unavailable
(3) Drug may not be absorbed orally or may be metabolised in GI track/liver
(4) Rapid effect (emergency)
(5) Delayed, prolonged, controlled or localised effect required
What range of volume is considered small volume?
SVP Less than or equal to 100ml
What range of colume is considered large volume?
LVP 100 - 1000 ml
Routes of delivery - injection
(1) Injection
(2) Intramuscular
(3) Intravenous
Dosage forms - Injections
(1) Sterile solution
(2) Emulsion
(3) Suspension
Packaging - Injections
(1) Ampoules
(2) Viles
(3) Prefilled solution
Are Infusions SVP or LVP
LVP >100ml - 1000ml
Administration - Infusions
Intravenous
Dosage forms - Infusions
(1) Sterile solution
(2) Emulsion
Do infusions contain perservatives?
No perservative - single use only
Packaging - Infusions
(1) Glass
(2) Plastice bottles
(3) Collapsible plastic bags (additive ports)
When are concentrated solutions used?
For injection or Infusion after dilution
What are concentrated solutions diluted with
(1) Water for injection
(2) 0.9% w/v sodium chloride
Why are powders used for parental products?
When the drug is unstable in aqeous solution, powders are used whch arereconstituted with water for injection prior to administration
Why are powders freeze dried?
To remove and water from the final product
Why are gels used?
Enhanced viscocity allows a modified-release of the active substance(s) at the site of injection
What are implants?
Sterile solid preperations containing one or more active ingridient
Why are implants used?
Provides release of the active ingridient over an extended period of time
Manufacturing of implants
Manufactured via:
(1) Titanium
(2) Silicone
(3) Polymers
Routes of administration - angles and location
(1) Intramuscular - 90° - Into muscle
(2) Subcutaneous - 45° - Into subcutaenous tissue
(3) Intravenous - 25° - Into veins
(4) Intradermal - 10° - Into dermis
Erros in administration
(1) Wrong route - IV instead of IM
(2) Wrong preparation - diluted in wrong solvent
(3) Wrong drug
(4) Wrong dose - decimal point/calculation error
(5) Wrong time
(6) Omission of drug
Where are parental porducts manufactured
?
Clean room - terminally sterilised or aseptically prepared
Why do parental products need to be sterile?
Microorganisms and oyrogens may bypass the bodys natural defence system and barriers going directly into blood stream or tissue - patients may be immunocomprimised, require nutrition, age compromised
Solutions must be ___ of ____ ____ and ___ number of ___ ___ particles
In suspensions particles __ __ __ but not delivered ___
What happens if particles are found in parental products?
Can lodge capilliries resulting in pulmanory embolism
What vehicles are used in parental products?
Water for injection
co-solvents (aid solubility in porly soluble drugs)
solubilizing agents (aid dissolution eg. cyclodextrins)
Oil in water (water insoluble drugs)
Oil (intramuscular injections for modified release)
purpose of preservatives in parental products
To inhibit growth of microorganisms introduced into multi-dose products
co-solvents can also exhibit microbal effects
Why are antioxidants involved in parental products?
oxidation - displacing oxygen with nitrogen gas
antioxidants - vitamin C and E, sulphate salts
Hydrolysis - removes all water
What ranges should the pH be for parental products and why?
pH must be between 3.0 - 9.0 so it is not too acidic or basic
How is pH maintained in parental products?
Buffers are used to maintain pH (eg. citric acid, sodium citrate)
acidifying or alkalizing agents (eg. hydrochloric acid / sodium hydroxide)
Purpose of suspending agents in parental products?
Ensures drug is readily and uniformly suspended prior to administration
eg. water soluble cellulose derivitives (methylcellulose)
Injections and infusions should be made ___ with ___ ___
Injections and infusions should be made isotonic with humsn plasma
Osmosis:
the movement of water from a lower solute concentration to higher solute concentration across a semi-permeable membrane
Tonicity adjustment agents
Used so injectin/infusion is isotnoic with human plasma
eg. 0.9& sodium chloride solution (osmolarity 286 mmol/L) = Isotonic with human plasma (osmolarity 280-295 mmol / kg)
What is meant by hypotonic
(1) Lower solute concentration (higher water concentration
(2) Lower osmotic pressure than blood plasma - water driven into cells by osmosis - Cell burst - Pain
(3) counter by adding sodium chloride/dextrose
(4) Restore cell volums by adding Saline`
What is meant by isotonic?
Same conentration of solute in solution and blood plasma - same osmotic pressure - no osmosis
what is meant by hypertonic?
(1) Higher solute concentration (lower water concentration)
(2) Higher osmotic pressure than blood plasma - water driven out of cells via osmosis - shrink - pain
Packaging of Vials
(1) Volume - 5-100ml
(2) Glass with reusable self sealing rubber closure, plastic dust cap
(3) Multiple use - preservative
Packagine Ampoules
(1) small volume - <1-10ml
(2) Glass or plastic
(3) Single use -unpreserved
(4) Open neck, selaed after filling
Packaging Prefilled syringe
(1) Small volume - 0.5 - 20ml
(2) Glass or plastic-base prefilled syringe and their corresponding syringe
(3) Convenient, affordable, sterile, safe
Packaging Infusion bags/bottles
(1) Volume (100-1000ml)
(2) Glass bottles, plastic collapsible bags, semi-ridged plastic bottles
(3) Addititve ports
(4) Single use
What are the disadvantages of Parental products?
(1) Patient compliance
(2) Painful/stressful (needle phobia)
(3) Expensive
(4) stringent require for manufacture
(5) Professional administration
