Parenteral Products

Question 1

What is the definition of parenteral product?

Answer 1

Sterile preparation intended for administration by injection, infusion or implantation

Question 2

What is a large volume parenteral?

Answer 2

100-1000ml but can be up to 3L

Question 3

What is a low volume partenteral?

Answer 3

Less than 100ml

Question 4

What is the definition of sterile?

Answer 4

Low in particulates

Question 5

Benefits of parenteral products

Answer 5

Bypasses first pass metabolism
Rapid response to IV
Delayed or prolonged release
Localised effect
Oral route is unavailable

Question 6

Disadvantages of parenterals

Answer 6

Reduced patient compliance
Painful
Expensive due to sterile production
Most require professional administration

Question 6

Injections

Answer 6

Small volume ≤ 100ml
IM, IV or SC
Sterile solution, emulsion or suspension
Ampoules, vials or prefilled syringes

Question 7

Infusions

Answer 7

Larger volume 100-1000ml
Delivered IV
No preservatives due to single use
Sterile solution or emulsion
Glass or plastic bottles
Collapsible bags with additive ports

Question 7

What is a concentrated solution?

Answer 7

Used for patient specific doses
Diluted with water for injection or 0.9%w/v NaCl

Question 8

Powders

Answer 8

Dry, solid, sterile powder sealed in a container
Unstable in aqueous solution
Reconstituted prior to administration
Freeze-dried product - prepared, filtered and freeze-dried

Question 9

Gels

Answer 9

Enhanced viscosity suitable to guarantee modified release of the active substances at the site of injection

Question 10

Ιmplant

Answer 10

Sterile solid preparation containing 1 or more active ingredients
Provides release of the API over an extended period
Titanium, silicone or polymer

Question 11

What are some administration errors with parenterals?

Answer 11

Wrong route
Wrong preperation - e.g solvent
Wrong drug
Wrong dose
Wrong time
Omission of drug

Question 12

What are some administration complications?

Answer 12

Extravasation
Air embolism
Thrombosis
Hypersensitivity
Phlebitis

Question 13

What is extravasation?

Answer 13

Leakage of IV medication into the extravascular tissue around the site of infusion

Question 14

What is the definition of stability?

Answer 14

Free from viable microorganisms and pyrogens

Question 15

What are particulates?

Answer 15

Microbes carrying particles or inert particles

Question 16

Where are sterile products made?

Answer 16

In a clean room or asceptic room

Question 17

What are vehicles for parenteral delivery?

Answer 17

Water for Injection
Co-solvent
Solubilising agents
Oil in water emulsions
Oils

Question 18

Why would an oil in water emulsion be used as a vehicle for parenteral delivery?

Answer 18

For water insoluble drugs

Question 19

Why is a co-solvent used as a vehicle in parenteral delivery?

Answer 19

Aids solubility of poorly soluble drugs

Question 20

Why are preservatives used?

Answer 20

To inhibit growth of microorganisms introduced into multidose vials

Question 21

What is the suitable pH range for parenterals?

Answer 21

pH 3-9

Question 22

What happens with parenteral products with pH > 9?

Answer 22

Tissue necrosis

Question 23

What happens with parenteral products with pH < 3?

Answer 23

Pain and phlebitis

Question 24

Why are buffers used in parenteral products?

Answer 24

To maintain suitable pH

Question 25

Why are suspending agents used?

Answer 25

To ensure drug is readily and uniformly suspended prior to administration

Question 26

Why are antioxidants used in parenteral products?

Answer 26

To prevent oxidative degredation

Question 27

Examples of antioxidants in parenteral products

Answer 27

Vitamin C Vitamin E Sulphite salts

Question 28

Why are tonicity adjustments made to parenteral products?

Answer 28

To make injections and infusions isotonic with human plasma

Question 29

What is osmotic pressure?

Answer 29

The ability of an extracellular solution to make water move into or out of a cell by osmosis

Question 30

What is osmosis?

Answer 30

The movement of water from lower solute concentration to higher solute concentration across a semi-permeable membrane

Question 31

What is a hypertonic solution?

Answer 31

Higher osmotic pressure than blood plasma Water is driven out of the cell by osmosis so cells shrink

Question 32

What must happen to hypertonic solutions before administration?

Answer 32

They must be diluted

Question 33

What is a hypotonic solution?

Answer 33

Lower solute concentration Lower osmotic pressure than blood plasma Water is driven into cells and causes cells to burst

Question 34

What must happen to hypotonic solutions before administration?

Answer 34

Add NaCl or dextrose

Question 35

What is an isotonic solution?

Answer 35

Same concentration of solute in solution and blood plasma Same osmotic pressure so no water movement

Question 36

What type of packaging is required for parenterals?

Answer 36

Vials, ampoules, pre-filled syringes and infusion bags

Question 37

What are the requirements of a vial for parenteral products?

Answer 37

5-100ml Type I Glass with reusable self-sealing synthetic rubber closure and plastic duct cap

Question 38

What are the requirements of an ampoule for parenteral products?

Answer 38

<1-10ml Type I Glass or plastic Single use so no preservatives

Question 39

What are the requirements of a pre-filled syringes for parenteral products?

Answer 39

0.5-20ml Glass or plastic based Sterile and safe

Question 40

What are the requirements of an infusion bag for parenteral products?

Answer 40

100-1000ml (up to 3L) Glass bottles, collapsible plastic bags or semi-ridged plastic bottles Additive ports to allow other drugs to be introduced Single use

Question 41

What are physical complications of manufacturing?

Answer 41

Mixing of drugs prior to administration Insolubility Colour change Cloudiness Precipitation Gas formation

Question 42

What are chemical complications of manufacturing?

Answer 42

Oxidation Hydrolysis Photolysis Changes in potency Increase in toxicity pH changes Drug degradation Packaging incompatibility

Question 43

What controls can be in place to prevent physical and chemical changes?

Answer 43

Mixing pH Time Temperature Light Dilution/concentration

Question 44

What contaminants can be in parenteral products?

Answer 44

Fungal, bacterial or viral Dust, fibres, metals, rubber, glass and precipitates