sterile products

Question 1

what are SVIs - small volume injectables

Answer 1

• composed of active ingredient, solvent system and excipients
  -injected by IV, IM , SC
  also by abs, arterial, heart

Question 2

what are LVIS

Answer 2

• volumes more than 100ml
• terminally sterilised
• IV infusions, daialysis

-

Question 3

what are the critical attributes of sterile producers

Answer 3

• vehicle
• ph
  -nprservation
• packaging
• sterility test for pyrogens
• test for sub visible particles

Question 4

how does the tonicitu of the solution affect the osmoliyy

Answer 4

• hypotonic = bursting RBC
• isotonic = nothing - solutions should be isontonis.
• hypertonic = shrivel RBC

Question 5

what are solubilises

Answer 5

• increase the solubility of poorly soluble drugs
• prevent the degradation by hydrolysis
• examples = liquid solvents, surface active agents
• there cannot be administrated IV as this will cause lysis to rbc

Question 6

buffets

Answer 6

maintain solubility of drugs and prevent precipitation
- this can cause blockages in the capillaries

Question 7

preservative s

Answer 7

• maintain sterility in the shelf life
• at low conv theses can fuse stability issues
• they can be highly toxic, easily oxides and can cause propnelsm with rubber closure permeation

Question 8

antioxidants

Answer 8

• react with molecular oxidation to stop free radicals reacting
  example SODIUM BISULPHATE
  the combination of antioxidants and chelating agents

Question 9

solids

Answer 9

• some SVIs are available as powders which can then be diluted, they contain bulking agents
• these are freeze dried vials
  another method is through crystallisation of the active ingredient