Pharmaceutics

  1. Quality Control
    The regulatory processes though which industry measures actual quality performance, compares it with standards and acts on the difference.
  2. Raw material control
    evaluate components used in the product
  3. in-process control
    assure specifications of the tests and procedures used
  4. Product control
    assure that the finished product meets the established specifications
  5. Pyrogen Test
    • Eight Rabbits
    • Record temp at 1, 2 and 3 hours after drug administration.
  6. 1st Stage of Rabbit test
    • Any reading > 0.6 fails
    • Total of 3 max readings for each rabbit >1.4 fails
  7. 2nd Stage of Rabbit Pyrogen Test
    • 24 total readings
    • Any 4 readings >0.6 fails
    • Total of 8 rabbits max temp >3.7 fails
  8. Limulus Test (LAL)
    Limulus Amebocyte Lysate
  9. Limulus Test Procedure
    amebocyte lysate causes gelation of the solution within an hour at 37C.
  10. Who needs TPN?
    TPN is needed when adequate nutritional intake cannot be provided by the oral route.
  11. 7 conditions of TPNs
    • Large volume
    • Long injection time
    • Hyperosmotic
    • Jugular Vein
    • Multiple drug therapy and vital organ support
    • Contains fat, glucose and protein
    • Emulsion/suspension
  12. Potential side effects of TPN
    • infection
    • thrombosis
  13. Calories from Dextrose
    3.4 kcal/g
  14. Calories from Proteins
    4.1 kcal/g
  15. Calories from Fat
    9 kcal/g
  16. Consequences of Fat Deficiency
    Fatty acids help keep blood from clotting, lower cholesterol and prevent cancer cell growth.
  17. Safe Handling Guidelines for Antineoplastic Agents
    • 1. Biological Safety Cabinet (class II)
    • 2. Vertical Flow Hood
    • 3. Fill syringes no more than 3/4 full
    • 4. Protective apparel
    • 5. Negative pressure - 0.2 mM filter
    • 6. Final Adjustment of fluid
    • 7. Labeling
    • 8. Storage
    • 9. Waste Disposal
    • 10. Spill kits
  18. Emollient
    an agent which softens or soothes the skin
  19. Occlusion
    • act of closure or state of being closed. Trapping material within cover or film
    • -hydrophobic compounds
  20. Semi-Solid
    • liquid molecules within either solid or liquid-crystalline material.
    • Material retains shape until acted upon by an outside force.
    • Plastic behavior allows uniformity in spreading over a surface.
  21. Ointment
    • Semi-solid
    • high viscosity
    • Emollient/occlusion
    • Thick film
  22. Cream
    • Suspension/Emulsion
    • Moderate viscosity
    • Emollient
    • Temporary film
  23. Lotion
    • Liquid
    • Low viscosity
    • Emollient
    • No film
  24. Hydrocarbon Ointment Base
    • Ex. White Petrolatum
    • Water Free

    • Emollient/Occlusive
    • Non-water washable/Hydrophobic
    • Greasy
  25. Silicone Ointments
    • Ex. Silicone ointment
    • contains polydimethylsiloxane oil

    • Emollient/Occlusive
    • Non-water washable/Hydrophobic
    • Greasy
  26. Absorption Bases - Emulsion Base
    • Water/oil emulsion
    • Ex. Lanolin, cold cream
    • Emollient/Occlusive
    • Contains water/absorbs additional water
    • Greasy
  27. Absorption Base - Anhydrous
    • Hydrophilic Petrolatum
    • Emollient/occlusive
    • Absorbs water
    • anhydrous
    • Greasy
  28. Water Removable Base
    • Hydrophillic Ointment
    • O/W Emulsion
    • Water-washable
    • Non-greasy
    • Can be diluted with water
    • Non-occlusive
  29. Water Soluble Bases
    • Polyethylene Glycol Ointment
    • Usually anhydrous
    • Non-greasy
    • Lipid-free
    • Non-occlusive
    • Water-soluble and washable
  30. Fusion A Method
    • heat materials together in a homogenous melt at 60-80C.
    • Hydrophobic compounds
  31. Fusion B Method
    • Hydrophilic Compounds.
    • Heat all phases separately. 60-80C.

    • Add emulsifiers to water phase.
    • Add oil phase to water phase
  32. Levigation A
    portion of powder mixed with portion of base
  33. Levigation B
    • Add all solid to a portion of base
    • Then add more base until mixed
  34. Benefits and Risks of Topical Preservatives
    • Potentially Toxic
    • Bad Odor
    • Irritating to skin
Author
Anonymous
ID
6113
Card Set
Pharmaceutics
Description
Quality control
Updated