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Pharmaceutics
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Quality Control
The regulatory processes though which industry measures actual quality performance, compares it with standards and acts on the difference.
Raw material control
evaluate components used in the product
in-process control
assure specifications of the tests and procedures used
Product control
assure that the finished product meets the established specifications
Pyrogen Test
Eight Rabbits
Record temp at 1, 2 and 3 hours after drug administration.
1st Stage of Rabbit test
Any reading
>
0.6 fails
Total of 3 max readings for each rabbit >1.4 fails
2nd Stage of Rabbit Pyrogen Test
24 total readings
Any 4 readings
>
0.6 fails
Total of 8 rabbits max temp >3.7 fails
Limulus Test (LAL)
Limulus Amebocyte Lysate
Limulus Test Procedure
amebocyte lysate causes gelation of the solution within an hour at 37C.
Who needs TPN?
TPN is needed when adequate nutritional intake cannot be provided by the oral route.
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
Potential side effects of TPN
infection
thrombosis
Calories from Dextrose
3.4 kcal/g
Calories from Proteins
4.1 kcal/g
Calories from Fat
9 kcal/g
Consequences of Fat Deficiency
Fatty acids help keep blood from clotting, lower cholesterol and prevent cancer cell growth.
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
Emollient
an agent which softens or soothes the skin
Occlusion
act of closure or state of being closed. Trapping material within cover or film
-hydrophobic compounds
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.
Ointment
Semi-solid
high viscosity
Emollient/occlusion
Thick film
Cream
Suspension/Emulsion
Moderate viscosity
Emollient
Temporary film
Lotion
Liquid
Low viscosity
Emollient
No film
Hydrocarbon Ointment Base
Ex. White Petrolatum
Water Free
Emollient/Occlusive
Non-water washable/Hydrophobic
Greasy
Silicone Ointments
Ex. Silicone ointment
contains polydimethylsiloxane oil
Emollient/Occlusive
Non-water washable/Hydrophobic
Greasy
Absorption Bases - Emulsion Base
Water/oil emulsion
Ex. Lanolin, cold cream
Emollient/Occlusive
Contains water/absorbs additional water
Greasy
Absorption Base - Anhydrous
Hydrophilic Petrolatum
Emollient/occlusive
Absorbs water
anhydrous
Greasy
Water Removable Base
Hydrophillic Ointment
O/W Emulsion
Water-washable
Non-greasy
Can be diluted with water
Non-occlusive
Water Soluble Bases
Polyethylene Glycol Ointment
Usually anhydrous
Non-greasy
Lipid-free
Non-occlusive
Water-soluble and washable
Fusion A Method
heat materials together in a homogenous melt at 60-80C.
Hydrophobic compounds
Fusion B Method
Hydrophilic Compounds.
Heat all phases separately. 60-80C.
Add emulsifiers to water phase.
Add oil phase to water phase
Levigation A
portion of powder mixed with portion of base
Levigation B
Add all solid to a portion of base
Then add more base until mixed
Benefits and Risks of Topical Preservatives
Potentially Toxic
Bad Odor
Irritating to skin
Author
Anonymous
ID
6113
Card Set
Pharmaceutics
Description
Quality control
Updated
2010-02-05T17:29:21Z
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