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Sacha - Characteristics and Requirements For Large Volume Parenterals PDF
Sacha - Characteristics and Requirements For Large Volume Parenterals PDF
Bethesda, MD
February 22 and 23, 2011
Presenter
Gregory A. Sacha, Ph.D.
Large Volume Intravenous Solution 2
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Characteristics of LVPs 3
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Types of Large Volume Intravenous Solutions 4
Electrolytes
Carbohydrates
Nutritional Solutions
Proteins
Lipid Emulsions
Peritoneal Dialysis
Irrigating Solutions
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Route of Administration 5
Intravenous
Direct Injection
Infusion
Subcutaneous
Intramuscular
Intradermal
Intraspinal
Intrathecal
Intra-arterial
Others
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Methods of Delivery for LVPs 6
A B
A. From http://www.hsc.wvu.edu/mbrcc/bmt/siteImages/centralVenousCatheter.jpg
B. From http://www.nursinghomesabuseblog.com/uploads/image/picc.png
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Methods of Delivery for LVPs 7
Peritoneal Dialysis
Dialysis membrane assisted hemodialysis
Continuous ambulatory dialysis
Patient warms solution to body temperature
Injects into abdominal cavity
Exchanges solution 4 to 5 times daily
A
A. From http://www.wirralchesterkidney.nhs.uk/images/principle.jpg
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Preparation and Hospital Practice 8
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Materials of Construction 10
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Most Common Polymers for Sterile Products 11
Polyethylene (PE)
Polyvinylchloride (PVC)
Polypropylene (PP)
Polyamide (Nylon)
Polycarbonate (PC)
Ethylene vinyl acetate (EVA)
Polyolefin (mixtures of low density PE, high density
PE, PP, and EVA)
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Large Volume Flexible Containers 12
Advantages
Durable and light weight
No air interchange. The bag collapses as it empties.
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Large Volume Flexible Containers 13
Disadvantages
Permeation of vapors and other molecules in either
direction through the walls.
Resolved by overwrapping the containers.
Leaching of constituents from the plastic into the product.
Plasticizers and anti-oxidants
Sorption of drug molecules or ions on the plastic material.
Proteins, warfarin sodium, diazepam
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Types of Flexible Containers 14
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Types of Flexible Containers 15
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Comparative Properties of Polymers 16
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Sterilization of Flexible Containers 17
Thermal Sterilization
Many plastics will soften or melt.
Ethylene Oxide (EtO)
May be used for the empty container and then aseptically
filled.
Must evaluate possible residues and degradants from
EtO.
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Sterilization of Flexible Containers 18
Gamma Radiation
May affect the appearance of the plastic and the
stability of the product
PVC can change color from clear to yellow, possible
pH shifts, increases in extractables
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Possible Extractables 19
Plastics
Antioxidants: BHT, thioesters, phosphates
Lubricants: silicones, polyethylene waxes
Plasticizers: phthalates
Glass
Major extractables: silicon and sodium
Minor extractables: K, Ca, Ba, Al
Trace extractables: Fe, Mg, Zn
Dependant upon pH, buffer, and other components in
formulation
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Summary 20
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