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PARENTERALNUTRITION
Parenteral nutrition (PN) is feeding a personintravenously, bypassing the usual process of eating
and digestion. The person receives nutritional
formulas containing salts, glucose, amino acids, lipids
and added vitamins.
It is called total parenteral nutrition (TPN) when no
food is given by other routes.
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Home TPN formula IV bags on a pole connected to IV lines.
Total Parenteral Nutrition (TPN) = Total NutritionAdmixture (TNA)
1. IV therapy that provides nutrition to patients
who cannot take nourishment by mouth.
2.
The aim of TPN is to replace and maintain byIV infusion essential nutrients when (and only
when) oral or tube feedings are contraindicated
or inadequate.
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3.
Typical situations when TPN is used include:
a. Severely undernourished patients without
oral intake > 1 week
b.
Severe pancreatitisc.
Severe inflammatory bowel disease
(Crohn’s disease and ulcerative colitis)
d.
Extensive bowel surgery (i.e., short bowel
syndrome)
e. Small bowel obstruction (SBO)
f. Pregnancy (in cases of severe nausea and
vomiting)
g. Head-injury patients
TPN or TNA formulations are TPNs containing IV fat
emulsion in the same container with traditional amino
acids, dextrose, and electrolytes formulations
Short-term PN may be used if :
1. a person's digestive system has shut down (for
instance by peritonitis), and
2.
they are at a low enough weight to cause concerns
about nutrition during an extended hospital stay.
Long-term PN is:
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Chronic PN is performed through a central
intravenous catheter, usually through the subclavian or jugular vein with the tip of the catheter at the
superior vena cava without entering the right atrium.
Another common practice is to use a PICC line, which
originates in the arm, and extends to one of the central
veins, such as the subclavian with the tip in thesuperior vena cava.
In infants, sometimes the umbilical vein is used.
In most US hospitals, clinical pharmacists evaluate the
patient's individual data and decide what PN formula
to use.
Basic Nutrients and Fluid:
a.
Dextrose – the major source of calories; each gram
of dextrose provides 3.4 kcal.
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b.
Amino acids – for the protein synthesis required
for tissue growth and repair; each gram of protein
provides 4 kcal.
c.
Fat – for required essential fatty acids and as a
source of calories; each gram of fat provides 9
kcal.
d. Basic electrolytes – Na, K, Mg, Ca, phosphate.
e.
Vitamins
f.
Trace elements – Cu, Cr, Zn, Mn, Se
Histamine H2-receptor antagonists
To prevent and treat upper gastrointestinal,stress-related ulceration and are often
included in TPN formulations
Intravenous Fat Emulsion
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Fat emulsions are used to supply in a small volume of
isotonic liquid a large amount of energy; they supply
the body with essential fatty acids and triglycerides.
Fat emulsions for IV nutrition contain vegetable oil
and a phospholipids emulsifier.
In Intralipid, purified egg-yolk phospholipids are used
as the emulsifier.
Isotonicity with blood is obtained by the addition of
sorbitol, xylitol, or glycerol.
Intralipid has been used as the basis of an IV drug
carrier, for example for diazepam.
To avoid adverse effects on injection it is importantthat the particle size of the emulsions is small and
remains so on storage.
After storage of Intralipid for two years at 4oC, more
than 99% of the particles visible by light microscopy
had a diameter of less than 1 µm; that is, there was
practically no change in mean diameter.
The addition of electrolyte or drugs to IV fat
emulsions is contraindicated because of the risk of
destabilizing the emulsion.
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Addition of cationic local anaesthetics reduces the
electrophoretic mobility of the dispersed fat globules,
and this is undoubtedly one contribution to instability.
One study found both minimum stability and
minimum zeta potential on addition to Intralipid of 3 x
10-3
Mol dm-3
CaCl2 and 2.5 x 10-1
Mol dm-3
NaCl.
These concentrations are recommended to be the
maximum levels of these additives.
TPN & ADMIXTURES
THE PHARMACEUTICAL
ISSUES
PN admixtures contain over 50 chemical entities
stability issues
PHYSICAL STABILITY
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Physical stability of TPN takes in forms of:
Precipitation of solids
Cracking of the lipid emulsion
Precipitation has two risks:
1.
the potential to infuse solid particles fatal
emboli
2. the nutrients may not be infused
Precipitation of calcium phosphate:
Ca (H2PO4)2 relatively soluble (solubility ~18 g/L)
CaHPO4(2H2O) precipitation is time limited
(solubility ~300 mg/L)
Ca3(PO4)2 precipitation is relatively immediate
Trace elements:
Iron PO4 and Cu PO4 are precipitated
LIPID DESTABILIZATION
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TPN the oil-in-water lipid emulsion
destabilized by positively charge ions and
heat
the large lipid globules could occlude the
lung microvasculature and cause
respiratory and circulatory compromise
and lead to death.
positively ions and especially divalent and
trivalent ions, such as Ca2+
and Mg2+
,
have more significant effect.
low concentrations of amino acids and
glucose reduce the stability and increase
the tendency for creaming.
identify the destabilization by using
optical microscope and particle size
counters.
CHEMICAL STABILITY
Chemical stability takes many forms
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Chemical stability of the vitamins and
amino acids.
Vitamin stability:Will define the shelf-life of the formulation
Vitamin C oxidation is accelerated by heat,
oxygen, trace elements (Cu)
Vitamin A photolysis and vitamin E photo-
oxidation
Prevention: minimize O2 presence and light
protection.
Amino acid stability:
The amino acid profile should be maintained
for the shelf-life of the formulation.
MICROBIAL STABILITY
PN is highly nutritious but hypertonic medium
Limit microbial growth.
Growth in lipid alone is greater
Manipulation should only be performedusing validated aseptic techniques
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SHELF-LIFE AND TEMPERATURE
CONTROL
PN formulation usually has a shelf-life up to 90days at 2 – 8oC followed by 24 hours at room
temperature for infusion.
The compounding should strictly be aseptic
The temperature during the infusion period
should be known
Formulations used at higher temperature must
have been validated.
DRUG STABILITY
The addition of drugs to PN admixtures or Y-site
co-administration:
Is actively discouraged unless the compatibility
has been formally confirmed
Extreme competition for IV access
prompt consideration of drug and PN
combinations.
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Many factors need to be considered for addition of
drugs to PN admixtures:1.
the physical and chemical stability of the PN
2.
the physical and chemical stability of the drug
3.
the bioavailability of the drug
4. The effect of stopping and starting Y-site
infusions on the actual administration rate.
The extrapolate data of stability should be used
with caution.
In practice, drugs should only be infused with PN
when all other possibilities have been exhausted,such as gaining further IV access and changing
the drug(s) to clinically acceptable non-IV
alternatives.
The relative risks of stopping and starting the
PN infusion in most cases the risks outweigh the
benefits
If the option is adopted, the line must be
flushed before and after with an
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appropriate volume of solution known to
be stable with both the PN and the drug.
FILTRATION
All IV fluids pass through the lung
microvasculature with its capillary diameter of 8 – 12
m.
The presence of particulate matters:
to cause direct embolization,
direct damage to the endothelia,
formation of granulomata,
formation of foreign body giant cells, and
To have thrombogenic effect.
The presence of microbial and fungal matter:
can cause a serious infection, or
Inflammatory response.
The precautions to minimize the particulate load
or the compounded regimen must include:
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use of in-lead filters (25 m) and filter needles
or straws (5 m) during compounding to
catch larger particles such as cored rubber
from bottles and glass shards from ampoules
air particle levels kept within defined limits in
aseptic rooms by the use of air filters and non-
shedding clothing and wipes
use of quality of raw materials with minimal
particulate presence, including empty bags and
leads
Confirmation of physical and chemical
stability of the formulation prior to aseptic
compounding applying approved mixing
order (stability for the required shelf-life timeand conditions).
The filters have been endorsed to be used for
patients requiring intensive or prolonged
parenteral therapy, including home patients, the
immunocompromised, neonates, and children.
The filters should be placed as close to the patient
as possible and validated for the PN to be used.
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For 2-in-1 formulations --> use the 0.2 m filters
For 3-in-1 formulations --> use 1.2 m filters
LIGHT PROTECTION
Vitamin A and E are degraded by phototherapy
light and sunlight.
It is recommended that all regimens should be
protected from light both during storage and
during infusion, since:
lipid does not totally protect againstvitamin photo-degradation
Maillard reaction (a complex pathway of
chemical reactions that starts with a
condensation of the carbonyl group of the
glucose and the amino group of the amino
acid) is influenced by light exposure
Lipid per-oxidation is accelerated by a
range of factors including exposure to
certain wavelengths of light
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In order to minimize confusion.
Validated bag covers should always be used.
THIS IS THE END OF THE LECTURE OF
TPN
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