lvp

1. LARGE VOLUME PARENTERALS
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2.  The USP provides the definition for large volume
parenterals (LVP’s) the Large Volume solution applies
to an injection that is intended for intravenous use and
is packaged in containers holding 100 ml or more.
 LVP’s” means a sterilized aqueous drug products
packaged in a single dose container with a capacity of
100ml or more.

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 Packaged in glass bottles or in large volume flexible containers.
➢ May contain greater than 100 mL to greater than 1 or 2 L
➢ Sterile (e.g., many LVP are sterilized in their container via heat,
although some are sterile-filled)
➢ Pyrogen-Free
➢ Essentially free of particulate matter
➢ No anti-microbial agents
➢ Isotonicity
➢ Longer term use
Characteristics of LVP

4.  Because of the large volumes administered, these solutions must
not contain bacteriostatic agents.
 These are packaged in single dose.
 Large volume parenterals solutions are employed in maintenance
therapy for the patient entering or recovering surgery and for the
patients who are unconscious and unable to take fluids,
electrolytes and nutrition orally.
 LVPs may also be used in replacement therapy for patients who
have suffered a heavy loss of fluids and electrolytes.

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TYPES OF LARGE VOLUME PARENTERALS
 Hyper alimentation solutions
 Cardiolpagic Solutions
 Peritonial Dialysis solution
 Irrigating solutions

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HYPERALIMENTATION SOLUTION: Admin. of large amount of
nutrients to patients who unable to take food orally.
Formulation: mix. of dextrose, amino acids , lipids, electrolytes, &
vitamines.
TOTAL PARENTERAL NUTRITION
Def. :A method of feeding patients by infusing a mixture of all
necessary nutrients into the circulatory system, thus bypassing
the GIT.

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CARDIOLPLEGIC SOLUTIONS
 LVP are used in heart surgery to prevent injury to myocardium
during reperfusion, as well as to maintain bloodless operating
field.
 Maintains the diastolic arrest.
 Administered in cold form.
 Slightly alkaline to compensate metabolic acidosis,
 Hypertonic
 USE: To minimize reperfusion injury resulting from tissue
edema.

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PERITONEAL DIALYSIS SOLUTION
Infused continuously into abdominal cavity, bathing peritonium &
are then continuously withdrawn.
USES :
 Removal of toxic substances from body.
 To aid & accelerate excretion normal.
 To treat acute renal insufficiency

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IRRIGATING SOLUTIONS
To irrigate ,flush, & aid in cleaning body activities & wounds.
Certain IV solution ( normal saline ) may be used as irrigating solution,
but solution designed as irrigating solution should not be used
parenterally.
USE: Treatment of serious wounds infused in to blood stream.

10. Total Parenteral Nutrition
 TPN stands for Total Parenteral Nutrition. This is a complete form
of nutrition, containing protein, sugar, fat and added vitamins
and minerals as needed for each individual.
 Total Parenteral Nutrition (TPN) may be
defined as provision of nutrition for metabolic
requirements and growth through the parenteral route.

11. •Components of TPN solutions:
(1) Protein as crystalline amino acids.
(2) Fats as lipids.
(3) Carbohydrate as glucose.
(4) Electrolytes–Sodium, potassium, chloride, calcium and
magnesium.
(5) Metals/Trace elements–Zinc, copper, manganese,
chromium, selenium.
(6) Vitamins A, C, D, E, K, thiamine, riboflavin, niacin,
pantothenic acid, pyridoxine, biotin, choline and folic acid.
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12. • TPN is normally used following surgery, when feeding by mouth or
using the gut is not possible,
• When a person's digestive system cannot absorb nutrients due to
chronic disease, or, alternatively, if a person's nutrient requirement
cannot be met by enteral feeding (tube feeding) and
supplementation.

13. IV Admixtures
• Definition:
• When two or more sterile products are added to an IV fluid for their
administration, the resulting combination is known as IV admixture.
• In hospitals, prepared by nurses by combining or mixing drugs to the
transfusion fluids.
• The drugs are incorporated in to bottles of LV transfusion fluids.

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15. CHARACTERISTICS OF LVPs
• Packaged in glass bottles or in large volume flexible containers.
• May contain greater than 100 ml to greater than 1 or 2 L
• Sterile
• Pyrogen-Free
• Essentially free of particulate matter
• Isotonicity

16. FORMULATION
Water for injection:
 WFI is the water purified by Distillation Or Reverse
Osmosis.
Inorganic Salts
 Carbohydrates
Nitrogen containing substances
Tonicity Modifiers


17. CONTAINERS AND CLOSURES:
Glass containers
 Glass containers have been employed for LVP’s. Solid rubber
stoppers are used for the container closure system.
 Because of weight and fragility ,the glass containers have
been largely replaced by plastic.
 Glass is used only for sol’ns which are basically incompatible
with plastic (e.g. lipid emulsions which may extract
plasticizers).
 Washed,cleaned glass containers should be held at a minimum
of 70oC to suppress microbial growth.

18. Types of Glass:
 Type I: Commonly known as neutral glass. It has a high
resistance to hydrolysis and withstands autoclaving,
weathering and solution of pH of up to 8.
 Type II : Containers may be treated with moist sulphur dioxide
at high temperature to create a neutral surface film with high
hydrolytic resistance. Lower resistance to autoclaving than for
type I glass.
 Type III : This offers very little resistance to hydrolysis and
should only be used for powders for reconstitution prior to
injection and for non aqueous preparations.

19. REFERENCES
• Pharmaceutical dosage forms: parenteral medications volume
1 and volume 2 by Kenneth E. Avis, Herbert A. Lieberman and
Leon Lachman.
• Leo. F. blow/ fill/ seal aseptic technology.
• USP chapter 797: Establishing a practice standard for
compounding sterile preparations in pharmacy.
• SCHEDULE M

20. THANK YOU