1. Large-Volume Parenteral Preparations in Hospitals
PRINCE SATTAM BIN ABDUL AZIZ UNIVERSITY
COLLEGE OF PHARMACY
Sterile Dosage Form (PHT 434)
Large-Volume Parenteral Preparations in Hospitals
PRESENTED BY :
Dr shahid Jamil

2. Large-Volume Parenteral Preparations

3. Learning Objectives
Gain an awareness of the historical roots of large-volume parenteral preparations.
Understand the physiology of fluid balance and the chemical properties of parenteral products.
Identify the risks associated with parenteral administration.
Describe the components and critical sites of various large-volume parenteral preparation supply items.
Identify the USP Chapter <797> procedures that must be performed prior to compounding large-volume parenteral preparations.
Demonstrate correct aseptic technique in preparing large-volume parenteral products.

4. Topics Learning Objectives Introduction
Properties of Parenteral Products
LVP Preparations
USP Chapter <797> Guidelines for LVPs
Understand the Resources and Supplies
Preview the Lab Procedure
Chapter Summary
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5. Introduction
In hospital pharmacy settings, IV technicians are largely responsible for preparing parenteral solutions for patient administration
medications administered by any route other than through the alimentary canal
maintain or correct the fluid status of patients whose conditions disrupt their bodies’ innate fluid balance

6. Properties of Parenteral Products
Because parenteral products are administered directly into a patient’s blood supply, these solutions must have certain chemical properties or characteristics that render them safe for patient administration
some characteristics include pH value, osmolarity, osmolality, and tonicity, as well as the compatibility of CSP additives

7. Properties of Parenteral Products…/2
pH Value
The degree of alkalinity or acidity of a solution is referred to as its pH value and is measured on a scale from 0 to 14
any solution with a pH of less than 7.0 is considered to be acidic
any solution with a pH greater than 7.0 is considered to be alkaline
a solution with a pH of 7.0 is considered to be neutral

8. Properties of Parenteral Products…/3
pH Value…continued
Human blood plasma has a pH of 7.4, which is slightly alkaline
the pH of blood plasma must be maintained for optimal health
Some facilities inject a buffer solution, such as sterile sodium bicarbonate, into the CSP to neutralize the pH and prevent patient discomfort

9. Properties of Parenteral Products…/4
Osmolarity and Osmolality
Osmolarity is a measure of the number of milliosmoles of solute per liter of solution (mOsm/L)
osmolarity refers to the osmotic pressure applied by a solution across a cell wall
osmotic pressure is the pressure required to maintain equilibrium within the cells
Osmolality is a measure of the number of milliosmoles of solute per kilogram of solvent
osmolality refers to the number of ions or molecules in a solution

10. Properties of Parenteral Products…/5
Osmolarity and Osmolality…continued
Osmolarity and osmolality affect the flow of fluid into and out of cells within the body
To maintain optimal health, the cells should be maintained in a state of equilibrium
CSPs must be neither hyperosmotic nor hypoosmotic
this state of equilibrium is called isoosmotic, meaning that the solution has relatively the same number of dissolved particles and the same osmotic pressure as human blood plasma

11. Properties of Parenteral Products…/6
Tonicity
Tonicity refers to the way that cells or tissues respond to surrounding fluid

12. Properties of Parenteral Products…/7
Tonicity…continued
A hypertonic solution contains a greater number of dissolved particles than human blood plasma
A hypotonic solution contains fewer dissolved particles than human blood plasma
An isotonic solution contains a number of dissolved particles equivalent to human blood plasma

13. Properties of Parenteral Products…/8
Tonicity…continued
Some conditions require treatment with a parenteral solution that is either hypertonic or hypotonic
Total parenteral nutrition (TPN) and other hypertonic solutions are generally administered into larger veins such as the subclavian vein or the superior vena cava
these larger veins have significantly more blood flowing through them and can more easily accommodate the hypertonic solution

14. Properties of Parenteral Products…/9
Tonicity…continued
Unlike hypertonic solutions, hypotonic solutions, are rarely administered to patients
occasionally, critical care patients who are experiencing diuresis are treated with these solutions to replace the high volume of fluid output without significantly increasing plasma sodium concentration (PNa)
these patients must be monitored closely to ensure that they do not develop a potentially life-threatening electrolyte imbalance such as hyponatremia

15. Properties of Parenteral Products…/10
Compatibility
Compatibility may be defined as the ability to combine two or more base components or additives within a solution, without creating a resultant change in the physical or chemical properties of any of the solution components or additives
a CSP comprised of one or more incompatible components may result in a change to the physical or chemical characteristics
this undesirable change is called an incompatibility and may be dangerous to the patient recipient

16. Pharmaceutical compounding sterile preparation USP Chapter <797> Guidelines for LVPs
During the preparatory and compounding procedures of LVPs, the IV technician must adhere to the overarching principles set forth in USP Chapter <797>
these guidelines are reinforced in each facility’s P&P manual as well
As an IV technician, you bear primary responsibility for the preparation and integrity of the (compounded sterile preparation) CSPs

17. Understand the Resources and Supplies
Essential Supplies
Most sterile compounding procedures require the same essential supply items to be available for use in both the anteroom and the clean room
For the anteroom, these include a standard calculator, aseptic garb, presaturated aseptic cleaning wipes, a waste container, and various other compounding supplies

18. Understand the Resources and Supplies…/2
Procedure-Specific Supplies
LVP Supplies – Vials
a vial is a sealed, sterile container that has a rubber top through which an IV technician draws fluid
contains a medication either in a powdered form, which must be dissolved with a liquid diluent, or in a liquid form
because a vial is a closed-system container, an IV technician uses a milking technique to easily and safely release the negative pressure within a vial
to perform this technique, the IV technician adds positive pressure to the closed system
this technique prevents aspiration

19. Understand the Resources and Supplies…/3
Procedure-Specific Supplies
LVP Supplies – Vials …continued
coring is an undesired event that occurs when a needle is inserted incorrectly into the rubber stopper atop a solution vial, causing a small bit of the stopper to tear off and contaminate the solution inside the vial

20. Understand the Resources and Supplies…/4
Procedure-Specific Supplies
LVP Supplies – IV Base Solutions
an IV base solution is commonly provided by the manufacturer in an IV bag made of flexible plastic or polyvinyl chloride (PVC)

21. Understand the Resources and Supplies…/5
Procedure-Specific Supplies
LVP Supplies – IV Base Solutions…continued
the button or nipple injection port can be found at the bottom of the IV bag’s face
the tail injection port, the most common type of IV injection port, is located at the very bottom of the IV bag

22. Understand the Resources and Supplies…/6
Critical Sites of Essential Supplies and LVP Supplies
Before beginning, the IV technician must recall the critical sites of the supplies
care must be taken not to taint the critical site of any of the supply items through touch contamination, shadowing, or incorrect placement of the item within the hood

23. Preview the Lab Procedure
Anteroom Preparatory Procedures
verifying the CSP label against the medication order
performing correct pharmacy calculations to determine type, size, and number of supply items needed
gathering and cleaning of supplies
performing aseptic garbing and hand washing
donning a sterile gown

24. Preview the Lab Procedure…/2
Clean Room Preparatory Procedures
cleansing hands with sterile, foamed 70% IPA
donning sterile gloves
cleaning the hood

25. Preview the Lab Procedure…/3
LVP Compounding Procedure
with the small supply items arranged in the outer six-inch zone and the large supply items placed in the DCA, you are ready to begin the LVP compounding procedure