Lecture 06 Reconstitution

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Calculations of Quantities of Water to Use

for Reconstituting Powders for Oral and


Parental Preparations
PHARMACEUTICAL CALCULATIONS
NTA LEVEL 4

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Introduction
• Reconstitution: is the process of adding a liquid diluent to a
dry ingredient to make a specific concentration of liquid.
• When reconstituting medications, it is important to follow
the reconstitution instructions carefully so the medication is
prepared in the correct concentration.
• When calculating the dosage of reconstituted medication to
administer to the patient, the amount of fluid used to dilute
the medication must also be considered.

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SYRUPS INJECTIONS

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Instructions for
reconstitution will be
provided on the drug
label or package insert.
(See next slide)

Be certain that you are


using the correct diluent
in the correct quantity for
each medication,

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• In the label above, 2.7 ml of sterile water is the specified
diluent for oxacillin sodium.
1. First inject 2.7 ml of air into the vial of sterile water to
compensate for the volume of fluid to be removed.
2. Then withdraw 2.7 ml of sterile water to use as the
diluent.

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3. Inject the sterile water into the vial of powdered
medication.
4. Swirl or rotate to mix as directed. The medication is
then ready to use.
5. The date and time of reconstitution and the name of
the reconstituter must be recorded on the vial of
medication because medication must not be used
after its shelf life has expired.
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Calculate the Volume of Dry Powder, Total Drug
Present
• Some drugs lose their potency in a relatively short period of
time when prepared in a liquid dosage form.

• Thus to enhance its shelf life, manufacturers provide


products to the pharmacy in dry powder form for constitution
with purified water or special diluents at the time a
prescription or medication order is received

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• After constitution, the resultant solution or suspension is stable
in the quantities usually dispensed, for up to 10 days at room
temperature or 14 days if maintained under refrigeration

• For children and adult, constituted products for oral solution or


suspension generally are formulated such that the usual dose of
the drug is contained in teaspoonful amounts of product

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o Calculating the amount of water to be used for
reconstitution of oral and parenteral preparations
o This calculation involved in calculating the amount of
diluents required to reconstitute the powder for oral
solution or injectable in order to get the desired
concentration

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• Dry powder for constitution are packed in self-
contained bottles of sufficient size to accommodate the
additional of the required volume of diluents

• In additional to the quantitative amount of therapeutic


agent, the powder contains such pharmaceutical
ingredients as solubilizing agents, stabilizers,
colorants, sweeteners, and flavorants
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Example 1. The label instructions for an ampicillin
product call for addition of 78 mL of water to make
100 mL of constituted suspension such that each 5mL
contains 125 mg of Ampicillin. What is the volume
occupied by dry powder and the total drug present?
For Volume of dry powder
Because the addition of 78 mL of water result in the preparation of 100
mL of product, the volume occupied by dry powder is:
100 mL-78 mL= 22 mL
22 mL is the volume occupied by dry powder.
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For Total drug (ampicillin) present
If in the constituted product, each 5 mL contains 125 mg of
ampicillin, the total amount of ampicillin in the 100 mL product is
as follows:
If 5 mL ------------->125 mg of ampicillin
100 mL -------------->how many mg of ampicillin?
(100 mL × 125 mg)/ 5 mL
=2500 mg of ampicillin is in the drug product.

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Example 1. The label instructions for an ampicillin
product call for addition of 82 mL of water to make
150 mL of constituted suspension such that each 5mL
contains 90 mg of Ampicillin. What is the volume
occupied by dry powder and the total drug present?
For Volume of dry powder
Because the addition of 82 mL of water result in the preparation of 150
mL of product, the volume occupied by dry powder is:
150 mL-82 mL= 68 mL
68 mL is the volume occupied by dry powder.
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For Total drug (ampicillin) present
If in the constituted product, each 5 mL contains 90 mg of
ampicillin, the total amount of ampicillin in the 150 mL product is
as follows:
If 5 mL ------------->90 mg of ampicillin
150 mL -------------->how many mg of ampicillin?
(150 mL × 90 mg)/ 5 mL
=2700 mg of ampicillin is in the drug product.

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Example 3. The label instructions for an ampicillin
product call for addition of 78 mL of water to make 100
mL of constituted suspension such that each 5mL
contains 125 mg of Ampicillin. If the physician desires
an ampicillin concentration of 100 mg/5 mL (rather
than 125 mg/5 mL), how many milliliters of water
should be added to the dry powder?
Because it was determined that 2500 mg (from example 1) of
ampicillin are in the dry product, the volume of product that can be
made with a concentration of 100 mg/5 mL may be calculated by,
If in every 5 mL of suspension contains 100 mg of ampicillin,
Then X mL of suspension contains 2500 mg of ampicillin.
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If 5 mL ------------->100 mg of ampicillin
how many mL of water --------->2500 mg of ampicillin
(5 mL × 2500 mg)/ 100mg
=125 ml of water

For water to be added


originally the contents were contained in 22 ml of water
125ml – 22ml =103mls
= 103 mls of water to be added

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Example 3. The label instructions for an ampicillin
product call for addition of 78 mL of water to make 100
mL of constituted suspension such that each 5mL
contains 125 mg of Ampicillin. If the physician desires
an ampicillin concentration of 90 mg/5 mL (rather than
125 mg/5 mL), how many milliliters of water should
be added to the dry powder?
Because it was determined that 2500 mg (from example 1) of
ampicillin are in the dry product, the volume of product that can be
made with a concentration of 90 mg/5 mL may be calculated by,
If in every 5 mL of suspension contains 90 mg of ampicillin,
Then X mL of suspension contains 2500 mg of ampicillin.
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Real Life Labels And Questions

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Example 4.The healthcare provider has
prescribed fluconazole oral suspension 200 mg
by mouth daily for 7 days. How many ml will
the nurse give to the client per dose? (Use Label from
previous Slide)
Note - The nurse has added 24 ml of distilled or purified
water to the powdered medication for reconstitution to
make it 35mls, but this data is not relevant in calculating
the dose to give.
So the Concentration after reconstitution is given on
the label and it states 40mg/ml
If 40mg -------------> 1ml
Required 200mg ---------> ? Mls
= 5mls
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Example 4. The healthcare provider has
prescribed fluconazole oral suspension 80 mg by
mouth daily for 7 days. How many ml will the
nurse give to the client per dose? (Use Label from
previous Slide)
Note - The nurse has added 24 ml of distilled or purified
water to the powdered medication for reconstitution to
make it 35mls, but this data is not relevant in calculating
the dose to give.
So the Concentration after reconstitution is given on
the label and it states 40mg/ml
If 40mg -------------> 1ml
Required 80mg ---------> ? Mls
= 2mls
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The healthcare provider has prescribed 2 g
streptomycin IM daily divided every 8 hours for your
client. Your charge nurse recommends that you use 1.8
ml of sterile water to reconstitute the medication to
reduce the volume to be injected. How many ml will
you give per dose?
400 mg = 1 ml (from the reconstitution directions on the label)
You do not use the 1.8 ml of diluent added in your calculations,
but you need this information to find the 400 mg per ml after
reconstitution from the drug label.
Equation for the dose in ml:

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•But because the Question Asks in every
dose therefore

= 5ml / 3doses
= 1.7 mls per each dose

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Take Home Key Points
• A number of drugs are unstable in an aqueous environment, even
when exposed for a short duration, thus requiring packaging,
storage, and shipping in a powder or lyophilized state to keep the
product stable during its shelf life
• Drugs used for parenteral administration, are commonly known as
powder for injection (PI), powder for reconstitution, dry powder
injection, or powder for constitution
• Typically, PI drugs are supplied in glass vials with rubber plugs and
are mixed or reconstituted with a diluent (usually 5% dextrose
solution, normal saline, bacteriostatic water, or sterile water for
injection) before administration

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Take Home Question
The label amoxicillin oral suspension calls for the
additional of water into a bottle (100 mL) with a 30 mL
of a dry powder such that when mixed with water will
produce a 250 mg / 5mL amoxicillin oral suspension.
• How many milliliters of water were added?
• How many milligram of amoxicillin are in the
suspension?

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