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. Kilimanjaro School of Pharmacy 6 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 Kilimanjaro School of Pharmacy 10 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. Kilimanjaro School of Pharmacy 11 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. Kilimanjaro School of Pharmacy 13 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. Kilimanjaro School of Pharmacy 15 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. Kilimanjaro School of Pharmacy 17 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 Kilimanjaro School of Pharmacy 19 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 Kilimanjaro School of Pharmacy 20 Kilimanjaro School of Pharmacy 21 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?