Compounding Facts and Information

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jbliss92
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239842
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Compounding Facts and Information
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2013-10-10 07:03:03
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Compounding pharmacy
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  1. allowable % error in mass in compounding pharmacy practice (typically)
    +/- 10%
  2. allowable % error in mass in manufacturing
    +/- 6% (sometimes 3%)
  3. Prescription Balance: Position of Drug
    Left pan
  4. Double-pan Torsion Balance Class
    • Class A (USP)
    • Class III (NIST)
  5. NIST name and former name
    • Current: National Institute for Standards and Technology
    • Former name: NBS (National Bureau of Statistics)
  6. How to avoid getting drug stuck in crease of folded weighing paper?
    Fold paper only at the corners.
  7. Top-Loading balance features
    • digital display
    • SR = 1 mg
    • Avoid errors of 5% or more (do not weigh < 20 mg)
  8. Percentage Error Formula:
    [(Qty. weighed - qty. desired)/(qty. desired)] x 100%

    [(Error x 100%)/(qty. desired)]
  9. if max potential error is +/- 5 mg in a total of 200 mg, what is the percentage of error?
    [(205 - 200)/(200)]x100% = +/- 2.5%
  10. Least Weighable Quantity factors
    • 1. sensitivity requirement of the balance used.
    • 2. potential error that may be allowed to incur in the weighing process.
  11. A pharmacist weighs 40 mg on a Rx balance having an SR of 6 mg. What is the percentage of error?
    6mg/40mg x 100% = +/- 15% error
  12. National Standard sensitivity requirement of Class A/Class III balance.
    6 mg
  13. A Class A Rx balance has a SR of 0.006 g. How would you weigh 0.015 g of Aspirin with a potential error not exceeding 5%, using lactose as the diluent?
    • LWQ = (6mg/5) x 100% = 120 mg
    • weigh 120 mg Aspirin
    • [(15)/(120) = (120)/(x)] ==> x = 960
    • add (960 - 120) 840 mg lactose to aspirin
    • take 120 mg of this mixture (contains 15 mg aspirin and 105 mg lactose)
  14. A balance has a SR of 0.001 g (1 mg). How would you weigh 5 mg of a drug with a potential error not exceeding 5% using lactose as the diluent?
    • LWQ = (1mg/5%) x 100% = 20 mg
    • weigh 20 mg of drug
    • [(5 mg)/(20 mg) = (20 mg)/(x)] ==> x = 80
    • add 60 mg of lactose to 20 mg drug
    • now weigh out 20 mg of this mixture to obtain 5 mg of drug and 15 mg lactose
  15. Electronic Prescription Balance Assumption
    • SR = 1 mg
    • Potential Error = 5%
    • LWQ = 20 mg
  16. Rx
    Aspirin 4 mg
    Acetaminophen 30 mg
    Assume LWQ = 20 mg
    • weigh 20 mg Aspirin
    • [(4)/(20) = (20)/(x)] ==> x = 100
    • add 80 mg diluent to aspirin
    • weigh out 20 mg of this mix to obtain 4 mg aspirin needed
    • now simply weigh and add 30 mg acetaminophen (it is over the lwq)
  17. Use of beaker
    mixing
  18. use of conical graduates
    ONLY ONE for measuring AND mixing
  19. Graduated Cylinder
    measuring only
  20. How to be accurate with graduated prescription bottles
    • QS the Rx bottle with exact-measured water and mark level on bottle with a line.
    • Fill formulation to this line, not the pre-marked line.

    this procedure is especially important for viscous compounds
  21. How would you measure 1.5 mL of a liquid using a 10 mL graduate cylinder calibrated from 2 mL to 10 mL in 1 mL divisions?
    • First try the least possible amount (2 mL in this case):
    • [(1.5 mL)/(2) = (2)/(x)] ==> x = 2.6
    • 2.6 mL cannot be measured with what you have.
    • Now Try 3:
    • [(1.5 mL)/(3) = (2)/(x)] ==> x = 4
    • so measure 3 mL of drug and dilute with 1 mL of diluent.
    • now extract 2 mL of this mixture (contains 1.5 mL drug)
  22. How would you measure 0.75 mL of a liquid using a 10 mL graduate cylinder calibrated from 2 mL to 10 mL in 1 mL divisions?
    • [(0.75 mL)/(2) = (2)/(x)] ==> x = 5.33 mL (not measurable)
    • [(0.75 mL)/(2) = (3)/(x)] ==> x = 8 mL
    • measure 2 mL of drug
    • add 6 mL of diluent liquid
    • extract 3 mL of this mixture to obtain 0.75 mL drug in 2.25 mL diluent liquid
  23. How would you measure 0.25 mL of a liquid using a nongraduated medicine dropper calibrated to 20 drops/mL?
    • 20 gtt/1 mL = x gtt/0.25 mL
    • x = 5 drops
  24. Volume of Body Water
    58%
  25. Normal physiologic pH of human blood
    7.4
  26. pH of blood suggesting life-threatening situation.
    <6.9 or >7.8
  27. Two Buffer Systems
    • 1. In the plasma.
    • -Carbonic Acid/Bicarbonate buffer
    • -Acid sodium salt of phosphoric acid/alkali sodium salt of phosphoric acid

    • 2. In Erythrocytes:
    • -Hemoglobin/oxyhemoglobin buffer
    • -Acid potassium salt of phosphoric acid/alkali potassium salt of phosphoric acid
  28. Total Extracellular Fluid
    • Plasma (3L for average 70 kg adult)
    • Interstitial-Lymph Fluid
    • Dense CT and cartilage fluid
    • Inaccessible bone water
  29. mEq calculation Formula
    mEq = (weight of solute in mg)/[(atomic weight)/(number of valence)]
  30. Calculating millequivalents of a salt
    mEq = (weight of solute in mg) / [(atomic weight)/ (number of valence x n)]

    where n is the number of ions created by the salt
  31. % weight by volume
    grams solute / 100 mL solution
  32. One Equivalent = ?
    the amount of positive (or equal negative) charge equal to the amount of charge in one mole of H+ ions.
  33. Preferred as the source of drug during extemporaneous compounding rather than the drug as pure powder.
    Especially when a small amount of drug is needed (this allows us to avoid the aliquot method)
    Tablets
  34. Advantages of Tablet Dosage Forms
    • Patient prefers them (ease of administration, self-medication, and convenience in carrying the day's supply)
    • Pharmacist prefers them (convenience in dispensing)
    • Prescriber favors them (accuracy of dose and patient compliance)
    • Manufacturer likes them (economy, packaging, production considerations)
  35. Advantages of Tablet Dosage Forms
    • Precision and accuracy of dose
    • possibility of variable dosage strengths
    • broad range of drug release
    • masking of bitter taste
    • durability and stability
    • convenience of handling, identification, and administration
    • less expensive than capsule forms
  36. REQUIRED in a Tablet Dosage Form:
    • Active Ingredient
    • Diluent
    • Binder
    • Disintegrants
  37. Force required to pass the breaking test for tablets:
    5 Kg
  38. Other components to tablets:
    • Lubricant, antiadherent, glidant
    • colorants
    • flavoring agents
    • sweeteners
  39. Classes of Tablets:
    • Oral tablets for ingestion
    • tablets used in the oral cavity
    • tablets administered by other routes (e.g. implantation tablets, vaginal tablets, etc.)
    • tablets used to prepare solutions
  40. Effervescent Tablets
    • active ingredient formulated with Citric acid monohydrate and/or Tartaric acid and sodium bicarbonate
    • when dissolved in water, citric acid reacts with sodium bicarbonate to produce sodium citrate and CO2 (or sodium tartrate and CO2)
    • liberation of CO2
    • increases absorption by pre-dissolving formulation
  41. Depot vs. Repository Sustained Release Products
    • Depot = Long Term
    • Repository = More Short Term
  42. USP has only TWO classifications of tablets:
    • 1. Immediate-Release Tablets (IRT) ("conventional tablet dosage form")
    • 2. Modified-Release Tablets (MRT) (e.g. delayed release, extended release, etc.)
  43. Oral Dosage Forms that SHOULD NOT be crushed:
    • EC products
    • ER products
    • Unpleasant tasting products
    • effervescent tablets
    • SL tablets
    • Misc. (dosage forms containing drugs that produce mucosa irritation; formulations with dyes; drugs that may stain teeth or mucosal tissue; potentially carcinogenic drugs; products manufactured to alter the release characteristics of the drug from the dosage form)
  44. Daily water requirements in patients < 10 Kg
    100 mL/Kg/day
  45. Daily water requirements in patients 10 - 20 kg
    1,000 mL plus 50 mL/kg/day for weight over 10 kg
  46. Daily water requirements in patients 20 - 80 kg
    1500 mL plus 20 mL/kg/day for weight over 20 kg
  47. Total body water birth to 11 days
    77.6%
  48. Total body water 11 days to 6 months
    72.2
  49. Total body water 6 months to 2 years
    63.1%
  50. Total body water 2 years to 7 years
    59.5
  51. Total body water 7 years to 16 years
    58.4%
  52. Total body water 16 years through adulthood
    58%

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