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compounding > Lecture 1: nonsterile compounding > Flashcards

Lecture 1: nonsterile compounding Flashcards

1
Q

Pharmacy Compounding definition

A

creating a drug by an RPh to meet the required needs of an individual patient when a commercially available drug does not meet those needs

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2
Q

Examples of clinical scenarios that require compounding

A
  1. drug or dosage form not comercially available
  2. dose unavailable
  3. formulation inappropriate for patient
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3
Q

Compounding definition

A

Preparing a drug from a licenced practitioner’s RX or med order in course of USP 1075 (good compounding practices)
Includes: batching = compounding ahead of time in anticipation of outstanding refills

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4
Q

Batching Prescriptions

A
  1. must keep batching records (manufacturer, lot #, exp date)
  2. pharmacy assigns own batch and lot# to product
  3. don’t batch more than you need
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5
Q

Manufacturing

A

compounding for long term inventory or sale
requires a special license and manufacturing facility
Subject to different laws, inspections, and industrial regulations (FDA)
Beyond the scope of hospital and community practice

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6
Q

Preparation definition

A

compunded drug dosage form to which a **compounder has introduced a drug **

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7
Q

Preparation example

A

aspirin powder paper

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8
Q

Product

A

Manufacturer pharmaceutical dosage forms

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9
Q

Product example

A

aspirin tablets from Bayer

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10
Q

examples of nonsterile compounding

A

solid/liquid oral preparations
vaginal/rectal preparations
topical preparations
nasal and sinus preparations
otic preparations

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11
Q

What is NOT nonsterile preparation

A

otic prep used for perforated eardrums
eye drops probably

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12
Q

when can we legally compound?

A

Regulated largely by state law
Some federal regulation

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13
Q

How do we safely compound?

A
  1. train
  2. practice techniques (calc w/ units, triple check, colleague verification, be aware of unusual quantities)
  3. use resources (master compounding sheets, compounding record sheets, standard operating procedures)
  4. follow rules and regulations (USP 795)
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14
Q

Examples of compounding errors

A

Lack of knowledge of aseptic standards
Inadequate training
Disregard for published guidelines (environmental controls/compounding procedures)
Mathematical errors
Weighing/measuring errors
Improper ingredient selection
Procedural errors

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15
Q

powder paper definition

A

Intimate mixtures of dry finely divided drugs/chemicals that may be intended for internal or external use
solid dosage form that may be comprised of only the active drug or a mixture of the active drug and other ingredients

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16
Q

Powder paper advantages (6)

A
  1. tailored dose
  2. easy administration when capsules are hard to swallow
  3. bad taste is less noticeable in powder form
  4. rapid onset (disintegration not req)
  5. multi use (external or internal)
  6. easily made into other dosage forms
17
Q

Communition definition

A

the process of reducing paricle size of a powder

18
Q

Benefits of communition

A
  1. creates uniform particle sizes
  2. improves dose accuracy
  3. avoids powder segregation
19
Q

3 methods of comminution

A
  1. trituration
  2. pulverization by intervention
  3. levigation
20
Q

trituration definition

comminution

A

continuous rubbing or grinding of powder in a mortar/pestle
used for hard, fracturable powders

grinding
hard fracturable

21
Q

Pulverization by intervention

comminution

A

Used with hard crystalline powders that do not dissolve easily

uses an intervening solvent (alcohol, acetone) to dissolve the powder.
dissolved powder is mixed in a mortar/pestle or spread onto an ointment slab to enhance the evaporation of solvent
Once the solvent evaporates, the powder will recrystalize out of solution as fine particles

Dissolve
recrystalize - evaporate
hard crystalline

22
Q

Levigation

comminution

A

reduce particle size by triturating in mortal w/ small amount of insoluble liquid solvent (mineral oil/glycerin)
for ointments and suspensions

triturate w/ insoluble solvent
ointment, suspension

23
Q

Blending

technique

A

Create a homogenous mixture
1. spatulation
2. trituration
3. sifting
4. tumbling
5. geometric dilution

24
Q

which blending method is preferred?

A

Trituration
accomplishes particle size reduction _ blending

25
Q

Geometric dilution

A

used when blending 2 or more powder ingredients of different quantities
method of choice: trituration
smaller volume is triturated with equal volume of excess powder

26
Q

Bulk Powders

A

Conc of active ingredient: %w/w, mg/g, etc
Med dose is very non-specific due to highly subjective administration

27
Q

topical bulk powders

A

gold bond
nystatin

28
Q

Oral bulk powders

A

Questran (cholestyramine)
miralax (PEG)

29
Q

unit dose powders

A

Capsules
powder papers
packets
inhalation

30
Q

Powder papers

A

aka charts
patient specific label should indicate quantity of active ingredients in one dose
powder paper contains a specific dose of medication

31
Q

BUD

USP 795

A

no later than the time remaining until earliest exp date

32
Q

MWQ

A

100 mg
if less than 100mg, add bulking agent

33
Q

Standard pharmacetuical accuracy

A

+/- 5% (5mg or less) required to cause a change in the reading on the electronic display

minimum sensitivity is 5mg/division

34
Q

Powder Paper procedure (7)

A
  1. count tablet [#, strength], place in mortar, Crush and refine [resultant powder = _g]
  2. weigh out _____g bulking agent
  3. geometrically triturate tablet mass and bulking agent in clean glass mortar
  4. weight out —–mg per dose and fold into powder paper
  5. repeat total ———- powder papers
  6. transfer powder papers to dispensing container
  7. label and dispense
35
Q

Powder paper calculation key points

A
  1. make 1 extra dose (NYSBOP policy)
  2. if MWQ less than 100mg, add bulking agent

compounding (12 decks)

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