Lecture 1: nonsterile compounding

Question 1

Pharmacy Compounding definition

Answer 1

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

Question 2

Examples of clinical scenarios that require compounding

Answer 2

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

Question 3

Compounding definition

Answer 3

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

Question 4

Batching Prescriptions

Answer 4

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

Question 5

Manufacturing

Answer 5

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

Question 6

Preparation definition

Answer 6

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

Question 7

Preparation example

Answer 7

aspirin powder paper

Question 8

Product

Answer 8

Manufacturer pharmaceutical dosage forms

Question 9

Product example

Answer 9

aspirin tablets from Bayer

Question 10

examples of nonsterile compounding

Answer 10

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

Question 11

What is NOT nonsterile preparation

Answer 11

otic prep used for perforated eardrums
eye drops probably

Question 12

when can we legally compound?

Answer 12

Regulated largely by state law
Some federal regulation

Question 13

How do we safely compound?

Answer 13

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)

Question 14

Examples of compounding errors

Answer 14

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

Question 15

powder paper definition

Answer 15

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

Question 16

Powder paper advantages (6)

Answer 16

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

Question 17

Communition definition

Answer 17

the process of reducing paricle size of a powder

Question 18

Benefits of communition

Answer 18

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

Question 19

3 methods of comminution

Answer 19

1. trituration
2. pulverization by intervention
3. levigation

Question 20

trituration definition

comminution

Answer 20

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

grinding
hard fracturable

Question 21

Pulverization by intervention

comminution

Answer 21

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

Question 22

Levigation

comminution

Answer 22

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

Question 23

Blending

technique

Answer 23

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

Question 24

which blending method is preferred?

Answer 24

Trituration
accomplishes particle size reduction _ blending

Question 25

Geometric dilution

Answer 25

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

Question 26

Bulk Powders

Answer 26

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

Question 27

topical bulk powders

Answer 27

gold bond nystatin

Question 28

Oral bulk powders

Answer 28

Questran (cholestyramine) miralax (PEG)

Question 29

unit dose powders

Answer 29

Capsules powder papers packets inhalation

Question 30

Powder papers

Answer 30

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

Question 31

BUD | USP 795

Answer 31

no later than the time remaining until earliest exp date

Question 32

MWQ

Answer 32

100 mg if less than 100mg, add bulking agent

Question 33

Standard pharmacetuical accuracy

Answer 33

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

Question 34

Powder Paper procedure (7)

Answer 34

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

Question 35

Powder paper calculation key points

Answer 35

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