Compounding III Flashcards

1
Q

Master formula record

A

The recipe that is followed to compound a preparation

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2
Q

Compounding log

A

The log book of all products made at the pharmacy

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3
Q

The documentation in the compounding log must be

A

detailed enough to replicate.

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4
Q

The pharmacy must keep record of all____________________related to compounding

A

all steps and processes

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5
Q

When ready to compound, the ________________will be similar for most formulations, including

A

Initial steps
-Weighing ingredients
Final steps will also be similar

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6
Q

What should you review for each bulk ingredient to determine safety procedures?

A

SDS

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7
Q

Master formula: What you

A

SHOULD do

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8
Q

Compounding record log: What you

A

DID

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9
Q

Minimal PPE for non sterile non hazardous drugs

A

Clean lab coat
Gloves

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10
Q

Comminution

A

Reduce particle size by grinding, crushing, milling, vibrating

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11
Q

How to reduce particle size

A

Comminution
-Trituration, levigation and spatulation, pulverization

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12
Q

After powders are finely ground, what are they placed in?

A

Sieve (sifter) to ensure uniform particle size

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13
Q

Once placed in a sieve, the powder is

A

stirred with a sieve brush or plastic spatula to force the particles through the mesh.
The sieve number is based on the number of holes per inch

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14
Q

Trituration

A

“mix thoroughly” or make homogenous
-Grinding tablets with a mortar and pestle
-Triturating an emaulsion by shaking it

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15
Q

Levigation

A

Using a liquid (levigating or wetting agent) to help with the grinding process and form a uniform paste.

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16
Q

Spatulation

A

Similar to levigation, but performed on ointment slab with a spatula instead of on a mortar and pestle

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17
Q

Pulverization by intervention

A

Used for powders not easily crushed.
The crystals are dissolved with an intervening solvent and mixed until the solvent evaporates.

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18
Q

Geometric dilution

A

Small amount of drug is mixed with equal amount of diluent. After thoroughly mixed, another equal amount is mixed in. Repeat until all mixed.

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19
Q

Solution

A

Solute dissolved in a solvent
Homogenous

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20
Q

Types of solutions

A

Syrups
Elixirs
Tinctures
Spirits

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21
Q

Suspension

A

Solid dispersed in liquid
Heterogenous
Wetting agent/levigating agent is used to incorporate the drug into the liquid.
Must redisperse easily by shaking

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22
Q

Emulsion

A

Liquid dispersed in a liquid
Heterogenous mixture, either oil-in-water or water-in-oil
Make sure emulsifier is chosen according to HLB

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23
Q

Precipitation/sedimentation

A

Occurs with suspensions and emulsions
Shake or roll to redisperse

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24
Q

How to prepare solutions

A

1.) Solute must dissolve in solvent. The drug must remain soluble at various temps.
2.) Calculate dissolution rate base don Ficks First Law of Diffusion
Larger SA- stir and use heat to increase dissolution rate
3.) Determine need for buffer system, preservative, flavorings, etc.

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25
How to prepare suspensions
1.) Wet powder and levigate to form paste. 2.) Homogenizer will help form a uniform suspension 3.) Preservative, flavorings, sweeteners may be needed Even with sufactants used as suspending agents, will still need to be redispersed
26
How to prepare emulsion
4 parts oil 2 parts water 1 part gum (acacia) Levigate gum with either oil or water. If oil, must be added slowly, Water can be added all at once.
27
Glidant/lubricant used to improve the flowability of powder
Magnesium stearate
28
Surfactant used to neutralize static charge of powder
Sodium lauryl sulfate
29
Melting point order
Melt ingredient with the highest melting point prior to adding the ingredients with a lower melting point
30
Eutectic mixtures
The combination of ingredients will melt at a lower temperature than the individual ingredients
31
Adsorbent powder
Magnesium oxide Magnesium carbonate Kaolin
32
What plasticizers are used to make capsules less brittle?
Glycerol Sorbitol
33
How to prepare capsules
Hand filling- punch method, open end of the capsule is punched into the powder. Manual capsule filling machine
34
Largest capsule size
000
35
Smallest capsule size
5
36
What is the most common tablet type used in compounding
Molded tablet
37
What is the most common tablet type used in manufacturing
Compressed tablet
38
How to prepare molded tablets
Triturate dry ingredients by geometric dilution Alcohol and/or water added to moisten the powder. Mold the pasty consistency into tablets using a tablet mold and allow to dry
39
Lozenges
troches Contains a base of sucrose or syrup for hard lozenges PEG for soft lozenges Glycerin or gelatin for chewable lozenges
40
How to prepare ointments
Powders should be triturated well using a levigating agent and mixed with base using geometric dilution. Some require heat- fusion method Melt highest melting point followed by lowest
41
What should be used for transdermal drug admin
PLO gel
42
Oil-soluble suppository base
Cocoa butter/ theobroma oil Hydrogenated vegetable iol
43
Water-soluble suppository base
PEG Gelatin
44
If a suppository melts easily
such as theobroma oil/cocoa butter, need to store in refrigerator. Will start to melt when helt.
45
Density factor
Calculate the amount of base needed
46
How to prepare suppositories
Hand molding Fusion molding- RT molds and left to harden Compression molding- uses drugs density factor
47
If a lubricant is used in a suppository, it must be
opposite of the base in terms of solbility Glycerin and PEG are good lubricants for oil-soluble supp bases Mineral oil or vegetable oil are good lubricants for water-soluble supp bases
48
Nonaqueous formulations BUD
no later than 6 months RT
49
Water containing oral formulation BUD
Not later than 14 days at refrigerator
50
Water containing topical formulations BUD
Not later than 30 days RT
51
BUDs for repackaged drugs
Manufacturers expiration date or 6 months from repackaging date, whichever is earlier
52
Lidocaine, alcohol USP and distilled water buccal dental gel BUD
30 days
53
Diclofenac powder in propylene glycol BUD
180 days
54
Lidocaine and Benadryl in poloxamer gel with lecithin/isopropyl palmitate BUD
30 days
55
Calamine powder prepared with glycerin and alcohol BUD
30 days
56
Progesterone supp in an oleaginous base BUD
180 dys
57
Morphine powder with stevia sweetener in a PEG lozenge BUD
180 days
58
Estradiol powder, black cohosh powder, soybean oil capsules BUD
180 days
59
Cipro and dex in Versabase lotion BUD
30 days
60
Polymyxin and hydrocortisone emulsion cream BUD
30 days
61
Nystatin popsicle with 80% sorbitol and water solution BUD
14 days refrigerated
62
Topical preparation of zinc oxide and white petrolatum BUD
180 days
63
APAP, benadryl, hydroxyzine oral suspension in lemon syrup (citric acid, water, lemon) BUD
14 days refrigerated
64
Metronidazole topical solution with propylene glycol and water BUD
30 days
65
Quality Assurance Plan
includes SOPs (how to perform routine and expected tasks) Include periodic testing of finished products- either in house or outsourex
66
Labeling of all compounded products
BUD Storage and handling Topical- for external use only Emsulsions, suspensions- shake well
67
ADRs from a compounded product should be
Reported to the pharmacy and the pharmacist must record in the compounding record
68
Isotonic to human blood
285 mOsm/L
69
Non-PVC bags should be used for
IV meds that have leaching or sorption issues
70
Prior to withdrawing any liquid from a vial,
inject a volume of air equal to the volume of fluid to be removed. DO NOT inject air prior to removing HD from vials.
71
Terminal sterilization
Required for high risk CSPs Steam sterilization-autoclave Do not use heat on heat sensitive drugs
72
CSPs that are heat labile
Hormones, insulin, other proteins Can be sterilized with filtration using a 0.22 micron filter Must use the bubble-point test to test the filter integrity
73
Label requirements on CSPs
Names and conc of ingredients Storage requirements If HD- label Auxilliary labels High alert meds have additional labels
74
Endotoxins
Produced by gram positive, negative, and fungi Gram negative is most potent. Pyrogens can come from using equipment washed with tap water
75
How to avoid pyrogens
Glassware and utensils should be rinsed with sterile water and depyrogenated using dry-heat/steam sterilization using an autoclave
76
If a CSP needs to be tested for endotoxins
Reagent for the bacterial endotoxin test is called limulus amebocyte lysate
77
Low risk sterile compounding
Uses 1-3 components that are supplied as sterile from the manufacturer
78
Medium risk sterile compounding
>3 ingredients added TPN Batch drugs
79
High risk sterile compounding
Non sterile ingredients used End product needs to be sterilized
80
CSPs intended for use beyond the recommended BUD must have
sterility testing using either TSB or fluid thioglycollate medium and include bacterial endotoxin testing prior to use
81
Low risk CSP BUD
48 hours RT 14 days refrigerated 45 days frozen
82
Medium risk CSP BUD
30 hr RT 9 days refrigerated 45 days frozen
83
High risk CSP BUD
24 hour RT 3 days refrigerated 45 days frozen
84
Low risk CSP prepared in an isolator BUD
12 hours
85
CSP prepared for immediate use BUD
1 hour
86
SDC punctured outside of ISO 5 BUD
1 hr
87
SDC punctured inside of ISO 5 BUD
Up to 6 hours
88
Ampule BUD
discard immediately
89
MDC BUD
28 days whether punctured in ISO 5 environment or not
90
Class I recall
Reasonable probability that exposure will cause serious AE
91
Class II recall
Probability of harm is remote
92
Class III recall
Exposure not likely to cause health effects
93
Osmolarity
Includes all solutes
94
Tonicity
Includes only solutes that do not cross the vasculature
95
Hypertonic saline
Causes water to move out of RBCs in an attempt to dilute the solute concentrations. Often restricted.
96
High osmolarity should be administered via
central line to avoid phlebitis
97
Hypotonic
Lower osmolarity than blood
98
When pH rises,
hydrogen ions will be released to make the blood more acidic
99
When pH falls,
Hydrogen ions will be picked up by bicarbonate to make the blood more basic
100
Preparations must be kept in narrow pH range to
avoid damaging tissue and causing pain
101
Compounding products with a narrow pH range need a
buffer system- consists of an acid and its salt