Compounding III Flashcards
Master formula record
The recipe that is followed to compound a preparation
Compounding log
The log book of all products made at the pharmacy
The documentation in the compounding log must be
detailed enough to replicate.
The pharmacy must keep record of all____________________related to compounding
all steps and processes
When ready to compound, the ________________will be similar for most formulations, including
Initial steps
-Weighing ingredients
Final steps will also be similar
What should you review for each bulk ingredient to determine safety procedures?
SDS
Master formula: What you
SHOULD do
Compounding record log: What you
DID
Minimal PPE for non sterile non hazardous drugs
Clean lab coat
Gloves
Comminution
Reduce particle size by grinding, crushing, milling, vibrating
How to reduce particle size
Comminution
-Trituration, levigation and spatulation, pulverization
After powders are finely ground, what are they placed in?
Sieve (sifter) to ensure uniform particle size
Once placed in a sieve, the powder is
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
Trituration
“mix thoroughly” or make homogenous
-Grinding tablets with a mortar and pestle
-Triturating an emaulsion by shaking it
Levigation
Using a liquid (levigating or wetting agent) to help with the grinding process and form a uniform paste.
Spatulation
Similar to levigation, but performed on ointment slab with a spatula instead of on a mortar and pestle
Pulverization by intervention
Used for powders not easily crushed.
The crystals are dissolved with an intervening solvent and mixed until the solvent evaporates.
Geometric dilution
Small amount of drug is mixed with equal amount of diluent. After thoroughly mixed, another equal amount is mixed in. Repeat until all mixed.
Solution
Solute dissolved in a solvent
Homogenous
Types of solutions
Syrups
Elixirs
Tinctures
Spirits
Suspension
Solid dispersed in liquid
Heterogenous
Wetting agent/levigating agent is used to incorporate the drug into the liquid.
Must redisperse easily by shaking
Emulsion
Liquid dispersed in a liquid
Heterogenous mixture, either oil-in-water or water-in-oil
Make sure emulsifier is chosen according to HLB
Precipitation/sedimentation
Occurs with suspensions and emulsions
Shake or roll to redisperse
How to prepare solutions
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.
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
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.
Glidant/lubricant used to improve the flowability of powder
Magnesium stearate
Surfactant used to neutralize static charge of powder
Sodium lauryl sulfate
Melting point order
Melt ingredient with the highest melting point prior to adding the ingredients with a lower melting point
Eutectic mixtures
The combination of ingredients will melt at a lower temperature than the individual ingredients
Adsorbent powder
Magnesium oxide
Magnesium carbonate
Kaolin
What plasticizers are used to make capsules less brittle?
Glycerol
Sorbitol
How to prepare capsules
Hand filling- punch method, open end of the capsule is punched into the powder.
Manual capsule filling machine
Largest capsule size
000
Smallest capsule size
5
What is the most common tablet type used in compounding
Molded tablet
What is the most common tablet type used in manufacturing
Compressed tablet
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
Lozenges
troches
Contains a base of sucrose or syrup for hard lozenges
PEG for soft lozenges
Glycerin or gelatin for chewable lozenges
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
What should be used for transdermal drug admin
PLO gel
Oil-soluble suppository base
Cocoa butter/ theobroma oil
Hydrogenated vegetable iol
Water-soluble suppository base
PEG
Gelatin
If a suppository melts easily
such as theobroma oil/cocoa butter, need to store in refrigerator. Will start to melt when helt.
Density factor
Calculate the amount of base needed
How to prepare suppositories
Hand molding
Fusion molding- RT molds and left to harden
Compression molding- uses drugs density factor
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
Nonaqueous formulations BUD
no later than 6 months RT
Water containing oral formulation BUD
Not later than 14 days at refrigerator
Water containing topical formulations BUD
Not later than 30 days RT
BUDs for repackaged drugs
Manufacturers expiration date or 6 months from repackaging date, whichever is earlier
Lidocaine, alcohol USP and distilled water buccal dental gel BUD
30 days
Diclofenac powder in propylene glycol BUD
180 days
Lidocaine and Benadryl in poloxamer gel with lecithin/isopropyl palmitate BUD
30 days
Calamine powder prepared with glycerin and alcohol BUD
30 days
Progesterone supp in an oleaginous base BUD
180 dys
Morphine powder with stevia sweetener in a PEG lozenge BUD
180 days
Estradiol powder, black cohosh powder, soybean oil capsules BUD
180 days
Cipro and dex in Versabase lotion BUD
30 days
Polymyxin and hydrocortisone emulsion cream BUD
30 days
Nystatin popsicle with 80% sorbitol and water solution BUD
14 days refrigerated
Topical preparation of zinc oxide and white petrolatum BUD
180 days
APAP, benadryl, hydroxyzine oral suspension in lemon syrup (citric acid, water, lemon) BUD
14 days refrigerated
Metronidazole topical solution with propylene glycol and water BUD
30 days
Quality Assurance Plan
includes SOPs (how to perform routine and expected tasks)
Include periodic testing of finished products- either in house or outsourex
Labeling of all compounded products
BUD
Storage and handling
Topical- for external use only
Emsulsions, suspensions- shake well
ADRs from a compounded product should be
Reported to the pharmacy and the pharmacist must record in the compounding record
Isotonic to human blood
285 mOsm/L
Non-PVC bags should be used for
IV meds that have leaching or sorption issues
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.
Terminal sterilization
Required for high risk CSPs
Steam sterilization-autoclave
Do not use heat on heat sensitive drugs
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
Label requirements on CSPs
Names and conc of ingredients
Storage requirements
If HD- label
Auxilliary labels
High alert meds have additional labels
Endotoxins
Produced by gram positive, negative, and fungi
Gram negative is most potent.
Pyrogens can come from using equipment washed with tap water
How to avoid pyrogens
Glassware and utensils should be rinsed with sterile water and depyrogenated using dry-heat/steam sterilization using an autoclave
If a CSP needs to be tested for endotoxins
Reagent for the bacterial endotoxin test is called limulus amebocyte lysate
Low risk sterile compounding
Uses 1-3 components that are supplied as sterile from the manufacturer
Medium risk sterile compounding
> 3 ingredients added
TPN
Batch drugs
High risk sterile compounding
Non sterile ingredients used
End product needs to be sterilized
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
Low risk CSP BUD
48 hours RT
14 days refrigerated
45 days frozen
Medium risk CSP BUD
30 hr RT
9 days refrigerated
45 days frozen
High risk CSP BUD
24 hour RT
3 days refrigerated
45 days frozen
Low risk CSP prepared in an isolator BUD
12 hours
CSP prepared for immediate use BUD
1 hour
SDC punctured outside of ISO 5 BUD
1 hr
SDC punctured inside of ISO 5 BUD
Up to 6 hours
Ampule BUD
discard immediately
MDC BUD
28 days whether punctured in ISO 5 environment or not
Class I recall
Reasonable probability that exposure will cause serious AE
Class II recall
Probability of harm is remote
Class III recall
Exposure not likely to cause health effects
Osmolarity
Includes all solutes
Tonicity
Includes only solutes that do not cross the vasculature
Hypertonic saline
Causes water to move out of RBCs in an attempt to dilute the solute concentrations.
Often restricted.
High osmolarity should be administered via
central line to avoid phlebitis
Hypotonic
Lower osmolarity than blood
When pH rises,
hydrogen ions will be released to make the blood more acidic
When pH falls,
Hydrogen ions will be picked up by bicarbonate to make the blood more basic
Preparations must be kept in narrow pH range to
avoid damaging tissue and causing pain
Compounding products with a narrow pH range need a
buffer system- consists of an acid and its salt
