Lab Practical Exam

USP Chapter 795

Pharmaceutical Compounding-Nonsterile Preparation

USP 797

Pharmaceutical Compounding- Sterile Preparations

USP 800

Hazardous Drugs- Handling in Healthcare setting

key points of USP 795

• The responsibility of the compounder

• Facilities and equipment must meet minimum standards

• Stability of the preparation and the beyond-use-date

• Selection of ingredients and their quality

• Compounding process

• Necessary records and documentation

• Quality control

responsibility of compounder according to US 795

must assure quality in the areas of personnel, ingredients, finished preparations, processes, environment, stability and documentation.

facilities & equipment req according to USP 795

adequate and appropriate space, similar to those mandated by the state boards of pharmacy. Equipment must be appropriate and suitable for the purpose for which is used, and be properly maintained, used, calibrated, and cleaned.

stability of compounded preparations according to USP 795

beyond-use- date is the responsibility of the compounder and is determined from the time of compounding, not the time of dispensing.

• Compounders can consult appropriate literature, and analytical laboratories to determine proper BUD.

ingredient selection according to USP 705

USP and NF grade ingredients should be used. Do not use items on the FDA negative list.

what should the prescription container label include according to USP 795?

• The name of the preparation

• The internal identification number (control number)

• The beyond-use date

• The initials of the pharmacist who prepared the compound

• Any storage requirements

• Other legal components of the Rx label.

beyond use date must take into consideration the experation dates of _________

all ingredients used

• bc you are manipulating & mixing together, the resulting preparation must have a shorter date than any one ingredient

2 compounding records & documents for USP 795

1. master compounding formulation record

2. compounding record

master compounding formulation record (USP 795)

this is kept for each preparation that is compounded. The directions and procedures for compounding the preparation are listed here to ensure consistency each time it is prepared.

• more general than compounding record

compounding record

this is the documentation each time the prescription is prepared. It contains specific information for each specific instance: lot numbers of the ingredients, calculations, processes used, assigned beyond-use-dates, control-number, name of the compounder, quantity prepared, etc...

BUD for non-preserved aqueous dosage forms according to USP 795

14d

BUD for preserved aqueous dosage forms according to USP 795

35d

BUD for oral liquids (nonaqueous) according to USP 795

90d

BUD for nonaqueous dosage forms according to USP 795

180d

SOP

Standard Operating Procedures are documents

that describe how to perform routine tasks. They

contain step-by-step instructions to perform tasks

reliably and consistently; including how a task will be

performed, who will do the task, and who is

responsible.

MSDS

MSDS- Material Safety Data Sheets may be either hard copy or accessible electronically. They are needed for all drug substances or bulk chemicals located in the compounding pharmacy. The package insert serves for commercial products.

maximum capacity of torsion balance

120g

minimum capacity of torsion balance

120mg

20% rule for conical and cylindrical graduates

minimum measurable quantity is 20% of total quantity

when are USP BUD guidelines used?

only when stability studies are unavailable

• general in nature

powders

Intimate mixtures of dry, finely, divided drugs and/or chemicals that may be intended for internal or external use.

packaging for powders

protect from moisture (can cause clumping)

• glassline paper, wax paper, white bond paper, zip-loc bags

• store in dry places

fold correctly to prevent spillage

always base powder paper calculations on _______ doses

2 extra

MWQ for powder papers

300mg

general steps for powder paper compounding

1. weigh ingredients

2. mix w geometric dilution

3. weigh each dose

4. fold & dispense in box

capsules

Solid dosage in which the drug is enclosed within either a hard or soft soluble container or “shell.” The shells are usually formed from gelatin; however, they also may be made from starch or suitable substances.

advantages of capsules

• easy to swallow

• masks taste & odor of drugs

• absorption

routes of capsule administration

1. oral

2. rectal

3. vaginal

soft-shell gelatin capsules

• gelatin is pliable

• thick one-piece shell

• filled w liquid

hard-shell gelatin capsule

• cap and body lock together

• many colors

MWQ for capsules

120mg

smallest capsule size

5

largest capsule size

000

what determines capsule size?

amt active ingredient

general steps of capsule compounding

1. prepare powder mixture in mortar via geometric dilution

2. transfer powder mixture to pill tile for filling

3. tare empty shell, weigh capsules individually (capsules must be shiny)— taring makes sure you’re weighing contents of capsule only, not shell/capsule

when are capsule machines useful?

• frequent compounding

• large quantities

• accuracy/precision

are liquids or capsules more stable?

capsules

BUD for capsules

180d

packaging/storage for capsules

• room temp

• constant humidity

• away from excessive heat (melting)

solubility

amt of a solute that dissolves in a given amt of solvent at a given temp

• refers to a constant for a given substance at a given temp

• amt of drug that can be dissolved in a given amt of solvent won’t change but rate of dissolution might vary

what should go last in solution compounding table?

item that is qs

how do you precalibrate when compounding a soln?

for 180 mL ex,

• measure 100 mL + pour in

• measure 80 mL + pour in

• draw line at meniscus

can you compound in amber vials?

no- concentration will be off

suspension

liquid preparation that consists of solid particle dispersed thru a liquid phase

• particles are NOT soluble

ideal suspension

1. uniform particle size

2. uniform drug distribution

3. settles slowly

4. disperses readily upon shaking

5. particle size remains constant thru long periods of undisturbed standing

once dispersed, suspension should…

• settle slowly

• pour readily & evenly

• consist of particles small enough to avoid gritty feeling (topical)

advantages of suspension

1. taste masking-oral preparations

2. slows absorption

suspensions as a dosage form

1. otic preparations

2. ophthalmic preparations

3. oral suspensions

4. injectable— NOT IV

5. topical preparations

3 sources of drugs for suspensions

1. pure drug (powder/crystals)

2. capsules/tablets (inactive excipients— default to suspension)

3. injectable drugs

2 common suspending agents

1. ora-plus (50%)

2. ora-blend (qs)

why are suspending agents added to susp?

increase viscosity & slow settling

general steps of suspension compounding

1. remove tablet coating using USP alcohol— never isopropyl

2. triturate to fine particle size

3. levigate to wet solid w glass mortar and pestel

4. add suspending agent

5. washing technique

6. bring preparation to volume (adequate drain time)

7. shake well label

do you put brand or generic on the label?

generic