PTCB - Chapter 8 - Compounding - Definitions

Chapter < 795 >
- regulations from USP-NF pertaining to compounding non sterile formulations

Chapter < 797 >
- regulations from USP-NF pertaining to compounding sterile formulations

Compounding record
- a record of what actually happened when the formulation was compounded

Formulation record
- formulas and procedures (ie. recipes) for what should happen when a formulation is compounded

Grade of Chemical

1. Technical (commercial): commercial or industrial quality, generally of indeterminate quality
2. CP (chemically pure): more refined than technical grade, but still of unknown quality; only partial analytical information available
3. USP or NF: meets standards set by the USP-NF
4. FCC: meets specifications of Food Chemical Codex
5. ACS reagent: high purity; meets specifications of the Reagent Chemicals Committee of the American Chemical Society
6. AR (analytical reagent): very high purity
7. HPLC: very high purity; used in high pressure chromatography
8. Spectroscopic grade: very high purity
9. Primary standard: highest purity; used in standard solutions for analytical purposes

Storage Temperature Definitions

1. Freezer ⮞ -20C to -10C
2. Protect from Freezing ⮞ store above 0C
3. Cold ⮞ any temperature not exceeding 8C
4. Refrigerator ⮞ between 2C and 8C
5. Cool ⮞ between 8C and 15C
6. Room Temperature ⮞ temperature in the work area
7. Controlled Room Temperature ⮞ thermostatically controlled at 20C to 25C
8. Warm ⮞ between 30C and 40C
9. Excessive Heat ⮞ any temperature above 40C

Records must be kept for each formulation

• a formulation record
• a compounding record
• standard operating procedures (SOPs) for equipment maintenance, equipment calibration, handling and disposal of supplies, etc
• an ingredients record with certificates of purity and Material Safety Data Sheets (MSDS)

Beyond use date

- a date assigned to compounded prescription beyond which the formulations should not be used

Stability

- the extent to which a dosage form

Aliquot

- a portion of a mixture

Calibrate

- to set, mark, or check the graduations of a measuring device

Sensitivity

- the amount of weight that will move the balance pointer one division mark on the marker plate

* Class A torsion balances have a sensitivity requirement of up to 6mg

* Class A torsion balances have a minimum weighable quantity of 120mg with a 5% error

* Sometimes a prescription calls for less than 120mg of an ingredient. When this happens, the ingredient is mixed with an inert (inactive) powder so that the resulting mix will contain the precise amount of drug needed and also weigh at least 120mg

Arrest knob

- the knob on a balance that prevents any movement of the balance pans

Volumetric

- measures volume. Volumetric vessels are either TD (to deliver) or TC (to contain)

Meniscus

- the curved surface of a column of liquid

Geometric dilution

- a technique for mixing two powders of unequal quantity

Spatulation

- mixing powders with a spatula

Trituration

- the process of grinding powders to reduce particle size

Levigation

- triturating (grind) a powder with a solvent in which it is insoluble to reduce its particle size

Sonification

- exposure to high frequency sound waves

Flocculating agent

- electrolytes used in the preparation of suspensions to form particles that can be easily redispersed

Thickening agent

- an ingredient used in the preparation of suspensions to increase the viscosity of the liquid

Emulsifier

- a stabilizing agent in emulsions

Hydrophilic emulsifier

- a stabilizing agent for water based dispersion mediums

Immiscible

- cannot be mixed

Lipophilic emulsifier

- a stabilizing agent for oil based dispersion mediums

Mucilage

- a wet, slimy liquid formed as an initial step in the wet gum method

Oil in water Emulsion

- an emulsion in which oil is dispersed in a water base

Primary Emulsion

- the initial emulsion to which ingredients are added to create the final product

Water in oil Emulsion

- an emulsion in which water is dispersed in an oil base

Miscible

- capable of being mixed together

Compression molding

- a method of making suppositories in which the ingredients are compressed in a mold

Fusion molding

- a suppository preparation method in which the active ingredients are dispersed or dissolved in a melted suppository base

Finger cots

- protective coverings for fingers

Punch method

- a method for filling capsules by repeatedly pushing, or "punching", the capsule into an amount of drug powder

Capsule size / Liquid volume (mL)

000                 1.37    largest

00                   0.95

0                     0.68

1                     0.50

2                     0.37

3                     0.30

4                     0.20

5                     0.13     smallest