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CMB-Chapter 17
CMB - Chapter 17 - Non-Sterile Product Compounding
| Question | Answer |
|---|---|
| Compounding is defined as | the preparation, mixing, assembling, packaging, and labeling of a drug or device. |
| Extemporaneous compounding is the | on-demand preparation for a drug product according to a prescriber's prescription, formula, or recipe. |
| medications such as ? are never prepared in a nonsterile environment | IVs or TPNs |
| 1st set of records that must be kept in the compounding area | Formulation record (compounding formula and procedure) |
| 2nd set of records that must be kept in the compounding area | Compounding record (what actually happened when the formulation was compounded) |
| 3rd set of records that must be kept in the compounding area | Standard operation procedures (SOP) for equipment maintenance, equipment calibration, handling and disposal of supplies, etc. |
| 4th set of records that must be kept in the compounding area | Ingredient records with certificates of purity and material safety data sheets (MSDS) |
| Freezer temps | -20°C to -10 C |
| Protect from Freezing temps | Store above 0°C |
| Cold Setting temps | Any temperature not exceeding 8°C |
| Refrigerator Setting temps | Between 2°C and 8°C (36°F to 46°F) |
| Controlled Room Temperature | 15°C to 30°C (59 to 86°F) |
| Excessive Heat | Any temperature above 40°C (>86°F) |
| compounded products must be | individually prescribed for an identified patient. |
| ? balances are preferable because they are precise | Electronic or analytic |
| Use ? to crush tablets or grind crystals & large particles into fine powders | Wedgewood mortars and pestles |
| Grinding powders to reduce particles size is called | trituration |
| Always use ? for mixing liquids and semisolid dosage forms | glass mortars and pestles |
| Graduated cylinders are available in what sizes | 5 ml to 4,000 ml |
| ? cylinders are preferred because they are more accurate | Cylindrical or Graduated |
| Designed to be used for only a specific volume, such as 50 mL or 100 mL & can only be used to measure liquids | Volumetric Flasks |
| Thin glass tubes recommended for the delivery of all volumes less than 5 mL & required for delivering volumes less than 1 mL | pipets |
| The Class A balance may be used to measure weights between | 120mg & 120g |
| The correct side for the weights is the pan on the | right side. |
| When measuring volumes that are less than one milliliter, use a | calibrated pipet, micropipet, or syringe. |
| When measuring an oily or viscous liquid, use a | syringe, or measure by weight, rather than volume. |
| Never use these as measurement devices | prescription bottles, non-volumetric flasks, beakers, or household teaspoons |
| ? can be used to deliver small doses of liquid medication | medicine droppers |
| factors that may affect the total volume measured by a dropper | Calibration, Variations in pressure, Speed of dropping, & Angle at which the dropper is held |
| Trituration is | a mixing technique in which two solid powders are mixed together using a mortar and pestle |
| Levigation is | a mixing technique in which two substances are mixed together on an ointment slab using a spatula to reduce the particle size |
| Geometric dilution is | a technique used to mix two powders of unequal quantities |
| geometric dilution process | 1. Mix 50mg of drug A with about 50mg of drug B with the pestle in the mortar 2. Add and mix the other 50mg of drug B with the mortar & pestal |
| compounded prescriptions can be viewed as a four-step process | measure, mix, mold, and package |
| biggest capsule size | 000 |
| smallest capsule size | 5 |
| capsule size 000 | 650-1450 mg; 1.37 ml |
| capsule size 00 | 400-1000 mg; 0.95 ml |
| capsule size 0 | 300-700 mg; 0.68 ml |
| capsule size 1 | 250-500 mg; 0.5 ml |
| capsule size 2 | 200-400 mg; 0.37 ml |
| capsule size 3 | 150-300 mg; 0.3 ml |
| capsule size 4 | 100-250 mg; 0.2 ml |
| capsule size 5 | 50-150 mg; 0.13 ml |
| Remember, the least weighable quantity (LWQ), or least amount weighable (LAW), is ? for a class A balance | 120 mg |
| the most commonly compounded products are | Solutions |
| oil-in-water emulsions are generally composed of | 4 parts oil, 2 parts water, and 1 part emulsifying agent |
| waterin-oil emulsions are generally composed of | 4 parts water, 2 parts oil, and 1 part emulsifying agent |
| the dry gum method | the 4 parts oil are mixed with the 1 part emulsifier, then the 2 parts water are added |
| the wet gum method | the 2 parts water are mixed with the 1 part emulsifier, then the 4 parts oil are added |
| three types of suppository bases | Oleaginous, Water soluble or miscible, & Hydrophilic or emulsion bases |
| ? is the most common method of preparing suppositories, in which suppositories are melted over hot water baths | Fusion |