compounding exam 2

what does thixotropic mean?

semisolid on standing but liquefy when shaken

1 multiple choice option

examples of two-phase systems include?

aluminum hydroxide gel and Bentonite Magma

what are examples of natural polymers?

tragacanth, acacia, gelatin, alginic acid

2 multiple choice options

what are examples of semisynthetic cellulose derivatives?

methylcellulose and HPMC

2 multiple choice options

what are examples of synthetic polymers?

carbomer polymers and poloxamers

2 multiple choice options

viscosity depends on what four factors?

temperature; ions; pH; and concentration of polymer

Carbomer (Carbopol®) gels require neutralization to form a proper gel. What happens when you add a neutralizer like sodium hydroxide?

the pH increases and the dispersion thickens into a gel

3 multiple choice options

poloxamer are copolymers of what?

polyoxyethylene and polyoxypropylene

1 multiple choice option

what does thermoreversible gel mean?

liquids at cool (refrigerator) temperature, but are gels at room or body temperature

1 multiple choice option

what is the oil phase of PLO?

lecithin dissolved in isopropyl palmitate

1 multiple choice option

what is the aqueous phase of PLO gel?

aqueous solution of 20-30% of PF-127

examples of hydrocarbon bases (aka oleaginous base)

vaseline, white/yellow ointment

3 multiple choice options

examples of absorption base

cold cream, eucerin, rose water ointment

3 multiple choice options

examples of water-miscible/emulsifying bases

derma base, hydrophilic ointment, and vanishing cream

3 multiple choice options

example of water soluble bases

PEG ointment

3 multiple choice options

in an o/w emulsion, what is the continuous phase? what is the dispersed phase?

oil = dispersed

water = continuous

1 multiple choice option

in an o/w emulsion, what is the external phase?

water is the external phase

1 multiple choice option

what levigating agent should be used when oil is the external phase?

mineral oil or castor oil

1 multiple choice option

what levigating agent should be used when water is the external phase?

glycerin, propylene glycol, PEG 400, or Tween 80

1 multiple choice option

ointment mill

utilizes high shear force to reduce particle sizes, disperse agglomerates, and homogenize viscous materials. processing ur topical mixtures through an ointment mill can increase absorption and eliminate grittiness completely.

what is an example of an aqueous paste?

carboxymethylcellulose sodium paste

1 multiple choice option

what is an example of an oleaginous (fatty) paste?

zinc oxide paste

1 multiple choice option

what is the advantage of oleaginous (fatty) pastes over aqueous pastes?

fatty pastes consists of thick, stiff ointments, that do not flow at body temperatures, and therefore serve as protective coatings over the areas they are applied too.

fill in the blank: ________ normally contain 80% oleaginous base and < 20% water, while _________ is usually 50:50 or more water.

ointments; creams

1 multiple choice option

which of the following are generally considered greasier, have thicker consistencies, and are more difficult to spread over large areas?

A. ointments

B. creams

A. ointments

1 multiple choice option

which of the following topical preparations are absorbed into the skin and cause the skin to dry up faster, leading it to be a better option for individuals with greasy or oily skin?

A. creams

b. ointments

A. creams

1 multiple choice option

which of the following topical preparations stay on the surface of the skin longer and do not get absorbed, which is why they are often prescribed for dry skin and promotes faster healing?

A. creams

B. ointments

B. ointments

1 multiple choice option

which cream emulsion, o/w or w/o, is considered more comfortable and cosmetically acceptable bc they are less greasy and easier to wash off with water?

o/w creams

1 multiple choice option

what is an advantage of w/o creams?

they are more moisturizing because they provide an oil barrier, which reduces water loss from the stratum corneum

what are examples of o/w creams?

foundation creams, hand creams, shaving creams, and vanishing creams

what are examples of monophasic liquid dosage forms?

solution; drops; linctus; syrups; elixir; douche; and mouthwash

1 multiple choice option

what are examples of biphasic liquid dosage forms?

suspension; emulsion; liniment; lotion

1 multiple choice option

if a drug is susceptible to degradation (ie hydrolysis, oxidation, racemization), what could you add?

antioxidants. also, storage recommendations like storing it in the fridge, protecting it from light, or using a non-aqueous solvent (alcohol, glycerin, or oil)

If a drug is insoluble in water, what would we add?

a cosolvent (alcohol, propylene glycol); a surfactant; or a micronized powder (tiny particles stay suspended longer)

if a drug has an extremely bitter taste, what could we add?

sweeteners; flavoring agents; flavor masking vehicles (Ora-Sweet or Ora-Blend); form a capsule or coated beads instead

if a drug is susceptible to microbial growth, what could we add?

preservatives (methylparaben, propylparaben, benzoic acid)

what is the difference between quality assurance and quality control?

quality assurance ensures the process is done correctly, while quality control tests the final product

1 multiple choice option

what is the recommended BUD and storage for an aqueous preparation containing water and no preservatives?

14 days; refrigerator

3 multiple choice options

what is the recommended BUD and storage for an aqueous preparation containing water and has preservatives?

35 days; room temperature or fridge

3 multiple choice options

what is the recommended BUD for a non aqueous oral liquid preparation?

90 days

3 multiple choice options

what is the recommended BUD for other non aqueous preparations, like ointments and suppositories?

180 days

3 multiple choice options

what needs to be included on the compounding record?

1. name, strength, and dosage form

2. date (time) of preparation

3. assigned internal identification number

4. compounder's name

5. name, manu, lot #, and expiration date of each component

6. weight of each component used

7. total quantity prepared

8. BUD and storage requirements

9. calculations, only if applicable

10. physical description of the final product

11. results of quality control procedures (pH testing and visual inspection)

12. master formulation record reference

1 multiple choice option

what must be included in a master formulation record?

1. name, strength, and dosage form of product

2. identities and amounts of all components used

3. container closure system(s)

4. instructions for preparing the product including equipment, supplies, and description of steps

5. physical description of the final product

6. BUD and storage requirements

7. reference source to support BUD

8. calculations, if applicable

9. labeling requirements

10. quality control procedures and expected results

11. other info needed to describe the compounding process and ensure repeatability

1 multiple choice option

define quality assurance.

a system of procedures, activities, and oversight that ensures that the compounding process consistently meets quality standards

1 multiple choice option

define quality control.

the sampling, testing, and documentation of results that, taken together, ensure that specifications have been met before release of the non-sterile preparation.

1 multiple choice option

define compounded non sterile preparation (CNSP).

a preparation not intended to be sterile that is created by combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer's labeling, or otherwise altering a drug product or bulk drug substance.

deine containment ventilated enclosure (CVE).

a full or partial enclosure that uses ventilation principles to capture, contain and remove airborne contaminants through high-efficiency particulate air (HEPA) filtration and to prevent their release into the work environment.