Compounding III: Documentation & Preparation Flashcards

1
Q

master formula record

A

AKA master formula

the recipe that is followed to compound a preparation

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2
Q

compounding record

A

AKA compounding log

log book of all products made at the pharmacy

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3
Q

Minimal PPE for preparing non-sterile, non-HD preparations should include…

A

a clean lab coat & gloves

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4
Q

Communition means to _______ particle size by grinding, crushing, milling, vibrating, or other processes

A

reduce

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5
Q

Sieves, which are sifters, are used to ensure that…

A

the particle size is uniform

  • powder is put into the sieve & sifted through the mesh
  • the sieve number is based on the number of holes per inch
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6
Q

three main methods of comminution

A

TRITURATION
- term to “mix thoroughly” (or make product homogenous)
- grinding tablets with mortar & pestle or can also describe liquids (e.g. triturating an emulsion by shaking it)

LEVIGATION & SPATULATION
- involves triturating the powder with a mortar & pestle and incorporating a small amount of liquid (called a levigating or wetting agent) to help with grinding process
- spatulation is similar to levigation but performed on an ointment slab with a spatula

PULVERIZATION BY INTERVENTION
- used for crystalline powders that will not crush easily; crystals are dissolved with an intervening solvent

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7
Q

geometric dilution

A

method of mixing ingredients to ensure evenly distributed; a small amount of drug mixed into an equal amount of the diluent & this is repeated until all ingredients mixed together

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8
Q

A solution is a ________ dissolved in a _________.

A

A solution is a solute dissolved in a solvent (such as NaCl, dissolved in water). Solutions are homogenous.

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9
Q

types of solutions

A

syrups, elixirs, tinctures, spirits

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10
Q

A suspension is a _________ ____________ in a liquid.

A

A suspension is a solid dispersed in a liquid. It is a two-phase heterogenous (not uniform) mixture.
- A wetting agent/levigating agent is a type of surfactant used to incorporate an insoluble drug into a liquid, which makes a suspension.
- A desirable suspension does not have rapid precipitation of the solids; particles can be redispersed easily by shaking.

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11
Q

A emulsion is a _________ dispersed in a __________.

A

A emulsion is a liquid dispersed in a liquid.
- It is a two-phase heterogenous mixture.
- Emulsions are oil-in-water or water-in-oil
- An emulsifier is a type of surfactant that is used to reduce the surface tension between two liquids.
- To make the emulsion, choose emulsifier according to the hydrophilic-lipophilic balance (HLB)

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12
Q

Precipitation/sedimentation is when…

A

the dispersed phase settles (clumps) together.
- sedimentation is the process of a solid settling on the bottom of a container
- can happen with suspensions & emulsions (& less commonly with solutions)

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13
Q

The dissolution rate is calculated using Fick’s First Law of Diffusion. A ________ surface area, stirring the preparation, & using heat will increase the dissolution rate.

A

larger

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14
Q

Emulsions can be made by either the ___________ or ____________ method.

A

Continental or English gum method; mixing oil, water, & an emulsifier (gum) in a 4:2:1 ratio
- 4 parts oil, 2 parts water, 1 part gum (e.g. acacia)

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15
Q

steps of continental (dry gum) method

A
  1. Levigate gum with oil
  2. Add water all at once.
  3. Triturate
  4. Add other ingredients
  5. Homogenize
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16
Q

steps of English (wet gum) method

A
  1. Triturate gum with water to form a mucilage.
  2. Add oil slowly
  3. Add other ingredients
17
Q

Powders often include excipients such as glidant/lubricant to improve the flowability of a powder (_____________) & surfactant to neutralize the static charge (______________).

A

Powders often include excipients such as glidant/lubricant to improve the flowability of a powder (magnesium stearate) & surfactant to neutralize the static charge (sodium lauryl sulfate).

18
Q

If melting ingredients, melt the ingredient with the _________ melting point first.

A

higher

19
Q

A eutectic mixture means that…

A

the combination of the ingredients will melt at a lower temperature than either of the individual component’s melting temperature.

20
Q

If the components are solid powders at room temp, the mixture of the powders can melt & turn into a sticky mess. An adsorbent powder such as ________________ can be used to keep the powder dry.

A

magnesium oxide, magnesium carbonate, or kaolin

21
Q

Capsules are soluble shells of gelatin (an ___________ product) or hypromellose (a __________ product.

A

Capsules are soluble shells of gelatin (an animal product) or hypromellose (a vegetable product.

22
Q

What are used as plasticizers to make the capsules less brittle & more flexible?

A

glycerol & sorbitol

23
Q

What is the “punch method”?

A

putting powder into the capsules by hand-filling (opposed to using a capsule-filling machine)
- base is filled then fitted with the cap

24
Q

Common capsule sizes range from…

A

size 000 (largest) to 5 (smallest)

25
Q

Tablets contain the active drug & excipients, including…

A

diluents, binders, disintegrants, lubricants, coloring agents, & flavoring agents

26
Q

A lozenge contains the active drug in a base of _______ or _________ for hard lozenges, __________ for soft lozenges, & ____________ or ________ for chewable lozenges.

A

A lozenge contains the active drug in a base of sucrose or syrup for hard lozenges, PEG for soft lozenges, & glycerin or gelatin for chewable lozenges.

27
Q

Which topical contains the most water?

A

lotions

28
Q

Which topical contains the least water?

A

ointment

29
Q

Certain ointments will require heat in order to mix the components together well. This is called the _______ method.

A

fusion

30
Q

A suppository base is either…

A

oil-soluble (oleaginous) or water-soluble
- Oil-soluble bases include cocoa butter (AKA theobroma oil) & hydrogenated vegetable oils
- Water-soluble bases include PEG polymers & glycerinated gelatin.

31
Q

BUD for a non-sterile compounded non-aqueous formulation (e.g. a drug in petrolatum)

A

not later than 6 months (180 days). store at room temperature

32
Q

BUD for a non-sterile compounded water-containing oral formulation (such as an oral suspension)

A

not later than 14 days when stored at controlled cold temps. store in refrigerator

33
Q

BUD for a non-sterile compounded water-containing topical/dermal & mucosal liquid & semisolid formulation (such as a cream or lotion)

A

not later than 30 days. store at room temperature

34
Q

BUDs for repackaged drugs should be…

A

the manufacturer’s expiration date from the original container or 6 months from the repackaging date (whichever is earlier)

35
Q

left off on pg 274

A

.