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.

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
Tablets contain the active drug & excipients, including...
diluents, binders, disintegrants, lubricants, coloring agents, & flavoring agents
26
A lozenge contains the active drug in a base of _______ or _________ for hard lozenges, __________ for soft lozenges, & ____________ or ________ for chewable lozenges.
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
Which topical contains the most water?
lotions
28
Which topical contains the least water?
ointment
29
Certain ointments will require heat in order to mix the components together well. This is called the _______ method.
fusion
30
A suppository base is either...
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
BUD for a non-sterile compounded non-aqueous formulation (e.g. a drug in petrolatum)
not later than 6 months (180 days). store at room temperature
32
BUD for a non-sterile compounded water-containing oral formulation (such as an oral suspension)
not later than 14 days when stored at controlled cold temps. store in refrigerator
33
BUD for a non-sterile compounded water-containing topical/dermal & mucosal liquid & semisolid formulation (such as a cream or lotion)
not later than 30 days. store at room temperature
34
BUDs for repackaged drugs should be...
the manufacturer's expiration date from the original container or 6 months from the repackaging date (whichever is earlier)
35
left off on pg 274
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