COMPOUDING LAB MIDTERM Flashcards

1
Q

How to operate a class A torsion balance

A
  1. Arrest torsion
  2. Screw both knobs (left or right) same directions until they are equal- check the right side of balance
  3. To “0” balance
  4. Small knob -> arrest to release turn left
  5. View the displace
  6. Adjust it by using bottom knobs (inwards to the left, outward to the right)
  7. Look to arrest position
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2
Q

Prescription Label

A
  • Name of patient
  • Prescription number
  • Date written or dispensed
  • Directions for use
  • Name of prescriber
  • Pharmacy info
  • Special cautionary statements
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3
Q

Prescription Requirements

A
Prescriber information
Patient information
Date prescribed/written
Medication prescribed and dosage
(denoted as: Rx: drug name and dosage)
Medication information (quantity, dosage form, etc.)
Patient directions
Refills
Prescriber signature
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4
Q

BUD

A

Determined from the date when preparation is compounded
Manufacturer expiration date cannot be used as only source to determine bud
BUD general stability and drug specific considerations:
Nature of drug and degradation
Dosage form and components
Potential microbial growth
Final container
Storage conditions
Duration of therapy

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5
Q

OBRA-90 Info

A
  • Name and description
  • Dosage form, route, and duration
  • Adverse effects
  • Precautions
  • Refill info
  • Storage
  • Missed doses
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6
Q

Oleaginous internal phase with aqueous external phase

A

Oil in water (o/w)

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7
Q

Compound White Ointment

A

White petrolatum and white wax over heat

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8
Q

Solutions

A

Liquid preparations that contain one or more chemical substances dissolved in a suitable solvent or mixture of mutually miscible solvents

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9
Q

Syrup

A

Aqueous solutions containing sugar

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10
Q

Solubility

A

Indicates the maximum concentration to which a solution may be prepared with that agent and that solvent

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11
Q

FDA recommendation for OTC alcoholic products

A
  • Children under 6yrs 0.5%
  • Children 6-12yrs 5%
  • Over 12yrs 10%
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12
Q

Diluted alcohol

A

Prepared by mixing equal volumes of water and alcohol (strength approximately 49%)

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13
Q

Dry Mixtures for Solution

A
  • Insufficient stability to meet extended shelf-life

- Once reconstituted, solution remains stable for 7-14 days

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14
Q

Flavored Vehicles

A

Non-medicated syrups containing flavoring agents

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15
Q

Syrup Components

A
  • Sugar
  • Antimicrobial preservatives
  • Flavorants
  • Colorants
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16
Q

Trituration

A

Process of grinding a drug in a mortar to reduce its particle size

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17
Q

Levigation

A

Used in ointments to reduce the particle size and grittiness of added powders

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18
Q

Transdermal

A

Designed to deliver drugs through the skin into circulation for system effects

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19
Q

Ointments

A

Semisolid preparations intended for external application to the skin or mucous membranes

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20
Q

Hydrocarbon Ointment Bases

A
  • AKA oleaginous bases
  • Protect against the escape of moisture
  • Difficult to wash off with water
  • Ex. Petrolatum, white ointment, etc
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21
Q

Water-Removable Absorption Bases

A
  • Oil in water emulsions resembling creams
  • Easily washed from skin
  • Have the ability to absorb serous discharges
  • Ex. hydrophilic ointment
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22
Q

Water-Soluble Absorption Bases

A
  • Do not contain oleaginous components
  • Completely water washable
  • Referred to as greaseless
  • Used mostly for incorporation of solid substances
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23
Q

Base Selection Factors

A

Factors

  • Desired release rate
  • Desirability for topical or percutaneous absorption
  • Desirability of occlusion of moister from skin
  • Stability in ointment base
  • Effect of drug on consistency etc
  • Desire for a base that is easily water-washable
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24
Q

Ointment Incorporation

A
  • Solids or liquids

- Components are mixed until a uniform preparation is attained by using a mortar/pestle, or a spatula and ointment slab

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25
Q

Ointment Fusion

A

-All or some of the components are combined by being melted together and cooled with constant stirring

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26
Q

USP Ointment Requirements

A
  • Microbial content
  • Minimum fill
  • Packaging, storage, and labeling
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27
Q

Creams

A

Semisolid preparations containing one or more medicinal agents dissolved or dispersed in either oil-in-water emulsion or in another water-washable base

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28
Q

Pluronic Lecithin Organogel (PLO)

A
  • Two phases(Oil and water)
  • Phospholipid liposomal microemulsion used for transdermal drug administration
  • Usually 1 part oil phase/4 parts water phase
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29
Q

Pastes

A
  • Semisolid preparations intended for application to the skin
  • Contain larger proportion of solid material than ointments
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30
Q

Packaging for Semisolid Preparations

A
  • Ointment tubes

- Ointment jars

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31
Q

CarBAMazepin

A

Carbatrol; Epitol; Equetro; TEGretol; TEGretol-XR
Anticonvulsant
IV ( 4 infusions (every 6 hours) over 30 minutes.) and oral : 1,600 mg/day.
Epilepsy
US Boxed Warning: Blood dyscrasias, Dermatologic toxicity
Adverse Reactions: dizziness, drowsiness, nausea
Dosage form: chewable, tablet, suspension

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32
Q

Escitalopram

A

Lexapro
10 mg once daily; dose may be increased to a maximum of 20 mg once daily after at least 1 week
Treatment of major depressive disorder; generalized anxiety disorders (GAD)
US Boxed Warning: Suicidal thinking/behavior
Adverse effect: headache, nausea
Dosage: oral and solution
no children
Oral: 5mg, 10mg, 20mg 5mg/5ml

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33
Q

lopid

A

Gemfibrozil
Oral: 600 mg twice daily 30 minutes before breakfast and dinner.
Treatment of hypertriglyceridemia in Fredrickson types IV and V hyperlipidemia
Adverse effect: Dyspepsia
no children

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34
Q

1 inch = ______ cm

A

2.54 cm

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35
Q

1 tsp = _______ mL

A

5mL

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36
Q

1 tbsp = ______ mL

A

15mL

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37
Q

1 fl. oz = _________ mL

A

30mL

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38
Q

1 pint = _______ fl.oz or ________ mL

A

16 fl.oz or 473mL

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39
Q

1 quart = ________ fl. oz or ________ mL

A

32 fl. oz or 946mL

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40
Q

1 gallon = ________ fl. oz or _________ mL

A

128 fl. oz or 3785mL

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41
Q

1 kilogram = _______ lb

A

2.2 lb

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42
Q

1 ounce = _________ g

A

28.4 g

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43
Q

1 grain = _________ mg

A

65 mg

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44
Q

Compounding

A

Preparation, mixing, assembling, packaging, or labeling of a drug or device

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45
Q

Manufacturing

A
  • Production, preparation, propagation, conversion, and/or processing of a drug or device
  • Any packaging or repackaging of substances
  • Preparation and promotion of commercially available products from bulk compounds
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46
Q

Active Ingredients

A

Chemicals, substances, or other components of articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases/nutritional supplementation

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47
Q

Added Ingredients

A

Necessary for preparing dosage forms or for enhancing the stability of finished preparations

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48
Q

USP Ingredient

A

Certified to meet or exceed the specifications prescribed in the current edition of USP

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49
Q

NF Ingredient

A

Certified to meet or exceed the specifications prescribed in the current edition of NF

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50
Q

FCC Ingredient

A

Certified to meet or exceed the specifications listed in the current edition of the Food Chemical Codex

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51
Q

ACS Ingredient

A

Certified to meet or exceed the specifications listed in the current edition of Reagent Chemicals

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52
Q

AR Ingredient

A
  • aka Analytical Reagent Grade

- Grade assigned to chemicals of high purity that is suitable for analytic laboratory work

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53
Q

CP Ingredient

A
  • aka Chemically Pure
  • Chemicals which are much more refined than technical grade, but for which only partial analytic information is available
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54
Q

Technical Ingredient

A
  • aka Commercial Grade

- Grade assigned to chemicals of commercial or industrial quality

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55
Q

Food Grade

A

Grade assigned to chemicals that have clearance for use in foods

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56
Q

Cosmetic Grade

A

Designation can be given to chemicals approved for use in cosmetics

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57
Q

Freezer Storage Temp

A

-25 to -10 degrees celsius

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58
Q

Cold Storage Temp

A

Not exceeding 8 degrees celsius

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59
Q

Refrigerator Storage Temp

A

2 to 8 degrees celsius

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60
Q

Cool Storage Temp

A

8 to 15 degrees celsius

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61
Q

Controlled Room Storage Temp

A

20 to 25 degrees celsius

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62
Q

Warm Storage Temp

A

30 to 40 degrees celsius

63
Q

Excessive Heat Storage Temp

A

Above 40 degrees celsius

64
Q

Dry Place Storage

A

Controlled room temperature with relative humidity (not exceeding 40%)

65
Q

Light-Resistant Container

A

Protect the article or product from the effects of light

66
Q

Well-Closed Container

A

Provides protection from extraneous solids getting in, or the contents of the container getting out under normal conditions

67
Q

Tight Container

A

Protects from contamination by extraneous liquids, solids, vapors, from loss of the article, and from efflorescence, deliquescence, or evaporation

68
Q

Hermetic Container

A
  • Most secure container type

- Impervious to air or other gas under normal conditions

69
Q

Steps in Compounding Process

A
  • Preparatory
  • Compounding
  • Final Check
  • Sign Off
  • Clean up
70
Q

Handling Hazardous Materials

A

The Occupational Safety and Health Admin (OSHA) of the federal government protects the health and safety of all workers and is responsible for enforcing the HCS

71
Q

Hazard Communication Standard (HCS)

A
  • Pharmacies/Labs must maintain comprehensive inventory
  • Material Safety Data Sheets must be maintained
  • All containers of hazardous chemical must be labeled with warnings
  • Students and employees must be informed of chemical hazards, and elements of HCS
72
Q

Legend drug

A

A drug that is available to a patient by prescription only.

73
Q

National drug code (NDC)

A

A permanent number (10 digits) assigned to a drug and registered with the FDA identifying the manufacturer or distributor, the drug identity and formulation, and the package size.

74
Q

Solution

A

a liquid preparation containing one or more drug substances that are evenly dispersed in a soluble solvent or mixture of miscible solvents.

75
Q

Schedule I controlled substance

A

Drugs with NO ACCEPTED medicinal use that have a high potential for abuse

76
Q

Schedule II controlled substance

A

Drugs with accepted medical uses and a HIGH potential for abuse, which if abused may lead to severe psychological or physiological dependence.

77
Q

Schedule III controlled substance

A

Drugs with accepted medical uses and a lower potential for abuse when compared to schedule I and II agents. If abused may lead to moderate or low physiological dependence or high psychological dependence.

78
Q

Schedule IV controlled substance

A

Drugs with accepted medical uses and a lower potential for abuse when compared to Schedule III agents. If abused may lead to limited physiological or psychological dependence.

79
Q

Schedule V controlled substance

A

Drugs with accepted medical uses and a low potential for abuse relative to the agents in schedule IV. If abused may lead to limited physiological or psychological dependence.

80
Q

• National formulary (NF)

A
  • Formulary that contained many popular drugs and formulas denied admission to the usp
  • USP purchased NF combining and creating one national Official compendia
81
Q

• USP

A

Contains Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP (dietary supplements and ingredients appear in a separate section)

82
Q

• NF

A

Contains Excipient monographs

83
Q

• Monograph includes

A

name of the ingredient or preparation; definition; packaging, storage, and labeling requirements; and the specification (series of tests, procedures for the tests, and acceptance criteria according to official USP reference standards)
Medicinal ingredients and products will have the stipulated strength, quality, and purity

84
Q
  1. Protection of a drug substance from the destructive influences of atmospheric oxygen or humidity
A

Example: Coated tablets, sealed ampules

85
Q
  1. Protection of a drug substance from the destructive influence of gastric acid after oral administration
A

Example: Enteric-coated

86
Q
  1. Conceal the bitter, salty, or offensive taste or odor of a drug substance
A

Example: Capsules, coated tablets, flavored syrups

87
Q
  1. Provide liquid preparations of substances that are either insoluble or unstable in the desired vehicle
A

Example: Suspensions

88
Q
  1. Provide clear liquid dosage forms of substances
A

Example: Syrups, solutions

89
Q
  1. Provide rate-controlled drug action
A

Example: Controlled-release tablets, capsules, and suspensions

90
Q
  1. Provide optimal drug action from topical administration sites
A

Example: Ointments, creams, transdermal patches, ophthalmic, ear, and nasal preparations

91
Q
  1. Provide for the insertion of a drug into one of the body’s orifices
A

Example: Rectal or vaginal suppositories

92
Q
  1. Provide for the placement of drugs directly into the bloodstream or into body tissues
A

Example: Injections

93
Q
  1. Provide for optimal drug action through inhalation therapy
A

Example: Inhalants and inhalation aerosols

94
Q

Compound vs manufacturing

A
- Compounding
Preparation
Packaging
Labeling of a drug
Result of a prescription drug order
- Manufacturing
Preparation
Packaging
Labeling a container
Relabeling a container
Repackaging
Promotion
Marketing
95
Q

Aqueous solution

A

Medications dissolved in water along with any other necessary agents
Distilled or purified water should be used
Examples: Syrup

96
Q

Nonaqueous Solution

A

Contain solvents other than water either alone or in addition to water
Alcohol most commonly used

97
Q

Solubility

A

Degree of being able to dissolve
Maximum concentration to which a solution may be prepared with agent and solvent
Usually expressed as the number of mL of solvent required to dissolve 1 gram of drug

98
Q

Unsaturated solution

A

more solute dissolves

99
Q

Saturated solution

A

no more solute dissolves

100
Q

Supersaturated solution

A

becomes unstable crystals form

101
Q

Solvents

A

Capable of dissolving another substance

Completely dissolve the drug and other solid ingredients at desired concentration
Nontoxic
Safe for ingestion or topical application
Aesthetically pleasing

102
Q

Syrups

A

Concentrated aqueous preparations of a sugar or sugar substitute with or without flavoring agents and medicinal substances

Concentrated sugar or sugar substitute aqueous liquids
Flavoring vehicle
Contains no medicinal substance
Any water-soluble drug that is stable in aqueous solution may be added to a flavored syrup

103
Q

Antimicrobial Preservative

A

Protect against microbial growth
Amount varies with the proportion of water available for growth, the nature and inherent preservative activity of materials

104
Q

Demulcent

A

relieving inflammation or irritation.

105
Q

Hard sticks

A

Ex: Styptic pencil (razor cuts)

106
Q

Soft Opaque sticks

A

Ex: Lip balm

107
Q

Soft Clear sticks

A

Ex: Deodorant stick

108
Q

Eutectic Liquid

A

Mixture of substances that melts and solidifies at a single temperature that is lower than the melting points of the separate constituents

109
Q

Suspension

A

Preparations containing finely divided drug particles distributed somewhat uniformly throughout a vehicle with minimum degree of solubility

110
Q

Suspension Physical Features

A
  • Particle diameter 1-50 micrometers

- Slower sedimentation as particle size decreases

111
Q

Sustained Release Suspension

A

-Uses ion-exchange resin complex and particle coating

112
Q

Elderly Suspension Considerations

A

Cautious with alcohol containing products

113
Q

USP/NF background: Pharmacopeia

A
  • Any recipe or formula or other standards required to make or prepare a drug
  • 1st united states pharmacopeia (Usp) published in 1820
114
Q

Compounding Suspensions

A
  • Capsule contents are emptied and crushed in mortar
  • Selected vehicle is slowly added to create paste
  • Dilute to desired volume
115
Q

Neonate Considerations

A

Avoid preservatives, colorings, flavorings, or alcohol

116
Q

Suspension Packaging

A
  • Wide mouth, tight containers
  • Protected from freezing, excessive heat and light
  • Shake well before use
  • Most will need to be refrigerated
117
Q

Emulsion External Phase

A

Dispersion medium

118
Q

Emulsion

A

A dispersion in which the dispersed phase is composed of small globules of a liquid distributed throughout a vehicle in which it is immiscible

119
Q

Patient Counseling Steps (5)

A
  • Greeting
  • Open ended questions
  • Educate
  • Summarize
  • Follow up/closing
120
Q

Emulsion Internal Phase

A

dispersed phase

121
Q

What is needed to prepare a stable emulsion?

A

Third phase emulsifying agent

122
Q

Emulsifying Agents Carbs

A

Acacia, agar pectin

123
Q

Emulsifying Agents Proteins

A

Gelatin, egg yolk, casein

124
Q

Emulsifying Agents High molecular weight alcohols

A

Stearyl alcohol, cetyl alcohol, glyceryl monostearate

125
Q

Methods of Emulsion Preparation

A
  • Continental or Dry Gum Method
  • English or Wet Gum Method
  • Bottle or Forbes Bottle Method
126
Q

When are emulsions physically unstable?

A
  • Internal phase upon standing tends to form aggregates of globules
  • Large globules rise to top or fall to bottom
  • If all or part of the liquid of the internal phase becomes unemulsified and forms layer
127
Q

Emulsion Examples

A
  • Mineral oil
  • Castor oil
  • Simethicone
128
Q

Gel

A

Semisolid system consisting of dispersions made up of either small inorganic particles or large organic molecules enclosing and interpenetrated by a liquid

129
Q

Magma

A

The gel mass consists of small distinct particles and is classified as a two-phase system

130
Q

Inhibition

A

Taking up of a certain amount of liquid without measurable increase in volume

131
Q

Swelling

A

Taking up of a liquid by a gel with an increase in volume

132
Q

Syneresis

A

Interaction between particles of the dispersed phase becomes so great that the medium is squeezed out in droplets and the gel shrinks

133
Q

Thixotrophy

A

Reversible gel-sol formation with no change in volume or temperature

134
Q

Xerogel

A

Formed when the liquid is removed from a gel and only the framework remains

135
Q

Types of Gels

A
  • Inorganic
  • Organic
  • Hydrogels
  • Organogels
  • Animal/Vegetable Fats
  • Soap base
  • Hydrophilic Organogels
136
Q

Aerosols

A

Pressurized dosage forms containing one or more active ingredients which upon actuation emit a fine dispersion of liquid and/or solid material

137
Q

Space Sprays

A

Used to provide airborne mist(room disinfectants)

138
Q

Surface Sprays

A

Used to carry the active ingredient to a surface (dermatologic aerosols)

139
Q

Elixir

A

Sweetened hydroalcoholic solutions

140
Q

Spirits

A

The solvent is alcoholic

141
Q

Aromatic waters

A

The solvent is acqueous

142
Q

Tincture

A

Solution of chemical substances dissolved in alcohol or in a hydroalcoholic solvent

143
Q

Solution Absorption

A

Occurs more rapidly than from suspension or solid dosage forms

144
Q

Spatulation

A

Small amounts of powders may be blended by the movement of a spatula through the powders on a sheet of paper

145
Q

Sifting

A

Powder is passed through a sifter. Results in a light fluffy product

146
Q

Tumbling

A

Powder is enclosed in a rotating container

147
Q

Internal Medicated Powders

A
  • Taken orally after mixing with water
  • Faster rates of dissolution and absorption
  • Taste disadvantage
148
Q

External Medicated Powders

A
  • Dusted on the affected area

- Should have EXTERNAL USE ONLY label

149
Q

Inhalation Medicated Powders

A
  • Administered with the aid of dry-powder inhaler

- Particle size must be small in order to reach deep into the lungs

150
Q

Bulk Powders

A
  • Antacid
  • Laxative
  • Douche
  • Antifungals
  • Limited to nonpotent substances
151
Q

Granules

A
  • Smaller particles of powder that are irregularly shaped
  • Prepared by wet methods and dry methods
  • Flow better than powders
  • More stable to effects of humidity
  • More easily wetted by liquids
152
Q

Divided Powders

A
  • After blending a powder it may be divided into individual dosing units
  • Headache powders
  • Powdered laxatives
  • Douche
  • We used folding paper method
153
Q

Topical

A

Designed to deliver a drug into the skin (skin is target organ)

154
Q

Intrathecal

A

Injection into the meninges of the spinal cord