T1 - Week 6 Flashcards

1
Q

What is the USP defintion of powders?

A

A single solid or mixture of solids in a finely divided state

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2
Q

What is a powder?

A

A dry substance composed of finely divided particles

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3
Q

How is powder pharmaceutically prepared?

A
  1. A medicated powder
  2. Limited use in therapeutics
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4
Q

What are granules?

A

Prepared agglomerates of powdered material

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5
Q

Define micromeritics

A

The study of small particles

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6
Q

Describe the characteristics of powders

A
  1. Bulk volume of a powder (Vbulk)
  2. True volume
  3. Void= (Vbulk-V)/Vbulk
  4. Porosity
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7
Q

What is true volume?

A

The space occupied by the powder exclusive of the intramolecular space

Excluding void volume

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8
Q

What is envelope density?

A

Includes pore volume but not interparticle spaces

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9
Q

What is bulk density?

A

Includes pore volume and interparticle spaces

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10
Q

What is porosity?

A

Measure of void volume

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11
Q

What variables does micromeritics study?

A
  1. Partical size
  2. Shape
  3. Angle of repose
  4. Porosity
  5. True volume
  6. Bulk volume
  7. Apparent density
  8. Bulkiness
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12
Q

What are some methods of determining particle sizes?

A
  1. Sieving
  2. Microscopy
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13
Q

What are USP’s descriptive terms for particle size of powder?

A
  1. Very coarse (Sieve #8)
  2. Coarse (Sieve #20)
  3. Moderately coarse (Sieve #40)
  4. Fine (Sieve #60)
  5. Very fine (Sieve #80)
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14
Q

How are granule particle analysized?

A
  1. Typically fall within the range of 4 - to 12-sieve size
  2. Sometimes 12- to 20-sieve range are used in tablet making.
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15
Q

What are the roles of particle size?

A
  1. Stability
  2. Drug Absorption
  3. Side Effects
  4. Manufacturing aspects (Mixing, compression, wetability, flow)
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16
Q

What is comminution?

A

Reduction of the particle size of a solid substance to a finer state

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17
Q

What are the methods of reducing particle size on a small scale?

A
  1. Rough surface (as a porcelain mortar) result in a finer grinding action than a smooth surface (as a glass mortar).
  2. Grinding a drug in a mortar to reduce its particle size is termed trituration or comminution.
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18
Q

What are the methods of reducing particle size on a large scale?

A

Mills and pulverizers

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19
Q

What is levigation?

A

Used in small-scale preparation of ointments and suspensions to reduce the particle size and grittiness of the added powders.

A mortar and pestle or an ointment tile may be used.

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20
Q

What are the steps of levigation?

A
  1. A paste is formed by combining the powder and a small amount of liquid (the levigating agent) in which the powder is insoluble.
  2. The paste is then triturated, reducing the particle size.
  3. Mineral oil and glycerin are commonly used levigating agents.
  4. The levigated paste may then be added to the ointment base and the mixture made uniform and smooth by rubbing them together with a spatula on the ointment tile.
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21
Q

What is the angle of repose?

A

Technique for estimating the flow properties of a powder

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22
Q

How is the angle of repose achieved?

A
  1. Done by allowing the powder to flow through a funnel and fall freely onto a surface.
  2. The height and diameter of the resulting cone are measured and the angle of repose is calculated.
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23
Q

What are the different methods of powder blending?

A
  1. Spatulation
  2. Trituration
  3. Sifting
  4. Tumbling
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24
Q

How would we make blended powder?

A

Reducing the particle sizes of each powder to make it more uniform

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25
Q

What is spatulation?

A

Blending small amounts of powders by movement of a spatula through them on a sheet of paper or an ointment tile.

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26
Q

Why isn’t spatulation suitable for large quantities of potent drugs?

A

Because homogenous blending may not be ascertained

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27
Q

Can this be used to incorporate potent drugs into diluent powder?

A

No

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28
Q

What is trituration?

A

Used to both comminute and mix powders

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29
Q

What is used for trituration?

A

Glass mortar

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30
Q

What is sifting?

A

Mixing powders by passing through sifters

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31
Q

What is tumbling

A

Mixing powders in a rotating chamber but time-consuming

32
Q

Describe geometric dilution method

A
  1. Used with a small amount of a poten substance is to be mixed with a large amount of diluent
  2. Done by placing the potent drug with an approximately equal volume/amount of the diluent in a mortar and is mixed thoroughly by trituration.
  3. Process continued by adding an equal volume of diluent to the powder mixture.
33
Q

What is segregation?

A

Undesirable separation of the components of the blend, occurred by sifting, air entrapment, and particle entrapment

34
Q

What are advantages of medicated powders for internal use?

A

The doses of some drugs are too bulky to be formed into tablets or capsules of convenient size, so they may be administered as powders.

35
Q

What are disadvantages of medicated powders for internal use?

A

Undesirable taste of the drug

36
Q

What is bulk powder?

A
  1. Reasonably dosed with inaccurate measuring devices
  2. Susceptible to degradation
37
Q

What is oral powder?

A
  1. Bulk or Divided Powders (accurate single dose)
  2. Effervescent granules
  3. Granules for suspension
38
Q

What is dusting powder?

A
  1. Topical use
  2. Medicated, Protectant, Absorbent, Astringent, Coolant
39
Q

What is douche powder?

A
  1. Powders to add to solution
  2. Enhanced portability Usually acidic
40
Q

What is insufflation?

A

Fine powders introduced to body cavities by mechanical means

41
Q

What is inhalation powder for?

A

Delivery to lungs

42
Q

What is efflorescent powder?

A

Drugs or chemicals that contain water of hydration that may be released when the powders are manipulated or are stored under conditions of low relative humidity

43
Q

What is hygroscopic powder?

A

Solid drugs or chemicals that absorb moisture from the air

44
Q

What is deliquescent powder?

A

Hygroscopic powders that may absorb sufficient moisture from the air to dissolve and form a solution.

45
Q

What is pharmaceutical eutectic mixture?

A

A mixture of two or more solid substances that may liquefy when intimately mixed at room temperature

46
Q

What are the components of hard gelatin capsules

A
  1. Size 000 - 5
  2. 1.4 mL - 0.13 mL
47
Q

How are capsules closed?

A
  1. Hard Gelatin Capsule Closures
  2. Coni-snap
  3. Capsule seals
48
Q

What are the powders that require special handling?

A
  1. Efflorescent powder
  2. Hygroscopic powder
  3. Deliquescent powder
  4. Pharmaceutical eutectic mixture
49
Q

What goes in a capsule?

A
  1. Powder or granule
  2. Pellet
  3. Paste
  4. Capsule
  5. Tablet
50
Q

What are the types of capsule fillings?

A
  1. Manual
  2. Tablet mold
51
Q

What is the process of industry’s filling capsules?

A

Ingredients go into the milling/sieving → Blending → Powder blend go into the capsule filler → Capsule inspection screen → Capsule check-weighing system → Finished capsules → Packaging

52
Q

What are soft gelatin capsules?

A
  1. More moisture than hard gelatin capsules
  2. Often have preservatives like methyl and propyl paraben
  3. Designed to hermetically seal
53
Q

What does in soft gelatin capsules?

A
  1. Liquid
  2. Paste
  3. Powder
  4. Tablets
54
Q

What is direct compression?

A
  1. For Blends with good flow and compressibility
  2. Simple, time-effective and cost-effective process
  3. Conformity of low dose actives is a problem
  4. High-dose actives are difficult to process
  5. Segregation can occur
  6. Static Charge can occur due to lack of moisture
55
Q

What is wet granulation?

A
  1. Can densify materials
  2. Improved flow and compressibility
  3. Improves content uniformity
  4. Reduces fine particles and electrostatic charge
  5. Can process drugs susceptible to high shear
56
Q

What are the disadvantages of wet granulation?

A
  1. Multiple process step
  2. Expensive
  3. Time consuming
  4. Not good for heat
  5. Moisture sensitive
57
Q

What is dry granulation?

A
  1. Can densify materials
  2. Improved flow and compressibility
  3. Can process moisture sensitive materials
  4. Less time and cost effective than direct compression
  5. Can not process drugs susceptible to high shear
  6. Process creates dust and fine particles.
58
Q

What are examples of compression testing?

A
  1. Tablet Hardness (crushing strength)
  2. Disintegration Testing
  3. Friability (mechanical shock)
  4. Weight Variation
  5. Content Uniformity
  6. Assay of API
59
Q

What are the types of capping defects?

A
  1. Top of tablet is broken
  2. Trapped air on compression
60
Q

What are the types of lamination defects?

A

Layering of particles instead of bonding together

61
Q

What are the types of picking and sticking defects?

A
  1. Logos, lettering, imprint codes
  2. Particles stick to machinery
62
Q

What are types of coating defects?

A
  1. Logo bridging and filling
  2. Picking and Sticking
  3. Twinning- tablets sticking together
  4. Orange peel – roughness of coating
  5. Color Variation
  6. Cratering
  7. Cracking
  8. Core Erosion- core breaks down
  9. Edge Chipping
63
Q

What are compressed tablets?

A
  1. Any shape or size
  2. Scored or unscored
64
Q

What are multi-compressed tablets?

A

Tablet with a tablet or multi-layer

65
Q

What is multi-compressed tablets used for?

A
  1. Overcoming imcompatibilities
  2. Altering drug release
  3. Unique appearance
66
Q

What are film-coated tablets?

A
  1. Thin polymer coat
  2. More durable, less time-consuming, less bulky than sugar coating
  3. Designed to rupture at the desired location in GI tract
67
Q

What are sugar-coated tablets?

A
  1. Mask taste
  2. Protect formulation
  3. Makes imprinting easier
  4. Improves appearance
  5. Bulky- adds 50% to weight of tablet.
  6. Difficult coating process
68
Q

What are gelatin-coated tablets?

A
  1. Gelatin Coat over compressed tablet
  2. Provides smaller dosage form than filling a capsule of same amount of ingredients
  3. Facilitates swallowing
  4. More tamper evident
69
Q

What are enteric-coated tablets?

A
  1. Delayed release properties
  2. Designed to pass through stomach unchanged
  3. Drug release in small intestine
70
Q

What is an enteric coat used for?

A
  1. Stomach degrades API
  2. API is irritating to stomach lining
  3. Enhance absorption of drug
71
Q

What are chewable tablets?

A

Chewable and dissolves quickly

72
Q

What are effervescent tablets?

A

Dissolves in water prior to administration

73
Q

What are chewable dispersible tablets?

A

Can be swallowed, chewed or dispersed prior to administration

74
Q

What are other types of tablets?

A
  1. Rapidly Disintegrating Tablets (Orally Disintegrating Tablets) (RDT, ODT)
  2. Vaginal Tablets
75
Q

What are the characteristics of molded tablets?

A
  1. Base is lactose
  2. Combinations with sucrose, dextrose, and/or mannitol are commonly used.
  3. Small tablets usually around 1 grain (65 mg)
  4. Very soluble in water
  5. Good for buccal and sublingual delivery
  6. Usually potent drugs
76
Q

What occurs when molded tablets have too much liquid?

A
  1. Hamper cohesion
  2. Extend drying time
  3. Cause creeping of API to surface