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Pharmaceutical Sciences > PSII Exam III > Flashcards

PSII Exam III Flashcards

1
Q

What is a tablet?

A

Solid oral dosage form composed of DRUG SUBSTANCE and EXCIPIENTS compressed from powder into a solid.

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2
Q

What are four (4) types of tablets?

A
  1. Oral tablets for ingestion
  2. Tablets used in oral cavity (oral release)
  3. Tablets administered by other routes
  4. Tablets used to prepare solution/suspension
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3
Q

What are five (5) advantages of tablets?

A
  1. Accurate and uniform dose
  2. Superior stability
  3. Ability to modify drug release
  4. “Easy” to mask taste
  5. Economical
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4
Q

What are three (3) disadvantages of tablets?

A
  1. Large tablet size may be difficult to SWALLOW.
  2. Poor FORMULATION may cause therapeutic FAILURE – disintegration and dissolution as rate limiting steps.
  3. Properties of API may cause ‘COMPRESSION PROBLEMS’ resulting in non-uniform dose.
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5
Q

What are eight (8) types of excipients?

A
  1. Binders
  2. Disintegrants
  3. Lubricants
  4. Anti-adherents
  5. Fillers/diluents
  6. Glidants
  7. DISSOLUTION enhancers/retarders
  8. Miscellaneous
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6
Q

What is a binder and give an example.

A

Helps particles stick together to form granules.

Ex. Starch

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7
Q

What is a disintegrant and give an example.

A

Helps tablet break apart in GI.

Ex. Sodium starch glycolate.

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8
Q

What is a lubricant and give an example.

A

Reduce friction between wall and die cavity (manufacturing machinery).
Ex. Magnesium stearate

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9
Q

What is an anti-adherent and give an example.

A

Reduce sticking of granules to punch or die cavity (manufacturing machinery).
Ex. Talc

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10
Q

What is a filler/diluent and give an example.

A

Increase bulk of formulation to a convenient size for compression.
Ex. Lactose

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11
Q

What is a glidant and give an example.

A

Improve flow of powder mixture.

Ex. Silicon dioxide

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12
Q

What is a DISSOLUTION enhancer/retarder?

A

Control release of drug

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13
Q

What are four (4) examples of miscellaneous excipients?

A
  1. Wetting agents
  2. Flavoring agents
  3. Coloring agents
  4. Antioxidant
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14
Q

What are six (6) considerations for the CHOICE of an EXCIPIENT in a DRUG FORMULATION?

A
  1. Delivered dose
  2. Route of administration
  3. Desired release characteristics
  4. Properties of drug
  5. Properties of excipient
  6. Manufacturing requirements
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15
Q

What are four (4) criteria for a substance to be used as an excipient in a drug formulation?

A
  1. Generally Regarded as Safe Status
  2. Available
  3. Physiological/Biological Stability
  4. Cost effective
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16
Q

What are three (3) FUNDAMENTAL properties of particles?

A
  1. Size
  2. Shape
  3. True density
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17
Q

What are five (5) DERIVED properties of particles?

A
  1. Bulk density
  2. Porosity
  3. Flow
  4. Cohesion/adhesion
  5. Surface area
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18
Q

What are seven (8) UNIT OPERATIONS in tablet manufacturing?

A
  1. Mill (API)
  2. Screen (EXCIPIENT)
  3. Blend/Mix
  4. Granulate (SOLVENT)
  5. Blend/Mix (EXCIPIENT)
  6. Compress
  7. Coat
  8. Package (CONTAINER)
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19
Q

What is the function of milling?

A

To reduce particle size and size variation.

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20
Q

What are four (4) ways to reduce particle size with milling?

A
  1. Compression
  2. Abrasion
  3. Shearing
  4. Impact
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21
Q

What are three (3) examples of milling equipment?

A
  1. Ball Mill
  2. Hammer Mill
  3. Attrition Mill (high velocity air)
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22
Q

What are three (3) potential failure modes of milling?

A
  1. Reduce size too much or too little
  2. Generate static electricity (explosion risk)
    * *3. Induce physical or chemical changes (from heat or mechanical stress) [ex. Gabapentin stability reduced with increased processing]
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23
Q

What is the function of blending/mixing?

A

Content uniformity

24
Q

What are three (3) forces acting during blending/mixing?

A
  1. Acceleration [mechanical] forces
  2. Gravitation forces
  3. Cohesive forces
25
Q

What are four (4) approaches to blending/mixing?

A
  1. Trituration (mortar and pestle)
  2. Spatulation (geometric dilution)
  3. Tumbling (container moves)
  4. Stationary mixer (container does not move; blade moves)
26
Q

What is the most effective example of a tumbling equipment?

27
Q

What are three (3) examples of stationary mixers?

A
  1. Hobart mixer (kitchen aid type)
  2. Ribbon blender (ribbon-shaped blade)
  3. Helical flight (conical rotating screw)
28
Q

What are four (4) possible mixing failure modes?

A
  1. Difficulty with poorly flowing/highly cohesive powders.
  2. Over mixing can cause poor lubrication
  3. Non-uniform mixing of low dose drug
  4. Segregation (demixing of powder during later unit operation)
29
Q

What is the function of granulation?

A

Create a compressible conglomerate of API and excipient

30
Q

What are three methods of granulation?

A
  1. Direct compression
  2. Dry granulation
  3. Wet granulation
31
Q

What are three (3) considerations for choosing a granulation method?

A
  1. Flow
  2. Compressibility
  3. Compactibility
32
Q

When can direct compression be used?

A

Flow, compressibility and compactibility of drug are all GOOD.

33
Q

When can dry granulation method be used?

A

Only FLOW of drug is poor.

34
Q

When must wet granulation method be used?

A

When any attribute besides FLOW is poor.

35
Q

What is the function of compression?

A

Bind powder into solid.

36
Q

What is the physical basis for tablet formation by compression?

A

Formation of lasting areas of TRUE CONTACT between particle surfaces.

37
Q

What are four (4) steps in the compression cycle?

A
  1. Fill the die
  2. Adjust the weight
  3. Compress
  4. Eject
38
Q

What are three (3) examples of compression machinery?

A
  1. Hydraulic Tablet Machine
  2. Rotary Tablet Machine
  3. Multi-punch Tablet Machine
39
Q

What are two types of poorly formed tablets?

A
  1. Capped tablet (separation of crown from main body)

2. Laminated tablet (separation into distinct layers)

40
Q

What are four (4) processing problems in tablet compression?

A
  1. Picking/sticking (adhesion of powder to machinery)
  2. Mottling (unequal color distribution)
  3. Whiskering (cracking and chipping)
  4. Weight variation
41
Q

What are three (3) properties of TABLETS AND their relationship to the amount of COMPRESSION FORCE

A
  1. Apparent porosity (inversely proportional)
  2. Hardiness (directly proportional)
  3. Disintegration time (directly proportional)
42
Q

What are five (5) potential reasons for coating a tablet?

A
  1. Mask taste, odor or color of drug
  2. Control release of drug
  3. Reduce interaction between incompatible ingredients
  4. Protect tablet from gastric environment
  5. Enhance compliance
43
Q

What are four (4) components of a coating mixture?

A
  1. Polymer
  2. Plasticizer
  3. Colorant
  4. Solvent/Dispersing agent
44
Q

What are five (5) attributes of a polymer film (coating) former?

A
  1. GRAS status
  2. Soluble in [a] solvent of choice/[b] solution pH
  3. Resistant to cracking
  4. Provides adequate protection from moisture, light, heat, etc.
  5. No taste, color or odor (unless desirable).
45
Q

What are the disadvantages of sugar coating a tablet?

A
  1. Multistep
  2. Labor intensive
  3. Time consuming
46
Q

What are three (3) types of polymer film coatings?

A
  1. Fast dissolving
  2. Sustained release/Extended release
  3. Enteric/Delayed Release
47
Q

What are two (2) examples of non-enteric film forming polymers?

A
  1. Ethylcellulose

2. Hydroxypropylcellulose

48
Q

What are two (2) examples of enteric film forming polymers?

A
  1. Cellulose acetate phthalate

2. Cellulose acetate trimelletate

49
Q

What are two (2) examples of water-soluble plasticizers?

A
  1. Glycerin

2. Propylene glycol

50
Q

What are two (2) examples of water-insoluble plasticizers?

A
  1. Glyceryl citrates

2. Dialkyl phthalate

51
Q

What are two (2) coating methods?

A
  1. Pan coating

2. Air suspension (fluidized-bed) coating

52
Q

What are five (5) film defects?

A
  1. Sticking and picking
  2. Roughness
  3. Orange peel
  4. Bridging and Filling
  5. Cracking
53
Q

What causes sticking and picking of tablet coating and how is it remedied?

A
  1. Caused by over-wetting

2. Remedied by reducing coating spray rate.

54
Q

What causes roughness of tablet coating and how is it remedied?

A
  1. Caused by improper coalescence of polymer

2. remedied by using fluidized-bed coater

55
Q

What causes orange peeling of a tablet coating and how is it remedied?

A
  1. Caused by inadequate spreading of coating solution

2. Remedied by diluting the coating solution

56
Q

What causes bridging and filling of tablet coating and how is it remedied?

A
  1. Caused by coating solution drying too rapidly

2. Remedied by adjusting drying temperature

57
Q

What causes cracking of tablet coating and how is it remedied?

A
  1. Caused by insufficient tensile strength of polymer

2. Remedied by using higher molecular weight polymer (or combination of polymers) or different plasticizer.

Pharmaceutical Sciences (9 decks)

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