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Pharmaceutics > Solid Dosage Forms & Micromeritics > Flashcards

Solid Dosage Forms & Micromeritics Flashcards

1
Q

Granule

A

agglomerates of powders

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2
Q

Advantages of powder and granule dosage forms (3)

A
  1. more stable (ex- reconstituted antibiotics)
  2. faster dissolution rate
  3. convenient for large dose drugs (ex- Benefiber)
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3
Q

Disadvantages of powder and granule dosage forms (4)

A
  1. bulky
  2. poor for low dose drugs: accuracy is difficult (ex- digoxin)
  3. not suitable for drugs inactivated in the stomach
  4. pronounced unpleasant taste (mask with effervescence)
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4
Q

powder and granule dosage forms are dispensed as:

6

A
  1. bulk for internal use (ex- Metamucil, Slim-Fast)
  2. divided for internal use (ex- Tums powder packs, Theraflu)
  3. reconstitution (ex- Amoxil, Solu-Medrol)
  4. dusting powders for external use (ex- baby powder, Tinactin)
  5. aerosolized powders (insufflators) for ear, nose, throat, lung (ex- Tinactin, Alupent)
  6. inhalation powders (ex- Advair diskus)
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5
Q

Micromeritics

A

The science and technology of small particles

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6
Q

Particle size influences:

5

A
  1. dissolution rate (solutions): Noyes-Whitney equation
  2. suspendability (suspensions)
  3. penetrability (inhalants): 1-10 um, <0.5 um gets exhaled
  4. grittiness (topicals): <44 um
  5. uniformity
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7
Q

Comminution definition

A

reduction of particle size

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8
Q

Trituration, comminution

A

mortar and pestle to reduce particle size

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9
Q

Levigation

A

ointment preparation (powder + levigating agent to paste, trituration, + ointment base)

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10
Q

Comminution types (2)

A
  1. trituration

2. levigation

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11
Q

Blending powders

A

creation of uniform mixture

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12
Q

Spatulation

A

smear on tile

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13
Q

Trituration, blending

A

geometric dilution (equal volume drug and solvent, mix, add second volume…)

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14
Q

Sifting

A

mix by sifting

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15
Q

Tumbling

A

mix in rotating chamber

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16
Q

Blending types (4)

A
  1. spatulation
  2. trituration
  3. sifting
  4. tumbling
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17
Q

Powders and granules are used to prepare:

3

A
  1. tablets, capsules
  2. solutions, suspensions
  3. creams, ointments
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18
Q

The size and size range of particles can impact the physical, chemical, and pharmacological properties of a drug

A

:)

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19
Q

Important properties of polydisperse particles (2)

A
  1. number/weight and size

2. shape and surface area

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20
Q

fine powders, size

A

50-100 um

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21
Q

coarse powders, size

A

150-1000 um

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22
Q

granule, size

A

1000-3360 um

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23
Q

Particle Number (N)

A

number of particles per unit weight

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24
Q

Coefficient of Variation (%CV)

A

100 / [ (N)^(1/2) ]

want large N, small %CV

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25
Q

Properties affected by particle shape:

3

A
  1. packing
  2. flow
  3. surface area
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26
Q

Properties affected by surface area per unit weight/volume:

2

A
  1. dissolution rate

2. surface adsorption

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27
Q

For a perfect sphere, as/av =

A

6

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28
Q

Pores impact:

2

A
  1. dissolution and therefore

2. adsorption

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29
Q

Sw units

A

surface area per unit weight

cm^2/g, um^2/g…

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30
Q

Sv units

A

surface area per unit volume

cm^-1, um^-1…

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31
Q

bulk volume

A

total volume (particles + empty space)

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32
Q

true volume

A

volume of only particles

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33
Q

void volume

A

volume of empty space between particles

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34
Q

real porosity range

A

30-50%

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35
Q

true density

A

density calculation using true volume (does not include empty space)

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36
Q

bulk density

A

density calculation using bulk volume (includes empty space)

37
Q

angle of repose estimates:

A

flowability of a powder

measures frictional forces in a powder

38
Q

flowability of a powder is affected by:

6

A
  1. excipients (glidants)
  2. particle size
  3. particle shape
  4. surface texture
  5. porosity
  6. density
39
Q

Lipinski’s Rule of 5

A

Poor absorption/permeation if:

  1. > 5 H bond donors
  2. > 10 H bond acceptors
  3. log P > 5
  4. MW > 500
40
Q

Advantages of compressed tablets

6

A
  1. simple, convenient
  2. accurate dosage
  3. control rate
  4. more stable than liquid
  5. uniform product
  6. easy and cheap mass production
41
Q

Essential properties of tablets

6

A
  1. uniform weight, diameter, appearance
  2. stable to air, moisture, temperature, light
  3. withstand normal transport and patient handling
  4. known strength
  5. readily disintegrate in stomach
  6. dissolve in gastric/intestinal fluids
42
Q

separate different drug agents in a Multiple Layer Tablet due to:
(3)

A
  1. drug incompatibility
  2. staged release
  3. unique appearance
43
Q

Multiple layer tablet example

A

Gaviscon

44
Q

Tablet within a tablet example

A

Vimovo (naproxen core surrounded by esomeprazole)

45
Q

Advantages (3) and disadvantages (2) of sugar-coated tablets

A

Advantages:

  1. protect drug
  2. conceal taste
  3. imprint info

Disadvantages:

  1. increased time and expertise to manufacture
  2. increase tablet size (up to 50%)
46
Q

Sugar coated tablets examples

A

Advil, M.Ms, Skittles

47
Q

Film coated tablets, plus advantages over sugar coated (3)

A

compressed tablet surrounded by thin polymer; more durable, less time-consuming, less bulky than sugar-coated

48
Q

Film coated tablets examples

A

Tylenol film coated, Xarelto

49
Q

Gelatin coated tablets, plus advantages over sugar coated (3)

A

compressed tablet with gelatin; gelatin facilitates swallowing, less bulky, more tamper evident

50
Q

Gelatin coated tablets example

A

Tylenol gel tabs

51
Q

Enteric coated tablets/capsules used for drugs that are:

3

A
  1. destroyed by gastric acid
  2. particularly irritating to gastric mucosa
  3. has substantially enhanced absorption if stomach is bypassed
52
Q

Enteric coated tablets/capsules examples

A

aspirin (stomach irritant), omeprazole/esomeprazole (are acid activated–prevent early activation), fish oil (prevent stomach digestion and fish burps)

53
Q

Lozenges

A

at least 18 mm in diameter, do not contain disintegrant

54
Q

Two types of lozenges

A
  1. Local effect (ex- Sucrets)

2. Systemic effect (ex- Fentanyl)

55
Q

Effervescent tablets

A

improve palatability; combination of alkali carbonates/bicarbonates and tartaric/citric acid–quick dissolution of active ingredient with liberation of CO2

56
Q

Immediate release tablets

A

designed to disintegrate and release drug with no special rate controlling features

57
Q

Rapidly dissolving tablets (RDTs)

A

designed to disintegrate/dissolve within 1 minute; very water soluble excipients; prepared by soft compression, lyophilized foam (freeze drying)

58
Q

Disadvantages of RDTs (5)

A
  1. drug loading
  2. taste masking
  3. friability
  4. stability
  5. manufacturing costs
59
Q

drug loading

A

ratio of active drug to total components in a dosage form

60
Q

friability

A

tendency to crumble

61
Q

RDT preparation: Soft compression

A

compressed thinner than regular tablets (more surface area); super disintegrant excipients (wick water into tablet) plus effervescence to increase tablet disintegration (ex- Rolaids softchews, Dimetapp ND)

62
Q

RDT preparation: Lyophilized foam

A

foam is lyophilized (freeze-dried) into tablets; fastest disintegration (ex- Claritin Reditabs, Zofran ODT, Maxalt MLT)

63
Q

Advantages (2) and disadvantages (4) of extended/controlled release tablets

A

Advantages:

  1. reduced side effects (esp for drugs with narrow therapeutic windows)
  2. decreased frequency of dosing (improved adherence)

Disadvantages:

  1. slow clearance
  2. overdosing
  3. large tablet size
  4. cost
64
Q

Vaginal tablets examples

A

Vagifem (estrogen), Mycelex G clotrimazole (yeast infection)

65
Q

Implants

A

small pellets (2-3 mm); no excipients

66
Q

Implants example

A

Testopel testosterone (males more noncompliant, daily gel reminds them of testosterone deficiency)

67
Q

Powder fluidity and compressibility are important for tablet formulation. How to increase fluidity and compressibility?

A

Granulation improves both fluidity and compressibility

68
Q

Tableting methods (3)

A
  1. Wet granulation: wet mass is forced through sieve producing wet granules, recrystallization upon drying
  2. Dry granulation: granulation by compression or roller compaction
  3. Direct compression (dry): compress directly
69
Q

Quality standards and compendial requirements of compressed tablets (6)

A
  1. content uniformity (within 85-115% of label claim, <6% standard deviation)
  2. weight/weight variation
  3. thickness
  4. hardness/friability (minimum 4 kg of force, <1% loss)
  5. disintegration
  6. dissolution
70
Q

Extended release definition

A

allows a reduction in dosing frequency

71
Q

Delayed release definition

A

designed to release at a time other than immediately after administration

72
Q

Which drugs are candidates for extended release?

5

A
  1. for chronic rather than acute conditions
  2. neither very slow nor very fast absorption and excretion
  3. uniform absorption (otherwise too unpredictable)
  4. good margin of safety
  5. relatively small doses (so it’s not a huge tablet)
73
Q

Methods of achieving controlled-release:

4

A
  1. Diffusion-controlled release: insoluble matrix or coating (ex- Choledyl)
  2. Dissolution-controlled release: water-insoluble carrier, coat individual drug granules, reduce disintegrating agent, (ex- Dimetapp extentabs)
  3. Ion exchange-controlled release: drug is released in a high concentration of charged ions in GI tract (ex- Tussionex tablets)
  4. Osmotic pressure-controlled release: release by osmosis (ex- Procardia XL)
74
Q

Hard capsule

A

2 pieces, produced empty and later filled; contain 13-16% moisture; filled with dry solids (powders, granules, tablets) and semisolids

ex- Amoxil, Prozac

75
Q

Soft capsule

A

manufactured and filled all at once; include plasticizers for softness and flexibility (glycerol, etc); roughly 1:1 water to gelatin; filled with liquid; often used to improve dissolution rate and bioavailability

76
Q

Capsule

A

package made of gelatin

77
Q

What is the most important factor to ensure uniformity of the filled capsule, and how can it be improved (3 excipient types)?

A

powder flowability

improved by:

  1. diluents (ex- starch)
  2. glidants (ex- fumed silicon dioxide)
  3. lubricants
78
Q

Advantages of soft capsules (4)

A
  1. poorly compressible drugs
  2. poorly soluble drugs
  3. drugs with low bioavailability
  4. drugs sensitive to oxidation or hydrolysis (oil dispersion)
79
Q

Things you cannot put in a soft capsule:

4

A
  1. water content >5%
  2. extremes of pH (2.5-7.5 okay)
  3. emulsions
  4. aldehydes (“tanning” effect)
80
Q

surface area of intestinal epithelium

A

200 m2

81
Q

esophageal transport time

A

upright: 10-14 sec
supine: 300 sec

82
Q

stomach transit time

A

minutes up to 2 hours

83
Q

Where does tablet disintegration and dissolution begin?

A

stomach (affected by pH)

84
Q

Where does the majority of absorption occur?

A

small intestine (pH affects ionization, drugs with ionization constants near enteric pH may precipitate)

85
Q

pH range of small intestine

A

duodenum: pH 4
ileum: pH 8

86
Q

small intestine transit time

A

4 hours

87
Q

opposing forces to GI permeability (2)

A
  1. gut wall metabolism

2. efflux

88
Q

Absorption in the colon is important for which formulations and compounds?

A

controlled release (continuous or pulsed); highly lipophilic drugs

89
Q

Lactose advantages (4) and disadvantages (2)

A

Advantages:

  1. pleasant taste
  2. dissolves quickly
  3. absorbs little moisture
  4. chemically neutral

Disadvantages:

  1. poor flow
  2. cost

Pharmaceutics (4 decks)

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