Tablets Flashcards

1
Q

Tablets are usually prepared by ______ of the drug with several excipients

A

compression

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2
Q

T/F Tablets may be scored for fairly accurate breaking

A

TRUE

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3
Q

Why does the powder in tablets need to be compacted?

A

because it is not filled in a gelatin shell and has a BINDER and DISINTEGRATE (helps facilitate compaction)

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4
Q

Types of compressed tablets? (7)

A
  • immediate release
  • sugar coated
  • film coated
  • enteric coated
  • multiple compressed tablets
  • chewable
  • controlled release
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5
Q

immediate release tablets

A

breaks up in the body immediately

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6
Q

film coated tablets (2)

A
  • used when the drug is bitter

- typically uses thin polyminic film

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7
Q

enteric coated tablets dissolve in the ______ and are resist to dissolution in the _______

A

intestine; stomach

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8
Q

What polymer is used for enteric coated tablets?

A

cellulose acetate phthalate

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9
Q

Variations of Tablets? (3)

A
  • caplets
  • geltabs
  • gelcaps
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10
Q

An enteric coated tablet must disintegrate in simulated gastric (stomach) fluid within:

a. 2 minutes
b. 15 minutes
c. 30 minutes
d. None of the above

A

NONE OF THE ABOVE

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11
Q

multiple compressed tablets can be: (2) explain?

A
  • layered tablets (used when 2 drugs are incompatible)

- press-coated tablets (tablet inside a tablet)

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12
Q

chewable tablets (2)

A
  • contain a lot of mannitol

- meant to be chewed because they may not contain a disintegrate

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13
Q

controlled release tablets

A

slow release

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14
Q

Effervescent tablets involve the reaction of _____ with _______, liberating _______

A

sodium bicarbonate; tartaric or citric acid

liberating carbon dioxide

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15
Q

T/F Effervescent tablets ARE NOT temperature dependent.

A

FALSE: ARE

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16
Q

EFFERVESCENT TABLET:

What could be the solid material undissolved in water?

A

-magnesium stereate or talc

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17
Q

Rapid dissolving tablets disintegrate/dissolve in 15-30 ses in the mouth due to ______

A

super disintegrate

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18
Q

Advantages of Rapid dissolving tablets? (4)

A
  • fast absorption
  • good for travel
  • increase patient compliance
  • good for children and elderly
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19
Q

Disadvantages of Rapid dissolving tablets? (2)

A
  • high friability (too soft)

- taste masking is difficult

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20
Q

What manufacturing techniques can be used to make rapid dissolving tablets? (3)

A
  • Zydis delivery system
  • soft direct compression
  • fast dissolving excipients + effervescent material
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21
Q

________ lyophilize a foam of drug/gelatin/sugar in a mold that also serves as the unit dose dispensing package

A

Zeds delivery system

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22
Q

_______ or molded tablets are small masses of molded powders with rapidly soluble materials

A

tablet triturates

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23
Q

T/F The MORE dense the powder the LESS you can fit in a tablet

A

FALSE: the more dense the powder the more you can fit in a tablet

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24
Q

Lozenges or Troches dissolve….

A

slowly for localized effects

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25
Q

Tablet presses compress powdered/granulated tableting material through…..

A

the use of various shaped punches and dies

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26
Q

_____ punches + _____ die + 1 Station

A

2 punches; 1 one

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27
Q

To improve the flow of tablets we can use ______

A

granules

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28
Q

Example: one revolution with 27 stations will make _____ tablets

A

27

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29
Q

Granules or powder is compressed within a steel die cavity by the ________ exerted by the movement of two steel punches

A

pressure

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30
Q

concave punches = ___ tablets

A

convex

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31
Q

What is controlled by the amount of die fill and compression pressure?

A

-weight and thickness

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32
Q

In a rotary press, material flows from _____ to ______

A

hopper (where the powder is put in) to feed frame

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33
Q

What can be induced to produce a high production rate?

A

die feeder

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34
Q

Making a tablet?

-How can you make a size that can be handled?

A

diluent (provide bulk to make the tablet a practical size for compression)
-examples LACTOSE, MICROCRYSTALLINE CELLULOSE

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35
Q

Making a tablet?

-How can you make sure the powder is flowing freely?

A

Glidant (improve flow characteristics of powders)

-examples: COLLOIDAL SILICONE DIOXIDE, TALC

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36
Q

Making a tablet?

-How can you make sure the tablet is lubricated?

A

lubricant (prevents adhesion of powder to surfaces of die and punches and may improve flow)
-examples MAGNESIUM STEREATE, TALC

37
Q

Making a tablet?

-How can you make sure the tablet is cohesive?

A

binder (imparts cohesiveness to the tablet formulation)

-examples STARCH, GELATIN, POVIDONE, NATURAL SYNTHETIC GUMS

38
Q

Making a tablet?

-How can you make sure the drug is released in the body?

A

disintegrant (facilitate the breakup of tablets after administration)

39
Q

What will happen if a lubricant is not added to a tablet?

A

it may stick to the die during production

40
Q

T/F If a drug dose is HIGH you MAY NOT need a diluent.

A

TRUE. vs

If the drug is potent (low dose) may need a LOT of diluent

41
Q

Talc is both a ____ and ______

A

lubricant and glidant

42
Q

Excess lubricant may result in ….

A

poor disintegration or delayed dissolution (makes the tablet more resistant to water)

43
Q

Colloidal silicone dioxide is a…

A

light, loose powder with a particle size of about 15 nm

44
Q

HPMC is an example of a ____

A

binder

45
Q

The same excipients can have different roles, an example is

A

starch paste in water–> binder

starch dry powder–> disintegrant

46
Q

What are colors useful in tablets?

A

help distinguish one dose from another

47
Q

CLASS ACTIVITY: A tablet batch failed the disintegration test. Upon investigation, the only thing found different was that the batch as left for mixing for an extended period of time over lunch break. What could be the possible reason for failure of disintegration test?

A

-the magnesium had more time to coat the batch–> resistant to dissolving

48
Q

What are the methods of making tablets? (3)

A
  • wet granulation
  • dry granulation
  • direct compression
49
Q

What is the purpose of granulation?

A

so that powder can flow evenly and freely from the hopper into the dies

50
Q

What are the steps of granulation? (2)

A
  1. Powders are first weighed and blended

2. Treated with either binder (wet granulation) or compacted (dry granulation)

51
Q

What is a drawback of wet granulation?

A

when the drug is not stable to heat or moisture

52
Q

wet granulation

A

-optimum amount of binding agent added and damp mass screened

53
Q

What is the next step in wet granulation after added the appropriate amount of binder?

A

drying, dry screening, lubrication and compression

54
Q

When is dry granulation used? (2)

A
  • when drug is moisture or heat sensitive

- and/or powder has cohesive properties

55
Q

Dry granulation has ____ slugs and broken and dry screened

A

compressed

56
Q

Fluid Bed Granulation (2)

A
  • granulation and drying takes place in same equipment

- can be used for coating

57
Q

When is granulation not required? what is used instead?

A

drugs/excipients that possess free flowing and cohesive properties; direct compression

58
Q

What are 3 potential problems in compression process?

A
  • capping or splitting (soft granulation, excess fines, worn/imperfect punches)
  • lamination
  • reduced disintegration and/or dissolution
59
Q

CLASS ACTIVITY: Your marketing department is insisting on filling a drug with 700 mg dose formulation into size 0 Capsule? What can be done?

A

-change the formulation–> add a binder to change the bulk density (INCREASE BULK DENSITY) so it can be compressed

60
Q

Tablet Coating (3)

A
  • protect from air/moisture
  • taste masking/identification
  • improve product appearance
61
Q

Gelatin is a ______ in capsules, but a ____ in tablet

A

capshell lubricant; binder

62
Q

Types of Tablet Coating (3)

A
  • sugar
  • film
  • compression

(coating pans (warm air supply) or fluid bed processing equipment or modified tablet machines)

(first step is water proofing)

63
Q

Sugar Coating is a multistep process that involves:

A
  • sealing
  • subcoating (to build up the mass/weight)
  • smoothing
  • color coating
  • polishing & printing (wax applied)
64
Q

SUGAR COATING:

Sealing coat applied using alcoholic solution of resin such as _____

A

shellac

65
Q

Film Coating

A

-preferred method applies thin, uniform coating on tablet

66
Q

What has allowed the use of aqueous application?

A

transition to vented pans and fluid-bed equipment

67
Q

The formulation for FILM COATING contains: (4)

A
  • polymer
  • plasticizer
  • colorant
  • solvent
68
Q

HPMC: Hydroperoxy methyl cellulose….

A

a binder

69
Q

Glycerin, PG, PEG, or dibutyl subacetate are…..

A

used as plasticizers

70
Q

What are possible problems with coating?

A
  • picking and peeling
  • orange peel effect
  • mottling
  • bridging
71
Q

picking and peeling

A

flaking of the film fragments

72
Q

orange peel effect

A

roughness of the surface

73
Q

mottling

A

uneven distribution of color

74
Q

bridging

A

filming in of the scoring line

75
Q

All dosage forms must be taken with _____; and should be taken at least ___ hour before retiring

A

water; one

76
Q

When can prefabricated dosage forms be used for compounding special needs…

A

when bulk drug is not available (i.e you can use a tablet to make a suspension if not soluble and solution if soluble)

77
Q

Components of quality control for tablets? (4)

A
  • specifications
  • uniformity of dosage form
  • disintegration test
  • dissolution test
78
Q

SPECIFICATIONS:

Tablet Hardness

A
  • measure the force when the tablet breaks

- made in house–>USP does not make recommendations b/c it can vary

79
Q

SPECIFICATION:

Tablet Friability

A

how much powder the tablet will shed; should not be more than 1%

80
Q

Tablet ____ and ____ both have in house specifications

A

thickness and hardness

81
Q

CLASS ACTIVITY:A company started to make tablets on a rotary press but during the initial run, tablets are too friable. What can be done?

A
  • add a binder

- the upper punch may not be coming down to compress properly

82
Q

CLASS ACTIVITY: A weight variation test on a tablet batch shows individual tablet weighs of 97mg, 101 mg, 103 mg, 98 mg. Can we be sure the patient is expected to receive correct drug dose from this formulation?

A

-No, this is not okay. Even though the weights are similar the amount of drug and excipient may vary between the tablets

83
Q

Disintegration vs. Dissolution

  • A basket rack assembly with open ended glass tubes held vertically on a 10-mesh screen
  • A mechanical device raises and lowers the tubes
  • Typically 15-30 minutes
A

disintegration test

84
Q

Disintegration vs. Dissolution
-A stirrer shaft with a paddle or cylindrical basket moves in the dissolution media at 37 deg C (used to stimulate the body temperature)

A

dissolution test

85
Q

Dissolution test equipment:
Type 1…..
Type 2…..

A

Type 1: Basket

Type 2: Paddle

86
Q

Dissolution Test is used toL

A
  • guide formulation development
  • monitor process
  • establish bioequivalence from batch to batch
87
Q

IVIVC

A

in vitro in vivo correlation(drug absorption in the body)

88
Q

Successful IVIVC depends on (2)

A
  • drug solubility

- permeability

89
Q

Which BCS (biopharmaceutic classification system) is the best?

A

Category 2: best correlation: low solubility and high permeability (they are absorbed quickly)