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Pharmaceutics Spring 2016 > Tablets > Flashcards

Flashcards in Tablets Deck (89)
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1

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

compression

2

T/F Tablets may be scored for fairly accurate breaking

TRUE

3

Why does the powder in tablets need to be compacted?

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

4

Types of compressed tablets? (7)

-immediate release
-sugar coated
-film coated
-enteric coated
-multiple compressed tablets
-chewable
-controlled release

5

immediate release tablets

breaks up in the body immediately

6

film coated tablets (2)

-used when the drug is bitter
-typically uses thin polyminic film

7

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

intestine; stomach

8

What polymer is used for enteric coated tablets?

cellulose acetate phthalate

9

Variations of Tablets? (3)

-caplets
-geltabs
-gelcaps

10

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

NONE OF THE ABOVE

11

multiple compressed tablets can be: (2) explain?

-layered tablets (used when 2 drugs are incompatible)
-press-coated tablets (tablet inside a tablet)

12

chewable tablets (2)

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

13

controlled release tablets

slow release

14

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

sodium bicarbonate; tartaric or citric acid
liberating carbon dioxide

15

T/F Effervescent tablets ARE NOT temperature dependent.

FALSE: ARE

16

EFFERVESCENT TABLET:
What could be the solid material undissolved in water?

-magnesium stereate or talc

17

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

super disintegrate

18

Advantages of Rapid dissolving tablets? (4)

-fast absorption
-good for travel
-increase patient compliance
-good for children and elderly

19

Disadvantages of Rapid dissolving tablets? (2)

-high friability (too soft)
-taste masking is difficult

20

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

-Zydis delivery system
-soft direct compression
-fast dissolving excipients + effervescent material

21

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

Zeds delivery system

22

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

tablet triturates

23

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

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

24

Lozenges or Troches dissolve....

slowly for localized effects

25

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

the use of various shaped punches and dies

26

_____ punches + _____ die + 1 Station

2 punches; 1 one

27

To improve the flow of tablets we can use ______

granules

28

Example: one revolution with 27 stations will make _____ tablets

27

29

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

pressure

30

concave punches = ___ tablets

convex

31

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

-weight and thickness

32

In a rotary press, material flows from _____ to ______

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

33

What can be induced to produce a high production rate?

die feeder

34

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

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

35

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

Glidant (improve flow characteristics of powders)
-examples: COLLOIDAL SILICONE DIOXIDE, TALC

36

Making a tablet?
-How can you make sure the tablet is lubricated?

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

37

Making a tablet?
-How can you make sure the tablet is cohesive?

binder (imparts cohesiveness to the tablet formulation)
-examples STARCH, GELATIN, POVIDONE, NATURAL SYNTHETIC GUMS

38

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

disintegrant (facilitate the breakup of tablets after administration)

39

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

it may stick to the die during production

40

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

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

41

Talc is both a ____ and ______

lubricant and glidant

42

Excess lubricant may result in ....

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

43

Colloidal silicone dioxide is a...

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

44

HPMC is an example of a ____

binder

45

The same excipients can have different roles, an example is

starch paste in water--> binder
starch dry powder--> disintegrant

46

What are colors useful in tablets?

help distinguish one dose from another

47

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?

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

48

What are the methods of making tablets? (3)

-wet granulation
-dry granulation
-direct compression

49

What is the purpose of granulation?

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

50

What are the steps of granulation? (2)

1. Powders are first weighed and blended
2. Treated with either binder (wet granulation) or compacted (dry granulation)

51

What is a drawback of wet granulation?

when the drug is not stable to heat or moisture

52

wet granulation

-optimum amount of binding agent added and damp mass screened

53

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

drying, dry screening, lubrication and compression

54

When is dry granulation used? (2)

-when drug is moisture or heat sensitive
- and/or powder has cohesive properties

55

Dry granulation has ____ slugs and broken and dry screened

compressed

56

Fluid Bed Granulation (2)

-granulation and drying takes place in same equipment
-can be used for coating

57

When is granulation not required? what is used instead?

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

58

What are 3 potential problems in compression process?

-capping or splitting (soft granulation, excess fines, worn/imperfect punches)
-lamination
-reduced disintegration and/or dissolution

59

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

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

60

Tablet Coating (3)

-protect from air/moisture
-taste masking/identification
-improve product appearance

61

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

capshell lubricant; binder

62

Types of Tablet Coating (3)

-sugar
-film
-compression

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

(first step is water proofing)

63

Sugar Coating is a multistep process that involves:

-sealing
-subcoating (to build up the mass/weight)
-smoothing
-color coating
-polishing & printing (wax applied)

64

SUGAR COATING:
Sealing coat applied using alcoholic solution of resin such as _____

shellac

65

Film Coating

-preferred method applies thin, uniform coating on tablet

66

What has allowed the use of aqueous application?

transition to vented pans and fluid-bed equipment

67

The formulation for FILM COATING contains: (4)

-polymer
-plasticizer
-colorant
-solvent

68

HPMC: Hydroperoxy methyl cellulose....

a binder

69

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

used as plasticizers

70

What are possible problems with coating?

-picking and peeling
-orange peel effect
-mottling
-bridging

71

picking and peeling

flaking of the film fragments

72

orange peel effect

roughness of the surface

73

mottling

uneven distribution of color

74

bridging

filming in of the scoring line

75

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

water; one

76

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

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

Components of quality control for tablets? (4)

-specifications
-uniformity of dosage form
-disintegration test
-dissolution test

78

SPECIFICATIONS:
Tablet Hardness

-measure the force when the tablet breaks
-made in house-->USP does not make recommendations b/c it can vary

79

SPECIFICATION:
Tablet Friability

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

80

Tablet ____ and ____ both have in house specifications

thickness and hardness

81

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?

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

82

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?

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

83

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

disintegration test

84

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)

dissolution test

85

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

Type 1: Basket
Type 2: Paddle

86

Dissolution Test is used toL

-guide formulation development
-monitor process
-establish bioequivalence from batch to batch

87

IVIVC

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

88

Successful IVIVC depends on (2)

-drug solubility
-permeability

89

Which BCS (biopharmaceutic classification system) is the best?

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