Solid dosage forms Flashcards

1
Q

What are some of the disadvantages of tablets?

A

manufacture requires a series of unit processes - product loss at each stage
drug absorption is dependent on gastric emptying rate
compression difficulties due to powder physical properties

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2
Q

What is the definition of excipient?

A

An inert substance that is used as a diluent or vehicle for preparing a drug product

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3
Q

For high dose tablets, the active ingredient is < 5% of the tablet weight. True or false?

A

False >50% of tablet weight

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4
Q

For low dose tablets, what % of tablet weight dose the active ingredient make?

A

< 5%

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5
Q

The total tablet weight should be less than ___mg to be viable to swallow

A

800mg

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6
Q

High dose tablets require a filler. True or false?

A

False - low dose <5mg tablets do

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7
Q

The filler used in tablets should be hygroscopic. True or false?

A

False - non-hygroscopic as you don’t want it to absorb water as they make bulk of tablet

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8
Q

Why is a filler needed in a low dose tablet?

A

For ease of manufacture and handling

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9
Q

What is the need for a disintegrant in a tablet?

A

To ensure the tablet breaks up into smaller fragments

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10
Q

What is the role of a binder in a tablet?

A

Added to ensure that the tablet can be formed with the required mechanical strength

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11
Q

What is the role of a glidant in a tablet?

A

To improve flowability of the powder - either for direct compaction or for granulation

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12
Q

Name a glidant

A

talc

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13
Q

Name a binder

A

PVP

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14
Q

Name a filler

A

Sucrose

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15
Q

Name a disintegrant

A

Starch

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16
Q

What is the role of a lubricant in a tablet?

A

To ensure that tablet formation and ejection can occur with low friction between the tablet and the die

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17
Q

Name a lubricant

A

Magnesium stearate

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18
Q

Why would you want to minimise the amount of lubricant in a tablet, although it helps with tablet formation?

A

Because they are usually lipophilic and so will hinder the dissolution and disintegration of the tablet if too much is used

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19
Q

What is the role of an antiadherent in tablet?

A

To reduce the adhesion between the powder and the punches which could otherwise lead to uneven tablet surface

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20
Q

What is tensile strength used to measure?

A

adhesive/cohesive properties

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21
Q

What is meant by tensile strength?

A

How easy it is to introduce a breakage in the tablet

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22
Q

What does a high angle of repose indicate?

A

High cohesive forces

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23
Q

When the angle of inclination is greater than the frictional force, does the powder slide or stop sliding?

A

Slide

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24
Q

How can powder flow be improved?

A

Increase the particle size of powder e.g. by granulation
Alter surface forces - controlled temp, humidity etc.
Formulation additives e.g. glidants, lubricants
Change process conditions - vibration assisted hoppers, force feeders

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25
Q

What is granulation?

A

Primary powder particles are made to adhere to form larger multi-particle entities called granules

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26
Q

Why use granulation?

A

Granules flow better than powder
Prevent segregation of ingredients
Improve compaction
Ease of transport as they are less dense than powder and so occupy less vol/unit weight

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27
Q

What is the mechanism of granulation? (3 steps)

A

Nucleation
Transition (nuclei growth)
Granule growth

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28
Q

Wet granulation is suitable for temperature and moisture sensitive material. True or false?

A

False - dry granulation is

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29
Q

What are some advantages of dry granulation?

A

Economical - less energy costs
Low equipment costs
Easy to scale up

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30
Q

Bulk density affects die filling. True or false?

A

True

31
Q

Uniformity of content test is recommended for all pharmaceutical preparations. True or false?

A

False - compulsory

32
Q

How many tablets should be tested for uniformity of content?

A

More than 5 - to be representative

33
Q

What are the accepted % limit for API in uniformity of content test?

A

90-110%

34
Q

There is a direct correlation between uniformity of content and tablet weight. True or false?

A

True

35
Q

In tablet weight testing, no more than two tablets should have a mass difference of more than 20%. True or false?

A

False - 10%

36
Q

What happens to a tablet that is ingested but doesn’t disintegrate in the body?

A

It gets excreted

37
Q

How many tablets need to fail the disintegration test for it to be repeated on a second full batch?

A

2 tablets

38
Q

What is the definition of dissolution?

A

The transfer of molecules or ions from the solid state into solution

39
Q

What are the two methods of conducting dissolution tests?

A

Stirred vessel method

Continuous flow method

40
Q

Dissolution is independent of temperature. True or false?

A

False - dependent on temperature

41
Q

If a reaction is exothermic, will dissolution be favoured by an increase in temperature?

A

No

42
Q

What are the two possible apparatus for dissolution in the stirred vessel method?

A

Basket

Paddle

43
Q

Which dissolution method is a better mimic of GIT conditions?

A

Continuous flow

44
Q

The mechanical strength of a tablet it associated with resistance of the solid specimen to what two thing?

A

Fracturing and attrition

45
Q

What are friability tests used to mimic?

A

Forces that are present in production, storage and administration

46
Q

In the friability test you are looking for a less than 5% weight loss in the tablet. True or false?

A

False - less than 1%

47
Q

In a friability test, how many tablets are tested?

A

20 tablets in revolving cycle

48
Q

When testing the tablets resistance to crushing, if the tablet splits in two, does it pass the test?

A

Yes

49
Q

What are gastro-retentive tablets designed for?

A

To be retained in the upper GIT

50
Q

Mucoadhesive tablets are designed to stick for a long period of time. True or false?

A

True

51
Q

What are the 3 types of coating?

A

Film
Sugar
Compression

52
Q

What is titanium dioxide used as in coating?

A

A colourant

53
Q

Are tablets more evenly coated if a horizontal spray is used or a tilted spray is used?

A

Tilted

54
Q

What are some problems that are associated with coating?

A

Erosion, peeling and breakage
Poor mechanical strength
Uneven coat
Tablet peeling

55
Q

Sugar coating involves successive applications of ______ solution

A

sucrose

56
Q

What are the characteristics of tablets that are coated with a sugar coating?

A

Immediate release of drug - as sugar is very soluble in water
Masked taste of tablet

57
Q

Main reason of using a sugar coating is for masking taste rather than functionality. True or false?

A

True - would still need a film coat e.g. enteric if you want functionality

58
Q

A sugar coat doesn’t add much weight to the total tablet weight. True or false?

A

False - adds a lot of weight 30-50%

59
Q

Sugar coating a tablet is a quick process. True or false?

A

False - takes over 8 hours

60
Q

What are the 6 steps involved in sugar coating process?

A
Sealing
Subcoating 
Smoothing
Colouring 
Polishing 
Printing
61
Q

Compression coating allows for 2 drugs to be present in one tablet. True or false?

A

True - one drug in the coating and one in the core

62
Q

Soft gelatin capsules cannot be filled with liquid. True or false?

A

False - can be filled with liquid - helps to increase solubility or permeability of drug across cell membrane

63
Q

Soft gel capsules are not suitable for potent drugs. True or false?

A

False

64
Q

Why is there no risk of leakage in a soft gel capsule?

A

Because it is one piece that is sealed

65
Q

Why is it harder to have a liquid in a hard capsule?

A

Because there is risk of leakage - the capsule is made of two pieces

66
Q

Hard capsules are all one size. True or false?

A

False - they can be different sizes to accommodate for different volumes within the capsule

67
Q

Hard capsules are filled with liquid. True or false?

A

False - powder, or more normally pellets

68
Q

The hard capsule shell doesn’t give any controlled release properties. True or false?

A

True - if you want controlled release, this has to be done at the granulation stage of the process

69
Q

Hydrolysis only occurs in the presence of water. True or false?

A

False - water, acid or base

70
Q

Most ibuprofen is supplied as a racemic mixture. Unusually, this drug is converted to the R-form in the body. True or false?

A

False - converted to the S form

71
Q

What does a maillard reaction occur between?

A

Lactose and an amide containing drug, resulting in a glycosylamine.

72
Q

How can a maillard reaction be prevented?

A

By using an alternative diluent to lactose such as mannitol

73
Q

Replacing an aqueous solvent with a non-aqueous solvent will maximise the stability of the drug. Why?

A

Because it will be less prone to hydrolysis

74
Q

Magnesium stearate only acts as a lubricant. True or false?

A

False - lubricant, glidant, anit-adherent