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Pharm Y2S2 Medicine > Tabletting and Associated Technologies (OSD 1-5) > Flashcards

Tabletting and Associated Technologies (OSD 1-5) Flashcards

1
Q

What is a coat?

A

A dry, outer layer of material applied to the surface of a dosage form to improve different properties such as the release of the drug

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2
Q

What are the types of coating?

A
  • Film coating
  • Sugar coating
  • Compression coating
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3
Q

What methods of bed coating are used?

A

Fluidised or pan bed coating

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4
Q

What is an immediate release film coat used for?

A

Non-biological properties such as appearance

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5
Q

What is a modified release film coat used for?

A

Delaying or controlling drug release

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6
Q

Give examples of film coating compounds

A
  • Polymers : HMPC / MC or EC / cellulose acetate for modified release
  • Plasticisers : PEG, PG or diethyl phthalate
  • Colourants : iron oxide or titanium dioxide
  • Solvated compounds : organic polymer solutions
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7
Q

What will affect the properties of the coat?

A

The methods and conditions of the coating process

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8
Q

What are some problems with coating?

A
  • Erosion
  • Peeling - due to excess moisture inside
  • Breakage - due to poor mechanical strength
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9
Q

What does sugar coating allow you to do?

A
  • formulate immediate release drugs
  • mask taste
  • use combination of film and sugar
  • alter drug profile
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10
Q

How long can sugar coating take?

A

> 8 hours

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11
Q

What is the process of sugar coating?

A
  1. Seal porous core with : shellac, PVAP or CAP
  2. Sub-coat with bulking agents, anti-adherents and binders
  3. Smoothing : adding a coat to sub-coat
  4. Colouring
  5. Polish with wax
  6. Print with edible ink (if necessary)
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12
Q

What is compression coating?

A

A novel drug development process - it is a dry process that requires specialist equipment

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13
Q

What does the 1st compression allow you to do?

A

Make the core

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14
Q

What does the 2nd compression allow you to do?

A

Make the coating

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15
Q

What does compression coating allow you to do?

A

Formulate 2 drugs, one in the core and the other in the coat

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16
Q

What are soft gels good for?

A

Poorly soluble drugs
Potent drug
Liquid formulations

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17
Q

What is the process of manufacturing soft gels?

A
  1. Gelatin preparation
  2. Material preparation
  3. Encapsulation
  4. Drying
  5. Inspection
  6. Polishing
  7. Packaging
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18
Q

How are hard capsules supplied?

A

As closed units which have to be filled

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19
Q

What is the process of manufacturing hard capsules?

A
  1. Capsules are separated by a vacuum
  2. Check if they open
  3. Eject unopened ones
  4. Fill with pellet/granule/powder for injection
  5. Recover unused powder
  6. Rejoin and eject capsules
  7. Clean any residue left behind and repeat the process again
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20
Q

Define drug stability

A

Length of time a drug retains its chemical and physical properties without any loss of potency

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21
Q

What are the 3 stages for determining drug stability?

A
  1. Drug in native form
  2. Drug in formulation / in presence of excipients
  3. Drug when stored
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22
Q

Which drug becomes toxic in the presence of water?

A

Flucytosine - formulate in absence of water

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23
Q

What does aspirin convert to in the presence of water?

A

Salicylic acid

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24
Q

What is chloramphenicol converted to in the presence of water?

A

a non-active compound

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25
Q

What modes of degradation can a drug undergo?

A 
Hydrolysis 
Oxidation 
Dimerisation 
Isomeric changes 
Photodegradation 
Photodegradation 
Conformational changes
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26
Q

What happens to ascorbic acid when oxidised?

A

Converts to dehydroascorbic acid - reversible reaction in the body. But it can irreversibly convert to 2,3-diketogluoinc acid

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27
Q

What is dimerisation?

A

Joining together of 2 molecules

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28
Q

What happens if a drug undergoes isomeric changes?

A

It can convert between stereoisomers which can have toxic effects or no effects

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29
Q

What catalyses photodegradation?

A

UV at wavelength 300-400nm

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30
Q

What can lead to conformation changes?

A

Changes in physical conditions which can damage biological molecules

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31
Q

Give examples of degradation due to chemical incompatibility

A

Presence of another drug

Presence of an excipient

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32
Q

What are transacetylation reactions?

A

The moving of a functional group to another - this can remove functionality

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33
Q

What is the Maillard reaction?

A

This react occurs between lactose and amides. A glucosamine is formed.

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34
Q

What can be avoided by use of mannitol as a diluent?

A

Maillard reaction

glycoamination

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35
Q

How can drugs be stabilised?

A
  • Temp : store at 2 - 8 degrees C or RT
  • Solvent : replace aq with non-aq
  • Stability at pH : control with buffer
  • Limit exposure to light and O2
36
Q

What is forced stability testing?

A

Exposing material to harsh conditions

37
Q

What can forced stability testing determine?

A
  • Formulation approach
  • Excipient types
  • Protective additives
  • Packaging considerations
38
Q

What properties should analytical methods used have?

A
  • Sensitive to pick up small amounts
  • Selective to pick up all degradation
  • Reproducible
39
Q

What should drug analysis identify?

A
  • Weight
  • Purity
  • Chemical structure
  • Impurities
  • Degradation products
  • Solubility
  • pKa
  • Partition coefficient
40
Q

What is the method for analysis?

A
  1. Prepare calibration plot / linear response graph for drug and breakdown or degradation products
  2. Extract drug from formulation or biological sample into solvent
  3. Analyse standards and extraction samples using analytical methods
  4. Calculate conc in the sample

For HPLC analysis - look at different retention times

41
Q

What are the advantages of oral drug delivery to the patient?

A
  • Improved compliance
  • Convenient
  • Safe and easy to use
  • Carry multiple doses
  • Accurate
  • Reproducible doses
42
Q

What are the advantages of oral drug delivery to a pharmacist?

A
  • Easy to store

- Easy to dispense

43
Q

What are the advantages of oral drug delivery to the manufacturer?

A
  • Better chemical and physical stability
  • Low cost
  • Modify release
  • Masking of appearance and taste
44
Q

What are the disadvantages of oral drug delivery?

A
  • Needs a serious of unit processes
  • Drug absorption is dependent on gastric emptying
  • Compression difficulties
  • Certain patient groups can’t take tablets
45
Q

Give examples of types of tablets

A

Effervescent, chewable, buccal / sublingual, lozenge, controlled release, dispersible, rectal / vaginal

46
Q

What API weight range should be in a tablet?

A

5 - 500mg

47
Q

What is considered to be a high API dose?

A

> 50% of the tablet weight

48
Q

What is considered to a low API dose?

A

<5% of the tablet weight

49
Q

What should tablet size be proportional to?

A

Amount of drug present present

50
Q

What is the ideal total tablet weight?

A

<800mg

51
Q

Give examples of diluents

A

Lactose, sucrose, glucose and mannitol

52
Q

What is the purpose of a disintegrant?

Give examples

A

Ensures the tablet breaks up

E.g. starch, cellulose, calcium carbonate

53
Q

What is the purpose of a binder?

Give examples

A

Ensures tables are formed with required mechanical strength

E.g. gelatin, PVP, HPMC, PEG, sucrose, starch

54
Q

What is the purpose of a glidant?

Give examples

A

Improves flowability for direct compaction or granulation

E.g. Talc, colloidal silicon, magnesium stearate

55
Q

What is the purpose of an anti-adherent?

Give examples

A

Reduce adhesion

E.g. magnesium stearate, talc, starch

56
Q

What is the purpose of a lubricant?

Give examples

A

Ensure tablet formation and ejection can occur with low friction
E.g. magnesium stearate, stearic acid, PEG, SLS, liquid paraffin

57
Q

What are physiochemical properties of a drug governed by?

A
  • Solubility, Log P, stability of the drug, pH, pKa
  • Manufacturing process
  • Type of tablet
58
Q

What is the site of absorption governed by?

A

Dissociation constant, lipid solubility and pH

59
Q

What are the unit processes of tableting?

A 
Weighing 
Mixing
Tablet manufacture
Quality assurance checks 
Dissolution 
Coating
Quality control checks
60
Q

What does uneven powder flow result in?

A

Air trapped in the powder, capping & lamination, excess fine powder and dust contamination

61
Q

What properties do particles <100µm have?

A

They have greater cohesion and so will need a glidant or lubricant to increase surface area

62
Q

Define tensile strength

A

How easy it is to introduce breakage - the stronger the cohesive & adhesive forces the less likely it is that breakage will occur

63
Q

What is tensile strength determined by?

A

Tilting table method

64
Q

Define angle of repose

A

The angle ont eh ode of the cone - the higher the angle the greater the cohesive forces

65
Q

When would a powder slide?

A

When the inclination angle is larger than friction

66
Q

When would a powder stop sliding?

A

when friction is greater than the inclination angle

67
Q

What contributes to bulk flow?

A

Particle: size, shape, density and packing geometry

68
Q

How can bulk flow be measured?

A

Measure a volume of powder
Determine the weight of powder
Subject powder to taps
Determine tapped volume

69
Q

What effect does high bulk density have on bulk flow?

A

There is no change in density after tapping as the particles are already tightly packed

70
Q

What is the ideal Carr’s / compressibility index?

A

0 - 10%

71
Q

How can powder flow be improved?

A
  • Changing particle size
  • Alter surface forces
  • Formulation additives
  • Change process conditions
72
Q

What is the process of wet granulation?

A

Spray with binder
Bridges are formed between particles
Evaporate and remove solvent leaving granules
Create solid bridges

73
Q

What are the advantages of wet granulation?

A
  • Improves flow
  • Prevents segregation
  • Improves compaction
  • Reduces fine powder particles
  • Reduces water uptake
  • Less dense granules
74
Q

What is dry granulation useful for?

A

Moisture sensitive material

75
Q

What are the advantages of dry granulation?

A
  • Doesn’t involve solvents
  • Fewer pieces of equipment
  • Useful for temp and moisture sensitive material
  • Economical
76
Q

What does variation in uniformity content suggest?

A
  • Non-homogeniety
  • Segregation of powders
  • Problems with compression
77
Q

How can tablet weight be checked?

A
  • Weigh 20 at random
  • No more than 2% should be >10% of tablet weight
  • None should be >20% of tablet weight
78
Q

Describe the method used to check disintegration

A

Test 6 tablets

  • Drop tablet and agitate it
  • Monitor time taken to disintegrate
  • Repeat if 2 tablets fail
79
Q

What is a dissolution test?

A

The cumulative amount of drug that passes into solution over a given period of time

80
Q

Why are dissolution tests performed?

A

Performed to evaluate potential effect of formulation and process variables on drug bioavailability

81
Q

What is the stirred vessel method for dissolution testing?

A

SDF is dropped in dissolution medium using a basket or paddle
Dissolution is dependent on temperature or on the dissolution media

82
Q

What is the continuous flow method for dissolution testing?

A

SDF is held in a cell and dissolution is pumped at a controlled rate

83
Q

Why does mechanical strength need to be determined?

A

To assess importance of formulation and production variables for the resistance of a tablet to fracture and attrition during design, development and production.

84
Q

What happens in a tablet fails a crushing test?

A

It fails - got to split in 2 to pass

85
Q

What is chipping an indicator of?

A

Friability failure
Machine related issues
Powder compaction problems

Pharm Y2S2 Medicine (10 decks)

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