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Pharm Y2S2 > Tabletting > Flashcards

Tabletting 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

How long can sugar coating take?

A

> 8 hours

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10
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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11
Q

What is compression coating?

A

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

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12
Q

What is the 1st compression stage for?

A

Making the core

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13
Q

What is the 2nd compression stage for?

A

Making the coating

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14
Q

What does compression coating allow you to do?

A

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

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15
Q

What are soft gels good for?

A

Poorly soluble drugs
Potent drug
Liquid formulations

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16
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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17
Q

How are hard capsules supplied?

A

As closed units which have to be filled

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18
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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19
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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20
Q

Which drug becomes toxic in the presence of water?

A

Flucytosine - formulate in absence of water

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21
Q

What modes of degradation can a drug undergo?

A 
Hydrolysis 
Oxidation 
Dimerisation 
Isomeric changes 
Photodegradation 
Photodegradation 
Conformational changes
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22
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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23
Q

What catalyses photodegradation?

A

UV at wavelength 300-400nm

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24
Q

What are transacetylation reactions?

A

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

25
Q

What is the Maillard reaction?

A

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

26
Q

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

A

Maillard reaction

glycoamination

27
Q

What is forced stability testing?

A

Exposing material to harsh conditions

28
Q

What properties should analytical methods used have?

A
  • Sensitive to pick up small amounts
  • Selective to pick up all degradation
  • Reproducible
29
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
30
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
31
Q

What API weight range should be in a tablet?

A

5 - 500mg

32
Q

What is considered to be a high API dose?

A

> 50% of the tablet weight

33
Q

What is considered to a low API dose?

A

<5% of the tablet weight

34
Q

What is the ideal total tablet weight?

A

<800mg

35
Q

Give examples of diluents.

A

Lactose, sucrose, glucose and mannitol

36
Q

What is the purpose of a disintegrant?

Give examples

A

Ensures the tablet breaks up

E.g. starch, cellulose, calcium carbonate

37
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

38
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

39
Q

What is the purpose of an anti-adherent?

Give examples

A

Reduce adhesion

E.g. magnesium stearate, talc, starch

40
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

41
Q

What are the unit processes of tableting?

A 
Weighing 
Mixing
Tablet manufacture
Quality assurance checks 
Dissolution 
Coating
Quality control checks
42
Q

What does uneven powder flow result in?

A

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

43
Q

What properties do particles <100µm have?

A

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

44
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

45
Q

Define angle of repose

A

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

46
Q

What is tensile strength determined by?

A

Tilting table method

47
Q

What contributes to bulk flow?

A

Particle: size, shape, density and packing geometry

48
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

49
Q

What is the ideal Carr/ compressibility index?

A

0 - 10%

50
Q

How can powder flow be improved?

A
  • Changing particle size
  • Alter surface forces
  • Formulation additives
  • Change process conditions
51
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

52
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
53
Q

What is dry granulation useful for?

A

Moisture sensitive material

54
Q

What does variation in uniformity content suggest?

A
  • Non-homogeniety
  • Segregation of powders
  • Problems with compression
55
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
56
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
57
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.

58
Q

What is chipping an indicator of?

A

Friability failure
Machine related issues
Powder compaction problems

Pharm Y2S2 (26 decks)

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