Education /Pharm Y2S2 - Tabletting Part 2

Pharm Y2S2 - Tabletting Part 2

Education28 CardsCreated 11 days ago

This deck covers key concepts in tablet formulation, including API weight ranges, excipients, unit processes, and quality control measures in tabletting.

What API weight range should be in a tablet?

5 - 500mg
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Key Terms

Term
Definition
What API weight range should be in a tablet?
5 - 500mg
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What is considered to be a high API dose?
50% of the tablet weight
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What is considered to a low API dose?
<5% of the tablet weight
What is the ideal total tablet weight?
<800mg
Give examples of diluents.
Lactose, sucrose, glucose and mannitol
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What is the purpose of a disintegrant? | Give examples
Ensures the tablet breaks up | E.g. starch, cellulose, calcium carbonate

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TermDefinition
What API weight range should be in a tablet?
5 - 500mg
What is considered to be a high API dose?
50% of the tablet weight
What is considered to a low API dose?
<5% of the tablet weight
What is the ideal total tablet weight?
<800mg
Give examples of diluents.
Lactose, sucrose, glucose and mannitol
What is the purpose of a disintegrant? | Give examples
Ensures the tablet breaks up | E.g. starch, cellulose, calcium carbonate
What is the purpose of a binder? | Give examples
Ensures tables are formed with required mechanical strength | E.g. gelatin, PVP, HPMC, PEG, sucrose, starch
What is the purpose of a glidant? | Give examples
Improves flowability for direct compaction or granulation | E.g. Talc, colloidal silicon, magnesium stearate
What is the purpose of an anti-adherent? | Give examples
Reduce adhesion | E.g. magnesium stearate, talc, starch
What is the purpose of a lubricant? | Give examples
Ensure tablet formation and ejection can occur with low friction E.g. magnesium stearate, stearic acid, PEG, SLS, liquid paraffin
What are the unit processes of tableting?
Weighing Mixing Tablet manufacture Quality assurance checks Dissolution Coating Quality control checks
What does uneven powder flow result in?
Air trapped in the powder, capping and lamination, excess fine powder and dust contamination
What properties do particles <100µm have?
They have greater cohesion and so will need a glidant or lubricant to increase surface area
Define tensile strength.
How easy it is to introduce breakage - the stronger the cohesive & adhesive forces the less likely it is that breakage will occur
Define angle of repose
The angle on the side of the cone - the higher the angle the greater the cohesive forces
What is tensile strength determined by?
Tilting table method
What contributes to bulk flow?
Particle: size, shape, density and packing geometry
What effect does high bulk density have on bulk flow?
There is no change in density after tapping as the particles are already tightly packed
What is the ideal Carr/ compressibility index?
0 - 10%
How can powder flow be improved?
Changing particle size Alter surface forces Formulation additives Change process conditions
What is the process of wet granulation?
Spray with binder Bridges are formed between particles Evaporate and remove solvent leaving granules Create solid bridges
What are the advantages of wet granulation?
Improves flow Prevents segregation Improves compaction Reduces fine powder particles Reduces water uptake Less dense granules
What is dry granulation useful for?
Moisture sensitive material
What does variation in uniformity content suggest?
Non-homogeniety Segregation of powders Problems with compression
How can tablet weight be checked?
Weigh 20 at random No more than 2% should be >10% of tablet weight None should be >20% of tablet weight
Describe the method used to check disintegration
Test 6 tablets Drop tablet and agitate it Monitor time taken to disintegrate Repeat if 2 tablets fail
Why does mechanical strength need to be determined?
To assess importance of formulation and production variables for the resistance of a tablet to fracture and attrition during design, development and production.
What is chipping an indicator of?
Friability failure Machine related issues Powder compaction problems