Education /Pharm Y2S2 - Tabletting Part 2
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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Term | Definition |
---|---|
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 |