2. Different chemical substances, including the active
drug, are combined to produce a final medicinal
product.
3.
4. To ensure that every tablet contains the amount of
drug substance intended with little variation among
tablets within a batch.
5. Used for testing the consistency
Bulk powders
Liquid orals
Also during filling of powders into capsules or liquids
into vials or ampoules
Amount of active pharmaceutical ingredient within
individual units of tablets or capsules.
6. Measures crushing strength property defined as
compressional force applied diametrically to a tablet
which just fracture it.
7. Limits:
4 kg is considered to be the minimum for satisfactory
tablets.
Oral tablets: 4 to 10 kg
Hypodermic and chewable tablets: 3 kg.
Sustained release tablets: 10 to 20 kg.
8. Why do we measure Hardness:
Need for pressure adjustment on the tableting
machine.
Affects the disintegration and dissolution
Factors affecting Hardness:
Compression of the tablet and compressive force.
Amount of binder. (More binder a more hardness)
Method of granulation in preparing the tablet
9. Predict in vivo drug release profiles.
Test is intended for a capsule or Tablet.
Condition maintained:
Temperature: 37 ± 0.5°C
Speed: 25-150 rpm
10. BASKET TYPE:
Vessel is cylindrical
Hight: 100-210mm
Inside diameter: 98-106mm
Basket position: the distance between the inside of
bottom vessel & basket maintained at 25 ± 2mm.
11. PADDLE TYPE:
Vessel is cylindrical
Hight: 160-210mm
Inside diameter: 98-160mm.
Blade position: distance between the inside bottom of
vessel & the blade is maintained at 25 ± 2mm.
12. Apparatus should be chemically inert.
Do not adsorb, react or interfere with dissolution
medium.
All metal parts of the apparatus must be made
from stainless steel.
15. Above mentioned tests are very essential in order to
ensure,
• Constant dose of drug
• Sufficient mechanical strength
• Released in controlled and reproducible way.