TESTS ON FORMULATIONS: �Content Uniformity, Hardness, Dissolution.

1. TESTS ON FORMULATIONS:
Content Uniformity, Hardness,
Dissolution.

2.  Different chemical substances, including the active
drug, are combined to produce a final medicinal
product.

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.

13. Volume
Deaeration
Examples Of Typical Media

15. Above mentioned tests are very essential in order to
ensure,
• Constant dose of drug
•Sufficient mechanical strength
•Released in controlled and reproducible way.

16. Bibliography:
Indian Pharmacopoeia.
Webliography:
www.pharmainfo.net