Pharmaceutical Production related various technical problems, causes of problems and remedies strategies
Porosity related problems
1. Problems of remaining porosity
⇨ Enhance the rate of liquid uptake by tablets.
⇨ Increase the rate of disintegration.
Tableting Problems
1. Capping
Capping is the partial or complete separation of the top or bottom crowns of a tablet from the main body of the tablet.
Causes of capping
⇨ Large amount of fine powders
⇨ Too dry or very low moisture content
⇨ Insufficient amount of binder
⇨ Insufficient lubricant
2.Lamination
Lamination is the separation of tablet into two or more distinct layer.
Causes of Lamination:
⇨ Rapid relaxation of tablet from die wall
⇨ Rapid decompression
3.Chipping
The breaking of tablet after press leaves or during subsequent handing and coating operation.
Causes of chipping:
⇨ Too dry granules
⇨ Too much binding
4. Cracking
Crack on the upper & and lower central surface of tablets or very rarely on the die wall.
Causes of Cracking:
⇨ Large size of granules
⇨ Too dry granules
⇨ Tablet expand
⇨ Granulation too cold
5. Sticking
Granules adhere to the die wall and thereby lower punch can not move freely.
Causes of sticking:
⇨ Insufficient lubrication
⇨ Granules not dried properly
⇨ Too much binder
6. Picking
A small surface of the material is removed by the punches and adhere to the punches therefore the show a pitted surface instead of smooth surface.
Causes of picking:
⇨ Excessive moisture in granules.
⇨ Insufficient lubrication
⇨ Too much binder
7. Mottling
An unequal distribution of colour on a tablet.
8. Double impression
Film coating problems, causes & Remedies
1. Bridging
Films pulls out of intagliation forming bridge across the edges of the mark of blister.
Causes of bridging:
High internal stresses in film.
2.Blushing
Whitist specks or haziness in film.
Causes of blushing:
Precipitation of polymer due to high temparature or poor solvent.
3. Blistering
Film becomes detached from substrate forming a blister.
Causes of blistering:
⇨ Overheating during spraying of at the end of coating run.
4. Blooming
Coating becomes dull immediately or after a prolong storage.
Causes of Blooming:
Due to low molecular weight plasticizers included in the coating formulation.
Blender related problems
1. Problems of overloading of blender
⇨ Retard the free flow of the granulation
⇨ Reduces the efficiencies of the blender
2. Problems of too small loading of blender
⇨ The powder slide rather than roll in the blender
⇨ Time increases for uniform mixing of powder
Mixing time related problems
1. Problems of Excessive mixing time:
⇨ May fracture fragile excipients and ruin their compressibility
Particle size related problems
1.Problems of too large size particles:
⇨ Unable to fill the die cavity uniformly during compression
⇨ Weight of tablet fluctuate considerably
⇨ Affect tablet content uniformity
Fine powder related problems
1. Problems of too many fines:
⇨ Weight variation occurs because of flow problem
⇨ Tendency of capping increase
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