Tablet defects can come from any of the unit operations upstream and from the tablet press. The raw materials may be of poor quality or do not meet specifications, causing excessive fines that lead to a host of defects. The formulation may be the source of defects if the material does not compress well or the processing step specified within the formulation fail to produce a powder with a good flow, compressibility, and ejection properties. The processing and granulation of powder are often the sources of the defect.
Every product behaves differently on a tablet press, even if it‘s the same product run on a different day. The variation often
stems from changes in the properties of the raw materials—active ingredients and excipients- from batch to batch. Naturally,
the goal is to minimize these changes. Tablet press operators, however, don‘t have any control over formulation and
granulation. Tablet specifications are tight, and the list of possible defects is long: Variable weight, sticking, picking, capping, lamination, variable hardness, among others. This article focuses on these variations. It pinpoints the possible causes of these defects and offers advice on preventing and fixing the source of the problems.
3. INTRODUCTION
In the normal process of developing formulations,
and in the routine manufacture of tablets, various
defects are observed. Sometimes, the source of the
problem or the defect is the formulation, the
compression equipment, or a combination of the two.
Some defects are noticed immediately during
manufacturing but others may be noticed during
storage as in the case of capping.
4. DEFECTS IN TABLETS AND ITS
RECTIFICATION
CAPPING AND LAMINATION
PICKING AND STICKING
MOTTLING
DOUBLE IMPRESSIONS
BINDING
CHIPPING AND SPLITTING
5. CAPPING AND LAMINATION
Capping is defined as the partial or complete separation of the
top or bottom crowns of a tablet from the main body of the
tablet.
Lamination is the separation of a tablet into two or more
distinct layers.
These processing problems are readily apparent immediately
after compression or may occur hours or even days later.
Subjecting tablets to the friability test is the quickest way of
revealing such problems.
7. Air entrapment
Reduce press speed
Precompress granulation
Reduce quantity of fine particles in the granulation
Excessive pressure
Reduce tablet weight and/or increase its thickness within
allowable tolerances
Adjust pressure
RECTIFICATION
8. Too rapid expansion of tablet upon ejection
Taper dies
Poor granulation
Increase quantity of binder; use strong binder
Excessively dry granulation
Increase lubricant
Excessive lubrication of granulation
Decrease lubricant; blend all ingredients before adding
lubricant
9. PICKING AND STICKING
Picking refers to a tablet
material being removed from
the tablets surface by a punch.
Sticking refers to a tablet
material adhereing to die wall.
Tablet materials adhering to
punches can accumulate to the
point of obliterating the tip
design.
10. RECTIFICATION:
Excessive moisture
Check moisture content of granulation; drying
Check room humidity
Presence of low-melting-point substances
Dilution with higher-melting-point materials
Insufficient compaction force
Reduce tablet weight and/or increase its thickness within
allowable tolerances
Inadequate lubrication of granulation
Check and/or adjust level of lubricant used
11. MOTTLING
Unequal distribution of color on a tablet, with light or dark
areas standing out in an otherwise uniform surface.
12. RECTIFICATION:
Drug whose color differs from the tablet excipients or
a drug whose degradation products are colored.
Use of colorants
Migration of dyes to the surface of granulation during
drying
Change the solvent system
Reduce the drying temperature
Grind to a small particle size
13. DOUBLE IMPRESSION
This problem is encountered with punches that have a
monogram or other engraving on them.
RECTIFICATION :
Rotation of punches
Adjust antiturning devices
Use keyed punches
14. BINDING :
Sticking of the tablet to the die and does not eject
properly out of die.
With excessive binding the tablet sides are cracked
and it may crumble apart.
15. RECTIFICATION:
To moist granules and extrudes around lower punch.
•Dry grannules properly
Insufficient or improper lubricant
• Increase the amount of lubricant or use more effective lubricant
Too coarse granules
•Reduce granular size,and more fines
Granular material too warm , sticks to the die
•Reduce temperature
•Increase clearance if is extruding.
.
16. CHIPPING OR SPLITTING
Poor surface finish on punch tips;
worn punches and dies
Poor tooling design
(e.g., sharp embossing or bisect lines)
Polish punch tips; replace
punches and dies
17. RECTIFICATION:
Sticking on punch faces
• Dry the granules properly
Or increase lubrication
To dry granules .
• Moisten the grannules to plasticize
add hygroscopic substances.
18. REFERENCES
Herbert A. Lieberman, Leon Lachman, Joseph B.
Schwartz, Pharmaceutical dosage forms : Tablets,
Second Edition,vol 3.
James Swarbrick, James C. Boylan, Encyclopedia of
Pharmaceutical technology, Volume 15, 1996.
James Swarbrick, Encyclopedia of Pharmaceutical
technology, Third Edition, Volume 6, 2007.
Website:
www.pharmainfonet.com