Tablet Problems
S. No. 1. Problem General discription Capping & Complete or partial loss of top Lamination and bottom crowns of a tablet from the main body is called capping. The separation of a tablet into two or more distinct layers is called lamination. Cause 1. Air entrapment 2.Deep concave punch 3. Claw formation of Punch 4.Wear ring formation in die wall 5.Incorrect setting of the press 6.Compression of too dry material 1. Picking occurs when punch tips are engraving or embossing. Small enclosed areas in letters A. Remedy 1.precompression 2.Slowing tableting 3. Reducing final compression force 4. Using flat punch 5. Using hygroscopic materials to maintain proper moisture level eg. - PEG-4000 and Methyl Cellulose
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Picking & Surface materials from a tablet that is sticking to the punch and Sticking: being removed from the tablet surface is picking. Sticking refers to tablet materials adhering to the die wall. When sticking occurs, additional force is required to overcome the friction between the tablet and die wall during ejection. It is an unequal distribution of Use of a drug Mottling colors on a tablet with light and whose color differs dark areas on tablet surface. from tablet excipients 2. Use of a drug whose dehydration products are colored
1. The use of colorant may solve the problem but can create another Problem. A dye can cause mottling by migration to the surface of a Granulation during drying to overcome this difficulty. Change the Solvent system, reduce drying temperature. 2. Disperse a dry color additive during powder binding steps.
Weight Variation
Variation of tablet weight also causes variation of active medicament which change the bioavailability
(a) Granule size & size distribution: Variations in the ration of small to large granules and difference in granule size determine how the void space between particles
are filled. Since volume of die cavity remain same , different proportions of large and small particles may change the weight of fill in each die. (b) Poor Flow: The die fill process in based on a continuous and uniform flow of granules from the hopper through the feed frame. When the granulation does not flow uniformly some dies are incompletely filled. Dies are also not filled properly when machine speed is in excess of granulations flow capability. With poor flow the addition of a glidant such as talcum or colloidal silica may be helpful.
4. Cause: Depending on the geometry of the hopper, poor flow give rise to another problems like arching or bridging & rat holling (1) Arching or Bridging: Granules separate at the neck of the hopper and flow stops completely. Addition of glidant to prevent flow can overcome the problem.
Fig. 13 Bridging
(Courtesy, The theory and practice of Industrial pharmacy Leon Lachman, third Edition
(2) Rat Holling: In this case particles segregate near the wall of the hopper and at the center flow continues forming hole. In rat holling flow rate decreases which can overcome by using glidant
Fig. 14 Rat holling
(Courtesy, The theory and practice of Industrial pharmacy Leon Lachman, third Edition
(c) Punch Variation: When length of lower punches is unequal, the fill in each die varies which causes weight variations of tablet. (d) Poor Mixing: Some times lubricants and glidants are not thoroughly distributed. The flow of particles then impaired and the granules do not move efficiently into the dies. 5. Hardness Variation: Hardness depends on the weight of materials and space between upper and lower punch at the moment of compression. If the volume of materials and distance between the punches varies hardness also alters. 6. Double Impression: This involves only punches that have monogram or engraving. If the monogram present in upper punch, slight rotation of punch after precompression produce double impression. If monogram present in lower punch after compression is over lower punch move slightly downward to free the tablet and produce double impression. This problem can overcome using non-rotating cam track.
