1. Sticky on Die

Manifestations:
  • Inherent in the die and difficult to remove
  • Loud noise in engine
  • Tablet brittle, ugly, rough side of the tablet, sometimes black

Cause:
  • Antidherent less
  • lack of or improper lubricant
  • Example: Tablet aspirin sticky with Magnesium stearate, stearic acid should be used (which micronize because the function of lubricant between the particles are so fine that will be covered by the lubricant).
  • Water content is high will cause the attachment or sticky on the die, while low water levels can cause the laminating or capping.
  • The possibility of chemical or physical interaction, example :physical interaction between etoxy benzamin with caffeine, glyceryl guaiacolate with promethazine HCl, which are melting so high adhesives and eventually become sticky.
  • Raw materials with very low melting point. Example: Ibuprofen, glyceryl guaiacolate, Ciprofloxacin (antibiotic imidazole derivatives).

Settlement Issues/Problem Solution:
  • Improve antiadherent and lubricants
  • Replacement of a suitable lubricant
  • Reduce the number of coarse granules
  • Reduce the amount of water but do not get under the optimum, because the tablet becomes less good. If you already know the amount of wetting agent, carried out by adding the wetting agent to a binder solution, ie materials that do not evaporate but wet, for example : Propylene glycol or glycerin.
  • If there is sticky because of the punch and die may be damaged, because if defects in the punch, it will be attached so that the smooth punch and die.
  • If possible compressing at low temperature and low humidity due specifically to the active ingredient with a low melting point or eutectic mixture occurs, the eutectic mixture of substances more easily absorb water. Example: The combination of ampicillin with Clavulanic acid, where clavulanic acid easily destroyed by high humidity and temperature. Therefore, the manufacturing is done in a low temperature and RH.
  • Change of filler, filler material with high melting point and can adsorbing, such as SiO2 and Aerosil (adsorbent). Aerosil Addition in tablet tablets will cause the appearance of good, clear and shiny, but the longer the disintegration time.



2. Sticky in the pons
Manifestation:
  • Peeled of the tablet because the tablet surface attached to the pons. Cause the same as earlier
  • Lack of anti adherent
  • high water content
  • Sticky at puncher

Overcome the same:
  • Change the size of the granules
  • Add adsorbent
  • Fix tool
  • Tools polished, so that the adhesives are very small on tablets and pons. 
 3. Capping / Laminating
Capping = detached
Laminating = split

Cause:
  • Air trapped in tablets because granules are very fine
  • Porosity is high, especially in the use of a new puncher, with that air is trapped between the punch and die
  • The hardness tablet is too low or too high (there is optimal)
  • The granules that are too dry. Solution: add the ingredients that are not easily evaporated in the solvent liquid binder
  • Substances that are less precise fastener.
  • Binder whose numbers are too small (right but the numbers are small)

Abatement
  • Preparation of granules repeated if the cause is excess or shortage of suitable binder or not.
  • Add dry binder such as gum arabic, sorbitol, PVP, saccharin, NHPC, LHPC 21, methylcellulose with high consistency, thus increasing the cohesiveness of the tablet.
  • Reduction of particle size of the granules, because the specification must be the same size.

4. Cleft or cracks on the surface of the tablet


Manifestations:
As a result of the three previous issues: laminating, sticky or sometimes because of the pons that are too deep.

Completion:
  • Polish pons and die
  • For large granule size, reduce the particle granules.
  • Replaced punch and die
  • Add dry binder

5. Weight uniformity


First Cause:
  • The flow is poor
  • Distribution of granule size that is not appropriate, because with such a high porosity may arise, which can not guarantee the uniformity of weight because of the new distribution at the time ofcompressing.
  • Mixing system that is notright, so the machine must be locked down as well, especially the pons can vary so that different weights.

Problem solving:
  • Fix or repeat the process of making granules, granule size improvement, binders, granulation, blending repair compressed mass.
  • Repair engine tablets tablets ie validating machine.
  • The speed of flow can lead to different weight of tablets. The cause of the flow velocity: water content is so high and the flow adhesivity become less; high porosity, the air trapped because of fines and binder are many who do not fit or less. The number of fines increased, the porosity increases, the flow is not good.

The second reason: the distribution of granules is not good.

Settlement Issues:

  • Reduce the moisture content
  • Creation of new granule, causing a small porosity, the distribution of fine granules optimal flow.

6 The uniformity of content

Done when:
  • Levels below 50 mg of active ingredient
  • When comparing levels of active ingredients by weight of the tablet is less than the 50%

Causes of poor uniformity of content:
  • Due to poor flow
  • Mixing of pre-granulation is not right then used to determine the homogeneity of the active substance in the granules (in factory)
  • Because of the high fines content, the high porosity (weights vary)
  • High water content so that the flow is less well
  • The condition of the engine is not right.

Problem solving :
  • Improvements include the mixing of granule size, binder changes, granulation.
  • Calibration of the machine.

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