Problems that may arise is with regard to how to make good preparations and in accordance with their intended use.

To make good preparations needed pre-formulation data covering stability, organoleptic, physicochemical properties, and other data that can be expected to support the raw materials that are suitable for the formation of a preparation is good and the achievement of the intended use.

As for the problems that may occur:

1. Incompatible active substance (melting, change color, decompose, and so on).



2. Stability of active ingredient:

a. For substances that are damaged by the presence of water, made with a tablet-making methods that do not use water and need to be considered solvent used for granulation.

b. For substances that are easily oxidized by heating and UV light, used in tablet manufacturing method that does not use heat and UV rays in the process.

c. For substances that are hygroscopic, do not use a wet granulation method used amyli mucilago because it’s difficult to be dried. This can be overcome by the addition of adsorbents such as Aerosol <3%. d. For substances that are not waterproof and heat, can be used method of making tablets by direct compression or dry granulation • For substances with a small amount (the amount of fines <30%) can be made by Direct Compression • For substances with a large number (the number of fines> 30%) can be made by Dry Granulation.


3. Selection of suitable materials
For the determination of excipient should be note the incompatibility with the active ingredient. In addition, the materials used should have a melting point high enough, so that the compressing process does not melt.

4. The number of total fines
The number of fines were added at the time of compressing is maximum of 30%, ideally 15%. If a bigger nuisance in the compressing of tablets.

5. Comparison of specific gravity of the active ingredient with the carrier (if too much should the amount of the fine as little as possible)

6. The concentration of Mg stearate as a lubricant maximum of 2%. If it's too big will happen laminating.

7. Use of mucilago amyli as a binder in tablet manufacturing process will complicate the dissolution of the active substance in the granules because mucilago amyli of dried water impenetrable. To fix this, need to be added wetting agent(Tween 80 0.05% -0.15%) so that the tablet has a disintegration time better.

8. On the use of PVP as a binder, PVP should be dissolved in alcohol 95%. But in the early stages, the volume of alcohol used is not known so it can be given as a powder.

9. Use of Amylum that too much (maximum 30%) causing the tablet can not be compressed because the compressibility is very ugly.

10. Amylum used as a disintegrant in outer phase should be dry Amylum because the presence of water would reduce its stability as disintegrant. Amylum drying should be performed at 700C because at this temperature does not occur gelatin from Amylum.

11. In the manufacture of tablets with direct compression method, the diluents can be used the combination of Primogel with Avicel or Avicel with Starch 1500 with a ratio of 7:3 or 3:1. Since Avicel has good compressibility but the flow is not good, then to improve the flow can be used Primogel or Starch 1500.

12. To cope with drought granules due to uncontrolled drying it is necessary to increase humectan namely glycerin or propylene glycol 1-4% calculated on mucilago.

Glycerin is added to the mucilago (binder) to facilitate the homogeneity of glycerin on the tablets, as well as the addition of Tween to the hydrophobica active substance in mucilago.

The addition of glycerin and Tween is for the purpose of:
- Glycerin: fear on the drying time of water lost / evaporate all
- Tween: worry about the composition of the used water-repellent, making it necessary for the addition of Tween so the tablets are not broken.

The exact amount of Tween depends on:
• The amount of active ingredients
• The amount of ingredients used

13. Number of Aerosil are added should be no more than 3% because of Aerosil are voluminous and absorb water so tablet had longer disintegration time.

14. When the weight of the tablet is too high and varied

Probably caused by:
• Distribution at Hoover caused the vibration. So a little push, large granules will come out first, because there is a process of consolidation. Therefore needs to be put a uniform granule size.
• The flow of granules is less well
• particle distribution is not normal, because the specific gravity is so different, so the flow is bad.
• less lubricant so the flow is bad.

15. If the active ingredient water-soluble :
• Do not granulate it with water
• As a binder, use a solvent which does not dissolve the tablet mass.
Conditions: eg used solvents X, there may be substances that dissolve in solvent X used as solvent bonding, but a maximum of 30%.

Search