NO. 40 PESIGAN, LEA ELLANA E. SEPT. 30, 2015

Name of Defect Description Illustration Reason Remedy1. Chipping Defect where the film becomes

chipped and dented, usually at the edges of the tablet

It may be due to sticking or to damaged punches or incorrectly to tablet machine.

- Increase hardness of the film by increasing the molecular weight grade of polymer

2. Mottling Unequal distribution of color on a tablet, with light or dark spots standing out in an otherwise uniform surface

One reason for mottling is drug whose colour differs from the tablet excipients, or a drug whose degradation products are coloured.

-Use appropriate colorants- Mix properly and reduce size if it is of a larger size to prevent segregation

3. Capping Upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling

It is due to air entrapped in the die which compressed as punches move together to apply pressure, and which then expands when the pressure is released.

- Use flat punches- Reduce speed of turret (Increase dwell time)- Polish dies properly- Dry the granules properly

4. Orange Peel (Roughness)

Surface defect resulting in the film being rough and nonglossy. Appearance is similar to that of an orange.

Inadequate spreading of the coating solution before drying.

- Adjust the spray rate and drying conditions.

5. BlisteringIt is local detachment of film from the substrate forming blister.

Entrapment of gases in or underneath the film due to overheating either during spraying or at the end of the coating run.

Use of mild drying condition.

6. Binding The resistance of the tablet to ejection from the die cavity, due to adherence to the die wall.

It is generally due to insufficient lubrication

Can be solved in some cases by modifying granules to reduce granule size or by increasing punch die clearance.

7. CrateringDefect of film coating whereby volcanic-like craters appears exposing the tablet surface

The coating solution penetrates the surface of the tablet, often at the crown where the surface is more porous, causing localized disintegra-tion of the core and disruption of the coating

- Use efficient and optimum drying conditions- Increase viscosity of coating solution to decrease spray application rate

8. LaminationIt is the separation of a tablet into two or more horizontal layers.

It is caused by the same factors as capping but by exaggerated conditions at high speed. It’s also due to poorly cohesive or oily granules.

Modifying mixing process. Add adsorbent or absorbent. Another one is to use a less amount of lubricant or change the type of lubricant.

9. CrackingSmall, fine cracks observed on the upper and lower central surface of tablets, or very rarely on the sidewall are referred to as ‘cracks’

It is due to expansion to expansion as distinguished from capping and laminating. It may be also due to binding or sticking.

Remedied by replacing or refacing nicked or chipped punches, resetting the tablet machine, by increasing binder or by wetting granulation. It can also be corrected by polishing punch tips, removing some or all lines and by reducing the granule size.

10. Picking Defect where isolated areas of film are pulled away from the surface when the tablet sticks together and then part.

It is particular concern when punch tips have engraving or embossing letters, as well as the granular material is improperly dried.

- Use optimum and efficient drying conditions or increase the inlet air temperature- Decrease the rater of application of coating solution by increasing viscosity of coating

solution.