- Blistering
- Blooming/Dull film
- Blushing
- Chipping/ Edge Erosion
- Cratering
- Cracking/Splitting
- Color variation
- Core Erosion/ Surface Erosion
- Discoloration
- Logo Bridging
- Logo In-filling /Break Lines In-filling
- Orange Peel (Roughness)
- Pitting
- Peeling
- Sticking and Picking
- Scuffing of Film-coated Tablets
- Twinning
- Tablet Breakage
Causes | Remedies | |
1. | Entrapment of gases or vapor in or under the film due to overheating either during spraying or at the end of the coating. | Use mild drying conditions. |
2. | Effect of temperature on the adhesion, elasticity, and strength of the film. | Use mild drying conditions. |
Causes | Remedies | |
1. | High concentration of plasticizer. | Use lower concentration of plasticizer. |
2. | Low molecular plasticized coating system. | Use high molecular weight of plasticizer. |
Causes | Remedies | |
1. | Precipitation of coating polymer due to use of a poor solvent or high coating temperature. | Decrease the drying air temperature. |
2. | Use of sorbitol in coating formulation which causes major fall in the thermal gelation temperature of the HPMC (Hydroxy Propyl Methyl Cellulose), HPC (Hydroxy Propyl Cellulose), Cellulose ethers, and Methyl Cellulose. | Avoid the use of sorbitol with HPMC (Hydroxy Propyl Methyl Cellulose), HPC (Hydroxy Propyl Cellulose), Cellulose ethers, and Methyl Cellulose. |
Causes and Remedies:
Causes | Remedies | |
1. | Excessive pan speed | Decrease pan speed |
2. | Low solids content in coating liquid | Increase solids content of coating liquid |
3. | Worn tablet punches | Refurbish or replace punches |
4. | Low tablet hardness/friability | Improve mechanical strength of core by increasing compaction force, changing tablet shape, modifying core formulation or changing process by which core is produced (e.g. use granulation process instead of direct compaction) |
5. | Pan loading with insufficient amount of core tablets. | Pan fill with a sufficient amount of core tablets. |
6. | Inappropriate baffles design. | Use appropriate baffles design |
7. | Worn tablet punch/tooling. | Replace tablet tooling. |
8. | Sharp edge on tablets. | Use the proper tablet shape. |
9 | Low spray rate. | Use an optimum spray rate. |
10. | Low-coating suspension solid. | Increase suspension solid level. |
11. | High degree of attrition related to the coating process. | Increase the hardness of the film by increasing the molecular weight of the coating polymer. |
Causes | Remedies | |
1. | Penetration of coating solution at the surface of the tablet, often at the crown where the surface is more porous causing localized disintegration of the core. | Decrease the spray rate and use optimum drying conditions. |
2. | Inefficient drying. | Use efficient and optimum drying conditions. |
3. | Application of higher rate of the coating solution. | Decrease spray application rate. |
4. | Low the viscosity of the coating solution. | Increase viscosity of coating solution to decrease spray application rate. |
Causes | Remedies | |
1. | Higher internal stresses in the film than the tensile strength of the film. | Adjusting the type and concentration of plasticizer. |
2. | High molecular weight polymeric blends or polymers. | Use lower molecular weight polymeric blends or polymers. |
3. | Coating and core have different thermal expansion properties. | Avoid mineral type excipient. |
4. | Expansion of core due to overheating. | Avoid overheating the tablet core. |
5. | Low mechanical strength of the coating. | Use coating with proper mechanical strength. |
6. | Inadequate coating formulation. | Use proper coating formulation. |
7. | Insufficient plasticization or too much pigmentation. | Use adequate plasticizer or pigment. |
COLOUR VARIATION
Causes | Remedies | |
1. | Hygroscopic tablet core. | Reduce the amount of hygroscopic excipient such as disintegrant. |
2. | Spray rate is too high or low. | Use the appropriate spray rate. |
3. | Pan speed too high. | Use the correct pan speed. |
4. | High friability of core tablet. | Use less friable tablet. |
5. | Insufficient film strength to provide resistance to edge damage. | Use high film strength. |
6. | Poor punch design. | Use high-quality punch. |
7. | Punch wear. | Use a non-wear punch. |
8. | Poor logo design or placement. | Use proper logo design. |
9. | Low-coating suspension solid. | Increase suspension solid level. |
LOGO BRIDGING
- This occurs when the coating fills in the lettering or logo on the tablet and is typically caused by improper application of the solution, poor design of the tablet embossing, high coating viscosity, high percentage of solids in the solution, or improper atomization pressure.
- During drying, the film may shrink and pull away from the sharp corners of an intagliation or bisect, resulting in a bridging of the surface.
- This defect can be so severe that the monogram or bisect is completely obscured.
Causes | Remedies | |
1. | Poorly plasticized coating system. | Use optimal plasticizer coating. |
2. | Low adhesion coating system. | Use high-adhesion coating. |
3. | Low adhesion core ingredients. | Use high-adhesion core ingredients. |
4. | Spray rate too high. | Reduce spray rate. |
5. | Product temperature too low. | Increase temperature. |
6. | Poor logo design. | Improve logo design. |
LOGO IN-FILLING / BREAK LINES IN-FILLING
Causes | Remedies | |
1. | High atomizing air pressure. | Reduce atomizing air pressure. |
2. | High drying air temperature. | Reduce drying air temperature. |
3. | High coating suspension solid. | Use a low viscosity coating suspension. |
4. | Too high gun to bed distance. | Optimize gun to bed distance. |
5. | Poor spray gun design. | Use proper spray gun design |
6. | Turbulent air flow. | Minimize pan depression. |
7. | Aeration of coating suspension. | Use optimized suspension preparation to avoid aeration. |
8. | Poor logo design. | Improve logo design. |
9. | Excessive foaming of the coating solution. | Improve the mixing process. |
10. | Foam and Bubble formation because of air spraying of a polymer solution. | Add alcohol or use spray nozzle capable of finer atomization. |
11. | Over drying of spray. | Optimum drying of spray. |
Causes | Remedies | |
1. | Rapid Drying. | Use mild drying conditions. |
2. | Too high coating suspension viscosity. | Reduce the viscosity coating suspension. |
3. | Too low atomizing air pressure. | Increase Atomizing air pressure. |
4. | High spay rate/ Over-wetting. | Decrease spray rate. |
5. | Poor spray gun performance. | Use better spray guns. |
6. | Inadequate distribution of the coating suspension. | Decrease in viscosity of coating suspension. |
7. | Very close gun to bed distance. | Adjust gun to bed distance. |
Causes | Remedies | |
1 | Inappropriate drying (inlet air) temperature. | Use appropriate drying (inlet air) temperature. |
2 | Melting or dissolution of lubrication on tablet surface or melting of core ingredient due to high core temperature. | Use control drying temperatures |
PEELING
Causes and Remedies:
Causes | Remedies | |
1. | Low adhesion core ingredients. | Use high-adhesion core ingredients. |
2. | Low mechanical strength of the coating. | Use proper composition with improved mechanical strength |
3. | Low adhesion coating system. | Use high adhesion coating. |
4. | Coating is rubbing off due to excessive attritional effects. | Reduce pan speed. |
STICKING & PICKING
Causes and Remedies:
Causes | Remedies | |
1. | Inadequate drying. | Use optimum drying conditions. |
2. | High viscosity of coating solution. | Increasing viscosity of coating solution. |
3. | Spray rate too high. | Reduce spray rate. |
4. | Too low drying air volume | Increase air volume. |
5. | Too low drying air temperature. | Increase the inlet air temperature. |
6. | Pan speed too low. | Increase pan speed. |
7. | Low atomization pressure. | Increase atomization pressure. |
8. | Poor spray gun set up. | Improve spray gun setting. |
9. | Surface solubility. | Increase gun to bed distance. |
10. | High tablet surface porosity. | Improve core characteristics. |
Causes | Remedies | |
1. | Commonly flat surfaces along the edges of capsule-shaped tablets. | Change tablet shape. |
2. | Excessively tacky coating formulation. | Use coating formulation which is less tacky. |
3. | Inappropriate tablet shape. | Use appropriate tablet shape. |
4. | Pan speed too low. | Increase pan speed. |
5. | Spray droplet size too large. | Increase atomizing air pressure. |
6. | Spray rate too high. | Reduce spray rate. |
7. | Insufficient drying. | Use optimum drying conditions. |
TABLET BREAKAGE
Causes and Remedies:
Causes | Remedies | |
1. | Core tablets are too soft. | Change core formulation. |
2. | Tablets are too brittle. | Change core compression parameters. |
3. | Poor tablet shape for coating. | Use the appropriate tablet shape. |
4. | Poor baffle design. | Change baffle design. |
5. | Too high pan speed. | Reduce pan speed. |
6. | Loading and unloading tablets from the coating pan. |
Carefully load and unload tablets. |
7. | Less binder used in the formula. | Use optimum binder quantity. |
ALSO READ: What is Maximum Compression Force?