Defeccts of tablet coating unit ii
- 1. INDUSTRIAL PHARMACY(UNIT-II) CONTENTS: 1.Tablet Coating Defects and their Remedies 2. QUALITY CONTROL TEST(IN PROCESS & FINISHED PRODUCT) BY : Suryam.G Asst.Professor M.Pharm, CPC 28-Oct-19 SURYAM,G ASST.PROFESSOR,M.PHARM,CPC 1
- 2. Tablet Coating Defects and their Remedies 1. Blistering 2. Chipping 3. Cratering 4. Picking 5. Pitting 6. Blooming 7. Blushing 8. Colour Variation 9. Infilling 10. Orange Peel (Roughness) 11. Cracking (Splitting) 28-Oct-19SURYAM,G ASST.PROFESSOR,M.PHARM,CPC 2
- 3. 1. Blistering: Blistering of a surface film occurs when its elasticity or adhesive properties are compromised. The result is that the film becomes detached from the tablet’s substrate. Causes: Blistering is usually a result of high temperatures that may occur during the drying process, during the spraying stage or at the end of the coating process. Remedy: Use mild drying conditions, and ensure moderate temperatures at other stages of the coating process. 28-Oct-19SURYAM,G ASST.PROFESSOR,M.PHARM,CPC 3
- 4. 2. Chipping Chipping occurs when the film becomes dented and chipped and this is most notably visible on the edges of the tablet. Causes: Deformity in the tablet cam occur when there is a decrease in the rotation speed in the machinery during the coating process. Another cause would be a poor polymer or coating solution – e.g., an incorrect amount of plasticizer is used in the coating solution,. Remedy: Increase the hardness of the film by adjusting the proportion of plasticizer in the coating solution or selecting a polymer with a higher molecular weight. 28-Oct-19SURYAM,G ASST.PROFESSOR,M.PHARM,CPC 4
- 5. 3. Cratering Cratering happens when a defect on the film’s coating results in craters appearing on the tablet which in turn results in the exposure of the tablet’s surface. Causes: Cratering can occur in certain instances where there is insufficient drying time to seal the film or a high volume of coating solution is applied. In these cases excess polymer solution can penetrate to the surface of the tablet, especially in the crown area, causing the disruption of the coating and degeneration of the tablet’s core. Remedy: Check the efficiency of the drying process and optimize drying conditions. 28-Oct-19SURYAM,G ASST.PROFESSOR,M.PHARM,CPC 5
- 6. 4. Picking Picking happens when part of the film sticks to the pan resulting to some of the tablet pieces being detached from the core. Causes: Picking occurs when there is overwetting of tablets by the polymer solution, making the film become tacky which results to the tablets sticking to one another. Remedy: Overwetting can be avoided by increasing the efficiency of the drying process e.g, by increasing the air inlet temperature. Alternatively, the rate of applying coating solution can be decreased, or the solution viscosity increased. 28-Oct-19SURYAM,G ASST.PROFESSOR,M.PHARM,CPC 6
- 7. 5. Pitting Pitting is the deformation of the core of the tablet without any visible signs of disruption of the film coating . Causes: Pitting can occur when the tablet core becomes hotter than the melting point of the materials used in its preparation. Remedy: Dispense with preheating procedures at the start of coating and modify the drying (inlet air) temperature such that the temperature of the tablet core does not become greater than the melting point of the batch of additives used. 28-Oct-19SURYAM,G ASST.PROFESSOR,M.PHARM,CPC 7
- 8. 6. Blooming Blooming is the fading or dulling of a tablet colour after a prolonged period of storage at a high temperature. Causes: The tablet colour can become dull as a result of changes in the composition of the surface film. It is usually the result of using too much plasticizer or of using a plasticizer with a low molecular weight. Remedy: Decrease the concentration and increase the molecular weight of the plasticizer in the polymer. 28-Oct-19SURYAM,G ASST.PROFESSOR,M.PHARM,CPC 8
- 9. 7. Blushing appearance of white specks in the film. Causes: Haziness or white specks are particles of polymer that has precipitated in the film. It usually forms as a result of an excessively high coating temperature. Alternatively it may be formed by gelation of the polymer when used in certain combinations with other materials. Remedy: Decrease the drying temperature to avoid precipitation of polymer. Avoid the use of sorbitol with polymers such as hydroxy propyl cellulose, hydroxy methyl cellulose, methyl cellulose and cellulose ethers. 28-Oct-19SURYAM,G ASST.PROFESSOR,M.PHARM,CPC 9
- 10. 8.Color Variation Variation in the colour of tablets within a batch. Causes: Colour variations may occur by a number of different faults in the preparation e.g., poor mixing, uneven spray patterns of the machinery, insufficient coating, migration of soluble dyes-plasticizers and other additives during drying. Remedy: Aim for even geometric mixing, reformulate with different plasticizers and additives and/or use mild drying conditions. 28-Oct-19SURYAM,G ASST.PROFESSOR,M.PHARM,CPC 10
- 11. 9. Infilling This refers to the filling of intagliations - i.e., the distinctive words or symbols formed on the tablet. Causes: Infilling is caused when a polymer solution that is sprayed onto the table is unable to disperse. When sprayed with air, bubbles can form in the solution leading to a foam. Unlike a liquid, foams may accumulate within the intagliations rather than dispersing over the whole tablet. The result is that droplets of liquid become concentrated in the intagliations. This leads to a higher concentration of polymer within the intagliations. If the droplets build up, they can coat the whole pellet giving rise to an uneven polymer film. Remedy: Add alcohol to the polymer solution to improve dispersion, or use a spray nozzle capable of finer atomization. 28-Oct-19SURYAM,G ASST.PROFESSOR,M.PHARM,CPC 11
- 12. 10. Orange Peel (Roughness) The tablet has the appearance of an “Orange Peel” on account of having a rough surface, which may also have a matt rather than glossy texture. Causes: Orange peel can be the result of poor tablet composition causing it to become soft. It can also be caused by too high a spray pressure combined with a fast spray rate, leading to uneven coating of the tablet. Remedy: Use mild drying conditions or use additional solvents to decrease the viscosity of the polymer solution so that spraying rate can be reduced. 28-Oct-19 SURYAM,G ASST.PROFESSOR,M.PHARM,CPC 12
- 13. 11.Cracking (Splitting) Cracking occurs when the film coating the tablet cracks in the crown area or splits around the edges. Causes: Cracking occurs when the film’s internal stress exceeds the tensile strength of the film. This is common with higher molecular weight polymers or polymeric blends. Remedy: Use lower molecular weight polymers or polymeric blends. Also adjust plasticiser type and concentration. 28-Oct-19SURYAM,G ASST.PROFESSOR,M.PHARM,CPC 13