tablet defects
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Tablet coating provides benefits like masking taste, protecting drugs from the environment, and modifying drug release. Sugar coating is a multistep process using sucrose to coat tablets. Defects in coating like chipping, sticking, cracking and color variation can occur due to factors like coating solution properties, processing parameters, and moisture. Proper control of these factors is needed to produce quality coated tablets.
tablet defects
- 1. Defects in Tablet Sugar Coating AACP Bangalore
- 2. TABLET COATING โข Tablet coating is the application of coating material to the exterior of a tablet with the intention of conferring benefits and properties to a dosage form over the uncoated variety.
- 3. Why To Coat ?? โข Bitter taste or unpleasant odour. โข Protecting the drug from surroundings (Stability). โข Handling & ease of ingesting by patients. โข Mechanical protection from breakage. โข Light incompatibility or Environmental Oxidation. โข In-elegent core. โข modifying the drug release profile. โข Product identity.
- 4. Coating for Processing Increase packaging speed Reduces damage during the packaging process Printing efficiency and clarity Product identification Reduced changeover and cleandown time Reduces operator exposure to active substances
- 5. Coating for Marketing Allows product to stand out from the competition Colour and tablet shape for branding and trademark Zocor and Cozaar trademark of MSD Neurontin trademark Pfizer
- 6. Coating for Product Stability Light Moisture Oxidation CO2 2 O2 LIGHT H20
- 7. Coating for Release % No functional coat. Immediate release Provide release of drug at time various GI sites depending on % pH. Delayed release (enteric protection) Change rate of release of pH active e.g. control rate of % active release over 24 hours. Extended release time
- 8. Coating for Consumers Patient compliance is affected by a productโs : โฆ Ease of Use โฆ Identity โฆ Efficacy โฆ Swallowability โฆ Taste โฆ Odour
- 9. Types of Coating โข Sugar coating โข Film coating โข Enteric coating โข Controlled release coating โข Specialized coating ๏ผ Compressed coating ๏ผ Electrostatic coating ๏ผ Dip coating ๏ผ Vacuum film coating
- 11. Sugar Coating
- 12. SUGAR COATING โข Sugar coating is the most conventional multistep coating process. โข As the name suggests, this process involves application of sugar (sucrose) based coating solution to the tablets. โข It is carried out in coating pans having variable capacities & mounted at an angel of 40o โข Its use of labour is more, require a fair degree of skill.
- 13. Advantages of S.C. cheap, safe coating material cheap coating machine good patient compliance can be reprocessed require less hardness core
- 14. Disadvantages of S.C time consuming process. high weight gain. increase in packaging & shipping. required trained personnel. Imprinting problems.
- 15. Materials for S.C. Sugar & itโs Subtituents Glucose, lactose, isomalt, sugar alcohols Binders Acacia, gelatin, PVP Coloring agents Water soluble (dyes), water insoluble (lakes) Anti- Adherents Talcum, colloidal silica Fillers CaCO3, CaSO4, starch, talcum, TiO2 Polishing Agents beeswax, carnauba wax, paraffin Other agents Flavouring agents, surfactants
- 16. Steps involved in S.C. Sealing/Seal coating Syrup Coat Subcoating Sub Coat Seal Coat Grossing/Smoothing Tablet Core Coloring Polishing/Finishing Printing
- 17. Steps involved in S.Cโฆโฆ SEAL COATING โข to prevent water from coating solution โข to prevent migration from core โข to produce enteric coating (some cases) โข to reduce core abrasion
- 18. Steps involved in S.Cโฆโฆ SUBCOATING โข to round off sharp edge of core (smooth surface is not required) โข to provide a good substrate for subsequent smoothing step
- 19. Steps involved in S.Cโฆโฆ GROSSING โข to smooth the rough core surface. โข to provide a smooth base for color coat
- 20. Steps involved in S.Cโฆโฆ COLORING โข to achieve an evenly colored, smooth surface
- 21. Steps involved in S.Cโฆโฆ POLISHING โข to enhance gloss. โข to provide moisture protection.
- 22. Coating Defects
- 23. Coating Defects CHIPPING โข Involves increased brittleness of the tablet. โข Causes : High degree of attrition associated with the coating process like: ๏ผ excessive use of fillers & pigments ๏ผ low amount of polymers โข Remedy : Increase hardness of the film by increasing the molecular weight grade of polymer.
- 24. Coating Defects STICKING & โข Sticking involves sticking of the tablets with each other & with pan walls. PICKING โข Picking is the aftermath case of sticking involves adhering of some portion of coated layer to pan or to another tablet at the point of contact. โข Causes : Higher rate of application of coating solution Inefficient drying. โข Remedy : Use optimum and efficient drying conditions. Increase the inlet air temperature. Decrease the rater of application of coating solution by increasing viscosity of coating solution.
- 25. Coating Defects ROUGHNESS โข Involves presence of previously dried sprayed coating solution droplets onto the core. โข Causes : Drying of coating solution before reaching the surface of tablet during spraying. Excessive pigments concentration. โข Remedy : Moving the nozzle closer enough. Reducing the degree of atomization.
- 26. Coating Defects CRACKING โข The coating cracks when the internal stress exceeds the tensile strength of tablets. โข Causes : Absorption of moisture. Internal stress relaxation after compaction. Excessive coating material concentration. โข Remedy : Adjusting the coating solution concentration.
- 27. Coating Defects TWINNING โข Two or more tablets that sticking together. โข Causes : Inefficient drying. Higher rate of application of coating solution. โข Remedy : Choosing appropriate shaped tablets. Controlling the drying & rate of movement of pan. Adjusting the coating solution concentration.
- 28. Coating Defects BLOOMING/HAZING โข The polish of product to take on a fogged appearance. โข Causes : High temperature during formulation. Exposure to high humidity conditions. โข Remedy : Controlling humidity conditions. Formulation temperature monitoring.
- 29. Coating Defects BRIDGING/FILLING โข Occurs in tablets consisting monogram or bisection. โข Coating shrink or pull away โ Bridging โข Too much filling & thereby narrowing - Filling โข Causes : improper application of the solution. poor design of the tablet embossing. high coating viscosity. high percentage of solids in the solution. improper atomization pressure. โข Remedy : Control of spraying of coating solution. Soft edged font for monogram. Atomization control. Concentration of coating material.
- 30. Coating Defects BLISTERING โข An un-smooth coated surface shows a number of uneven spots called blisters. โข Causes : Effect of temperature on the strength, elasticity and adhesion of the coat. โข Remedy : Use mild drying condition.
- 31. Coating Defects ORANGE PEEL EFFECT โข Coating texture that resembles the surface of an orange. โข Before drying causes a bumpy or โorange-peelโ effect on the coating. โข Causes : high atomization pressure in combination with spray rates. Too rapid drying. High solution viscosity. โข Remedy Thinning the solution with additional solvent. Controlling the drying procedures.
- 32. Coating Defects COLOUR VARIATION โข Variation in the proposed colour for coating. โข Causes : Improper mixing. Uneven spray pattern. In-sufficient coating. Unevenness of the surface of the sub coat. โข Remedy Using lake dyes. Go for geometric mixing. Use mild drying conditions.