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Tablet coating

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Tablet coating, equipment, coating troubleshooting

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Tablet coating

  1. 1. TABLET COATING Present by Rikesh Lal Shrestha Nepal Pharmaceticals Lab.Pvt.ltd
  2. 2. CONTENTS • INTRODUCTION • COATING TYPES • COATING PARAMETERS • COATING COMPOSITIONS • COATING TROUBLE SHOOTING • COATING EQUIPMENTS • IDEAL CURES PRODUCTS
  3. 3. WHY NECESSARY ??? Coating is the process that involves application of coating polymer film to the core tablet. • Mask Bitter taste. • Mask unpleasant odour. • To increase the Product Stability, that is to protect from  Light  Moisture  Oxidation • To modify the drug release profile. • Reduce operator exposure to active substance. • Reduce damage during packaging process. • For Product identity.
  4. 4. TYPES 1) Sugar Coating 2) Film Coating 3) Enteric coating
  5. 5. SUGAR COATING • As the name suggests, this process involves application of sugar (sucrose) based coating solution to the tablets. • This is a highly skilled, multistep process that is very labour intensive. • Sugar coated products are aesthetically pleasing and have wide consumer acceptability. Steps involve in sugar coating  Seal-coating  Sub-coating  Syruping(smoothing)  Finishing  Polishing  Printing
  6. 6. • Seal coating: To prevent moisture penetration to the tablet core. • Sub coating: To round off the Sharpe edge of core. • Smoothing: To smooth the rough core surface
  7. 7. • Coloring : To obtain uniform color • Polishing : To enhance gloss. • Printing: Use edible ink and print by inkjet or pad printing process.
  8. 8. FILM COATING • It involves the application of a thin film of polymer material to tablet surface. • Film thickness range 20-200 μm • Substantial reduction in quantity of coating applied (2-4% for film coating, compared with 50-100% for sugar coating) • It is a single stage coating process in which coating solution includes: – Plasticiser – Polymer – Solvent – Colorant
  9. 9. ENTERIC COATING • This coating facilitates the acid labile drug from the gastric pH, bypass the stomach and release of drug in intestine. • To prevent gastric stress due to drug irritation. • To provide delay release of drug.
  10. 10. COATING PARAMETERS 1. Effect of pan load  Under load lead to over wetting of tablet and overloading pan lead to turbulent air flow pattern to tablet bed. 2.Spray Gun position – 6-18 inches from the tablet bed – 450 angle to the tablet bed – spray gun too far : Overlapping spray band – Spray gun too close: Over wetting may occur.
  11. 11. 3. Air volume and temperature Balance the inlet and exhaust air flow rates such that there is slight negative pressure in the chamber. It is important to monitor the following three temperatures. 1. Inlet Air temperature (45-500C) 2. Tablet Bed temperature (40-450C) 3. Exhaust air temperature (35-450C) 4. Spray distribution Spray gun having airless spray don’t control flow rate of suspension and droplet so not recommend for aqueous coating. Air automized gun control flow rate of suspension and droplet size.
  12. 12. Coating Composition Polymers/ Film Former: it is long chain organic molecule. The vicosity, film strenght and elasticity increase with polymer chain length. Eg: HPMC, PolyVinylAlcohol, PolyEthyleneGlycol Plasticizer : It decrease the elasticity and increase the plasticity of the polymer. Eg: PEG, Propylene Glycol, Solvent: It is the medium in which coating materials disperse. Eg: water, IPA , methylene chloride. Colorants : For ease of product identification. Eg: Quinolin lake color, Tartrazine lake color
  13. 13. COATING TROBULE SHOOTING COATED TABLET DEFECTS CAUSE REMEDY Sticking and Picking Coating solution spray rate too high. Pan speed too low Low tablet bed temp Optimize the spray rate. Increase pan speed Increase tablet bed temp. Orange Peel Effect Too rapid drying. High viscosity solution. Decrease in drying rate. Use Instacoat high solids low viscosity system. Twinning Tablet shape too flat or capsule shape Insufficient inlet air volume Change tablet shape. Increase inlet air volume.
  14. 14. COATED TABLET DEFECTS CAUSE REMEDY Roughness Tablet too hygroscopic Poor tablet surface hardness i.e friable core. Minimize superdisintegrants in formulation. Modify the formulation Bridging/Filling Poor logo design in core tablet. Low plasticizer in formulation. High gun to bed distance Improve logo design. Increase plasticizer. Decrease the distance. Color Variation Improper mixing of the tablet in the coating pan. Poor opacity in coating formulation. Increase pan rpm or modify baffle design. Use optimized instacoat coating system.
  15. 15. COATING EQUIPMENT • Conventional coating pan  Circular metal pan(mounted angularly on a stand)  8-60 inches in diameter  Rotated on its horizontal axis by a motor  heated air is supplied by inlet air supply  Exhaust by means of ducts  use of atomizing system to produce even distribution of coating soln or suspension
  16. 16. Perforated coating pan
  17. 17. Perforated coating pan • Accela cota system • Pan is fully perforated. • Contains mixing blades. • Inlet air is by a plenum in contact with the top of the pan. • Air is exhausted by a plenum located below the pan.
  18. 18. Fluidzsed bed coater
  19. 19. Three type of fluidized bed coater
  20. 20. Spray guns on basis of port Port Two Port Gun Three Port Gun Four Port Gun Port 1 Coating Suspension Coating Suspension Coating Suspension Port 2 Operating Air Operating Air Operating Air Port 3 Atomizing Air Atomizing Air Port 4 Pattern Air ABC gun is used widely nowadays!!!
  21. 21. ABC spray gun • Breading blocks liquid and air orifices, distorted spray distribution and require frequent cleaning of gun. • Thus Anti Breading Cap gun is used for smooth spraying. Some Examples : Standard gun with horns, schlick ABC series spray gun.
  22. 22. IDEAL CURES PRODUCTS 1) INSTANUTE Series  INSTANUTE Immediate Release film coating  INSTANUTE Moisture Barrier coating  INSTANUTE Delayed Release coating 2) Speciality Products  INSTAGLOW  INSTASPRAY  INSTAMASK  INSTA FLAVOR 3) INSTAMODEL Blend
  23. 23. INSTANUTE IMMEDIATE RELEASE FILM COATING Brand name polymer reconstitution INSTACOAT 4G PVA 35% (AQUEOUS) INSTACOAT EHP PVA 25% (AQUEOUS) INSTA COAT AQUA II Graft PVA 20% (AQUEOUS) INSTA COAT AQUA III HPMC 15% (AQUEOUS) INSTACOAT UNIVERSAL HPMC 11% (AQUEOUS) INSTACOAT P4 Sodium alginate 20% (AQUEOUS)
  24. 24. INSTANUTE MOISTURE BARRIER COATING Brand Name Polymer Reconstitution INSTACOAT EMB PVA 20% (AQUEOUS) INSTACOATSHIELD AQUA II PVA 25% (AQUEOUS) INSTACOATSHIELD HPMC AND EC 5% (ORGANIC) INSTANUTE DELAYED RELEASE Brand Name Polymer Reconstitution INSTACOAT EN SUPER-II METHACRYLIC ACID COPOLYMER 20% (AQUEOUS) INSTACOAT EN SUPER-IV METHACRYLIC ACID COPOLYMER 25% (AQUEOUS) / 9%(ORGANIC) INSTACOAT EN HPMC-P HPMC PTHALATE 5% (ORGANIC)
  25. 25. Why INSTANUTE Series??? • Rapid reconstitution in water that contribute to speed up process and save time. • Aqueous processing promotes safe working environment • Aqueous processing prevents atmosphere pollution. • Easy scale up and transfer to different equipment sites • Enhance stability, longer shelf life.
  26. 26. Speciality Products • INSTAGLOW : It is a dry ready to mix polishing system that can be reconstitute in water or organic solvents. It enhance coated tablet appearance at lower weight gain (0.5%). • INSTASPRAY: It is a customized pigmented dispersion for tablet film coating. It provide fast batch to batch color uniformity. • INSTAMASK: It is a tailor made Potassium polyacrylates system for taste masking. It is use in bitter drug like ceterizine, azithromycin, ofloxacin. • INSTA FLAVOUR: It is used to improve palatability.
  27. 27. Ideal Cures Approach : Instamodel blend • Instamodel blend: • It consists of hydrophilic polymers, pH sensitive polymers and other GRAS excipients providing matrix system producing predefine release pattern • It fulfill the formulation of Extended release dosage form. • Meets the dissolution requirement of various pharmacopoeial monographs. • Cost effective and ready to use.
  28. 28. Ideal Cures: Existing custom formulation • INSTAMODEL for Gliclazide 30mg. • INSTAMODEL for Metformin 500mg and 1000mg USP • INSTAMODEL for Diclofenac sodium 100mg USP • INSTAMODEL for Aceclofenace 200mg • INSTAMODEL for Acetaminophen 650 mg USP
  29. 29. IDEAL CURES : Regulatory Compliance • Product developed using Instamodel reportedly compatible with drug substance and having pharmacopoeial monograph or GRAS status. • Dissolution criteria shown to be in compliance with pharmacopoeial monograph and benchmarked to the international inventor brand. • Stability studies limited to the physical test, assay and release behavior having been conducted as per ICH guidelines.
  30. 30. THANK YOU...!!!!

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