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Coated Pharmaceutical Dosage Forms

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Coated Pharmaceutical Dosage Forms

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  1. Coated Pharmaceutical Dosage Forms Sontaya Limmatvapirat

  2. Scope of the study Introduction 15 min Core and core properties 20 min Coating apparatus 45 min Sugar coating 100 min Film coating 100 min Evaluation 20 min

  3. Introduction

  4. Introduction History 9 BC. Coating of pill with psyllium Coating by dipping 1800 Invention of tableting machine Sugar coated tablet 1950 Semi-, automatic coating machine 1953 Film coating 1956 Microencapsulation

  5. Introduction Purpose of coating - To mask unpleasant taste, odor or color - To protect products from environment, e.g. light, moisture, oxygen - To reduce incompatibility - To control drug release - enteric coating - sustained release coating

  6. Introduction Purpose of coating - To promote aesthetic property - To increase manufacturing effeciency

  7. Introduction Type of coating - Sugar coating

  8. Introduction Type of coating - Film coating

  9. Introduction Type of coating - Specialized coating e.g. compression coating, hotmelt coating, microencapsulation

  10. Core

  11. Core - powders, granules, pellets, tablets, capsules,liquid

  12. Core Properties Hardness - sufficient hardness ( > 6kg) and less friability (< 0.5 %) - Less hardness is require for sugar coating

  13. ความง่ายในการเคลือบ band Core Properties Shape

  14. Core incomplete cover edge twinning agglomerate ปัญหาการเกาะกันของยาเม็ดเคลือบจากขอบที่หนาหรือโค้งน้อย

  15. Core Properties Surface properties - Wettability - Surface roughness - Logo

  16. Core Properties Other properties - Stability of drug or excipients - Melting point - etc.

  17. Core Calculation of surface area Examples r T h d CR Surface area = 2(rh+r2+d2)  2(rT + r2)

  18. Coating apparatus

  19. Coating apparatus - Coating machine - Polishing machine - Coating parts and accessories

  20. Coating machine - Conventional coating pan - Modified conventional coating pan - Perforated or side vented coating pan - Air suspension or fluid bed coater

  21. Coating machine Conventional coating pan - Modified from pan used for confectionery - mainly used for sugar coating

  22. Spherical shape Hexagonal shape Pear shape Coating machine Conventional coating pan

  23. Coating machine Conventional coating pan Drawbacks - Insufficient mixing, dead spot - Low drying efficiency - Inadequate exhaust system

  24. Coating machine Baffle

  25. Coating machine Baffle Advantages - Increase mixing efficiency - Ensure distribution of coating solution Disadvantages - Tablet erosion, break - Difficult to clean

  26. Coating machine Modified conventional coating pan Pellegrini coating pan • angular rotation • (to increase mixing efficiency) - baffle • increase air flow efficiency • increase drying efficiency

  27. Coating machine Modified conventional coating pan Pellegrini coating pan กระบัง ลมเข้า ลมออก

  28. Coating machine Modified conventional coating pan Improved drying efficiency • immersion tube • immersion sword • deep bed air extraction

  29. Coating machine Modified conventional coating pan Improved drying efficiency ลมเข้า ท่อลมพ่น ลมออก ท่อน้ำยาเคลือบ immersion tube กองยาเม็ด

  30. Coating machine Modified conventional coating pan Drawbacks - inadequate drying efficiency, especially for film coating (aqueous formular) - inadequate exhaust system

  31. Coating machine Perforated coating pan - improved drying efficiency - improved exhaust system - suitable for film coating (both aqueous and non-aqueous formula)

  32. Coating machine Perforated coating pan Accela Coata Hi Coater Driacoater Glatt Perforated coating pan Dumoulin pan Huettlin butterfly pan

  33. ลมเข้า ลมออก หัวพ่นน้ำยา กองยาเม็ด Coating machine Perforated coating pan หม้อเคลือบเจาะรูพรุน Accela Cota

  34. Coating machine Perforated coating pan Accela Cota model 75

  35. Coating machine Fluidized bed coating pan Principle

  36. Coating machine Fluidized bed coating pan Classification • - Top spray coater • Wurster bottom spray coater • Rotor tangential spray coater • Kugel coater

  37. Coating machine Fluidized bed coating pan Advantage - maximize drying efficiency - suitable for particle coating Disadvantage - not suitable for friable core

  38. Coating machine Selection criterion - core properties e.g. hardness, size.,etc. - required coated product e.g. sugar, film coated tablet - specification of coating machine e.g. capacity, GMP, accessories

  39. Polishing machine - necessary for sugar coating - polishing by wax

  40. Coating parts and accessories Air system Application system Product charging Product discharging Other accessories

  41. Coating parts and accessories Air system - air inlet system, exhaust system - air inlet system clean, dry, optimum temperature drying - air exhaust system > air inlet (30%) dust, moisture removal

  42. Coating parts and accessories Application (feeding) system - ladle application, spray application ladle application suitable for sugar coating spray application airless atomization, air atomization, ultrasonic spray system

  43. Spray application airless atomization • - high pressure, small orifice • - suitable for large scale production • suitable for organic solvent based coating solutions • suitable for sugar or film coating • not suitable for small scale or lab scale • easily clogged by coating solution

  44. Spray application air atomization • - lower pressure, larger orifice • - suitable for lab scale production • suitable for aqueous based coating solutions • suitable for film coating • less clogged by coating solution

  45. Sugar coating

  46. Sugar coating Advantages and disadvantages Coating materials Steps of sugar coating Problems of sugar coating

  47. Advantage and disadvantage Advantage • - cheap, safe coating materials • - cheap coating machine • good patient compliance • can be reprocessed • require less hardness core

  48. Advantage and disadvantage Disdvantage • - time consuming process • - high weight gain • required trained personnel • fragile

  49. Coating materials Sugar • - main component of syrup • - cold or hot syrup • be avoided formation of “invert sugar” by excessive heat and low pH (<6) • be avoided crystallization of sugar from syrup before coating

  50. Coating materials Sugar substitutes • glucose, lactose, isomalt, sugar alcohols • some sugar substitutes can not be single use due to low solubility e.g. lactose, mannitol