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Tablet coating process

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This presentation is briefly explains about the steps involved in the coating process and problem arised during the process with their solutions.

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Tablet coating process

  1. 1.  Presented By : Abdul Raheem.T Industrial pharmacy Bapuji pharmacy collage Davangere 1
  2. 2. INTRODUCTION Coated tablets are defined as “tablets covered with one or more layers of mixture of various substances such as Natural Or Synthetic Resins  Gums  Inactive And Insoluble Filler,  Sugar  Plasticizer  Polyhydric Alcohol  Waxes  Authorized Colouring Material and Flavoring agents 2
  3. 3. I. Therapy  Avoid irritation of esophagus and stomach  Avoid bad taste  Avoid inactivation of drug in the stomach  Improve drug effectiveness  Prolong dosing interval  Improve patient compliance 3
  4. 4. II. Technology  Reduce influence of moisture  Avoid dust formation  Reduce influence of atmosphere  Improve drug stability  Prolong shelf life 4
  5. 5. III. Marketing  Improve product brand identification  Improve appearance and acceptability Coating aids in improving sales and marketing appeal of a drug 5
  6. 6. Tablet coating is the application of coating composition to moving bed of tablets with concurrent use of heated air to facilitate evaporation of solvent. Basic Principle of Tablet coating 6
  7. 7.  Sugar coating  Film coating  Enteric coating  Controlled release coating  Specialized coating Compressed coating Electrostatic coating Dip coating Vacuum film coating 7
  8. 8. The objectives of tablet coating are as follows:  To mask the unpleasant taste and odour of the drug.  To offer a physical and/or chemical protection to the drug.  To control and sustain the release of the drug from the dosage form. . 8
  9. 9.  To minimize product damage due to physical stress during handling.  To protect an acid-labile drug from the gastric environment.  To increase the mechanical strength of the dosage form  It helps maintaining the shape of the tablet 9
  10. 10. EQUIPMENTS FOR TABLET COATING Three general types of equipments are available 1.Standard coating pan e.g., Pellegrino pan system Immersion sword system Immersion tube system 2.Perforated pan system e.g.,Accela cota system Hi-coater system Glattcoater system Driacoated system 3.Fluidized bed coater 10
  11. 11. Standard Coating Pan Immersion- tube system Glatt Immersion sword system Pellegrini pan system STANDARD COATING PAN 11
  12. 12. PERFORATED PANS Accela cota system Hi-coater system 12
  13. 13. PERFORATED PANS (continue…) Dria coater pan Glatt coater 13
  14. 14. FLUID BED COATING SYSTEMS 14
  15. 15. 1. Sugar coating 2. Film coating 3. Press coating Main coating processes 15
  16. 16. 6. Printing 5. Polishing 4. Colouring 3. Smoothing 2. Sub coating 1. Seal tablet core  Sugar coating as the name suggests is the process which involves application of sugar (sucrose) based coating solution for the tablets.  Process: Multistage Process involving 6 separate operations. Sugar coating 16
  17. 17. 1- Sealing (Waterproofing)  Sealing is done by applying a polymer based water impermeable coating solution by either ladling or spray techniques. The polymers used are natural gums like shellac, acacia or derivatives of cellulose like cellulose acetate pthalate (CAP), PVAP, HPMC 17
  18. 18. (WHY Sealing?) a- Sugar-coatings are aqueous formulations which allow water to penetrate directly into the tablet core and thus potentially affecting product stability and possibly causing premature tablet disintegration. b- It enables sugar-coated product to exhibit modified- release pattern (extended release or delayed "enteric"- release characteristics). c- To protect the tablet core from adverse effect of moisture 18
  19. 19. 2. Subcoating  Large quantities of sugar-coatings are usually applied to the tablet core for increasing the tablet weight by 50- 100% WHY?  It is done to provide the sealed tablet cores with round edges and to build up the core weight. It is achieved by adding a bulking agent such as Calcium carbonate, to the sucrose solution.  Antiadherents e.g. Talc may be added after partial drying to prevent sticking of the tablets together. 19
  20. 20. 3- Smoothing  The sub coating stage results in tablets with rough surfaces. To facilitate the color application (which requires smooth surface), sub coated tablets are smoothed out by a thick sucrose syrup coating. 4- Coloring  Color coatings usually consist of thin sucrose syrup containing the requisite coloring materials (water-soluble dyes or water-insoluble pigments may be used). The colours used should be approved by FD and C. 20
  21. 21. 5- Polishing  After the colour coating, the tablet surfaces show a dull or matt appearance. To achieve glossy finish, application of waxes (beeswax carnauba wax) are employed. 6- Printing  Different tablets could be identified by manufacturer' logo, product name, dosage strength or other appropriate code. For sugar-coated tablets, such identification could be only achieved by printing process using special edible inks. 21
  22. 22. Brufen® POM  Available in 200mg and 400mg strength Premarin® POM  Conjugated oestrogens 625mcg (maroon) and 1.25mcg (yellow) Colofac ® P  Mebeverine hydrochloride 100mg Round, white, sugar coated Kalms ® GSL  45mg Hops powder,90mg Gentian powdered extract, and 135mg Valerian powdered extract EXAMPLE OF SUGAR COATED TABLETS 22
  23. 23. SUGAR COATED PROCESS 23
  24. 24.  Film coating involves application and deposition of a thin film of polymer solution around the tablet core.  Process: Single stage process, which involves spraying a coating solution containing the following; 1. Polymer 2. Solvent 3. Plasticizer 4. Colourant The solution is sprayed onto a rotating tablet bed followed by drying, which facilitates the removal of the solvent leaving behind the deposition of thin film of coating materials around each tablet. FILM COATING 24
  25. 25. Advantages Produce tablets in a single step process in relatively short period of time and suitable for diabetic patients. Disadvantage They do not have elegance as that of sugar coated tablets. Types of film coating A. Immediate release B. Modified release 25
  26. 26. 1.Polymer 26
  27. 27. 2.Plasticizers Plasticizers are generally added to film coating formulations to modify the physical properties of the polymer to make it more usable. One important property is that their ability to decrease film brittleness. Examples of plasticizers are: Polyols, such as polyethylene glycol 400 . Organic esters, such as diethyl phthalate. Oils/glycerides, such as fractionated coconut oil. In general, only water-miscible plasticizers can be used for aqueous- based spray systems. 27
  28. 28. 3.Colourants Colourants are used to improve the aesthetic value of the final product as well as helps in identifying the product. Pigments have certain advantages over water-soluble colours: they tend to be more chemically stable towards light, provide better opacity and covering power. Examples of colourants are: • Iron oxide pigments • Titanium dioxide • Aluminum Lakes. 28
  29. 29. 4.Solvents  Solvents play an important role in formulation of coating solution. They serve as a vehicle for dissolving and dispersing the constituents of coating solutions and helps in the applications of the coating to the tablet surface.  Examples for commonly used solvents are water, alcohol ( methanol, ethanol), ketones, esters etc. 29
  30. 30. 30 Film coating Tablet appearance  Retains shape of original core  Small weight increase of 2-3% due to coating material Process  Can be automated e.g. Accela Cota  Easy training operation  Single stage process  Easily adaptable for controlled release allows for functional coatings. Sugar coating Tablet appearance  Rounded with high degree of polish  Larger weight increase 30- 50% due to coating material Process  Difficult to automated e.g. traditional coating pan  Considerable training operation required  Multistage process  Not able to be used for controlled release apart from enteric coating.
  31. 31.  Use of compression to form coat around a pre-formed core  Used mainly to separate chemically incompatible materials and also dual release patterns possible PRESS COATING 31
  32. 32.  Sticking and picking : When the coating solution overwets, the tablets stick to each other or to the coating pan. On drying , a piece of film may remain adhered to pan or another tablet. Solution : It can be solved by reducing the liquid application rate or increasing the dry air temperature and volume. 32
  33. 33.  Roughness : ◦ When coating is applied as a spray, some droplets may dry before reaching the core and are deposited on the core resulting in roughness of the surface ◦ Solution : Moving the nozzle closer to the bed or reducing the degree of atomization. 33
  34. 34.  Orange-Peel effect : ◦ When the coating solution is sprayed inadequately or improperly before drying causes a bumpy or “Orange- Peel” effect on the coating. Solution : This can be solved by thinning the solution with additional solvent 34
  35. 35.  Bridging and Filling : ◦ This is observed in tablets consisting of monogram or bisection. During drying, the film may shrink and pull away from sharp corners resulting in Bridging of the surface depression. Filling is caused when too much of solution is applied which fills and narrows the monograms or bisect. ◦ Solution : Bridging can be solved by increasing the plasticizer content or changing the plasticizer 35
  36. 36.  Blistering : ◦ When coated tablets require further drying in ovens, too rapid evaporation of solvent from core and the effect of high temperature may effect th strength, elasticity and adhesion properties of the film results in blistering. An unsmooth film surface shows a number uneven spots called blisters. ◦ Solution : It can be solved by employing milder drying conditions. 36
  37. 37.  Dull film (Bloom) : ◦ This happens when high temperatures are used in formulations. It can also happen when the coated tablets are exposed to high humidity conditions and also due to migration of plasticizers to the surface of coat.  Colour Variation : ◦ It is caused by processing conditions of formulations , improper mixing, uneven spray pattern and insufficient coating may result colour variation 37
  38. 38.  Cracking : ◦ Cracking occurs due to internal stresses that occur in the film. If internal stress exceeds the tensile strength, cracking occurs. This can be solved by adjusting the type and concentration of plasticizer. 38
  39. 39.  Gilbert S, Banker, Chritopher, Rhodes T. Modern pharmaceutics.4th ed. Newyork: Marcel dekker; 2005. p.318- 24.  Leon L, Herbert A, Liberman, Joseph L, Kanig. The theory and practice of IP: Pharmaceutical dosage forms. 3rd ed. Bombay: Varghese publishing house; 1987. p. 346-373.  Loyd VA, Nicholas G, Popovich, Howard CA. Ansel’s pharmaceutical dosage forms and DDS: Solid dosage form and solid modified release DDS. 8th ed. Pheladelphia: Lippin cott williams and wilkins; 2005. P.247-52. 39
  40. 40.  Neelam DK, Prafulla S, Chaudhari1,Rajesh JO, Sandip S, Kshirsagar, Rishikesh VA. Innovations in tablet coating technology: a review. Int J Applied Bio PharmTech 2011 Mar; 2(1): 214-8.  Bharadia PD, Vikram MP. A review on aqueous film coating technology. Ind J Pharm Pharmacology 2014 ;1(1): 65-98.  Aalok, Anjan D, Suddhasattya D. Techniques of tablet coating: concepts and advancements: a comprehensive review. Journ Pharm Pharmaceut Sci 2013: 2(4); 1-6.  Yihong Q, Yisheng C, Geoff GZ, Zang. Developing solid dosage forms: pharmaceutical theory and practice. Elsvier.inc : 2009. p. 331-6. 40
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