![GUIDED BY āDR.U.C.GALGATTE [ASST.PROF]
PRESENTED BY ā MORE PRATIKKUMAR DEEPAK
QUALITY ASSURANCE TECHNIQUE
PEāS MODERN COLLEGE OF PHARMACY,PUNE-44
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PROBLEMS ENCOUNTERED COATING TECHNOLOGY
- 1. GUIDED BY āDR.U.C.GALGATTE [ASST.PROF] PRESENTED BY ā MORE PRATIKKUMAR DEEPAK QUALITY ASSURANCE TECHNIQUE PEāS MODERN COLLEGE OF PHARMACY,PUNE-44 1
- 2. 2 OBJECTIVE OF TABLET COATING ā¢ Mass the odour test or colour of the drug ā¢ Provide physical and chemical protection for drug ā¢ Control the release of drug from the tablet ā¢ Protect the drug from gastric environment of stomach in case of acid sensitive drug. ā¢ Avoid chemical incompatibility. ā¢ Improve pharmaceutical elegance by using colour and contrasting printing.
- 3. 3 TABLET COATING ā¢ Tablet coating is the last critical space in the tablet production cycle ā¢ It is the phenomenon of application of coating to the tablet
- 4. COATING PROCESS Coating composition( polymers, color, plasticizer, solvent) Is applied to moving bed of tablet Heated air is introduce evaporation of the solvent 4
- 5. Principle of tablet coater ļµ A tablet coating machine is an equipment that coats the external surface of a tablet using a thin film of coating material ļµ Working principle of tablet coating machine is relatively simple where the application of coating material is done on a moving bed of tablet and removing rapidly the solvent using a current of hot air 5
- 6. EQUIPMENTS ļµ The equipments used for the tablet coating are:- ļµ Standard coating pan ļµ Perforated coating pan ļµ Fluidized bed coater 6
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- 9. STANDARD COATING PAN ļµ Working :- ļµ It is also known as conventional pan system ļµ Circular metal pan (mounted angularly on a stand) ļµ 8-60 inches in diameter ļµ Rotated on its horizontal axis by a motor ļµ Heated air is directed into the pan and on to the tablet bed surface and is exhausted by means of ducts through the front of the pan 9
- 10. ļµ Coating solution are applied to the tablets by spraying the material on to the rotating tablet bed ļµ Use of spraying systems:- ļµ Produces a faster , more even distribution of the solution ļµ Reduces drying time between solution in sugar coating ļµ Allows continuous application of the solution in film coating 10
- 11. STANDARD COATING PAN,THE DRYING EFFICIENCY IS IMPROVED BY :- ļµPellegrini pan ļµThe Immersion sword ļµImmersion tube systems 11
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- 13. ā¢ PELLEGRINI PAN- ā¢ baffled pan ā¢ Diffuser( distributes the drying air uniformly over the tablet bed surface) ā¢ IMMERSION -SWORD SYSTEM- ā¢ Perforated metal sword device immersed in the tablet bed ā¢ Drying air is introduced through this device and flows upward from the sword through the tablet ā¢ IMMERSION - TUBE SYSTEM ā¢ Tube immersed in the tablets bed ā¢ Tube delivers the heated air 13
- 14. PERFORATED PAN SYSTEM ļµ Working:- ļµ Perforated or partially perforated drum ļµ Rotated on its horizontal axis in an enclosed housing ļµ The coating solution is applied to the surface of the rotating bed of tablets through spraying nozzles, which are present inside the drum ļµ Perforated pan coaters are efficient drying systems with high coating capacity 14
- 15. PERFORATED PAN SYSTEM HAS- ļµ Accela- cota system ļµ Hi coater system ļµ Dria coater pan ļµ Glatt coater 15
- 16. ACCELA- COTA 16
- 17. ā¢ ACCELA - COTA & HI COATER SYSTEM- ā¢ Drying air is directed into the drum ā¢ Passed through tablet bed ā¢ Exhausted through perforation in drum ā¢ ā¢ DRIA COATER PAN- ā¢ Drying air enters through hollow perforated ribs,located on inside periphery of the drum ā¢ As the coating pan rotates , the ribs dip into the tablet bed and drying air passes up through fluidizes the tablet bed 17
- 19. ā¢ GLATT COATER- ā¢ It is the latest perforated pan to be introduced in the industry ā¢ In this drying air can be directed from inside the drum through tablet bed ā¢ Exhausted put through an exhaust duct 19
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- 21. FLUIDIZED BED SYSTEM ļµ In this system of the tablet mass is achieved in a columnar chamber by the upward flow of drying air ļµ The air flow is controlled so that more air enters the centers of the column causing the tablets to rise in the center ļµ The movement of tablets is upward trough the center of the chamber 21
- 22. ļµ They then fall towards the chamber wall ļµ Move downwards to reenter the air stream at the bottom of the chamber ļµ Coating solutions are applied from a spray nozzle which is located at the bottom of the chamber 22
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- 25. SPARY APPLICATION SYSTEM ļµ 2 basic systems used to apply a finely divided spray of coating solutions on to tablet are- ļµ High pressure , airless ļµ Low pressure , air atomized 25
- 26. AIRLESS SPRAY SYSTEM ļµ Liquid is pumped at high pressure (250- 3000 pounds per square inch gauge (psig) ļµ Through a small orifice in the fluid nozzle which results in a finely divided spray ļµ In this the degree of atomization and the spray rate are controlled by ļµ Fluid pressure ļµ Orifice size ļµ Viscosity of the liquid 26
- 27. LOW PRESSURE AIR- ATOMIZED SYSTEM ļµ Liquid is pumped through a somewhat large orifice(0.020 inch- 0.060 inch in diameter) at relatively low pressure ļµ Low pressure air contacts with the liquid stream at the tip of the atomizer and a finely divided spray is produced ļµ The degree of atomization is controlled by the fluid pressure ļµ Viscosity of liquid ļµ Air pressure ļµ Air cap design 27
- 28. TABLET COATING TYPES ļµThe coating of tablets classified into three types- ļµSugar coating ļµFilm coating ļµEnteric coating 28
- 29. SUGAR COATING PROCESS ļµ It involves the application of sugar solution with color for several times to give UNIFORM AND ELEGANT FILM ADVANTAGES ļµ It prevents unpleasant odour ļµ Give sweet taste to tablet by masking bitter taste ļµ Highly elegant and glossed tablets are obtained 29
- 30. ļµSugar coating involves following steps- ļµSealing ļµSub-coating ļµSyruping ļµFinishing ļµPolishing 30
- 31. SEALING ļµ It prevents moisture penetration in to the tablet core ļµ Seal coating agents- ļµ Zein is alcohol soluble protein derivative ļµ Shellac is more effective ( because of polymerization of shellac) ļµ But it lengthens tablet disintegration and dissolution times 31
- 32. ļµ Over wetting of tablet ļµ Moisture is absorbed ļµ Lead to tablet softening or disintegration ļµ Effects physical and chemical stability (To over come this problem seal coating is done) 32
- 33. SUB COATING ļµ Sub coating is applied: ļµ To form uniform edges ļµ To build up the tablet size ļµ Sub coating increases the tablet weight from 50- 100 % ļµ EXAMPLES- ļµ gelatine , sugarcane powder , corn syrup ,gum acacia 33
- 34. In involves ļµ Application of binder solution ļµ To the tablet ļµ Followed by dusting of sub coating with powder ļµ Drying until the tablet edges have been covered and the desired thickness is achieved 34
- 35. SYRUPING ļµ It is done to cover the imperfections in the tablet surface caused during sub coating step ļµIt involves- ļµ Application of syrup coating with grossing syrups followed by the addition of dilute colorants to provide tinted base ļµ In subsequent steps the syrup solution containing dye are applied until final size and color are achieved 35
- 36. ļµ The final step a clear syrup coat without dye are applied ļµ No color is added until the tablets are quit smooth ļµ Premature application to the rough tablets can produce a mottled appearance in the final coated tablets ļµ Syrup coating constituents- colorants , calcium carbonate , cane sugar powder , corn starch 36
- 37. POLISHING ļµ Tablet are polished in a ļµ Standard coating pans ļµ Carnauba wax , bees wax , paraffin wax or suitable volatile solvent 37
- 38. FILM COATING ļµ It is the process of polymeric solution to bring a uniform film ADVANTAGES ļµ Film coating gives a tablet with less weight and small size ļµ The film formed is very thin ļµ In film coating engraving are possible on tablet surface which are not possible in sugar coating ļµ The cost of the film coated tablets is less 38
- 39. FILM COATING PROCESS ā¢ PAN - POUR METHOD ā¢ The coating solutions are poured over the tablet cores ā¢ The operator determines the quantity of solution to add the method and rate of the pouring ,when to apply drying air and how long or how fast the tablets should be tumbled in the pan ā¢ Tablet coated by pan pour methods are subjected to alternate solution application ,mixing and drying step. 39
- 40. PAN SPRAY METHOD- ā¢ The introduction of spraying equipment has improved the coating efficiency process ā¢ Spraying allows for automated control of liquid application ā¢ Spray patterns are selected to provide a continuous and across the tablet bed surface ā¢ Broad, flat spray patterns are usually chosen by selection of appropriate nozzle system so that the entire width of the tablet bed can be covered by the spray from 1to 5 nozzles 40
- 41. FILM FORMING AGENTS The film forming agents tablet coating are classified into:- ļµ Non- enteric film formers ļµ Enteric film formers 41
- 42. NON ENTERIC FILM FORMERS They are incorporated to give uniform film with desired mechanical strength which are as follows:- ļµ HPMC(hydroxyl propyl methyl cellulose) ļµ MHEC(methyl hydroxyl ethyl cellulose) ļµ EC(ethyl cellulose) ļµ HPC(hydroxyl propyl cellulose) ļµ POVIDONE 42
- 43. ENTERIC FILM FORMER ļµ REASONS FOR ENTERIC FILM FORMERS- ļµ To protect acid ā labile drugs from gastric fluids eg. Enzymes and certain antibiotics ļµ To prevent gastric distress or nausea due to irritation from the drug Eg. Sodium salicylate 43
- 44. ļµ To deliver drugs intended for local action in the intestine eg. Intestinal antiseptics ļµ To deliver drugs that are optimally absorbed in the small intestine to their primary absorption site ļµ To provide a delayed- release component for repeat action tablets 44
- 45. PROPERTIES OF AN IDEAL ENTERIC COATING MATERIAL ļµ Resistance to gastric fluids ļµ susceptibility or permeability to intestinal fluids ļµ Compatibility with most coating solution components and the drug substrates ļµ Formation of a continuous film , nontoxicity ,with low cost ļµ Ease of application without specialized equipment 45
- 46. ENTERIC FILM FORMERS ļµ ACRYLATE POLYMERS ļµ CAP(cellulose acetate phthalate) ļµ HPMCP( hydroxypropyl methyl cellulose phthalate) ļµ PVAP( polyvinyl acetate phthalate) 46
- 48. SOLVENT ļµ It is to dissolve or disperse the polymers and other additives and convey them to the substrate surface ļµ It should be- Colorless , tasteless , inexpensive , nontoxic , non flammable and rapid drying rate EXAMPLES- water , ethanol , methanol , chloroform , acetone 48
- 49. PLASTICIZERS ļµ It is used to modify the quality of the film ļµ Level of plasticizers ranges from 1-50% ļµ EXAMPLES- ļµ Castor oil ļµ Glycerin ļµ Surfactants ļµ Propylene glycol 49
- 50. COLORANTS ļµ It is provide the distinct color and elegance to the dosage form ļµ To achieve the proper distribution of suspended colorants in the coating solutions requires use of fine powdered colorants ( <10 microns ) ļµ For very light shade ā conc.Lt. 0.01% ļµ For dark shade- conc.2.0% is required ļµ the most common colorants in use are lakes, dyes ļµ The inorganic material and natural colorants are ļµ Iron oxides ļµ Carotenoids ļµ Flavones ļµ turmeric 50
- 51. OPAQUANT - EXTENDERS ļµ These are very fine inorganic powders used in the coating solution formulation to provide more pastel colors and increase film coverage ļµ Provide while coating or mask the color of the tablet core ļµ EXAMPLE- ļµ Carbonates like magnesium carbonate ļµ Sulphates like calcium sulphate 51
- 52. 52 PROBLEMS AND REMEDIES FOR TABLET COATING
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- 55. CONCLUSION ļµ Coating is one of the important technique in manufacturing of dosage forms ,improve the stability , shelf life and release pattern ļµ Coating of dosage forms helps in improving patient compliance 55
- 56. REFERENCE ļµ Neelam DK , prafulla S, chaudhari , 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 ļµ Bharadia PD,vikram MP, a review on aqueous film coating technology ind J pharm pharmacology 2014;(1):65-98 ļµ Lachman/Lieberman's "the theory and practice of industrial pharmacy" third edition,varghese publishing house ,Bombay page no- 346-371 56
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