coating technology
DESCRIPTION
Technology of tablet coating - process, equipment, problem and remedyTRANSCRIPT
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COATING TECHNOLOGYWICHAN KETJINDA PhD.Pharmaceutical TechnologyFaculty of Pharmaceutical Sciences PRINCE OF SONGKLA UNIVERSITY
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Milestone of Coating 850-923 pill mucilage1600s 1800s Moyse Charas 1875 William Cairns coating pan1953 . Abbott 1959 Dale Wurster Air suspension coater
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WHAT IS TABLET COATING?
WHY COAT TABLETS? INTRODUCTION 4.To Mask Color, Odour, Taste of the drug
3.Stability 5.Control the release
6.Protection from GI fluidsDEFINITIONOf coating
1.Identification
2.Improve elegance
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, imcopatability dosage form
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KEY FACTORS TABLET PROPERTIES - Shape - Tolerance - Surface area COATING PROCESS -Equipments - Parameters - Facility and ancillary equipment - Automation COATING COMPOSITION - Polymers - Solvents - Plasticizers - Colorants
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1. , Convexity ,
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convexity
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2. i. Rotating of tablet ii. Application of coating to tablet iii. Drying & exhausting2.1
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i. Rotating of tablet
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ii. Application of coating to tablet
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iii. Drying and exhausting Drying air Exhausting air
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Drying air Exhausting air iii. Drying and exhausting
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Drying air Exhausting air iii. Drying and exhausting
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Drying air Exhausting air iii. Drying and exhausting
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2.2 Coating process =
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Stesko : Inlet A(T1, H1) + C1(S) + pSA1 Exhaust A(T2, H2) + C2 + pSA2A(T,H) = Air capacity , C(S) = Coating compositionpSA = Tablet surface areaE = Equipment EfficiencyE
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2.3 (Coating Equipment)
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2.3.1 Conventional Coating System Coating Pan - Circular or doughnut shaped - , 25-40oWarmed-air and exhaust System - Inlet air T= 50o C, R.H.= 35 % - Exhaust air Solvent
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Application of Coating Solution by Spray Gun
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Spray system a. Airless atomization (hydraulic spray system) - coating solution droplet orifice - droplet size orifice air pressure - 1) small scale 2)clogging
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Spray system b. Air atomization ( Pneumatic spray system) - coating solution orifice (peristaltic pump) - small scale - 1) 2) droplet
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(a) high pressure airless nozzle(b) low pressure air atomized nozzle Type of Spray Nozzle
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2.3.2 Perforated Pan (perforated) exhaust plenumm() 3 - Accela-cota - Hi-coater - Dria-coater
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Perforated panInlet airExhaust plenum
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Accela - Cota
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Hi - Coater
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Dria - Coater
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2.3.3 Fluidized bed system Fluidization pellet Spraying of coating solution Drying by fluidized air - Top Spray Coater - Bottom Spray Coater - Rotor-tangential Spray Coater
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Application of Fluidization
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Configuration of Fluid bed
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Top Spray CoaterA. Basic Design - conical bowl - nozzle position ---> lowest - expansion chamber ---> conical - counter-current spray - random fluidization pattern
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B. Advantage - large batch capacity - short time between batch - film coating, hot melt coatingC. Disadvantage - agglomeration - fluidization ----> not good
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Bottom Spray Coater ( Wurster)A. Basic design - chamber and partition - orifice plate - expansion chamber -->conical - concurrent spray
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B. Advantage - best film characteristics - good fluidization - for coating of powder, pellet, tablet - suitable for controlled release productC. Disadvantage - hot melt coating - tall machine
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Rotor Tangential Spray Coater 1. Centrifugetion2. Fluidization3. Gravitation
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A. Advantage - simple setup - higher spray rate - nozzle access during process - shortest machine B. Disadvantage - mechanical stress on product
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3. Coating compositionFilm coating - Polymers - Solvents - Plasticizers - Colorants Sugar coating - Sugar, Talc - Water - Gelatin, acacia - Colorants
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1. (Sugar Coating)
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- - - - -
- ( Refine sugar)- invert sugar
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Method of coating 1. Pan-pour Pan ladling 2. Atomatic sugar coat - atomizing system - - coating pan
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Sugar Coating Process
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Core TabletSealingSubcoat3-5%45%35%15%Smooth Coat Syrup CoatPolishing Coat
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Core Tablet
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1. Sealing ,
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1. Sealing organic solvent (3-10 % Solution shellac, zein, cellulose acetate phthalate, hydroxypropyl methylcellulose, etc.
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1. Sealing 1-2 (4) talcum 25 - 30o C
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2.Subcoat
sealing sugar coat
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2. Subcoat Subcoating solution : sugar, acacia, gelatin, water Dusting powder : talc, acacia, kaolin, calcilum carbonate
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2. Subcoat traditional method - 50o C - - dusting powder - 3-5 -
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2. Subcoat Suspension subcoating - 50o C - - 3-5 - - -
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Subcoating
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2. Subcoat BuddingTwin,
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2. Subcoat Rough surfaceSliding pan
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3. Smooth Coat
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3. Smooth Coat Simple Syrup : - 70 % w/w solution of sugar in water Glossing Syrup : - suspension of Ca2CO3, Ti2O , corn starch, talcum
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3. Smooth Coat pan 60o C 3- 5 ( 2/3)
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3. Smooth Coat pan pan
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Smooth Coating
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4. Syrup Coat Solution : syrup, soluble dye Suspension : syrup , TiO2, lake
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Coloring Soluble dye FD&C Red - Ponceau4R,Carmoisine , Erythrosine Green - Fast green FCF Blue - Indigo Carmine Brilliant blue FCF Yellow - Tartrazine , Sunset yellow FCF : , , batch , migration
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Insoluble lake ( Aluminium-Dye) - , migration - - ( smooth coat) - opaque lake suspension talc, magnesium oxide, TiO2 , Al(OH)3 opacifying agent
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4. Syrup Coat pan 3-5 , slide . finished coat
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Syrup coating
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Finished Coat 2/3 jogging 2 .
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5. Polishing Coat 5 % wax solution carnuba wax, white bee wax
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5. Polishing Coat polishing pan warm polishing solution 10-15 solvent
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polished coating
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5. Polishing Coat wax carnuba wax
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2-3% rapid release3-5% enteric coat
2. (Film Coating)
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A) Pan-ladling methodB) Pan-spray methodC) Fluidized bed process
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Formulation of Film Coating Solution1. Film Former2. Solvent3. Plasticizers4. Colorants5. Opaquant- extender6. Miscellaneous
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Film Former Compatibility bridging filling
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Hydroxypropyl methylcellulose (HPMC)Hypromellose
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Methyl Cellulose
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Ethyl Cellulose
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Sodium CMC
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Eudragit EpH < 5
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Eudragit RL RS
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Enteric Material Delayed release Repeat action Bioavailability
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Cellulose acetate phthalatepH > 6
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Hydroxypropyl methylcellulose phthalateHypromellose phthalatepH > 5-5.56
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Eudragit L, S, RL, RSpH = 6-7
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PlasticizersInternal and external plasticizationExternal glass transition temperature (Tg) solubility parameter Soluble PEG 200- 400, PG, glycerin triacetin, triethyl citrate Insoluble dibutyl phthalate or sebacate, tributyl citrate
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Problems in Film CoatingSticking and PickingRoughnessOrange peel effectBridging and FillingBlisteringHazing/Dull film
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TABLET DEFECTS
STICKING AND PICKING ROUGHNESS ORANGE PEEL EFFECTS BRIDGING AND FILLING BLISTERING HAZING/DULL FILM COLOR VARIATION CRACKING http://pharmacy2011foru.blogspot.com/
http://pharmacy2011foru.blogspot.com/
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Coating Problemspicking/chipping
roughness
sticking
film cracking/peeling
http://pharmacy2011foru.blogspot.com/
http://pharmacy2011foru.blogspot.com/
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BRIDGING & FILLING
ORANGE PEEL EFFECT
http://pharmacy2011foru.blogspot.com/
http://pharmacy2011foru.blogspot.com/
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