coating technology

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COATING TECHNOLOGY WICHAN KETJINDA PhD. Pharmaceutical Technology Faculty of Pharmaceutical Sciences PRINCE OF SONGKLA UNIVERSITY

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Technology of tablet coating - process, equipment, problem and remedy

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  • COATING TECHNOLOGYWICHAN KETJINDA PhD.Pharmaceutical TechnologyFaculty of Pharmaceutical Sciences PRINCE OF SONGKLA UNIVERSITY

  • Milestone of Coating 850-923 pill mucilage1600s 1800s Moyse Charas 1875 William Cairns coating pan1953 . Abbott 1959 Dale Wurster Air suspension coater

  • 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

  • , imcopatability dosage form

  • KEY FACTORS TABLET PROPERTIES - Shape - Tolerance - Surface area COATING PROCESS -Equipments - Parameters - Facility and ancillary equipment - Automation COATING COMPOSITION - Polymers - Solvents - Plasticizers - Colorants

  • 1. , Convexity ,

  • convexity

  • 2. i. Rotating of tablet ii. Application of coating to tablet iii. Drying & exhausting2.1

  • i. Rotating of tablet

  • ii. Application of coating to tablet

  • iii. Drying and exhausting Drying air Exhausting air

  • Drying air Exhausting air iii. Drying and exhausting

  • Drying air Exhausting air iii. Drying and exhausting

  • Drying air Exhausting air iii. Drying and exhausting

  • 2.2 Coating process =

  • 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

  • 2.3 (Coating Equipment)

  • 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

  • Application of Coating Solution by Spray Gun

  • Spray system a. Airless atomization (hydraulic spray system) - coating solution droplet orifice - droplet size orifice air pressure - 1) small scale 2)clogging

  • Spray system b. Air atomization ( Pneumatic spray system) - coating solution orifice (peristaltic pump) - small scale - 1) 2) droplet

  • (a) high pressure airless nozzle(b) low pressure air atomized nozzle Type of Spray Nozzle

  • 2.3.2 Perforated Pan (perforated) exhaust plenumm() 3 - Accela-cota - Hi-coater - Dria-coater

  • Perforated panInlet airExhaust plenum

  • Accela - Cota

  • Hi - Coater

  • Dria - Coater

  • 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

  • Application of Fluidization

  • Configuration of Fluid bed

  • Top Spray CoaterA. Basic Design - conical bowl - nozzle position ---> lowest - expansion chamber ---> conical - counter-current spray - random fluidization pattern

  • B. Advantage - large batch capacity - short time between batch - film coating, hot melt coatingC. Disadvantage - agglomeration - fluidization ----> not good

  • Bottom Spray Coater ( Wurster)A. Basic design - chamber and partition - orifice plate - expansion chamber -->conical - concurrent spray

  • B. Advantage - best film characteristics - good fluidization - for coating of powder, pellet, tablet - suitable for controlled release productC. Disadvantage - hot melt coating - tall machine

  • Rotor Tangential Spray Coater 1. Centrifugetion2. Fluidization3. Gravitation

  • A. Advantage - simple setup - higher spray rate - nozzle access during process - shortest machine B. Disadvantage - mechanical stress on product

  • 3. Coating compositionFilm coating - Polymers - Solvents - Plasticizers - Colorants Sugar coating - Sugar, Talc - Water - Gelatin, acacia - Colorants

  • 1. (Sugar Coating)

  • - - - - -

    - ( Refine sugar)- invert sugar

  • Method of coating 1. Pan-pour Pan ladling 2. Atomatic sugar coat - atomizing system - - coating pan

  • Sugar Coating Process

  • Core TabletSealingSubcoat3-5%45%35%15%Smooth Coat Syrup CoatPolishing Coat

  • Core Tablet

  • 1. Sealing ,

  • 1. Sealing organic solvent (3-10 % Solution shellac, zein, cellulose acetate phthalate, hydroxypropyl methylcellulose, etc.

  • 1. Sealing 1-2 (4) talcum 25 - 30o C

  • 2.Subcoat

    sealing sugar coat

  • 2. Subcoat Subcoating solution : sugar, acacia, gelatin, water Dusting powder : talc, acacia, kaolin, calcilum carbonate

  • 2. Subcoat traditional method - 50o C - - dusting powder - 3-5 -

  • 2. Subcoat Suspension subcoating - 50o C - - 3-5 - - -

  • Subcoating

  • 2. Subcoat BuddingTwin,

  • 2. Subcoat Rough surfaceSliding pan

  • 3. Smooth Coat

  • 3. Smooth Coat Simple Syrup : - 70 % w/w solution of sugar in water Glossing Syrup : - suspension of Ca2CO3, Ti2O , corn starch, talcum

  • 3. Smooth Coat pan 60o C 3- 5 ( 2/3)

  • 3. Smooth Coat pan pan

  • Smooth Coating

  • 4. Syrup Coat Solution : syrup, soluble dye Suspension : syrup , TiO2, lake

  • 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

  • Insoluble lake ( Aluminium-Dye) - , migration - - ( smooth coat) - opaque lake suspension talc, magnesium oxide, TiO2 , Al(OH)3 opacifying agent

  • 4. Syrup Coat pan 3-5 , slide . finished coat

  • Syrup coating

  • Finished Coat 2/3 jogging 2 .

  • 5. Polishing Coat 5 % wax solution carnuba wax, white bee wax

  • 5. Polishing Coat polishing pan warm polishing solution 10-15 solvent

  • polished coating

  • 5. Polishing Coat wax carnuba wax

  • 2-3% rapid release3-5% enteric coat

    2. (Film Coating)

  • A) Pan-ladling methodB) Pan-spray methodC) Fluidized bed process

  • Formulation of Film Coating Solution1. Film Former2. Solvent3. Plasticizers4. Colorants5. Opaquant- extender6. Miscellaneous

  • Film Former Compatibility bridging filling

  • Hydroxypropyl methylcellulose (HPMC)Hypromellose

  • Methyl Cellulose

  • Ethyl Cellulose

  • Sodium CMC

  • Eudragit EpH < 5

  • Eudragit RL RS

  • Enteric Material Delayed release Repeat action Bioavailability

  • Cellulose acetate phthalatepH > 6

  • Hydroxypropyl methylcellulose phthalateHypromellose phthalatepH > 5-5.56

  • Eudragit L, S, RL, RSpH = 6-7

  • 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

  • Problems in Film CoatingSticking and PickingRoughnessOrange peel effectBridging and FillingBlisteringHazing/Dull film

  • 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/

  • Coating Problemspicking/chipping

    roughness

    sticking

    film cracking/peeling

    http://pharmacy2011foru.blogspot.com/

    http://pharmacy2011foru.blogspot.com/

  • BRIDGING & FILLING

    ORANGE PEEL EFFECT

    http://pharmacy2011foru.blogspot.com/

    http://pharmacy2011foru.blogspot.com/

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