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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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