 2.

Introduction General Properties Advantages Disadvantages Types of Tablets Tablet

Additives

 3. Continued…. Formulation Development Preformulation of drugs & additives

Introduction to tablet Additives Need of Granulation Mechanisms Manufacturing Processes
and Equipments for granulations Advance Granulation Techniques Characterization and
Evaluation All about Tablets. All about Tablet Coating

 4. Introduction Definition: Tablet is defined as a compressed unit solid dosage form

containing medicaments with or without excipients. According to the Indian Pharmacopoeia,
Pharmaceutical tablets are solid, flat or biconvex dishes, unit dosage form, prepared by
compressing a drugs or a mixture of drugs, with or without diluents. They vary in shape and
differ greatly in size and weight, depending on amount of medicinal substances and the
intended mode of administration.

 5. Absorption of drug form tablets

 6. Advantages Greatest dose precision and the least content variability. Cost is lowest
of all oral dosage form. Lighter and compact. Easiest and cheapest to package and strip. Easy
to swallowing with least tendency for hang-up.

 7. Continued… Sustained release product is possible by various techniques.

Objectionable odour and bitter taste can be masked by various techniques. Suitable for large
scale production. Greatest chemical and microbial stability over all oral dosage form. Product
identification is easy and rapid requiring no additional steps when employing an embossed
and/or monogrammed punch face.

 8. Disadvantages Difficult to swallow in case of children and unconscious patients.

Some drugs resist compression into dense compacts, owing to amorphous nature, low density
character. Drugs with poor wetting, slow dissolution properties, may be difficult to formulate
or manufacture as a tablet that will still provide adequate or full drug bioavailability. Bitter
testing drugs, drugs with an objectionable odor or drugs that are sensitive to oxygen may
require encapsulation or coating. In such cases, capsule may offer the best and lowest cost.

 9. General properties of Tablet dosage forms: A tablet should have elegant product
identity while free of defects like chips, cracks, discoloration, and contamination. Should
have sufficient strength to withstand mechanical shock during its production packaging,
shipping and dispensing. Should have the chemical and physical stability to maintain its
physical attributes over time. The tablet must be able to release the medicinal agents in a
predictable and reproducible manner. Must have a chemical stability over time so as not to
follow alteration of the medicinal agents.

 10. Different Types of Tablets (A) Tablets ingested orally: Compressed tablet, e.g.
Paracetamol tablet Multiple compressed tablet Delayed release tablet, e.g. Enteric coated
Bisacodyl tablet Sugar coated tablet, e.g. Multivitamin tablet Film coated tablet, e.g.
 Metronidazole tablet Chewable tablet, e.g. Antacid tablet (B) Tablets used in oral cavity:
Buccal tablet, e.g. Vitamin-c tablet Sublingual tablet, e.g. Vicks Menthol tablet Troches or
lozenges Dental cone

 11. (c) Tablets administered by other route: Implantation tablet Suppositories or

Inserts, e.g. Clotrimazole tablet (D) Tablets used to prepare solution: Effervescent tablet, e.g.
Dispirin tablet (Aspirin) Dispensing tablet, e.g. Enzyme tablet (Digiplex) Hypodermic tablet
Tablet triturates e.g. Enzyme tablet (Digiplex)

 12. Tablet Additives In addition to active ingredients, tablet contains a number of

inert materials known as additives or excipients. Different excipients are: Diluent Binder and
adhesive Disintegrents Lubricants and glidants Coloring agents Flavoring agents Sweetening
agents

 13. Diluents : Diluents are fillers used to make required bulk of the tablet when the
drug dosage itself is inadequate to produce the bulk. Secondary reason is to provide better
tablet properties such as improve cohesion , to permit use of direct compression
manufacturing or to promote flow . A diluents should have following properties: 1. They must
be non toxic 2. They must be commercially available in acceptable grade 3. There cost must
be low 4. They must be physiologically inert 5. They must be physically & chemically stable
by themselves & with the drugs. 6. They must be free from all microbial contamination. 7.
They do not alter the bioavailability of drug. 8. They must be color compatible.

 14. Commonly used tablet diluents 1. Lactose-anhydrous and spray dried lactose 2.
Directly compressed starch-Sta Rx 1500 3. Hydrolyzed starch-Emdex and Celutab 4.
Microcrystalline cellulose-Avicel (PH 101and PH 102) 5. Dibasic calcium phosphate
dehydrate 6. Calcium sulphate dihydrate 7. Mannitol 8. Sorbitol 9. Sucrose- Sugartab, DiPac,
Nutab 10. Dextrose

 15. 2. Binders and Adhesives : These materials are added either dry or in wet- form to
form granules or to form cohesive compacts for directly compressed tablet. Example : Acacia,
tragacanth- Solution for 10-25% Conc. Cellulose derivatives- Methyl cellulose, HPC, HPMC
Gelatin- 10-20% solution Glucose- 50% solution Polyvinylpyrrolidone (PVP)- 2% conc.
Starch paste-10-20% solution Sodium alginate Sorbitol

 16. 3. Disintegrants : Added to a tablet formulation to facilitate its breaking or

disintegration when it contact in water in the GIT. Example: Starch- 5-20% of tablet weight.
Starch derivative – Primogel and Explotab (1-8%) Clays- Veegum HV, bentonite 10% level
in colored tablet only Cellulose Cellulose derivatives- Ac- Di-Sol (sodium carboxy methyl
cellulose) Alginate PVP (Polyvinylpyrrolidone), cross-linked

 17. Superdisintegrants : Swells up to ten fold within 30 seconds when contact water.
Example : Crosscarmellose- cross-linked cellulose, Crosspovidone- cross-linked povidone
(polymer), Sodium starch glycolate- cross-linked starch. These cross-linked products swell
upto 10 fold with in 30 seconds when in contact with water. A portion of disintegrant is added
before granulation and a portion before compression, which serve as glidants or lubricant.
Evaluation of carbon dioxide in effervescent tablets is also one way of disintegration
 18. 4. Lubricant and Glidants : Lubricants are intended to prevent adhesion of the
tablet materials to the surface of dies and punches , Glidants are intended to promote flow of
granules or powder material by reducing the friction between the particles. Example:
Lubricants- Stearic acid, Stearic acid salt - Stearic acid, Magnesium stearate, Talc, PEG
(Polyethylene glycols), Surfactants Glidants- Corn Starch – 5-10% conc., Talc-5% conc.,
Silica derivative - Colloidal silicas such as Cab-O-Sil, Syloid, Aerosil in 0.25-3% conc.

 19. 5. Coloring agent: The use of colors and dyes in a tablet has three purposes: (1)
Masking of off color drugs (2) Product Identification (3) Production of more elegant product
All coloring agents must be approved and certified by FDA. Two forms of colors are used in
tablet preparation – FD &C and D & C dyes. These dyes are applied as solution in the
granulating agent or Lake form of these dyes. Lakes are dyes absorbed on hydrous oxide and
employed as dry powder coloring. Example: FD & C yellow 6-sunset yellow FD & C yellow
5- Tartrazine FD & C green 3- Fast Green FD & C blue 1- Brilliant Blue FD & C blue 2 -
Indigo carmine D & C red 3- Erythrosine. D & C red 22 – Eosin Y

 20. 6. Flavoring agents: For chewable tablet- flavor oil are used 7. Sweetening agents:
For chewable tablets: Sugar, mannitol. Saccharine (artificial): 500 time’s sweeter than sucrose
Disadvantage: Bitter aftertaste and carcinogenic Aspartame (artificial) Disadvantage: Lack of
stability in presence of moisture.

 21. Granulation Need To prevent segregation of the constituents of the powder mix. To
improve the flow properties of the mix To improve the compaction characteristics of the mix
Other reasons: Toxic, Slightly hygroscopic, denser. Methods Dry granulation Wet granulation
Effect of granulation methodon granule structure.

 Granulation technology on large scale by various

22.
techniques
 23. Mechanisms of Granulation There are Five Particle Bonding Mechanisms,
Adhesion and cohesion forces in the immobile liquid films Interfacial forces in mobile liquid
films within the granules Formation of solid bridges after solvent evaporation Attractive
forces between solid particles Mechanical interlocking

 24. Adhesion and cohesion forces in immobile liquid films between individual primary
powder particles. Interfacial forces in mobile liquid films Solid bridges Partial mellting,
Binder hardening, crystalization of dissolved sub. Attractive forces between solid particles
Mechanism of granule formation Mechanisms of Granulation

 25. Steps to make powder ready for compression

 26. Granulation Equipments (Granulators) Dry granulator Wet granulator

 27. Effective dose of drug is too high for direct compression Drug is sensitive to heat
or moisture or both. Dry granulators: Sluggers Roller Compactors Is used when……
 28. Wet granulators Shear mixer granulator High speed granulator Fluidized bed
granulator Spray driers

 29. WET GRANULATION: some equipment…. High Shear Granulator Littleford

Lodige Mixer/Granulator Littleford MGT Granulator Diosna Granulator Gral
Mixer/Granulator Granulator with Drying Facility Fluidized Bed Granulator Day Nauta
Mixer Processor Double cone/Twin Shell Processor Topo Granulator Special Granulator Roto
Granulator Marumerizer

 30. Wet granulation equipment shear granulator

 31. SOP Of Shear Mixture Granulator: Mixed powder are fed in to the bowl
Granulating liquid is added The moist mass has then transferred to a granulator such as
oscillating granulator

 32. Disadvantage Long duration Large number of equipment are needed High material
loss Advantage Not very sensitive to the material End point can be determined by inspection

 33. High speed granulator Widely used in pharmaceutical SS mixing bowl containing a
three blade main impeller, revolves in horizontal plane, and a three blade auxiliary chopper –
revolves vertical or horizontal plane Unmixed powder –in the bowl mixed for few minute
with rotating impeller Granulation

 34. High speed granulator

 35. Typical Time Sequence Mixing – 2 minutes Granulation – 8 minutes Discharge – 1

minutes Gives more normal PSD with lesser fines. Diosna Mixer / Granulator Rapid Mixer
Granulator (RMG) blade chopper

 36. Rapid Mixing Granulator: (RMG)

 37. Advantage Mixing,Massing,Granulation in a single equipment within few minutes

Disadvantage End point monitor needed

 38. Designs of FB granulators Top spray Bottom spray Rotating disc granulator
Suction Fan Fabric Filter Bag Granulating solution Product Bed Spray Nozzle Air Filter Air
Heater

 39. Fluidized Bed Granulator

 40. Fluidized Bed Granulator Advantage One unit so saving labour cost, transfer loses
and time 2-6 time greater heat transfer than tray dryer Uniform drying….prevent mottling.
Process can be automated once parameters optimized Disadvantage Expensive Multiple
process variable Filter clocking, demixing, electrostatic charge, solvent explosion

 41. Fluidized Bed Granulator (Industrial Equipment)

 42. Merumizer (spheronizer) Wet mass containing drug , diluents and binder is pass
through extruder to get rod shaped segments. Cylinder Screw-feed Extruder Segments are
placed in MERUMIZER where they are shaped into sphere by centrifugal and frictional
forces produced by rotating plates/blades and form granules Advantage Granules with regular
size, shape with lower friability, so less amount of fines.

 43. Other More Specialized Granulators Spray Driers

 44. Pelletizers

 45. MELT SOLIDIFICATION A melt granulation process has been investigated which
efficiently agglomerates pharmaceutical powders for use in both immediate- and sustained-
release solid dosage forms. The process utilizes materials that are effective as granulating
fluids when they are in the molten state. Cooling of the agglomerated powders and the
resultant solidification of the molten materials completes the granulation process. Both the
molten agglomeration and cooling solidification were accomplished in a high shear Collette
Gral mixer equipped with a jacketed bowl. Hence, the melt granulation process replaces the
conventional granulation and drying operations which use water or alcohol solutions.

 46. Direct Compression Need of other component Large dose- not suitable Small dose-
impractical Moderate dose- suitable Directly compressible vehicles Limitations Stratification-
poor content uniformity Large dose drugs [30%] Interaction Static charge Equipment and
procedures used Screening/Milling * Three Parts * Principle * Operation * Types of Mills

 47. Hammer Mill

 48. Ball Mill Bench top Model Industrial Model Working Mechanism

 49. Fluid-energy Mill

 50. Cutting Mill Roller Mill

 51. Colloid Mill

 52. Tablet Production Powders intended for compression into tablets must possess two
essential properties Powder fluidity The material can be transported through the hopper into
the die To produce tablets of a consistent weight Powder flow can be improved mechanically
by the use of vibrators, incorporate the glidant Powder compressibility The property of
forming a stable, intact compact mass when pressure is applied

 53. Tableting Procedure Filling Compression Ejection

 54. Tablet Compression Machines Hopper for holding and feeding granulation to be
compressed Dies that define the size and shape of the tablet Punches for compressing the
granulation within the dies Cam tracks for guiding the movement of the punches Feeding
mechanisms for moving granulation from the hopper into the dies
 55. Single Punch Machine The compression is applied by the upper punch Stamping
press

 56. Upper and Lower Collar Collar locker Single Punch Machine (Tablets) 

 58.

 59. Multi-station Rotary Presses The head of the tablet machine that holds the upper
punches, dies and lower punches in place rotates As the head rotates, the punches are guided
up and down by fixed cam tracks , which control the sequence of filling, compression and
ejection. The portions of the head that hold the upper and lower punches are called the upper
an lower turrets

 60. The portion holding the dies is called the die table The pull down cam (C) guides
the lower punches to the bottom, allowing the dies to overfill The punches then pass over a
weight-control cam (E) , which reduces the fill in the dies to the desired amount A swipe off
blade (D) at the end of the feed frame removes the excess granulation and directs it around the
turret and back into the front of the feed frame

 61. The lower punches travel over the lower compression roll (F) while simultaneously
the upper punches ride beneath the upper compression roll (G) The upper punches enter a
fixed distance into the dies, while the lower punches are raised to squeeze and compact the
granulation within the dies After the moment of compression, the upper punches are
withdrawn as they follow the upper punch raising cam (H)
 62. The lower punches ride up the cam (I) which brings the tablets flush with or
slightly above the surface of the dies The tablets strike a sweep off blade affixed to the front
of the feed frame (A) and slide down into a receptacle At the same time, the lower punches
re-enter the pull down cam (C) and the cycle is repeated 

 66. Although tablet compressing machinery has undergone numerous mechanical

modifications over the years, the compaction of materials between a pair of moving punches
within a stationary die has remained unchanged The principle modification from earlier
equipment has been an increase in production rate which is regulated by Number of tooling
sets Number of compression stations Rotational speed of the press

 67. Special adaptations of tablet machines allow for the compression of layered tablets
and coated tablets A device that chills the compression components to allow for the
compression of low-melting point substances such as waxes i.e. suppositories

 68. Compression Machine Tooling PUNCHES BB Tooling : 5.25” L, BD 0.75”, 1”. B

Tooling : LP 3 9/16” D Tooling : Large tablets L 5.25”, BD 1”, 1 ¼ ” HD. DIES OD 0.945”
7/16” RT or 9/16” Cap T OD 1 3/16” – 9/16” RT, 3/3” Cap T

 69. Evaluation of Tablet General Appearance: The general

appearance of a tablet, its identity and general elegance is essential for consumer acceptance,
for control of lot-to-lot uniformity and tablet-to-tablet uniformity. The control of general
appearance involves the measurement of size, shape, color, presence or absence of odor, taste
 etc. Size & Shape: It can be dimensionally described & controlled. The thickness of a tablet is
only variables. Tablet thickness can be measured by micrometer or by other device. Tablet
thickness should be controlled within a ± 5% variation of standard value.

 70. Unique identification marking: These marking utilize some form of embossing,
engraving or printing. These markings include company name or symbol, product code,
product name etc. Organoleptic properties: Color distribution must be uniform with no
mottling. For visual color comparison compare the color of sample against standard color.
Hardness : Tablet requires a certain amount of strength or hardness and resistance to friability
to withstand mechanical shocks of handling in manufacture, packaging and shipping.
Hardness generally measures the tablet crushing strength

 71. Different Hardness Tester Erweka Pfizer Schleuniger Monsanto Strong-cobb

 72. 6.Friability: Friability of a tablet can determine in laboratory by Roche friabilator.

This consist of a plastic chamber that revolves at 25 rpm, dropping the tablets through a
Distance of six inches in the friabilator, which is then operate for 100 revolutions. The tablets
are reweighed. Compress tablet that lose less than 0.5 to 1.0 % of the Tablet weigh are
consider acceptable.

 73. 7. Drug Content and Release: Weight Variation test (U.S.P.): T ake 20 tablet and
weighed individually. Calculate average weight and compare the individual tablet weight to
the average. The tablet pass the U.S.P. test if no more that 2 tablets are outside the percentage
limit and if no tablet differs by more than 2 times the percentage limit. (II) Content
Uniformity Test: Randomly select 30 tablets. 10 of these assayed individually. The Tablet
pass the test if 9 of the 10 tablets must contain not less than 85% and not more than 115% of
the labeled drug content and the 10 th tablet may not contain less than 75% and more than
125% of the labeled content. If these conditions are not met, remaining 20 tablet assayed
individually and none may fall out side of the 85 to 115% range .

 74. (III) Disintegration Test (U.S.P.): The U.S.P. device to test disintegration uses 6
glass tubes that are 3” long; open at the top and 10 mesh screen at the bottom end. To test for
disintegration time, one tablet is placed in each tube and the basket rack is positioned in a 1-L
beaker of water, simulated gastric fluid or simulated intestinal fluid at 37 ± 2 0 C such that the
tablet remain 2.5 cm below the surface of liquid on their upward movement and not closer
than 2.5 cm from the bottom of the beaker in their downward movement. Move the basket
containing the tablets up and down through a distance of 5-6 cm at a frequency of 28 to 32
cycles per minute. Floating of the tablets can be prevented by placing perforated plastic discs
on each tablet.

 75. According to the test the tablet must disintegrate and all particles must pass
through the 10 mesh screen in the time specified. If any residue remains, it must have a soft
mass. Disintegration time: Uncoated tablet: 5-30 minutes Coated tablet: 1-2 hours

 76. Dissolution Test (U.S.P.) Two set of apparatus: Apparatus-1: A single tablet is
placed in a small wire mesh basket attached to the bottom of the shaft connected to a variable
speed motor. The basket is immersed in a dissolution medium (as specified in monograph)
 contained in a 100 ml flask. The flask is cylindrical with a hemispherical bottom. The flask is
maintained at 37±0.5 0 C by a constant temperature bath. The motor is adjusted to turn at the
specified speed and sample of the fluid are withdrawn at intervals to determine the amount of
drug in solutions.

 77. Apparatus-2: It is same as apparatus-1, except the basket is replaced by a paddle.

The dosage form is allowed to sink to the bottom of the flask before stirring. For dissolution
test U.S.P. specifies the dissolution test medium and volume, type of apparatus to be used,
rpm of the shaft, time limit of the test and assay procedure for. The test tolerance is expressed
as a % of the labeled amount of drug dissolved in the time limit.

 79. Problems In Tableting Capping Lamination / Laminating Chipping

Cracking Sticking / Filming Picking Binding Mottling Double impression Granule Size and
size distribution Poor flow Punch Variation Hardness Variation

 88. Tablet Coating Tablet coating objectives. Three Primary

components involved in tablet coating Tablet properties Coating process Coating equipment.
Parameters of the coating process. Facility and ancillary equipment. Automation in coating
processes. Coating compositions

 89. 1. Tablet Properties Mechanical and Physical Strength Smooth surface Physical
shape Chemical nature of tablet ingredients Hygroscopicity

 90. 2. Coating Process Three types of equipments The standard coating pan The
perforated coating pan The fluidized bed (Air suspension) coater. These systems based on
three basic designs 1. Conventional pan system Depending on drying efficiency Pellegrini
system Immersion-sword system Immersion –tube system 2. Perforated pan system Accela-
coata Hi-coater systems Driacoater Glatt coater 3. Fluidized bed (Air suspension) system

 91. Convensional pan: 8-60 inches diameter revolving on its horizontal axis. Heated air
is directed into the pan and onto the tablet bed surface. Exhausted by means of ducts
positioned through the front of the pan Drying efficiency is achieved by, Pellegrini pan : Has
a baffled pan and diffuser for uniform distribution of drying air. Enclosed and automated .

 92. 2. Immersion-sword system Drying air through perforated metal sword immersed
in the tablet bed. Upward flow through bed. Spray onto the bed surface 3. Immersion-tube
system Tube immersed in tablet bed Delivers heated air and coating solution through spray
built in the tip of tube Flows upward and exhausted by a conventional duct.

 93. Perforated pan system: Perforated drum rotates on its horizontal axis in an enclosed
housing. Accela-Coata and Hi-coater system : Drying air is directed in to drum , is passed
through bed , and is exhausted through perforations in to drum.

 94. Driacoater : Introduces drying air through hollow perforated ribs located inside
periphery of the drum. With rotating pan, ribs dip into bed Drying air passes up through and
fluidizes bed Exhaust is from back of the pan Glatt coater : Drying air directed from inside the
 drum through bed and out an exhaust duct With an optional split-chambered plenum drying
air can be directed in the reverse manner Several air flow configurations are possible.

 95. 3. Fluidized bed (Air suspension system) Highly efficient Fluidization of tablet bed
is achieved in a columnar chamber by the upward flow of drying air. Industrial FBC with
bottom spray

 96. Spray application System Two basic types of spray system differ in manner in
which atomization of liquid is achieved High-pressure, airless (a) High pressure liquid (250-
3000psig) through a small orifice (.009”- .020” id) Degree of automization- fluid pressure,
orifice size, viscosity. 2. Low-pressure, air-automized (b) Low pressure liquid (5-50psig)
through a large orifice (.020”- .060” id) Degree of automization- fluid pressure, orifice size,
viscosity, air pressure, air cap design.

 97. Parameters of Coating Process Rate of coating composition application= Rate of

evaporation of volatile solvent Deviation from this results a serious coating problems
Mathematical modeling for automated aqueous coating process Inlet A(T 1 ,H 1 )+C 1 (S)
+pSA 1 -> E -> A(T 2 ,H 2 )+C 2 +pSA 2 Exhaust Where, A(T,H) = Air capacity, C(S) =
Coating Composition, pSA = Tablet surface area, E = Equipment efficiency.

 98. Air Capacity: Quantity of water or solvent removed during coating process
Depends on : 1. Quantity of air flow through tablet bed, 2. Temperature of air, 3. water
content of inlet air. Coating Composition: Inlet air-heated, exhaust air- cool. Drying of film-
rate of application Thin rapidly drying formulations dry quickly on the tablet surface allowing
constant application by efficient atomization of coating solution

 99. Tablet surface area: Size and presence of debossed features affects coating
conditions Total surface area per unit weight decreases from smaller to larger tablets For
same thickness of film, smaller tablets requires more coating composition as compared with
larger tablets Size of atomized coating droplets must be smaller and better controlled as the
features to be coated become smaller. Equipment efficiency, E:

 100. Facility and Ancillary Equipment Facility should meet to requirement of cGMP
Adequate space for equipment, processing, in-process storage Safety requirements depending
on nature of solvent- electrical explosion-proofing, specialized ventilation Exhaust air
treatment to recover solvent or to prevent entry in to atmosphere Federal EPA defines limits
of organic solvents and particulate allowed in atmosphere Aqueous based coating is
advantageous Other Equipments Tanks, filters, mixers, mills, jacketed tanks, portable
pressure tanks or pumping systems.
 101. Tablet Coating Process Final production step on which quality of product may be
judged Sugar Coating Steps involves, Sealing, Subcoating Syruping (Smooting) Finishing
Polishing

 102. Seal coating To prevent moisture penetration into tablet core Specially in pan-
ladling process in which localized overwetting of portion of tablet bed occur Shellac Affects
disintegration and dissolution time due to polymerization on aging Zein Such effect is not
reported 2. Subcoating To round the edges and build up size . Subcoating Steps Sticky binder
solution Dusting of subcoating powders Drying

 103. 3. Syrup (Smoothing/ color) coating To cover and fill in the imperfections in
tablet surface caused by subcoating To impart desired color First syrup coat contains some
suspended powders i.e. grossing syrups Dilute colorants– tinted base– uniform coating Syrup
solution containing dye applied until final size and color are achieved 4. Finishing Final syrup
coating step Few clear coats of syrup may be applied 5. Polishing Desired luster is obtained in
this final step Clean standard coating pan, canvas-lined coating pans Application of powdered
wax or warm solution of waxes in suitable volatile solvent

 105. Film Coating Film coating and sugar coating shares the same equipments and
process parameters Two methods, Pan-Pour method Same as that of pan-pour sugar coating
Method is relatively slow and relies heavily on skill and technique of operator Aqueous based
film coating is not suitable due to localized over-wetting 2) Pan-Spray method Use of
automated spraying system

 106. Process Variables To ensure the consistent product quality, certain elements of
process need to be controlled regardless of coating pan system The variables to be controlled
in pan-spray film coating process are: Pan variables Pan design/ baffling Speed Pan load 2.
 Process air Air quality Temperature Airflow rate/ volume/ balance 3. Spray variables Spray
rate Degree of atomization Spray pattern Nozzle-to-bed distance

 107. Development Of Film Coating Formulations Water vapor permeability Film

tensile strength Coated Tablet Evaluation Adhesion test with tensile strength tester Diametral
crushing strength of coated tablets Rate of coated tablet disintegration/ dissolution Stability
studies Surface roughness, hardness, color uniformity through instrumental mean Visual
inspection for coated tablet quality. Qualitative measure of resistance of a coated tablet to
abrasion by white paper.

 108. Coating Formula Optimization Modifications in basic formula, To improve

adhesion of the coating to the core To decrease bridging of intagliations To increase coating
hardness To improve any other property as per need of formulation Common modifications
are Changes in polymers-to-plastisizers ratio Addition of different polymers or plstisizers

 109. Material used in Film Coating Should have following attributes; Solubility in
solvent Solubility required for intended use Capacity to produce elegant looking product
Stability with heat, light, moisture, air, substrate. Essentially no color, taste, odor
Compatibility with common coating solution additives Nontoxic , therapeutically inert and
ease of application to the particles or tablets Resistance to cracking, and provision of adequate
moisture, light, odor, or drug sublimation barrier when desired No bridging or filling of the
debossed tablet surfaces by the film former Ease of printing procedures on high-speed
equipment

 110. A. Film Formers Classified in Nonenteric and Enteric Materials 1 . Nonenteric

Materials HPMC, MHEC, EC, HPC, Povidone, SCMC, PEG, Acrylate Polymers

 111. 2. Enteric Materials Reasons for enteric coating Protect acid labile drugs from
gastric fluid e.g. enzymes, ATBTs Prevent gastric distress or nausea due to irritation from
drug, e.g. Sodium Salicylate To deliver drugs for local action in intestines, e.g. Intestinal
antiseptic (Kanamycin) For drugs optimally absorbed in small intestine Provide delayed
release component for repeat-action tablets Material should have following properties
Resistance to gastric fluids Ready susceptibility or permeability to intestinal fluids Stability
with coating composition and drug substrate Stability alone and in coating solution Formation
of continuous film Nontoxicity, Low cost Ease of application without special equipments
Ability to be printed or to allow film to be applied to debossed tablets

 112. Enteric materials CAP, Acrylate Polymers HPMCP PVAP B. Solvents C.

Plasticizers “ Internal ” or “ External ” techniques D. Colorants E. Opaquant-Extenders F.
Miscellaneous Coating Solution Components

 113. Quality Control Stability Testing Film Defects Specialized Coatings Compression
Coating Electrostatic Coating Dip Coating Vacuum Film Coating

 114. Blistering Chipping Cratering Picking Pitting Blooming Blushing Colour

variation Infilling Orange peel/Roughness Cracking/Splitting Problems And Remedies For
Tablet Coating
T.B.EKNATH BABU
ARMOURZS
IV B.Pharm