Tablet coating, equipment, coating troubleshooting

1. TABLET COATING
Present by
Rikesh Lal Shrestha
Nepal Pharmaceticals Lab.Pvt.ltd

2. CONTENTS
• INTRODUCTION
• COATING TYPES
• COATING PARAMETERS
• COATING COMPOSITIONS
• COATING TROUBLE SHOOTING
• COATING EQUIPMENTS
• IDEAL CURES PRODUCTS

3. WHY NECESSARY ???
Coating is the process that involves application
of coating polymer film to the core tablet.
• Mask Bitter taste.
• Mask unpleasant odour.
• To increase the Product Stability, that
is to protect from
 Light
 Moisture
 Oxidation
• To modify the drug release profile.
• Reduce operator exposure to active substance.
• Reduce damage during packaging process.
• For Product identity.

4. TYPES
1) Sugar Coating
2) Film Coating
3) Enteric coating

5. SUGAR COATING
• As the name suggests, this process involves application of sugar
(sucrose) based coating solution to the tablets.
• This is a highly skilled, multistep process that is very labour
intensive.
• Sugar coated products are aesthetically pleasing and have wide
consumer acceptability.
Steps involve in sugar coating
 Seal-coating
 Sub-coating
 Syruping(smoothing)
 Finishing
 Polishing
 Printing

6. • Seal coating: To prevent
moisture penetration to the
tablet core.
• Sub coating: To round off
the Sharpe edge of core.
• Smoothing: To smooth the
rough core surface

7. • Coloring : To obtain uniform
color
• Polishing : To enhance gloss.
• Printing: Use edible ink and
print by inkjet or pad printing
process.

8. FILM COATING
• It involves the application of a thin film of polymer material to
tablet surface.
• Film thickness range 20-200 μm
• Substantial reduction in quantity of coating applied (2-4% for
film coating, compared with 50-100% for sugar coating)
• It is a single stage coating process in which coating solution
includes:
– Plasticiser
– Polymer
– Solvent
– Colorant

9. ENTERIC COATING
• This coating facilitates the acid labile drug from the
gastric pH, bypass the stomach and release of drug in
intestine.
• To prevent gastric stress due to drug irritation.
• To provide delay release of drug.

10. COATING PARAMETERS
1. Effect of pan load
 Under load lead to over wetting of tablet and overloading pan
lead to turbulent air flow pattern to tablet bed.
2.Spray Gun position
– 6-18 inches from the tablet bed
– 450 angle to the tablet bed
– spray gun too far :
Overlapping spray band
– Spray gun too close:
Over wetting may occur.

11. 3. Air volume and temperature
Balance the inlet and exhaust air flow rates such that there
is slight negative pressure in the chamber.
It is important to monitor the following three temperatures.
1. Inlet Air temperature (45-500C)
2. Tablet Bed temperature (40-450C)
3. Exhaust air temperature (35-450C)
4. Spray distribution
Spray gun having airless spray don’t control flow rate of
suspension and droplet so not recommend for aqueous
coating.
Air automized gun control flow rate of suspension and
droplet size.

12. Coating Composition
Polymers/ Film Former: it is long chain organic molecule. The
vicosity, film strenght and elasticity increase with polymer
chain length. Eg: HPMC, PolyVinylAlcohol,
PolyEthyleneGlycol
Plasticizer : It decrease the elasticity and increase the plasticity
of the polymer. Eg: PEG, Propylene Glycol,
Solvent: It is the medium in which coating materials disperse.
Eg: water, IPA , methylene chloride.
Colorants : For ease of product identification. Eg: Quinolin lake
color, Tartrazine lake color

13. COATING TROBULE SHOOTING
COATED TABLET DEFECTS CAUSE REMEDY
Sticking and Picking Coating solution spray rate
too high.
Pan speed too low
Low tablet bed temp
Optimize the spray rate.
Increase pan speed
Increase tablet bed temp.
Orange Peel Effect Too rapid drying.
High viscosity solution.
Decrease in drying rate.
Use Instacoat high solids low
viscosity system.
Twinning Tablet shape too flat or
capsule shape
Insufficient inlet air volume
Change tablet shape.
Increase inlet air volume.

14. COATED TABLET DEFECTS CAUSE REMEDY
Roughness Tablet too hygroscopic
Poor tablet surface hardness
i.e friable core.
Minimize superdisintegrants
in formulation.
Modify the formulation
Bridging/Filling Poor logo design in core
tablet.
Low plasticizer in
formulation.
High gun to bed distance
Improve logo design.
Increase plasticizer.
Decrease the distance.
Color Variation Improper mixing of the
tablet in the coating pan.
Poor opacity in coating
formulation.
Increase pan rpm or modify
baffle design.
Use optimized instacoat
coating system.

15. COATING EQUIPMENT
• Conventional coating pan
 Circular metal pan(mounted
angularly on a stand)
 8-60 inches in diameter
 Rotated on its horizontal axis by a
motor
 heated air is supplied by inlet air
supply
 Exhaust by means of ducts
 use of atomizing system to
produce even distribution of
coating soln or suspension

16. Perforated coating pan

17. Perforated coating pan
• Accela cota system
• Pan is fully perforated.
• Contains mixing blades.
• Inlet air is by a plenum in contact
with the top of the pan.
• Air is exhausted by a plenum
located below the pan.

18. Fluidzsed bed coater

19. Three type of fluidized bed coater

20. Spray guns on basis of port
Port Two Port Gun Three Port Gun Four Port Gun
Port 1 Coating
Suspension
Coating
Suspension
Coating
Suspension
Port 2 Operating Air Operating Air Operating Air
Port 3 Atomizing Air Atomizing Air
Port 4 Pattern Air
ABC gun is used widely nowadays!!!

21. ABC spray gun
• Breading blocks liquid and air orifices, distorted spray
distribution and require frequent cleaning of gun.
• Thus Anti Breading Cap gun is used for smooth spraying.
Some Examples : Standard gun with horns, schlick ABC series
spray gun.

22. IDEAL CURES PRODUCTS
1) INSTANUTE Series
 INSTANUTE Immediate Release film coating
 INSTANUTE Moisture Barrier coating
 INSTANUTE Delayed Release coating
2) Speciality Products
 INSTAGLOW
 INSTASPRAY
 INSTAMASK
 INSTA FLAVOR
3) INSTAMODEL Blend

23. INSTANUTE IMMEDIATE RELEASE FILM COATING
Brand name polymer reconstitution
INSTACOAT 4G PVA 35% (AQUEOUS)
INSTACOAT EHP PVA 25% (AQUEOUS)
INSTA COAT AQUA II Graft PVA 20% (AQUEOUS)
INSTA COAT AQUA III HPMC 15% (AQUEOUS)
INSTACOAT UNIVERSAL HPMC 11% (AQUEOUS)
INSTACOAT P4 Sodium alginate 20% (AQUEOUS)

24. INSTANUTE MOISTURE BARRIER COATING
Brand Name Polymer Reconstitution
INSTACOAT EMB PVA 20% (AQUEOUS)
INSTACOATSHIELD AQUA II PVA 25% (AQUEOUS)
INSTACOATSHIELD HPMC AND EC 5% (ORGANIC)
INSTANUTE DELAYED RELEASE
Brand Name Polymer Reconstitution
INSTACOAT EN SUPER-II METHACRYLIC ACID
COPOLYMER
20% (AQUEOUS)
INSTACOAT EN SUPER-IV METHACRYLIC ACID
COPOLYMER
25% (AQUEOUS) /
9%(ORGANIC)
INSTACOAT EN HPMC-P HPMC PTHALATE 5% (ORGANIC)

25. Why INSTANUTE Series???
• Rapid reconstitution in water that contribute to speed
up process and save time.
• Aqueous processing promotes safe working
environment
• Aqueous processing prevents atmosphere pollution.
• Easy scale up and transfer to different equipment sites
• Enhance stability, longer shelf life.

26. Speciality Products
• INSTAGLOW : It is a dry ready to mix polishing system that can
be reconstitute in water or organic solvents. It enhance coated
tablet appearance at lower weight gain (0.5%).
• INSTASPRAY: It is a customized pigmented dispersion for tablet
film coating. It provide fast batch to batch color uniformity.
• INSTAMASK: It is a tailor made Potassium polyacrylates system
for taste masking. It is use in bitter drug like ceterizine,
azithromycin, ofloxacin.
• INSTA FLAVOUR: It is used to improve palatability.

27. Ideal Cures Approach : Instamodel blend
• Instamodel blend:
• It consists of hydrophilic polymers, pH sensitive polymers and
other GRAS excipients providing matrix system producing
predefine release pattern
• It fulfill the formulation of Extended release dosage form.
• Meets the dissolution requirement of various pharmacopoeial
monographs.
• Cost effective and ready to use.

28. Ideal Cures: Existing custom formulation
• INSTAMODEL for Gliclazide 30mg.
• INSTAMODEL for Metformin 500mg and 1000mg USP
• INSTAMODEL for Diclofenac sodium 100mg USP
• INSTAMODEL for Aceclofenace 200mg
• INSTAMODEL for Acetaminophen 650 mg USP

29. IDEAL CURES : Regulatory Compliance
• Product developed using Instamodel reportedly compatible
with drug substance and having pharmacopoeial monograph or
GRAS status.
• Dissolution criteria shown to be in compliance with
pharmacopoeial monograph and benchmarked to the
international inventor brand.
• Stability studies limited to the physical test, assay and release
behavior having been conducted as per ICH guidelines.

30. THANK YOU...!!!!