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Tablet Coating: Understanding the Process and Troubleshooting

Presentation · December 2019

DOI: 10.13140/RG.2.2.34800.28164

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 12/26/2020

TABLET COATING
UNDERSTANDING THE PROCESS
Nasser Nyamweya, Ph.D.

Tablet Development Training Workshop 2019 December 3rd, 2019 1

OUTLINE
• Background
• Benefits/ Disadvantages
• Types of Coatings
• Process
• Equipment
• Formulation/Excipients
• Modified Release Examples

Tablet Development Training Workshop 2019 December 3rd, 2019 2

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But first, a closer look

Tablet Development Training Workshop 2019 December 3rd, 2019 3

Any differences between the 2 tablets?

Tablet Development Training Workshop 2019 December 3rd, 2019 4

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BACKGROUND
• Sugar coating: Inexpensive excipients (materials) and process equipment,
BUT time consuming, “art”, difficult to automate

• Film Coating: Reduced processing times, low weight gains (2 - 10% for film
coating vs. 50 - 100% for sugar coatings), stronger, less brittle coatings,
versatile
̶ Organic solvent based film coating (1950’s): health concerns,
environmental, disposal, flammability issue
̶ Aqueous based film coating (1970’s): facilitated by the use of coating
equipment with better air handling/drying capabilities and the
introduction of new excipients

Tablet Development Training Workshop 2019 December 3rd, 2019 5

FILM COATING: BENEFITS/ DISADVANTAGES

Benefits: Disadvantages:
• Improved product appearance, • additional unit process
aesthetics
• may require optimization of
• Facilitate product identification
the core, coating, and
• Taste/odor masking process variables
• Protection from moisture/light • moisture/ heat sensitive
• Improve mechanical strength drugs
• less dust, facilitates high
speed packaging
• Modified release: enteric or
sustained

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TYPES OF COATINGS
Non-functional: Functional:
• Coatings that do not alter the • Coatings that modify the release of
release of the drug the drug
• Immediate release (IR) • Delayed Release (Enteric)
coatings Coatings: for drugs that are
intended to be released in the
intestine, (e.g., acid sensitive drugs,
drugs that irritate the stomach)
• Extended/ Sustained Release (ER)
Coatings: reduce the dosing
frequency
Tablet Development Training Workshop 2019 December 3rd, 2019 7

PROCESS
• Dosage forms that may be coated include tablets, capsules,
beads, granules, and drug powders or crystals

• Solution or suspension is sprayed in the form of fine droplets

onto the surface of the dosage form

• Heat and circulating air are used to rapidly dry the dosage form
as it is being coated resulting in the gradual formation of a film
coating on the surface of the product

• Film thickness ranges from 20 - 200 µm

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EQUIPMENT
• Coating Pans: used for tablet coating

Exhaust Air Inlet Air

Spray Nozzle

Coating Pan

Baffles

Tablet Development Training Workshop 2019 December 3rd, 2019 9

EQUIPMENT: Coating Pan (non-perforated)

Ref: https://5.imimg.com/data5/IM/SU/MY-
7950049/revolving-coating-pan-500x500.jpg

Ref: Bhairy, S. (2015). International Journal of

Institutional Pharmacy and Life Sciences. 5. 79-126.

Tablet Development Training Workshop 2019 December 3rd, 2019 10

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EQUIPMENT: Coating Pan (perforated)

Ref: https://www.freund-vector.com/freund-vectors-perforated-coating-pans/

Ref: https://i2.wp.com/manoxblog.com/wp-
content/uploads/2018/07/facs14.jpg?resize=665%
2C501&ssl=1

Tablet Development Training Workshop 2019 December 3rd, 2019 11

EQUIPMENT: Spray Nozzles

Ref: http://www.pharmtech.com/comparison-atomization-conditions-
between-different-spray-guns-used-pharmaceutical-film-coating

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EQUIPMENT: Spray Nozzles

Ref: http://www.pharmtech.com/comparison-atomization-conditions-between-different-spray-guns-used-pharmaceutical-film-coating

Tablet Development Training Workshop 2019 December 3rd, 2019 13

EQUIPMENT: Spray Nozzles

Ref:
Cadar_Schlicknozzles_ML.pdf

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EQUIPMENT: Spray Nozzles

Ref:
https://www.directindustry.com/prod/
duesen-schlick-gmbh/product-107299-
1094125.html

Clips
1) https://www.youtube.com/watch?
v=fthA1XzDUUQ
2) https://www.youtube.com/watch?
v=-6JrFqDjD9s

Tablet Development Training Workshop 2019 December 3rd, 2019 15

EQUIPMENT: Spray Nozzles

Ref:http://www.spraytechindia.com/Table
t%20coating.html

Tablet Development Training Workshop 2019 December 3rd, 2019 16

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EQUIPMENT
• Fluid Bed Coaters: used to coat pellets, beads, granules, powders, drug
particles. Less commonly used for tablet coating.

Exhaust Air

Product Container

Spray Nozzle
Inlet Air

Tablet Development Training Workshop 2019 December 3rd, 2019 17

FORMULATION
Excipient Examples
Film former: typically polymers Hypromellose
Plasticizer: improves polymer flexibility, Polyethylene glycol
makes the film less brittle
Anti-adherent: prevents/reduces sticking of Talc
the drug product during & after coating
Iron oxides, aluminum lakes,
Coloring agents
titanium dioxide
Dispersion medium Water

Tablet Development Training Workshop 2019

* Hydroxypropyl methylcelluloseDecember 3 , 2019
rd
18

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IMMEDIATE RELEASE COATINGS

• Appearance, aesthetics
• Taste
• Protection from environmental factors (e.g., light)
• Most popular immediate release coating polymer is Hypromellose (HPMC)
• Also available in fully formulated products (i.e., pre-mixes with other
excipients & colors); just add water & mix

Tablet Development Training Workshop 2019 December 3rd, 2019 19

DELAYED RELEASE COATINGS

• These coatings are use for:
i. Acid sensitive drugs
ii. Drugs that irritate the stomach

• Polymers properties: typically contain acidic functional groups

(e.g., R - COOH) that are non-ionized and therefore insoluble at low pH
(stomach pH 1 - 3)
• at high pH ionization of these acidic functional groups
causes the polymer to become soluble and dissolve
− Drug release is controlled by the pH at which the polymer dissolves

 pH
R- COOH R-COO‒ + H+
(H2O insoluble) (H2O soluble)

Tablet Development Training Workshop 2019 December 3rd, 2019 20

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DELAYED RELEASE COATINGS

Coating dissolves at
higher pH values

Low pH
Higher pH Drug release

Tablet Development Training Workshop 2019 Ref: Ansel’s Pharmaceutical Dosage Forms, AllenDecember 3rd, 2019
et al. (2005) 21

EXTENDED RELEASE COATINGS

Advantages of Extended Release Dosage Forms
• Reduction in dosing frequency (e.g., taking one 75-mg tablet/day vs. three
25-mg tablets/day

• more convenient, improves patient compliance

Tablet Development Training Workshop 2019 December 3rd, 2019 23

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EXTENDED RELEASE COATINGS

• Polymer properties: water insoluble, function as a semi-permeable
membrane
• Drug release rate depends on: film thickness, film permeability

Insoluble Coating
(Semi-permeable)

H2O

Drug in core

Tablet Development Training Workshop 2019 December 3rd, 2019 24

TABLET COATING:
TROUBLESHOOTING
Nasser N. M. Nyamweya, Ph.D.

Tablet Development Training Workshop 2019 December 3rd, 2019 25

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OUTLINE
 Coating Process Overview

 Formulation and Processing Aspects

 Examples of Problems

 Considerations for Sustained Release Coating with Aqueous

Dispersions

Tablet Development Training Workshop 2019 December 3rd, 2019 26

IMPORTANT VARIABLES
Goal: a stable drug product that can be produced consistently on a
commercial scale

Core Coating Process

e.g., polymer,
e.g., API,
plasticizer,
Parameters
excipients, e.g., equipment, temperature
hardness, excipients,
spray rate, product movement,
friability, H2O
humidity

Storage
Conditions
e.g., humidity, temperature, time

Tablet Development Training Workshop 2019 December 3rd, 2019 27

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FILM COATING PROCESS

Droplet transport and
Spraying: by atomization Impingement onto the
of a solution or dispersion substrate
(& drying)

Important Parameters
 Dispersion uniformity  Viscosity  Spray nozzle
 Mixing  Atomization mechanism  Spray pattern
 Particle size of insoluble  Atomization air  Distance to product
excipients  Droplet size distribution  Temperature

Tablet Development Training Workshop 2019 December 3rd, 2019 28

FILM COATING PROCESS (CONT.)

Wetting and Polymer Inter-diffusion (solutions)
Adhesion Spreading
(& drying) Coalescence (dispersions)
(& drying) (& drying)

 Core surface properties (e.g.,  Dispersion viscosity  Viscosity

solubility, hydrophilicity, porosity)  Dispersion solids content  Temperature
 Dispersion surface tension  Temperature  Time

Tablet Development Training Workshop 2019 December 3rd, 2019 29

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PREPARATION OF COATING DISPERSIONS

 Products are available as:
1. Liquid Dispersions
• Usually diluted to lower solids content prior to spraying
2. Solid Forms (Powders)
• Dispersion process/procedure required to convert powder to a
liquid coating solution or suspension

 Prepare and process in accordance with manufacturer’s recommendations

Tablet Development Training Workshop 2019 December 3rd, 2019 30

EQUIPMENT
• Coating Pans: used for tablet coating

Exhaust Air Inlet Air

Spray Nozzle

Coating Pan

Tablet Development Training Workshop 2019 December 3rd, 2019 31

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PROCESS PARAMETERS THAT AFFECT COATING UNIFORMITY

 Product Movement
 Spray Characteristics
– Spray Rate
– Droplet size (Atomization air)
– Spray Pattern
– Spray Gun to Product Bed Distance
– Number of Spray Guns
– Position of Spray Guns
 Air Flow, Volume
 Temperature
 Humidity

Tablet Development Training Workshop 2019 December 3rd, 2019 32

EXAMPLES OF COATING PROBLEMS

 Preparation of Coating Formulation
 Blocking of Spray Lines or Tubing
 Erosion of Cores
 Edge Wear
 Sticking and Picking
 Twinning
 Logo Bridging
 Rough Surface of Coating
 Poor Film Adhesion to the Core
 Cracking of Film Coating
 Non-Uniform Color (Pigmented Coatings)
 Slow Weight Gain on Cores

Tablet Development Training Workshop 2019 December 3rd, 2019 33

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Preparation Of Coating Formulation

 Follow manufacturer’s recommendations

 Different products may require different preparation methods

 Polymers which form gels (e.g., HPMC or sustained release polymers in

organic solvents) require sufficient time to become dispersed and hydrated

Tablet Development Training Workshop 2019 December 3rd, 2019 34

Blocking of Spray Lines or Tubing

 Causes
− Polymer gel entrapped in line
− Settling of un-dissolved or suspended components (e.g., talc)

 Solutions
− Ensure proper mixing and dispersion of coating formulation prior to
spraying
− Reducing solids content of the coating formulation
− Screening (pass through sieve) of coating formulation prior to spraying
− Gentle mixing in the coating formulation container during spraying
− Reducing the diameter of the spray tubing; avoid excessive length of
tubing
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Core Erosion
 Causes
− Insufficient tablet mechanical strength for
coating (low hardness, high friability)
− Excessive pan speed of fluidization
− Very low initial spray rates
− Over-wetting

 Solutions
− Reformulate cores to improve mechanical
properties
− Use suitable pan speed or fluidization
Source: http://filmcoating-troubleshooting.com/film_coating/tablet-
surface-erosion.html − Use optimum spray rate
Tablet Development Training Workshop 2019 December 3rd, 2019 36

Edge Wear
 Causes
− Insufficient mechanical strength for coating
(low hardness, high friability)
− Tablets with sharp edges
− Worn tablet punches
− Excessive pan speed
 Solutions
− Reformulate cores to improve mechanical
properties
− Reduce tablet edge sharpness (tooling shape)
− Check/replace tablet punches
− Use suitable pan speed

Tablet Development Training Workshop 2019 December 3rd, 2019 37

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Tackiness

 Definition: excessive stickiness of the

coated product
 Can occur during and/or after the
coating process
 Attempting to mechanically separate
agglomerated drug product can lead to
damage of the film coating and a change
in protective and release characteristics

Source: http://filmcoating-troubleshooting.com/film_coating/picking-and-sticking.html

Tablet Development Training Workshop 2019 December 3rd, 2019 38

Sticking and Picking

 Formulation: Low polymer glass transition temperature, high plasticizer
level, low anti-adherent level

 Tablet shape (certain shapes are more prone to twinning)

 Equipment factors: poor product movement, incorrect product temperature,

low air volume, excessive spray rate, high humidity, inadequate atomization

 Post processing: tacky film coating, water uptake, sorption by film coating,
exposure to elevated temperature
− blending with an anti-adherent
− applying a seal coating

Tablet Development Training Workshop 2019 December 3rd, 2019 39

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Twinning: Tablet Shape

Vs.

Source: http://filmcoating-
troubleshooting.com/film_coating/tablet-
twinning.html

Tablet Development Training Workshop 2019 December 3rd, 2019 40

Logo Bridging

 Causes
− Logo design/placement
− Insufficient adhesion between
coating and core

 Solutions
− Use suitable logo design
− Alternative coating formulation

Rowe RC. In Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms 3 rd Ed. McGinity
and Felton, Eds. pg. 138

Tablet Development Training Workshop 2019 December 3rd, 2019 41

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Logo Bridging

Ref: Niblett, D et al. (2017). Int. J.

Pharmaceutics. 528. Pages 180-201

Tablet Development Training Workshop 2019 December 3rd, 2019 42

Coating Roughness
 Causes
− Over-wetting
− Excessive drying (spray drying, insufficient time for
spreading of coating droplets)
− Inadequate atomization of coating droplets
− High viscosity of coating formulation

 Solutions
− Reduce spray rate
− Reduce drying temperature/ air volume
− Increase atomization pressure
− Reduce viscosity of coating formulation (e.g., by dilution)

Rowe RC. In Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms 3 rd Ed. McGinity and Felton, Eds. pg. 136

Tablet Development Training Workshop 2019 December 3rd, 2019 43

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Poor Film Adhesion to Core

 Causes
− Waxy core or hydrophobic components in the core

 Solutions
− Coatings with increased adhesion
− Surfactant to improve wetting

Tablet Development Training Workshop 2019 December 3rd, 2019 44

Cracking of the Coating

 Causes
− Inadequate film flexibility or
mechanical strength
− Elastic recovery expansion after
compression

 Solutions
− Use alternative polymer;
Increase amount of plasticizer;
decrease level of insoluble solids
(e.g., pigments)
− Allow for elastic recovery of
Carlin B et al. In Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms 3 rd Ed. McGinity
and Felton, Eds. pg. 17 cores after compression

Tablet Development Training Workshop 2019 December 3rd, 2019 45

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Non-uniform Color: Pigmented Coatings

 Causes
− Migration of dyes with evaporating solvent
− Inadequate dispersion of pigments
− Tablet to tablet color variation
− Inadequate amount of coating
− Inadequate product mixing

 Solutions
− Use pigments instead of dyes
− Ensure adequate dispersion of pigments
Source: https://sensientpharma.com/product-
− Tablet to tablet color variation development/technical-expertise/

− Increase coating level (if possible)

− Optimize product movement

Tablet Development Training Workshop 2019 December 3rd, 2019 46

Slow Weight Gain on Cores

 Causes
− Spray drying
− Under-charged coating pan

 Solutions
− Optimize balance between spray rate and evaporation (air flow, volume
and temperature)
− Use recommended charge for the coating pan

Tablet Development Training Workshop 2019 December 3rd, 2019 47

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