P HA400 P HAR MACE U TI CA L TECHNOLOG Y III

TABL ET COATING

A S S I S T. P R O F. D R . N A I L L A J I W A
DR. JOSEPH TUREMI CHUNU

27.11.2023
CONTENT
• Introduction
• Reason for Coating
• Types of Coating
• Equipment Used for Coating
• Coating Defects
• References
INTRODUCTION

• Coating involves adding a dry outer layer of coating material to the surface of a medication.
This process serves various purposes, such as helping identify the product or adjusting how
the drug is released from the medication form.

• You can put coatings on various types of oral medicines, like tablets, capsules, and drug crystals.
Tablets are usually the ones that get coated the most, but coated multiparticulates are also
commonly used.
REASONS FOR COATING

The coating process is employed for several reasons:

• Masking: Concealing the taste, odor, and color of the drug.

• Protection: Offering both physical and chemical safeguarding for the drug.
• Acid Resistance: Safeguarding the drug from the gastric environment of the stomach through
an acid-resistant enteric coating.

• Aesthetic Improvement: Enhancing pharmaceutical elegance by incorporating special colors

and distinctive printing.

• GI Comfort: Preventing gastrointestinal irritation and instability.

TYPES OF COATING

The coating process involves applying a coating composition to a continuously moving bed of
tablets, aided by heated air to facilitate the evaporation of the solvent. There are three main types
of coating processes:

1. Sugar Coating
2. Film Coating
3. Compression Coating
Sugar Coating

• Sugar coating is a conventional method, sharing similarities with the process used for coating
confectionery items.
• Its use in the pharmaceutical field dates back to the late 19th century.
• The process includes applying successive layers of coating formulations, typically sucrose-based,
onto tablet cores using appropriate coating equipment.
• As the water evaporates from the syrup, it results in a dense sugar layer forming around each
tablet.
• Sugar-coated tablets often exhibit a glossy and vivid appearance.
Sugar coating involves the
following steps:

1. Sealing
2. Sub coating
3. Syruping(smoothing)
4. Color coating
5. Polishing
6. Printing
Sealing:

Objectives of the sealing process include:

1. Moisture Prevention: Applying a seal coat to prevent moisture from entering the tablet
core.

2. Core Strengthening: Reinforcing the tablet core for enhanced structural integrity.

3. Preventing Over-Wetting Issues: Without a seal coat, tablets may absorb excess
moisture, resulting in softening and potentially impacting both the physical and chemical
stability of the tablet.
Sub Coating:

The sub-coating process serves two main purposes:

1. Edge Rounding and Size Enhancement: The application of sub-coating is done to round
the edges and increase the overall size of the tablet.

2. Weight Increase in Sugar Coating: In sugar coating specifically, this step can lead to a
significant weight increase of 50-100%. During the sub-coating step, a sticky binder solution is
alternately applied to the tablet, followed by powder dusting, and then drying.
Syruping (Smoothing):

The smoothing process serves one main purpose:

1. Surface Smoothing and Imperfection Coverage: The primary goal is to cover and fill
imperfections on the tablet surface introduced during the sub-coating step.
Color Coating:

• The majority of sugar-coated tablets are colored because achieving visual elegance is typically
deemed crucial for this type of coated dosage form.

• Color coatings generally involve sucrose syrups containing the necessary coloring materials.

• Similar to film-coating colors, colorants for sugar-coating can be categorized as either water-
soluble dyes or water-insoluble pigments.

• Traditionally, water-soluble dyes were common, but to expedite the coating process and
reduce color migration issues, pigments have gradually replaced dyes.

• The colorants used must adhere to regulations set forth by the national legislation of the
country where the products are intended to be sold.
Polishing:

• Achieving the desired shine on the tablet surface is accomplished to produce the desired
luster.

• Tablets can undergo polishing in a standard coating pan to enhance their appearance.

Polishing materials used are:

• Beeswax
• Carnauba or
• Warm solutions of these waxes in naphthalene or other suitable volatile oils.
Printing:

• It is standard procedure to label all oral solid dosage forms with essential information like the
manufacturer's logo, product name, dosage strength, or other relevant codes.

• In the case of sugar-coated products, this identification is typically accomplished through a

printing process, often utilizing an offset gravure process with special edible inks. Nevertheless,
alternative printing methods like ink-jet and pad-printing processes have also become widely
accepted.
Advantages of Sugar Coating

• Cost-Effective and Accessible Materials: Utilizes inexpensive and readily available raw
materials.

• Widely Accepted Raw Materials: Constituent raw materials are widely accepted, posing no
regulatory problems.

• Simplicity in Equipment: No need for complex equipment or services.

• Aesthetic Appeal and Consumer Acceptance: Results in aesthetically pleasing tablets with
broad consumer acceptability.

• Ideal for Developing Countries: The simplicity of equipment and the ready availability of raw
materials make sugar coating an ideal method for developing countries.
Disadvantages of Sugar Coating

• Tedious and Time-Consuming: The process is tedious and time-consuming.

• Skilled Technician Requirement: Requires the expertise of a highly skilled technician.

• Increase in Size and Weight: Leads to an increase in the size and weight of the original tablets.

• Swallowing Convenience: Tablets may become less convenient to swallow, especially when they
are small.

• Batch Variability: The sugar coating may vary slightly from batch to batch within the same batch.
Film Coating

• Film coating is a modern and widely adopted method for coating oral solid dosage forms. This
process entails applying a thin film to the surface of a tablet, capsule, or multiparticulate core.

• Notably, all recently introduced coated products now favor film coating over sugar coating.
Types of Film Coating

• Immediate-release film coatings: sometimes referred to as 'nonfunctional' coatings, are

named so because they do not measurably alter the biopharmaceutical properties of the
dosage form. However, it's important to note that these coatings, as explained earlier, serve
various other functions and possess distinct properties.

• Modified-release film coating: it is also known as 'functional' coatings, can be categorized

as either delayed-release (e.g., gastro-resistant) or extended-release coatings. It's noteworthy
that the term 'gastro-resistant coating' is becoming more prevalent in pharmacopoeias,
replacing the older term 'enteric' coating.
Film coating typically increases tablet weight by 2-5%. The application of film coating can be
accomplished through various methods, and two common techniques are:

Pan-pour method:
• Viscous coating materials are directly poured from a container into the rotating pan, which is
in motion along with the tablet bed.
• Tablets undergo a cycle of solution application, mixing, and subsequent drying.

Disadvantages:
• The method is relatively slow.
• It heavily depends on the skill of the operator.
• Additional drying is required to eliminate the solvent.
Pan-spray method:
• The coating process involves spraying the coating material over the tablet bed using nozzles.
Subsequently, hot air is passed through the tablet bed to facilitate the drying of the coated
tablets. This method ensures that the coating material is evenly applied and dries efficiently,
resulting in a uniform and well-coated product.
Process Variables for Pan-Spray method

Pan Variable:
• Uniform mixing is crucial to deposit an equal quantity of film on each tablet during the coating process.

Pan Design:
• Different tablet shapes may require specific baffling arrangements to ensure sufficient mixing in the pan.
Disadvantage:
Improper selection of baffles may lead to chipping issues during the coating process.

Pan Speed:
• Effect on Mixing: Pan speed has a direct impact on the mixing process during coating.
• Optimum Speed: For nonaqueous film coating, the recommended optimum pan speed is 10-15 rpm. For
aqueous film coating, the suggested range is 3-10 rpm.
Spray Variables:
• Rate of Liquid Application: The speed at which the liquid coating material is applied to the tablets.
• Spray Pattern: The specific arrangement in which the coating material is sprayed onto the tablet bed.
• Degree of Atomization: The extent to which the liquid coating material is broken down into fine
particles or droplets during the spraying process.

Process Air Variables

• These variables are crucial for the optimal drying of the coating through the evaporation of the solvent.
• They include factors such as air temperature, flow rate, and direction, which collectively contribute to the
efficiency of the drying process during coating.
Major differences between sugar coating and film coating.
Compression Coating

• Compression coating represents a distinct approach compared to film coating and sugar
coating.
• In compression coating, the process revolves around compacting granular material around
preformed tablet cores through specialized tableting equipment.
• Unlike film coating and sugar coating, compression coating is essentially a dry process, even
though the coating formulation may have been created through a wet-granulation process.
• This method offers a unique way to apply coatings to tablets, providing certain advantages and
characteristics that differentiate it from other coating techniques.
EQUIPMENT USED FOR COATING
The predominant method for producing film-coated tablets involves atomizing (spraying) the
coating solution or suspension onto the tablet surfaces. This technique ensures a uniform and
controlled application of the coating material, contributing to the quality and consistency of the
final product.

Types of coating equipment:

1. Standard coating pan
2. Perforated coating pan
3. Fluidized bed coater
Standard Coating Pan

A standard coating pan used in the pharmaceutical industry has the following features:
• It consists of a circular metal pan mounted on a stand.
• The pan typically ranges from 8 to 60 inches in diameter.
• The pan rotates on its horizontal axis, driven by a motor.
• Heated air is directed into the pan and onto the tablet bed surfaces. The exhaust is managed
through ducts positioned in front of the pan.
• The coating solution is applied by spraying the material onto the rotating tablet bed.
• An atomizing system is employed to spray the liquid, ensuring a controlled and uniform application
of the coating material.
Standard
Coating
Pan
Perforated Coating Pan

A perforated coating pan, used in systems like Accela-Cota and Hi-Coater, has the following characteristics:
• It comprises a perforated drum that rotates on its horizontal axis within an enclosing housing.
• In systems like Accela-Cota and Hi-Coater, drying air is directed into the drum, passes through the tablet
bed, and exits through perforations in the drum.
• The Hi-Coater system introduces drying air through hollow perforated ribs positioned on the inside
periphery of the drum.
• As the coating pan rotates, the ribs dip into the tablet bed, and the drying air passes up through, fluidizing
the tablet bed.
These are some typical examples include of coating pans:

• Accela-Cota
• Premier
• Hi-Coater
• Driacoater
• FastCoat
Perforated
Coating
Pan
Fluidized Bed Coater

Fluidized bed coating is a highly efficient system characterized by the following features:
• It is a highly efficient coating system.
• Tablet mass is fluidized in a columnar chamber through the upward flow of drying air.
• The airflow is controlled to ensure that more air enters the center of the column, causing tablets to
rise in the center.
• Tablets move upward through the center of the chamber, then fall toward the chamber wall, and
finally, descend to re-enter the air stream at the bottom of the chamber.
• Coating solution is applied from a spray nozzle located at the bottom of the chamber.
Fluidized
Bed
Coater
Materials In Coating
Materials used in coating for tablets can be applied in different forms, including physical deposition or as a
continuous film. Examples of coating materials include:

Physical Deposition:
• Sugar
• Shellac
• Wax coating

Continuous Film:
• Synthetic polymers
• Solvents
• Plasticizers
• Colorants
• Opaquant-extenders, and others
Polymers in Non-enteric Coating:

Polymers are included in non-enteric coatings to achieve a uniform film with the desired
mechanical strength. One such polymer is Hydroxypropyl Methylcellulose (HPMC) USP, and its
characteristics include:

1. Hydroxypropyl Methylcellulose (HPMC) USP:

• This polymer is produced by reacting alkali-treated cellulose first with methyl chloride and
then with propylene oxide.
• Commercially available in various viscosity grades.
• It often needs to be mixed with other polymers or plasticizers to achieve the desired coating
properties.
2. Ethyl Cellulose NF:
• Manufactured by the reaction of ethyl chloride with cellulose dissolved in NaOH.
• Water insoluble, making it unsuitable for standalone tablet coating.
• Typically combined with HPMC to create a film with reduced water-soluble properties.

3. Sodium Carboxymethylcellulose USP:

• Available in low, medium, high, and extra high viscosity grades.
• It is the sodium salt of carboxymethylcellulose.
• Used as a polymer in non-enteric coatings, contributing to the desired viscosity and other
coating properties.
Polymers in Enteric Coating:

1. Cellulose Acetate Phthalate (CAP):

• Widely used in enteric coating.
• Exhibits hygroscopic properties and is relatively permeable to moisture and gastric fluids when
compared to some other enteric polymers.

2. Acrylate:
Two commercially available enteric acrylic resins are Eudragit L and Eudragit S.
• Eudragit L is accessible as an organic solution, solid, or aqueous dispersion.
• Eudragit S is available only as an organic solution and solid.
Solvents used for making film coating include water, ethanol, isopropanol, acetone, methylene chloride,
CCl4 (Carbon tetrachloride)

Ideal solvent characteristics for film coating include:

1. Dissolving or Dispersing Properties:

• The solvent should either dissolve or disperse the polymer system or other additives like
plasticizers.

2. Optimum Viscosity:
• It should result in an optimum viscosity, typically around 300 cps, for concentrations ranging
from 2% to 10% polymers.
3. Desirable Physical Characteristics:
• Colorless, tasteless, odorless, non-toxic, inert, non-flammable, and cost-effective.

4. Rapid Drying Rate:

• The solvent should have a rapid drying rate to facilitate efficient coating.

5. Environmental Impact:
• It should have minimal environmental impact.
COATING DEFECTS

• Tablet coating defects refer to issues or imperfections that can occur during the process of
coating tablets with a thin layer of film or coating material.

• However, several defects may arise during the coating process, compromising the quality and
effectiveness of the final product.
Problems Encountered in Coating and Their Remedies:

1. Sticking and Picking:

• Issue: Excessive film thickness causes tablets to stick together.
• Remedy: Reduce the liquid application rate or increase the drying air temperature.

2. Orange Peel Effect:

• Issue: Inadequate spreading of the coating solution before drying causes an orange peel effect.
• Remedy: Thin the polymer solution with additional solvent.

3. Bridging and Filling:

• Issue: During drying, the film may shrink and pull away from sharp corners, causing bridging.
• Remedy: Increase the plasticizer content or change the plasticizer. Adopt milder drying
conditions.
4. Blooming:
• Issue: Occurs when too high a processing temperature is used for a particular formulation.

5. Color Variation:
• Issue: Improper mixing or uneven spray pattern may lead to insufficient coating and result in
color variation.

6. Blistering:
• Issue: Coated tablets may require further drying in the oven due to rapid evaporation of
solvent from the core.
7. Pitting or Pockmarks:
• Issue: Incomplete dispersion of air bubbles in the coating solution, leading to trapped air
pockets.

8. Mottling:
• Issue: Uneven distribution of colorants or pigments in the coating solution.

9. Roughness:
• Issue: Inadequate spreading of the coating material or improper drying conditions.

10. Double Coating:

• Issue: Incomplete separation of tablets in the coating pan, leading to re-coating.
References

• Lachman L, Libermen H.A, Kanig J. The Theory and practice of industrial pharmacy, third edition
varghees publisher.
• Remington Essentials of Pharmaceutics. Printed in the United States of America by Edwards
Brothers Malloy ISBN 978 0 85711 105.
• Aulton’s Pharmaceutics The Design and Manufacture of Medicines, fourth edition.