Tablets

Ms. Sandunika Ilangamge

B.Pharm (KDU)
Lecturer (Probationary)
Department of Indigenous Medical Resources
GWUIM
 • Define the term tablet
• Explain advantages and
limitations of using tablets
At the end of the • Describe excipients in the tablets
lecture, students • Explain different tablet coating
should be able to; methods
• Discuss different tablet
manufacturing methods
• Identify different types of tablets
Definition
 Introduction

•Tablets are the most common type of solid oral dosage

form.
•They can be:
•Swallowed whole.
•Chewed before swallowing.
•Dissolved or dispersed in water before administration.
•Retained in the mouth to release the active substance.
Introduction

•Tablets are typically made by powder compression,

applying mechanical force to compress particles.
•In addition to the active ingredient, tablets contain
excipients that:
•Control biopharmaceutical and quality attributes.
•Aid in the manufacturing process.
 Advantages of Tablet dosage forms

•The oral route is a convenient and safe method of drug

administration.
•Compared to liquid dosage forms, tablets offer:
•Better chemical, physical, and microbiological stability.
•Tablets enable accurate dosing of the drug during preparation.
•They are convenient to handle and versatile for various uses and
drug delivery methods.
•Tablets can be mass-produced cost-effectively with robust, quality-
controlled procedures, ensuring consistent quality and elegance.
Disadvantages of Tablet dosage forms

•The main disadvantage of oral dosage forms is poor

bioavailability due to unfavorable drug properties, such as:
•Poor solubility.
•Poor absorption properties.
•Instability in the gastrointestinal tract.
•Some drugs may cause local irritant effects or harm the
gastrointestinal mucosa.
The quality attributes that a tablet must possess

• The tablet should include the correct dose of the drug.

• The appearance of the tablet should be elegant, and its weight,
size and appearance should be consistent.
• The drug should be released from the tablet in a controlled and
reproducible way.
• The tablet should be biocompatible, i.e. not include excipients,
contaminants and microorganisms that could harm patients.
The quality attributes that a tablet must
possess

• The tablet should be of sufficient mechanical strength to withstand

fracture and erosion during handling at all stages of its lifetime.
• The tablet should be chemically, physically and microbiologically
stable during the lifetime of the product.
• The tablet should be packaged in a safe manner.
Tablet manufacturing
 Die Filling
Powder flows from a hopper into the die via
The die is sealed at the bottom by the lower
gravitational flow (or centrifugal die filling in some
punch.
cases).

Tablet Formation
The upper punch descends into Compression may involve a After maximum force,
the die, compressing the powder stationary or upward-moving decompression occurs as the
to form a tablet. lower punch. upper punch retracts.

Tablet Ejection
The lower punch rises to bring the tablet to the A pushing device removes the tablet from the die
top of the die. table.
 1. Wet granulation
2. Dry granulation
3. Direct compression

Tablet
• The wet and dry granulation processes
manufacturing are designed to improve the flow and
methods compressibility of powders that would
otherwise be unsuitable for
compression.
• When the formulation has a satisfactory
flow and compressibility, the ingredients
can be mixed and directly compressed
Direct Compression
• Advantages:
• Fewer processing steps reduce production time and cost.
• Improved stability due to no exposure to heat or water.
• Faster drug dissolution due to quick tablet disintegration.
• Disadvantages:
• Requires specially designed, expensive fillers and binders.
• Mixing large particles for homogeneity is challenging.
• Poor compactability of drug-only powders.
• Difficulties in achieving uniform colouring.
Direct Compression
• Applications:
• Soluble drugs processed as coarse particles.
• Potent drugs mixed with coarse excipient particles to ensure good
flow and compaction.
Tablet excipients

Facilitate tableting Many excipients are

Categorized based
operations and multifunctional,
on primary
ensure specified affecting powder or
functions.
quality. tablet properties.
 • Increase bulk for low-dose drugs to ensure
proper tablet size (>50 mg).
• Requirements:
• Chemically inert, nonhygroscopic,
biocompatible.
Fillers (or • Good biopharmaceutical (e.g., water-
Diluents) soluble) and technical properties.
• Acceptable taste and cost-effective.
• Ex;
• Lactose, Microcrystalline Cellulose,
Dicalcium Phosphate Dihydrate
 • Enable tablets to break into fragments for rapid
dissolution.
• Mechanisms:
• Promote liquid penetration into tablet
pores.
• Rupture tablets via swelling, particle
Disintegrants repulsion, or recovery from deformation.
• Generate gas (e.g., in effervescent tablets).
• Common Disintegrants:
• Starches (e.g., maize, potato)
• Modified starches or celluloses
 • Aid in drug solubility for poorly water-
soluble drugs.
Dissolution • Example: Substances forming salts with the
Enhancers drug during dissolution.
 • Ensures granules/tablets have required
mechanical strength.
• Added as:
• Dry Powder: Mixed before wet agglomeration
or compaction.
Binder • Solution Binder: Used as agglomeration liquid
during wet agglomeration.
(Adhesive) • Typical concentration: 2%-10% by weight.
• Examples: Starch, sucrose, gelatin (traditional);
polymers like polyvinylpyrrolidone, cellulose
derivatives (modern).
• Solution binders are most effective, forming
binder-substrate granules.
 • Improves powder flowability.
• Added for direct compaction or before
tableting.
• Examples: Talc, colloidal silica, magnesium
Glidant stearate.
• Colloidal silica adheres to surfaces, reducing
interparticle friction.
 • Reduces friction during tablet formation and
ejection, preventing defects.
• Mechanisms:
• Boundary Lubrication: Thin film on sliding
surfaces.
• Examples: Stearic acid salts (e.g., magnesium
stearate).
Lubricant • Issues: Hydrophobic lubricants can retard
disintegration and dissolution.
• Alternatives: Hydrophilic substances (e.g.,
surface-active agents, polyethylene glycol).
• Sensitivity depends on substrate particle
properties and mixing conditions.
 • Flavour
• Masks unpleasant tastes or improves
palatability.
• Often added as ethanolic solutions after
heat-involving processes.
Flavoring and
• Colourant
coloring • Aids tablet identification and patient
agents adherence.
• Added during compaction or coating.
• Soluble dyes may cause colour migration
during drying.
 Common excipients used in tablet formulations
Excipient Function
Diluents Needed when the active mass per each tablet is not sufficient for
processing
Binders Adhesive materials used to hold powders together, form granules, and
maintain tablet stability after compression with sufficient hardness.
Disintegrating Cause the compressed tablet to disintegrate when exposed to aqueous
Agents environments.
Lubricants Enhance the flow of granules, reduce adhesion to punches and dies,
and Glidants facilitate ejection, and reduce die and punch wire friction in tablet press
processes.
Flavoring employed to control the taste and hence the acceptability of tablets
Agents
Sweetening to improve the appearance or to identify the finished product uniquely
Agents
 Reasons for Coating Tablets
1.Protects the drug from air, moisture, and
environmental conditions.
2.Masks the unpleasant taste of the drug.
3.Provides special drug-release characteristics (e.g.,
Tablet enteric coating).
Coating 4.Enhances aesthetics or provides product
distinction.
5.Prevents inadvertent contact with the drug to avoid
absorption risks (e.g., Proscar tablets for pregnant
women).
Tablet Coating
• An enteric coating is used to protect the drug from GI irritation and
from acidic degradation in the stomach.
• Film and sugar coatings are used to mask unpleasant taste and
improve pharmaceutical elegance of the tablet.
• A film coating can be used to protect the drug from environmental
degradation and to provide sustained action dosage forms.
• Special tablet coatings may help in targeting the drug to a certain area
of the GI tract (e.g., colon delivery).
Common coating methods
1. Sugarcoating

•Traditional, involves multiple layers.

•Improves appearance and taste but increases tablet size.

2. Film Coating

•Thin, skin-tight coating retains original tablet size and shape.

•More durable and resistant to abrasion.
•Can be colored or imprinted for identification.
Common coating methods
3. Enteric Coating

•Protects the tablet from stomach acid.

•Ensures drug release in the intestines (pH-sensitive).
Tablet types
conventional multiple enteric-
sugar-coated
compressed compressed coated
tablets
tablets tablets tablets

buccal and
film-coated chewable effervescent
sublingual
tablets tablets tablets
tablets

vaginal
tablets.
Conventional compressed tablets

•Widely used in clinical practice.

•Manufactured via a single compression

cycle with active and inactive agents
(powders or granules).

•Disintegrate and dissolve in the GI tract to

facilitate drug absorption through the gastric
mucosa.
 Multiple compressed tablets
• Fill material undergoes more than one compression,
resulting in,
Layered Tablets:
•Formed by compressing multiple layers of fill
material.
•Layers may differ in medicinal agents, color, or
release properties.
•Used to separate incompatible ingredients,
enable staged drug release, or create a unique
appearance.
Multiple compressed tablets
Tablet-in-Tablet (Core-Shell):
•Inner tablet (core) is surrounded by an outer
shell.
•Requires special machines for precise placement
of the core within the die.
Enteric-coated tablets
• coated with a polymer that does not dissolve under acidic conditions.
• providing protection against drug degradation or gastric mucosal
irritation
• Pass through the stomach unchanged.
• Disintegrate in the intestines for drug dissolution, absorption, and/or
effect.
• Protect drugs destroyed by gastric acid.
• Reduce irritation to the gastric mucosa caused by certain drugs.
• Enhance drug absorption by bypassing the stomach.
Sugar-coated tablets
•Coated with a colored or uncolored sugar layer.
•Advantages:
•Protects the drug from environmental factors.
•Masks unpleasant taste or odor.
•Enhances the tablet’s appearance.
•Disadvantages:
•Requires significant time and expertise for coating.
•Increases the tablet’s size, weight, and shipping costs.
•May add up to 50% to the tablet’s weight and bulk.
 Film-coated tablets
•Compressed tablets coated with a thin polymer
layer.
•More durable and less bulky compared to sugar-
coated tablets.
•Faster application process than sugar coatings.
•Coating composition is designed to rupture and
expose the core tablet at a specific location in the
gastrointestinal tract.
 Chewable tablets
• Chewed for mechanical disintegration in the
mouth.
• Drug dissolves in the stomach or intestine after
swallowing.
• Rapid Drug Effect: E.g., antacid tablets for quick
relief.
• Suitable for elderly individuals and children who
have difficulty swallowing.
• Can be taken without water.
• Similar to conventional tablets but typically exclude
disintegrants.
 Effervescent tablets
• Placed in water before use, releasing carbon dioxide.
• produce a drug suspension or aqueous solution due
to a chemical interaction between an organic acid
and sodium bicarbonate in water.
• Facilitates rapid tablet disintegration and dissolution
(within minutes).
• Allows for faster absorption of the therapeutic agent
• Packaging must be moisture-proof to protect
against humidity.
• Ex;Waterproof containers with desiccants, Blister
packs or aluminum foil.
 Buccal and
sublingual tablets

•Designed for absorption through the oral mucosa.

•Used for drugs destroyed by gastric juice or poorly absorbed in the GI tract.
•Buccal Tablets:
•Dissolved in the buccal pouch.
•Designed to erode slowly.
•Sublingual Tablets:
•Dissolved beneath the tongue.
•Provide rapid drug effects (e.g., nitroglycerin).
Vaginal tablets (Vaginal
Inserts)
•Uncoated, typically bullet-shaped or ovoid.
•Designed to fit snugly on plastic inserter
devices.
•Used for local effects within the vagina.
•Ex; Antibacterials, Antifungals
Orally Disintegrating Tablets (ODTs)
• They disintegrate rapidly,
(within seconds) when placed
on the tongue. They are
produced by dry granulation
and compression, have a
disintegration time of 30
seconds or shorter.
Sustained-Release Tablets
• Sustained-release tablets release a drug's initial effective amount,
maintaining it over an extended period.
• offers benefits like longer therapeutic effect, reduced administration
frequency, and improved patient compliance.
 QUALITY CONTROL OF TABLET DOSAGE FORM
Thickness important in packing operations
Variations should not be more than 65%
Hardness force required to break a tablet in a diametric compression
test
Friability measure of the tendency of a tablet to powder, chip, and
fragment during handling
Disintegration Breaking down of the tablets to granules and powders
before dissolving in the gastric fluid
ordinary compressed tablets, the disintegration time
should be within 5-30 minutes.
For enteric-coated tablets, no disintegration should occur
within 1 hour in simulated gastric fluid
Dissolution Absorption requires drug dissolution in
gastrointestinal fluid, as only the drug in solution
is absorbed.
to ensure that the drug is completely released or
close to 100% release from the tablet, and that the
rate of drug release is uniform from batch to batch
Weight Variation Tablets are manufactured with specific active
ingredients and weights, requiring a weight
variation test to confirm conformity to weight
criteria
Thank you