CAPSULE

CAPSULE
Define Capsule. Give classification. Explain it with
examples. Write advantages and disadvantages.
Capsule:
Capsule is a solid dosage form in which the drug is enclosed inside a hard or
soft gelatin shell.

Classification of Capsules
Capsules are mainly classified into two types:
1. Hard Gelatin Capsules
2. Soft Gelatin Capsules

1. Hard Gelatin Capsules

Definition:
Hard gelatin capsules are two-piece capsules made of hard gelatin used to fill
dry powder or granules of drug.
They consist of two parts: cap and body. Used for powders, granules and
pellets.
Examples:
• Amoxicillin capsule
• Ampicillin capsule

2. Soft Gelatin Capsules

Definition:

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 Soft gelatin capsules are one-piece capsules made of soft gelatin used to fill
liquid or oily drugs.
They are sealed capsules and cannot be opened. Used for liquid medicines and
oils.
Examples:
• Vitamin A capsule
• Cod liver oil capsule

Advantages and Disadvantages of Capsules

Advantages Disadvantages
Mask unpleasant taste and odor of drugs Not suitable for very hygroscopic drugs
Easy to swallow Gelatin shell is sensitive to moisture
Accurate dose of drug Cost is higher than tablets
Fast drug release and absorption Not suitable for very large dose drugs
Capsule shell may become brittle in dry
Can fill powder, granules or liquids
conditions

Explain Uses of Capsules

Capsules are widely used in pharmacy to deliver medicines safely and
effectively. The important uses of capsules are:
1. To mask unpleasant taste and odor
Capsules cover the drug completely, so the bitter taste and bad smell of
medicines are not felt by the patient.
2. To provide accurate dose of drug
Capsules contain a fixed amount of drug, so the patient receives the correct
dose.
3. To improve patient compliance
Capsules are smooth and easy to swallow, so patients prefer them.
4. To deliver powder, granules and liquids

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 Capsules can be filled with powder, granules, pellets or liquid medicines
depending on the type of capsule.
5. To protect the drug from air and light
The capsule shell protects the medicine from environmental factors, which
helps maintain drug stability.
6. To provide faster drug release
The gelatin shell dissolves quickly in the stomach, allowing the drug to be
released rapidly.

HARD GELATIN CAPSULES

Composition of Hard Gelatin Capsule
The hard gelatin capsule shell is mainly composed of gelatin and other additives
that improve flexibility, stability, and appearance.
1. Gelatin
Main structural material of capsule shell.
Obtained from collagen of animal bones and skin.
Provides strength and elasticity and dissolves in gastric fluid to release the
drug.
2. Plasticizers
Added to increase flexibility and prevent brittleness of the shell.
Examples: Glycerin, Sorbitol.
3. Colouring Agents
Added for identification and attractive appearance.
Examples: dyes and iron oxide pigments.
4. Opacifying Agent
Makes capsule opaque and protects drug from light.
Example: Titanium dioxide (TiO₂).

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 5. Preservatives
Prevent microbial growth and increase shelf life.
Examples: Methyl paraben, Propyl paraben.

Manufacturing of Hard Gelatin Capsules

Hard gelatin capsules are manufactured by forming capsule shells using gelatin
solution. The process involves the following steps:
1. Preparation of Gelatin Solution
Gelatin is mixed with water, plasticizers, and other additives and heated to form a
uniform viscous gelatin solution.
2. Dipping
Stainless steel pins (moulds) are dipped into the gelatin solution so that a thin
layer of gelatin coats the pins, forming the capsule shell.
3. Spinning (Rotation)
The pins are rotated to spread the gelatin evenly and obtain a uniform thickness
of the capsule shell.
4. Drying
The coated pins are passed through drying chambers where warm air removes
moisture and hardens the gelatin film.
5. Stripping
After drying, the capsule shells are carefully removed (stripped) from the pins.
6. Trimming
The edges of the capsule shells are cut to the required length to obtain uniform
capsule size.
7. Joining
Finally, the cap and body are joined together to form empty hard gelatin capsules
ready for filling.

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 Filling of Hard Gelatin Capsules
Filling of hard gelatin capsules is the process of placing the required quantity of
drug into the capsule body and then closing it with the cap.
Steps involved:
1. Separation of Cap and Body
The empty capsule is first separated into two parts, the cap (shorter part) and
the body (longer part).
2. Filling the Drug
The required quantity of powder, granules, or pellets is filled into the body of the
capsule.
3. Replacing the Cap
After filling, the cap is placed back over the body.
4. Locking the Capsule
Finally, the capsule is closed and locked properly to prevent opening and protect
the drug inside.

Capsule Filling Methods

Capsule filling is the process of placing the required quantity of drug into the
body of hard gelatin capsules. The main methods used are:

1. Punch Method
In this method, the empty capsule body is repeatedly pressed (punched) into a
bed of powder until it is completely filled with the drug. It is mainly used for small-
scale preparation in pharmacies.

2. Hand Filling Method

In this method, capsules are filled manually using a capsule filling plate. The
capsule bodies are arranged in holes, filled with powder, and then closed with
caps. It is suitable for small-scale production.

3. Semi-Automatic Capsule Filling Machine

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 This method uses mechanical equipment with some manual operation. Capsules
are separated, filled with drug, and closed using the machine. It is used for
medium-scale production.

4. Automatic Capsule Filling Machine

In this method, the entire process (separation, filling, and closing of capsules) is
performed automatically by high-speed machines. It is used in large-scale
industrial production.

Storage of Hard Gelatin Capsules

Temperature: ≈21°C
Relative humidity: 35–65%
Protect from heat, moisture & sunlight

Explain Hard Gelatin Capsules with Examples,

Applications, Advantages and Disadvantages
Definition
Hard gelatin capsules are solid dosage forms in which the drug (powder or
granules) is filled inside a hard gelatin shell made of two parts.
They are commonly used to deliver powdered medicines.

Examples
1. Amoxicillin capsule
2. Ampicillin capsule

Structure of Hard Gelatin Capsule

A hard gelatin capsule has two main parts:
1. Body – the longer part where the drug is filled.
2. Cap – the shorter part which covers the body.

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 Both parts fit together tightly after filling the drug.

Composition of Capsule Shell

The capsule shell is mainly made from:
Gelatin – main material for shell formation
Water – gives flexibility
Coloring agents – provide color
Preservatives – prevent microbial growth

Applications of Hard Gelatin Capsules

1. Used to fill powdered drugs.
2. Used for granules and pellets.
3. Used for antibiotic medicines.
4. Used when drug taste or odor needs to be masked.

Advantages and Disadvantages of Hard Gelatin Capsules

Advantages Disadvantages
Masks unpleasant taste and odor of
Not suitable for very hygroscopic drugs
drugs
Easy to swallow Gelatin shell is sensitive to moisture
Accurate dose of medicine Cost is higher than tablets
Rapid drug release in body Capsule shell may become brittle in dry conditions
Can fill powders, granules or pellets Not suitable for very large dose drugs

SOFT GELATIN CAPSULES

Characteristics of Soft Gelatin Capsules
1. They consist of one-piece shell.

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 2. The shell is soft, flexible, and elastic.
3. They are hermetically sealed.
4. Used for liquids, oils, suspensions, and semisolids.
5. They dissolve quickly in the stomach.

Nature of Shell AMD CASPULE CONTENT

Soft Gelatin Capsules
The shell of soft gelatin capsules contains the following ingredients:
1. Gelatin – Main component; provides strength and elasticity.
2. Plasticizer – Makes shell soft and flexible (e.g., glycerin, sorbitol).
3. Water – Used to prepare gelatin solution.
4. Colouring agents – Give colour and identification.
5. Opacifying agents – Make capsule opaque (e.g., titanium dioxide).
6. Preservatives – Prevent microbial growth (e.g., methyl paraben).
7. Flavouring/Sweetening agents – Mask unpleasant taste

Soft Starch Capsules

Instead of gelatin, starch can be used.
Characteristics:
1. Moisture content: 12 – 14%
2. Show similar dissolution as gelatin capsules
3. Better resistance to humidity and heat
4. Easier filling due to smooth surface

Size and Shapes of Soft Gelatin Capsules

SGC are available in many shapes and sizes.

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 Common shapes: Round, Oval, Oblong, Tube, Suppository, Fish shaped
Capacity: Usually 0.1 mL to 30 mL

Production Methods of Soft Gelatin Capsules

Soft gelatin capsules are manufactured by several industrial methods. The main
methods used for their production are:
1. Plate Process
In this method, two gelatin sheets are prepared and placed between plates.
The drug material is filled between the sheets, and pressure is applied to seal
and form the capsules.
2. Rotary Die Process
This is the most commonly used industrial method. Two ribbons of gelatin
are passed through rotating dies while the liquid drug is injected between
them. The dies cut and seal the capsules simultaneously.
3. Reciprocating Die Process
In this process, gelatin ribbons move between reciprocating dies that fill, cut,
and seal the capsules in a continuous operation.
4. Accogel Process
This method is used to fill powders, granules, or pellets into soft gelatin
capsules using special filling equipment.
5. Seamless Gelatin Capsule Process
In this method, capsules are formed by dropping gelatin solution and liquid
fill simultaneously into a cooling liquid, producing seamless spherical
capsules.
Among all these methods, the rotary die process is the most widely used for
commercial production of soft gelatin capsules.

Finishing of Soft Gelatin Capsules

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 After manufacturing, soft gelatin capsules undergo several finishing operations to
improve their appearance, ensure quality, and prepare them for packaging.
Steps involved:
1. Drying – Capsules are dried to remove excess moisture and to obtain the
proper hardness of the shell.
2. Sorting – Capsules are separated and checked to remove defective or
damaged capsules.
3. Polishing – Capsules are polished to remove oil or dust from the surface and
to give a smooth and shiny appearance.
4. Printing – Identification marks, symbols, or product codes are printed on the
capsules for easy identification.
5. Inspection – Capsules are carefully inspected to ensure they meet the
required quality standards.
After finishing, the capsules are packed in suitable containers such as LDPE
containers, HDPE bottles, or blister packs to protect them from moisture and
damage.

Storage of Soft Gelatin Capsules

Recommended conditions:
Temperature: 15 – 30°C
Relative Humidity: Below 50%
Reasons: Prevent moisture absorption, Prevent leakage or deformation

Quality Control Tests for Capsules

Quality control tests are performed to ensure that capsules are safe, effective,
and of uniform quality.

1. Size and Shape Test

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 This test ensures that capsules have uniform size and standard shape, which
helps in proper filling, packaging, and patient acceptance.

2. Identification Marking
Capsules may have symbols, colours, or printed codes to identify the product
and prevent confusion with other medicines.

3. Moisture Permeation Test

This test determines the rate of moisture absorption by the capsule shell. It is
usually done by placing desiccant pellets inside capsules and observing colour
change due to moisture.

4. Content Uniformity Test

This test ensures that each capsule contains the same amount of drug. Usually
10 capsules are selected randomly and their drug content is analysed.

5. Uniformity of Mass
In this test, 20 capsules are weighed individually to check that each capsule
contains a uniform amount of fill material.

6. Disintegration Test
This test checks the time required for capsules to break down into smaller
particles in the digestive fluid.

7. Dissolution Test
This test measures the rate and extent of drug release from capsules using a USP
or BP dissolution apparatus.

Explain Soft Gelatin Capsules with examples,

applications, advantages and disadvantages.

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 Soft gelatin capsules are one-piece sealed capsules made of soft gelatin that
contain liquid or semi-liquid drugs.
They are soft, flexible and cannot be opened, because the drug is already filled
and sealed inside.

Composition of Soft Gelatin Capsule Shell

The shell is mainly made of:
1. Gelatin – main material that forms the capsule shell
2. Plasticizer (glycerin or sorbitol) – makes the capsule soft and flexible
3. Water – helps in forming the gelatin shell
4. Coloring agents or preservatives – improve appearance and stability

Examples of Soft Gelatin Capsules

1. Vitamin A capsule
2. Cod liver oil capsule

Applications (Uses) of Soft Gelatin Capsules

1. Used to fill liquid medicines.
2. Used for oily drugs and oils.
3. Used for vitamins and nutritional supplements.
4. Used to protect drugs from air and moisture.

Advantages and Disadvantages of Soft Gelatin Capsules

Advantages Disadvantages
Easy to swallow because capsule is smooth Manufacturing process is expensive
Mask unpleasant taste and odor of drugs Not suitable for water-soluble drugs
Suitable for liquid and oily drugs Sensitive to heat and humidity

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 Advantages Disadvantages
Capsules may stick together in high
Accurate dose of drug
moisture
Attractive and easy to administer Shorter shelf life compared to tablets

Difference between Hard Gelatin Capsules and Soft

Gelatin Capsules
Hard gelatin capsules Soft gelatin capsules
The hard gelatin capsule shell consists of The soft gelatin capsule shell becomes a
two parts: Body and cap single unit
They are available in round, oval and tube-
They are cylindrical in shape
like shapes
The contents usually consist of medications The contents usually consist of liquids or
in the form of powder, beads or granules semisolids
Shell is perfectly dry Shell is not perfectly dry
These capsules can be adulterated These capsules cannot be adulterated
Example: Amoxycillin Capsule Example: Pudinhara Capsule

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