GOVERNMENT COLLEGE UNIVERSITY FAISALBAD
Subject: Dosage Form
Topic : Capsules
Submitted to: Madam Aisha Sethi
Submitted by :
Arham Islam
Mouaaz Tariq
Muhammad Abdullah Ghafar
Zain Ahmad
Fahad Yasin
Muhammad Anas
Zubair Ahmad
Introduction
Capsules are a widely used pharmaceutical dosage form designed to deliver medication
effectively and conveniently. They consist of a shell, typically made from gelatin or plant-based
materials, that encases the active drug and excipients. Capsules are available in two main types:
hard capsules, which contain powdered or granular substances, and soft capsules, which are
often filled with liquids or semi-liquids.
Gelatin
Gelatin is a natural protein derived from collagen, which is found in the skin, bones, and connective
tissues of animals. It is a translucent, colorless, and flavorless substance commonly used as a gelling
agent in food, pharmaceuticals, and cosmetics
Types of gelatin
Gelatin is classified into different types based on its source and processing method:
1. Type A Gelatin: Derived from pork skins through acid processing. It has a higher gel
strength and is commonly used in food and pharmaceutical applications.
2. Type B Gelatin: Obtained from bovine bones and hides through alkaline processing. It is
known for its high plasticity and elasticity.
3. Fish Gelatin: Extracted from the skin, bones, and scales of fish. It is suitable for
consumers with dietary restrictions and is often used in desserts due to its lower
melting point.
Properties of gelatin
Gelatin possesses several unique properties that make it a versatile material in various
industries:
1. Gelling Ability: Gelatin can form stable gels when dissolved in hot water and cooled,
making it ideal for desserts, capsules, and wound dressings.
2. Biodegradability: It is environmentally friendly and breaks down naturally, which is
beneficial for medical and cosmetic applications.
3. Transparency: Gelatin is translucent, which is useful in food and pharmaceutical
products.
4. Thermal Stability: It remains stable across a wide range of temperatures, enabling its
use in both hot and cold products.
Storage of gelatin
Gelatin should be stored properly to maintain its quality and effectiveness:
1. Unopened Gelatin: Keep it in a cool, dry place, away from direct sunlight and moisture.
It can be stored at room temperature in its original packaging.
2. Opened Gelatin: Once opened, transfer it to an airtight container to prevent exposure
to humidity and odors. Store it in a cool, dry place or in the refrigerator for added
protection.
Advantages of capsules
Here are five advantages of capsules:
1. Ease of Swallowing: Capsules are smooth and easy to swallow, making them a preferred
choice for many patients.
2. Tasteless and Odorless: They mask unpleasant tastes and odors of the medication,
enhancing the user experience.
3. Accurate Dosing: Capsules provide precise and consistent doses, ensuring effective
treatment.
4. Versatility: They can hold a variety of formulations, including powders, liquids, and
granules, making them adaptable for different medications.
5. Fast Dissolution: Capsules dissolve quickly in the stomach, allowing for rapid absorption
of the medication.
Disadvantages of capsules
Capsules, while widely used, have some disadvantages:
1. Not Suitable for All Patients: Capsules may not be ideal for very young children or
individuals who have difficulty swallowing.
2. Moisture Sensitivity: They can absorb moisture in humid conditions, leading to
softening or sticking, and may become brittle in very dry environments.
3. Higher Production Costs: Manufacturing capsules, especially soft gelatin ones, can be
more expensive compared to tablets.
4. Limited Compatibility: Certain substances may react with the gelatin shell or dissolve it,
making capsules unsuitable for those formulations.
5. Stability Issues: Capsules containing liquid fills may face stability challenges over time.
Size of capsules
Capsules come in various sizes, ranging from the largest (size 000) to the smallest (size 5).
Here's a quick overview:
1. Size 000: The largest capsule, with a capacity of about 1.37 mL, often used for
supplements.
2. Size 00: Slightly smaller, holding approximately 0.95 mL.
3. Size 0: A common size, with a capacity of around 0.68 mL.
4. Size 1: Holds about 0.50 mL, suitable for smaller doses.
5. Size 2: Has a capacity of 0.37 mL.
6. Size 3: Holds approximately 0.30 mL.
7. Size 4: A smaller size, with a capacity of 0.21 mL.
8. Size 5: The smallest capsule, holding about 0.13 mL.
Types of gelatin capsules
Here are the types of gelatin capsules:
1. Hard Gelatin Capsules
2. Soft Gelatin Capsules
Hard gelatin
Hard gelatin capsules are a type of pharmaceutical dosage form designed to hold solid
ingredients like powders, granules, or tablets. They consist of two parts: a body, which contains
the medication, and a cap, which securely covers the body.
Types of hard gelatin capsules
Hard gelatin capsules can be categorized based on their design and functionality:
1. Standard Hard Gelatin Capsules: These are the most common type, consisting of a cap
and body used to encapsulate powders, granules, or pellets.
2. Modified-Release Capsules: Designed to release the drug at a controlled rate or at a
specific location in the gastrointestinal tract.
3. Enteric-Coated Capsules: These capsules have a coating that prevents them from
dissolving in the stomach, ensuring the drug is released in the intestines.
4. Liquid-Filled Hard Gelatin Capsules: Used to encapsulate liquids or semi-solids, offering
an alternative to soft gelatin capsules.
Manufacturing of hard gelatin
The manufacturing of hard gelatin capsules involves several key steps:
1. Preparation of Gelatin Solution: Gelatin is dissolved in water along with plasticizers and
other additives to create a dipping solution.
2. Dip-Coating: Metal pins (molds) are dipped into the gelatin solution to form the capsule
shells.
3. Drying: The gelatin-coated pins are rotated and dried to solidify the shells.
4. Stripping and Trimming: The dried shells are removed from the pins and trimmed to the
desired size.
5. Joining: The capsule body and cap are joined together to form the empty capsule.
6. Printing: Capsules may be printed with labels or markings for identification.
Packaging of hard gelatin capsules
The packaging of hard gelatin capsules is crucial to maintain their integrity, protect them from
environmental factors, and ensure safe handling. Here are the common packaging methods:
1. Blister Packs: Capsules are sealed in individual cavities made of plastic and aluminum
foil, protecting them from moisture, light, and contamination.
2. Strip Packs: Capsules are enclosed between layers of aluminum or plastic film, offering
similar protection as blister packs.
3. Bottles: Capsules are stored in airtight plastic or glass bottles with desiccants to control
moisture.
4. Unit Dose Packaging: Capsules are individually packaged for single-use, ensuring
accurate dosing and hygiene.
Soft gelatin capsules
Soft gelatin capsules, often referred to as soft gels, are a type of pharmaceutical dosage form
made from a single, seamless gelatin shell. This shell is typically composed of gelatin,
plasticizers (like glycerin or sorbitol), and water, which give it flexibility and elasticity.
Composition of soft gelatin capsules
The composition of soft gelatin capsules typically includes:
1. Gelatin: Forms the primary structure of the capsule shell.
2. Plasticizers: Such as glycerin or sorbitol, to provide flexibility and elasticity.
3. Water: Maintains the shell's consistency and workability.
4. Optional Additives: These may include colorants, flavorings, or preservatives to
enhance appearance, taste, and shelf life.
Types of soft gelatin capsules
Here are the types of soft gelatin capsules:
1. Chewable Softgels
2. Suckable Softgels
3. Twist-Off Softgels
4. Meltable Softgels
Manufacturing of soft gelatin capsules (plate process)
The plate process is a traditional method used for manufacturing soft gelatin capsules. Here's a
brief overview:
1. Preparation of Gelatin Mass: Gelatin is mixed with plasticizers, water, and optional
additives to create a homogeneous mass.
2. Formation of Capsule Shells: A die plate with pockets is used to shape the gelatin into
capsule shells.
3. Filling: The medication or fill material is manually or semi-automatically placed into the
gelatin pockets.
4. Sealing: Another gelatin sheet is placed over the filled pockets, and the edges are sealed
using pressure or heat.
5. Drying: The capsules are dried to remove excess moisture and achieve the desired
consistency.
Manufacturing of soft gelatin capsules ( rotatory dye process)
The rotary die method is a modern and efficient process for manufacturing soft gelatin
capsules. Here's an overview:
1. Preparation of Gelatin Ribbons: Gelatin is mixed with plasticizers and other additives,
then formed into thin ribbons.
2. Filling Material Preparation: The liquid or semi-liquid medication is prepared for
encapsulation.
3. Encapsulation: Two gelatin ribbons are fed into a rotary die machine, where they
converge at rotating dies. The fill material is injected between the ribbons, and the
capsules are formed, sealed, and cut simultaneously.
4. Drying: The capsules are dried under controlled conditions to remove excess moisture
and achieve the desired consistency.
5. Inspection and Packaging: Capsules are inspected for quality, sorted, and packaged for
distribution.
Advantages
Here are some advantages of soft gelatin capsules:
1. Ease of Swallowing: Their smooth and flexible texture makes them easy to swallow,
improving patient compliance.
2. Taste and Odor Masking: They effectively mask unpleasant tastes and odors of the
encapsulated contents.
3. Enhanced Bioavailability: Softgels can improve the absorption of poorly soluble drugs
by delivering them in liquid form.
4. Hermetically Sealed: The capsules are airtight, protecting the contents from moisture,
oxygen, and light, which enhances stability.
5. Versatility: They can encapsulate a wide range of substances, including oils,
suspensions, and low-melting-point drugs.
Packaging
Here are some advantages of soft gelatin capsules:
1. Ease of Swallowing: Their smooth and flexible texture makes them easy to swallow,
improving patient compliance.
2. Taste and Odor Masking: They effectively mask unpleasant tastes and odors of the
encapsulated contents.
3. Enhanced Bioavailability: Softgels can improve the absorption of poorly soluble drugs
by delivering them in liquid form.
4. Hermetically Sealed: The capsules are airtight, protecting the contents from moisture,
oxygen, and light, which enhances stability.
5. Versatility: They can encapsulate a wide range of substances, including oils,
suspensions, and low-melting-point drugs.