UNIT 3 – CAPSULES (PART 1)

Useful for [Link], Government Pharmacist, Drug Inspector and Pharma Company
Interviews.

1. Introduction to Capsules
A capsule is a solid unit dosage form in which the drug is enclosed in a hard or soft
shell, usually made from gelatin or suitable polymers. Capsules improve patient
compliance by masking unpleasant taste and odor and providing accurate dosing.

2. Advantages of Capsules
• Easy to swallow.
• Mask unpleasant taste and smell.
• Accurate dose.
• Better patient acceptance.
• Suitable for powders, granules and some liquids (soft capsules).
• Faster disintegration than many tablets.

3. Disadvantages of Capsules
• Sensitive to moisture and humidity.
• Gelatin capsules are not suitable for some hygroscopic or highly aqueous
formulations.
• Higher manufacturing cost than many tablets.

4. Classification of Capsules
1. Hard Gelatin Capsules (HGC)
2. Soft Gelatin Capsules (SGC)

Detailed manufacturing and filling methods will be covered in the next parts.

5. Ideal Properties of Capsules

An ideal capsule should have:
• Uniform drug content
• Proper shell strength
• Rapid disintegration (unless modified release)
• Good stability
• Elegant appearance
Interview Questions
1. What is a capsule?
2. Name the two main types of capsules.
3. Why are capsules preferred for bitter drugs?
4. What is the major disadvantage of gelatin capsules?

Practice MCQs
1. The two main types of capsules are
Answer: Hard and Soft gelatin capsules

2. Capsules mainly improve

Answer: Patient compliance

3. Hard gelatin capsules usually contain

Answer: Powders or granules

4. Capsules mask
Answer: Taste and odour

5. Gelatin capsules are sensitive to

Answer: Moisture
UNIT 3 – CAPSULES (PART 2)
Hard Gelatin Capsules
Hard gelatin capsules consist of two parts: a body and a cap. They are mainly filled
with powders, granules or pellets. They are widely used because they are easy to fill
and provide accurate dosing.

Capsule Shell Composition

Typical shell ingredients include gelatin, purified water, colour, opacifier such as
titanium dioxide (where used), and preservatives in some formulations.

Capsule Sizes
Standard capsule sizes range from 000 (largest) to 5 (smallest). Size selection depends
on bulk density and dose of the formulation.

Manufacturing & Filling

Shells are manufactured separately and then filled using manual, semi-automatic or
automatic capsule filling machines. Filled capsules are locked, inspected and packed.

Interview & MCQs

Interview: What are the two parts of a hard gelatin capsule? Why is size 000 larger than
size 5? MCQ Answers: 1) Body and Cap 2) 000 is the largest standard capsule 3)
Powders are commonly filled in HGC.
UNIT 3 – CAPSULES (PART 3)
Soft Gelatin Capsules
Soft gelatin capsules are one-piece, hermetically sealed dosage forms generally used
for oils, lipid-based formulations and some liquid or semi-solid medicines.

Advantages
They improve bioavailability of some poorly soluble drugs, mask unpleasant taste and
provide accurate dosing for liquid formulations.

Manufacturing
Soft capsules are commonly produced by the rotary die process where the shell is
formed, filled and sealed in one continuous operation.

Quality Control
Important tests include appearance, fill weight variation, disintegration, dissolution,
leakage and stability testing.

Interview & MCQs

Interview: Why are soft gelatin capsules used for oils? Name the common
manufacturing process. MCQ Answers: 1) Rotary die process 2) Soft capsules are
one-piece shells 3) Leakage test is important.
UNIT 3 – CAPSULES (PART 4)
Capsule Filling Machines
Capsule filling machines accurately fill hard gelatin capsules with powders, granules or
pellets. According to production scale, they are classified as:
• Manual capsule filling machine
• Semi-automatic capsule filling machine
• Automatic capsule filling machine

Working Principle
The machine separates the capsule body and cap, fills the body with the required
quantity of formulation, rejoins the cap, locks the capsule and ejects the finished
product. Automatic machines perform these steps continuously with high speed and
accuracy.

Common Capsule Defects

• Improper locking
• Weight variation
• Cracked capsule shell
• Brittle shell (low moisture)
• Soft or sticky shell (high humidity)
• Powder leakage

Storage and Packaging

Capsules should be stored in a cool, dry place and protected from excessive humidity.
Common packaging includes blister packs, strip packs and HDPE bottles with proper
labeling.

GMP Points
• Line clearance before production.
• Correct capsule size selection.
• Equipment cleaning and calibration.
• In-process weight checks.
• Proper documentation and batch records.

Interview Questions
1. Name the three types of capsule filling machines.
2. Why are capsules protected from humidity?
3. What causes brittle capsule shells?
4. Which in-process check is most important during filling?

Practice MCQs
1. Automatic capsule filling machines are used for
Answer: Large-scale production

2. Low moisture may cause

Answer: Brittle capsule shell

3. Capsules are commonly packed in

Answer: Blister packs

4. A GMP requirement before production is

Answer: Line clearance

5. Improper locking may lead to

Answer: Capsule leakage
UNIT 3 – CAPSULES (PART 5) – DEEP NOTES
Introduction to Quality Control
Quality Control (QC) ensures that every capsule released to the market is safe,
effective and meets pharmacopoeial specifications. During manufacturing, in-process
checks and finished-product testing are both essential.

1. Weight Variation Test

Purpose: To confirm that each capsule contains nearly the same fill weight.
Principle: Capsules from the same batch should not show excessive variation in weight.
Procedure: Random capsules are weighed individually, emptied if required by the
method, shell and fill weights are determined, and results are compared with
specifications.
Importance: Ensures dose uniformity and prevents under- or overdosing.

2. Content Uniformity Test

Purpose: Confirms that each capsule contains the intended amount of API.
When important: Especially for low-dose medicines where small differences can affect
therapy.
Difference: Weight variation checks fill weight; content uniformity checks actual drug
content.

3. Disintegration Test
Purpose: Measures the time required for the capsule shell to break apart under
specified conditions.
Principle: The capsule should disintegrate so the drug becomes available for dissolution
and absorption.
Factors affecting: Shell composition, storage conditions and formulation.

4. Dissolution Test
Purpose: Measures the rate and extent of drug release into a dissolution medium.
Importance: Helps predict in-vivo performance and batch-to-batch consistency.
Common apparatus: USP Apparatus I (Basket) and USP Apparatus II (Paddle).

5. Moisture Content
Gelatin shells are sensitive to moisture. Low moisture may make shells brittle, while
excess moisture can cause soft, sticky capsules and leakage. Proper humidity control
during manufacturing and storage is essential.

6. Stability Studies
Stability studies evaluate how temperature, humidity and light affect capsule quality
during storage. They help determine shelf life and storage conditions.

Interview Questions
1. Difference between weight variation and content uniformity?
2. Why is dissolution testing important?
3. Why do gelatin capsules become brittle?
4. Name two QC tests for capsules.

Practice MCQs
1. QC test that measures drug release: Dissolution test
2. Test confirming amount of API: Content uniformity
3. Low moisture causes: Brittle capsule shell
4. Weight variation mainly evaluates: Dose consistency
5. USP Paddle apparatus is used for: Dissolution testing
UNIT 3 – CAPSULES (PART 6) – DEEP NOTES
Capsule Packaging
The primary purpose of packaging is to protect capsules from moisture, oxygen, light
and mechanical damage. Gelatin capsules are hygroscopic, therefore suitable
packaging is essential. Common packaging includes blister packs, strip packs and
HDPE containers with desiccants when required.

Storage Conditions
Store capsules in a cool, dry place away from direct sunlight. Excess humidity softens
gelatin shells and may cause sticking or leakage, while very low humidity can make
shells brittle and crack.

Defects During Manufacturing

Common defects include: • Split capsules • Loose cap locking • Weight variation •
Powder leakage • Denting and deformation • Soft or brittle shells Possible causes
include incorrect machine settings, poor humidity control, incorrect fill weight and
damaged capsule shells.

Troubleshooting
Maintain controlled humidity, calibrate filling machines, inspect empty shells before
filling, perform in-process weight checks and follow SOPs for cleaning and operation.

Documentation & GMP

Every manufacturing batch should have Batch Manufacturing Records (BMR), Batch
Packaging Records (BPR), equipment cleaning records and in-process QC records. GMP
requires proper documentation because undocumented work is treated as not
performed.

Interview Questions
1. Why are capsules sensitive to humidity?
2. What causes powder leakage?
3. Why is a desiccant used in HDPE bottles?
4. What is the role of BMR during capsule manufacturing?

Practice MCQs
1. Excess humidity causes Soft gelatin shells.
2. Low humidity causes Brittle shells.
3. HDPE bottles may contain Desiccants.
4. BMR stands for Batch Manufacturing Record.
5. GMP emphasizes Proper documentation.
UNIT 3 – CAPSULES (PART 8)
In-Process Quality Checks
During capsule filling, manufacturers monitor capsule weight, locking, appearance, fill
accuracy, leakage and machine performance. These checks help detect problems
before the batch is completed.

Validation Basics
Process validation demonstrates that the manufacturing process consistently produces
capsules meeting predetermined quality specifications. Equipment qualification and
cleaning validation are also important GMP activities.

Common Viva Questions

1. What is process validation?
2. Why are in-process checks important?
3. What is cleaning validation?
4. What parameters are checked during capsule filling?

Practice MCQs
1. In-process checks improve Batch quality.
2. Validation proves Consistency of the process.
3. Cleaning validation prevents Cross-contamination.
UNIT 3 – CAPSULES (PART 9)
High-Yield Revision
• Hard gelatin capsules have body and cap.
• Soft gelatin capsules are one-piece shells.
• Rotary die process is used for soft gelatin capsules.
• Moisture greatly affects gelatin shells.
• Weight variation and content uniformity are different QC tests.
• Dissolution evaluates drug release.

Interview Rapid Fire

Define capsule. Differentiate HGC and SGC. Name capsule QC tests. Why are
desiccants used? What is BMR?

Mixed MCQs
1. Largest capsule size: 000.
2. Soft capsules are commonly used for Oily formulations.
3. Brittle shells occur due to Low moisture.
4. Leakage is a common Capsule defect.
5. Dissolution test measures Drug release.

Final Note
Revise capsule types, shell composition, manufacturing, filling, defects, QC tests,
packaging, storage and GMP before interviews and competitive examinations.