The document provides an overview of solid unit dosage forms, specifically focusing on hard and soft gelatin capsules, their manufacturing processes, advantages, disadvantages, and quality control tests. It details the composition, preparation methods, and sealing techniques for both types of capsules, as well as outlines key quality control measures to ensure product integrity. Additionally, the document differentiates hard gelatin capsules from soft gelatin capsules in terms of structure, contents, and manufacturing processes.

1. Capsules
Prepared by:
Shivanee Vyas
Assistant Professor
SVKM’s NMIMS, School of Pharmacy and Technology Management
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Solid unit dosage forms the drug is enclosed within the water-soluble shell or an envelope
either a hard or soft shell. Shell is typically made of gelatin primarily intended for oral delivery
and provides a rapid release of contents.
Generally, the shells are formed from gelatin.
Introduction

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Capsules are available in two types:
1. Hard gelatin capsules
2. Soft gelatin capsules
Types of Capsules

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• The hard gelatin capsule consists of two pieces in the form of cylinders closed at one
end. The shorter piece is called the cap. This cap fits over the longer piece called the
body.
• Hard gelatin capsules are also known as dry-filled capsules or two-piece capsules.
• The drug substance is placed in the body and the caps are slid over it, hence enclosing
the drug substance.
1.HARD GELATIN CAPSULES:

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• Advantages:
1. The drug having an unpleasant odour & taste can be administered by enclosing
them in a tasteless shell.
2. Smooth becomes very slippery when moist &can be easily swallowed.
3. They are economical.
4. Easy to handle & carry.
5. Release the medicament as and when desired in GIT.
6. They are made up of gelatin hence they are therapeutically inert.
7. They are attractive in appearance.
8. Available in various sizes.
9. Microencapsulation provides the sustained-release dosage form.
10. Combination of powders we can use.

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• Disadvantages:
1. The hygroscopic drugs cannot be filled in capsules. They absorb water present in the
capsule shell & make it very brittle, which ultimately breaks into pieces.
2. Capsules are not suitable for liquids that dissolve gelatin, such as aqueous or hydro-
alcoholic solutions.
3. The filling process is laborious and time-consuming. Therefore production rate is
slower than tableting.

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SHAPES OF HARD GELATIN CAPSULE

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SIZE OF CAPSULE
Size Volume in ml Size in mm
000 1.37 26.3
00 0.95 23.7
0 0.68 21.8
1 0.50 19.2
2 0.37 18.3
3 0.30 15.3
4 0.21 14.7
5 0.15 11.9

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1. Gelatin
2. Plasticizers: These increase the plasticity of the film. E.g. glycerin, sorbitol, and propylene glycol.
3. Sweeting agent. E.g. Sugar is not more than 5%.
4. Water - 12 to 16 % (may vary depending on the storage condition)
5. Sulphur dioxide (15%) - prevent decomposition during manufacture
6. Colourants/ Opacifying agent: There are two types:
A) Water-soluble dyes– e.g. erythrosine
B) pigments– e.g. iron oxides, titanium dioxide (make the capsule opaque to provide protection.
7. Preservatives: To prevent microbial growth during manufacture. E.g. methylparaben, and potassium
bisulfite.
8. Diluents: lactose, mannitol, sorbitol, starch, etc.
9. Lubricants and Glidants: talc, magnesium stearate & calcium stearate.
10. Wetting agents: sodium lauryl sulphate.
11. Disintegrants: e.g. crospovidone, croscarmellose sodium.
Ingredients for manufacturing HGC

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• Gelatin is a heterogeneous product derived from the hydrolytic extraction of animal collagen. The
sources of gelatins include animal bones and frozen pork skin. It is the major component of the
capsule.
1. TYPE A - Derived from an acid-treated precursor that exhibits an isoelectric point at pH-9. It is
manufactured mainly from pork skin.
2. TYPE B - Derived from an alkali-treated precursor that exhibits an isoelectric point at pH-4.7. It is
manufactured mainly from animal bones.
GELATINE

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Preparation of filled hard gelatin capsules:
In large-scale or small preparations of filled hard gelatin capsules divided into the
following general steps:
Manufacture of empty gelatin capsules
Filling the capsule shell
Capsule sealing
Cleaning and polishing the filled capsules.

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Steps involved in making empty gelatin capsules…
1. Dipping
2. Spinning
3. Drying
4. Stripping
5. Trimming
6. Joining
7. Polishing
1. MANUFACTURE OF EMPTY GELATIN CAPSULES

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1. Dipping: Pairs of stainless steel pins are dipped into the dipping solution to form the
caps and bodies. The dipping solution is maintained at a temperature of about 500°C in a
heated, jacketed dipping pan.
2. Spinning: The pins are rotated to distribute the gelatin over the pins uniformly.
3. Drying: The gelatin is dried by a blast of cool air to form a hard shell. The pins are moved
through a series of air-drying kilns to remove water.

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4. Stripping: A series of bronze jaws strip the cap and body portions of the capsules from
the pins.
5. Trimming and joining: The stripped cap and body portions are trimmed to the
required length by stationary knives. After trimming to the right length, the cap and
body portion are joined and ejected from the machine.
6. Polishing Pan Polishing: Acela-Cota pan is used to dust and polish.
• Cloth Dusting: Capsules are rubbed with a cloth.
• Brushing: Capsules are fed under a soft rotating brush.

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2. Filling of hard gelatine capsules
Hand Operated methods
It consists of:—
1. A loading tray having 200-300 holes
2. A powder tray
3. A pin plate having 200-300 pins
4. A sealing plate having a rubber top
5. A lever
6. A cam handle
Capsule filling is a complex process. The capsule filling process may vary depending on the
filling operation selected, like hand-operated, bench scale capsule filling, semi-automated
capsule filling, or fully automated capsule filling machine.

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• Banding – Placing gelatin colour bands at the meeting point of caps and the bodies.
• Moistening – Moistening the inner surface of caps with a lukewarm gelatin
solution.
• By using Coni-snap capsules – Grooves help to lock the caps with the bodies.
3. Capsules Sealing

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4. Cleaning and polishing the filled capsules.
• Cloth dusting: Capsules are rubbed with a cloth.
• Pan Polishing: Acela-Cota pan is used to dust and polish.
• Brushing: Capsules are fed under a soft rotating brush.

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• Manufacturing Defects
Major defects:
1. It may have cracks, breaks, pinholes, or splits, losing its integrity.
2. Color variation, and non-uniformity of appearance.
3. Surface spots and embedded particles on capsules.
4. Body and cap are not uniform and do not fit properly.
Minor defects:
1. Capsule’s surface is not smooth.
2. Opacity is not proper.
3. There are pits, spots, or blemishes.

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• Soft Gelatin capsules also known as soft gels are one-piece, hermetically sealed, soft
gelatin shells containing a non-aqueous liquid, a suspension, or semisolid
preparations.
2. Soft Gelatin Capsules (Softgels)

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Size of Soft Gelatin Capsule

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Manufacturing of soft gelatin capsule
Capsule shell: The capsule shell is basically composed of Gelatin, a plasticizer & water, it
may contain additional ingredients which are the following as:
Primary ingredients of soft gelatin capsule

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SGC are manufactured by different methods like plate process, rotary die process, reciprocating die
process, accogel process etc.
ROTARY DIE PROCESS
1. In this machine, the soft gelatin capsules are prepared & then filled immediately with liquid medicaments
it is having two hoppers & two rotating dies.
2. Liquid mixture is placed in one hopper & the liquid medicament in another hopper.
3. The two rotating dies rotate in opposite directions when the fluid gelatin mixture enters the machine
from the hopper it produces two continuous ribbons.
4. The half shell of the capsule is formed.
5. At this stage, the measured quantity of the medicament is filled into it.
6. The two halve of the capsules are sealed together by the heat & pressure of the rotating dies.
7. As the die rolls rotate, the die pocket seals and cut out the filled capsules.
Manufacturing of soft gelatin capsule

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Whether capsules are produced on a small scale or large scale all of them are required to
pass through certain tests i.e., quality control tests to test the quality of the finished
product.
QUALITY CONTROL OF CAPSULES
• Size and shape
• Weight variation test
• Moisture permeation test
• Content uniformity
• Dissolution test
• Disintegration test

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1. Size and shape: This test is used to check the uniformity of size and shape by comparing it with the
standard.
2. Weight variation test: The gross weight of 20 intact capsules is determined individually. The contents are
removed and the solvent is allowed to evaporate at room temperature for about 30 minutes, the weight
of the content is different between the initial weight and weight of the shell.
–Avg. wt. of the cap. contents- Less than 300 mg-10% deviation allowed.
300 mg or more than 300 mg-7.5% deviation allowed.
3. Moisture permeation test: According to U.S.P the unit dose container is packed along with dehydrated
pellets, which have the property of changing colour in the presence of moisture. The weight of the test
capsule is compared with the under-test capsules. The difference in weight gives the amount of moisture
absorbed.
4. Content uniformity: According to BP the content of the active ingredients in each of the 10 capsules is
taken at random using a suitable analytical method of equivalent accuracy and precision.
QUALITY CONTROL OF CAPSULES

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4. Disintegration test for capsules: Place 1 capsule in each of the 6 tubes of the basket & suspend
the assembly in water, which is repeatedly immersed 30 times per minute. The capsules pass the
test if no residue of the drug or other than fragments of shell remains on the No. 10 mesh screen
of the tubes.
Temperature: 37±2%
Disintegration time for Hard gelatin capsule – 30 minutes
Disintegration time for Soft gelatin capsules – 60 minutes
5. Dissolution test for capsules:
• The dissolution test is carried out using the dissolution apparatus official in both the U.S.P and IP.
• The capsule is placed in a basket, and the basket is immersed in the dissolution medium and
caused to rotate at a specified speed.
• The dissolution medium is held in a covered 1000 ml glass vessel and maintained at 37°C ± 0.5°C.
• The stirrer speed and type of dissolution medium are specified in the individual monograph.

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Sr.No. Hard Gelatin Capsule Soft gelatin capsule
1. Hard Gelatin Capsule shell consists of two
parts 1. Body 2. Cap.
Soft gelatin capsule shell become a single unit
after sealing the two halves of the capsules.
2. They are cylindrical in shape They are available in round, oval & tube like
shapes
3. The contents of a hard gelatin capsules
usually consist of the medicaments is the
form of powder, beads or granules
The contents of soft gelatin capsules usually
consists of liquids or solids dissolved or
dispersed in suitable excipients to give a paste
like consistency.
4. These are prepared from gelatin, titanium
dioxide, coloring agents and plasticizer
These are prepared from gelatin plasticizer
(Glycerin or Sorbitol ) and a preservative
5. Capsules are sealed after they are filled to
ensure that the medicaments may not come
out of the capsule due to rough handling.
Filing and sealing of soft gelatin capsules are
done in a combined operation on machines.

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• Capsules should be packed in well-closed glass & plastic containers and stored at a temperature not
exceeding 30℃.
• In strip packing the capsule is hermetically sealed within the strips of an aluminium or plastic film.
• In blister packs, a press on the blister forces the capsule through the backing strip.
• Capsules have a larger shelf life in unopened glass bottles than in strip packs.
PACKING & STORAGE OF CAPSULES:

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