CAPSULES

Type of Solid Dosage

Form
 ADVANTAGES OF CAPSULES

1. Tasteless, odorless, and can

easily be administered 6. Physician can change dose and
2. Can use combination of combination of drug according to
powders patient requirement.
3. Easily filled (extemporaneously 7. Permit flexibility.
or large quantities commercially) 8. They are economical
4. Drugs having unpleasant odor 9. Exact dosage level.
and taste are enclosed in a 10. They are easy to handle and
tasteless shell carry.
5. Attractive in appearance
DISADVANTAGES OF CAPSULES

Hygroscopic drug are not suitable for The concentrated solution which
filling into capsules; they absorb water require previous dilution are unstable
in present in capsule shell, makes the for capsules because if administered
shell very brittle and ultimately lead to as such leads to irritation into
crumble into pieces. stomach.
TYPES OF CAPSULES
 HARD GELATIN CAPSULES
Also referred to as Dry-Filled Capsule (DFC).
Supplied in variety of size numbering from 000 (largest size) to 5
(smallest size).
Approximate capacity from 30-600mg, although may vary because of
the different densities of powdered drug materials.
Made largely from gelatin.
Water content is 12-16% but may vary depending on the storage
conditions.
CAPSULES SIZE
Size Volume in ml Size in mm Starch Fill in mg

Solid dosage forms in which

000 1.37 26.3 1,110

the drug substances is enclosed

00 0.95 23.7 775

in either a hard or soft soluble

0 0.68 21.8 530

container of shell of a suitable

1 0.50 19.2 365

2
form of gelatin.
0.37 18.3 300

3 0.30 15.3 200

4 0.21 14.7 160

5 0.15 11.9 100

GELATIN CAPSULES
Heterogenous product derived by the
hydrolytic extraction of animal’s collagen.

Sources of gelatin includes: animal bones,

hide portions, and frozen pork skin.

TYPE A: derived from acid treated precursor

that exhibits an isoelectric point (IEP) at pH 9.
It is manufactured mainly from pork skin.

TYPE B: derived from the alkali treated

precursor that exhibits an isoelectric point
(IEP) at pH 4.7. It is manufactured mainly from
animal bones.
 PARTS OF
CAPSULE
Body – longer piece

Cap – shorter piece

- Slipping over the other thus
completely surrounding the drug
formulation in an oblong shell
EXCIPIENTS
Defined as substances other than the
Active Pharmaceutical Ingredients (APIs)
used in the formulation of a drug product
for long-term stabilization. They play an
integral role in the formulation of a stable
medicinal drug and its administration.

There are 8 types of excipients:

1. Gelatin
2. FD & C and D & C Colorant
EXCIPIENTS
3. Opacifying agents
Water Soluble Dyes – Erythrosine
Pigments – Iron and Titanium Oxides

4. Fillers (Diluents) – Lactose, Mannitol,

Sorbitol, Starch, Dicalcium Phosphate.
- Used to increase the bulk of the formulation
- Improve flow properties and compatibility
 EXCIPIENTS
5. Glidants – Talc, Magnesium Stearate,
Calcium Stearate, Colloidal Silica, and Corn
Starch
- Used to improve the fluidity of powders

- Fine particles that appear to coat the surface of

bulk powders and enhance fluidity by reducing
roughness by filling surface irregularities reducing
attractive force by:
 EXCIPIENTS
Physically separating the host particles,
Modifying Electrostatic charges, Acting as
moisture scavengers, and Serving as ball
bearing between host particles

6. Lubricants – Talc, Magnesium Stearate, and

Calcium Stearate
- Ease the ejection of plugs
- Reduce filming on piston and adhesion of
powders to metal surface
- Reduce friction between sticking surfaces in
contact with powder
EXCIPIENTS
7. Surfactants – Sodium Lauryl Sulphate &
Sodium Docusate
- Increase the wetting of the powder mass
and enhance drug dissolution
- concentration range of 0.1-0.5% is usually
used
- lowers the surface tension in which it is
melted
EXCIPIENTS
8. Hydrophilic Agents
- Improve the wettability of poorly soluble
drug present in gelatin capsule
- For hexobarbital from dry-filled capsules,
Methyl Cellulose or Hydroxy Ethyl Cellulose
are used as hydrophilic agents
 ENCAPSULATION STEPS

Encapsulation – the principles and

methods for the uniform distribution of an
active medical agents in a powder mixture
similar to those of powders
 ENCAPSULATION STEPS
Filling intro hard gelatin capsules with the use of hand-operated
or automatic filling machine includes:
1 2 3 4

Separation of Filling the body Rejoining the Cleaning of

cap from the half cap and the filled capsules
body body halves
ENCAPSULATION STEPS
 CAPSULE SHELL MANUFACTURING
Dipping - several molding pins made of standardized steel are dipped
into the gelatin for a certain amount of time and certain depth,
separately for capsule cap and body.
The pins will be removed from the gelatin and transferred towards the
drying area while spinning around their axis in order the gelatin gets
distributed evenly
In the drying area, pins pass several drying stages so the gelatin
achieves desired moisture content
 CAPSULE SHELL MANUFACTURING

Capsule body and cap halves are stripped off the pins, cut to a correct
length.

In the final step, the capsules are joined together intro a pre-lock
position before they get ejected into containers for transport and filling
 CAPSULE SHELL MANUFACTURING
Capsule filling (encapsulation) – capsules are filled with the desired
ingredient which can be powder, beads, granules, pellets, tablets, liquids,
or a certain combination of these ingredients. This process is done by
capsule filling machines.

Feeding and Rectification - Empty capsules being inserted into the

machine and aligned so caps and bodies can get separated properly.
 CAPSULE FILLING
After separation, capsule bodies get filled with the ingredient and closed
with caps (joining).

Finally, they are ejected into the container for finished products.
METHODS OF FILLING DRY-FILLED CAPSULES
Feton capsule filling
The loader inserts the empty capsule into the filling unit and is removed
and the top plate is lifted to separate the caps from the bodies.
The powder is placed on the unit and the capsule bodies filled.

The top plate is returned to the unit and the caps placed on
filled capsules bodies
METHODS OF FILLING DRY-FILLED CAPSULES
Feton capsule filling
Example: Profill 100 – utilizes on
advanced design for fool-proof
manual filling of two piece
capsule. With this machine,
there is no need for expensive
capsule filling equipment and
electrical connection
 METHODS OF FILLING DRY-FILLED CAPSULES
2. Indirect Filling Methods
A.) Auger-Filling Principle

- Powder or granules are contained in

mass flow hoppers with rotating augers

- Powder is fed continuously out of the

hopper outlet due to the rotation of the
auger

- Amount of powder fed into the body

depends on the time capsule body
suspend underneath on the hopper
outlet and auger speed.
 METHODS OF FILLING DRY-FILLED CAPSULES
2. Indirect Filling Methods

B.) Vibratory Fill Principle

- In the powder, a perforated resin plate

is positioned and connected to a
vibrator.

- The powder blend tends to be fluidized

by the vibration of the plate and assist
the powder to flow into the bodies
through the holes in resin plate.
 METHODS OF FILLING DRY-FILLED CAPSULES
2. Indirect Filling Methods
C.) Piston Tamp Principle
- Piston pins lightly compress the individual doses of the powders into plugs and eject
the plugs into empty capsule bodies.

Piston stamp has 2 types of principles:

1. Dosing Disc Principle - solid stop brass plate is sliding down the dosing disc to close
off the holes. Five sets of piston compress the powder intro cavities to form plugs.

2. Dosator Principle – It consist of cylindrical dosing tube fitted with movable pistons.
The position of the piston is preset to a particular height to definite volume. Powders
enters the open end of dosator and is slightly compressed against the piston into a
plugs.
METHODS FOR COMMERCIAL MANUFACTURE OF
SOFT ELASTIC CAPSULE
Soft globular, gelatin shell

Somewhat thicker than that of hard gelatin capsules

Plasticized by the addition of glycerin, sorbitol, or similar polyol

Has a seam at the point of closure of two halves

Contents can be liquid, paste, or powder

METHODS FOR COMMERCIAL MANUFACTURE OF
SOFT ELASTIC CAPSULE
2. Rotary Die Process - Perfected by Robert P. Scherer (1933)
- The Rotary Die machine is a self-contained unit capable of continuously and
automatically producing finished capsule from a supply of gelatin and filling
material which may be any liquid, semi liquid, or paste that will not dissolve gelatin.

PROCESS:

1.) In this machine, the soft gelatin capsules are prepared and then filled
immediately with liquid medicaments. It has two hoppers and two rotating dies.

2.) Liquid Mixture is placed in one hopper and the liquid medicament in other
hoppers.
METHODS FOR COMMERCIAL MANUFACTURE OF
SOFT ELASTIC CAPSULE
2. Rotary Die Process - Perfected by Robert P. Scherer (1933)

PROCESS:

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.) These half shell of the capsule is formed.

5.) The measured quantity of the medicament is filled into it with the stroke of a
pump with the subsequent movement of the dies. The other half capsule is formed.
METHODS FOR COMMERCIAL MANUFACTURE OF
SOFT ELASTIC CAPSULE
2. Rotary Die Process - Perfected by Robert P. Scherer (1933)

PROCESS:

6.) The two halves’ of the capsules are sealed together by the heat and pressure of
the rotating dies.

7.) As the die rolls rotate, the convergence of the matching die pockets seals and
cuts out the filled capsule.
Rotary Die Process MACHINE
METHODS FOR COMMERCIAL MANUFACTURE OF
SOFT ELASTIC CAPSULE
3. Norton Capsule Machine

This machine produces

capsules completely
automatically by leading
two films of gelatin
between a set of vertical
dies.
METHODS FOR COMMERCIAL MANUFACTURE OF
SOFT ELASTIC CAPSULE
4. Accogel Capsule Machine – Developed by
Lederle Lab. Division of the American
Cyanamid Co. (1948)

The Accogel or Stem machine

uses a system of rotary dies
but is unique in that it is the
only machine that can
successfully fill dry powder
into a soft gelatin capsule. The
capsules can be made of a
variety of colors, shapes, sizes.
 MICROENCAPSULATION
MICROENCAPSULATION – a process or technique by which thin coatings
can be applied re­producibly to small particles of solids, droplets of liquids,
or dis­persions, thus forming microcapsules
The size of the particles involved range from several tenths of a
micrometer to 5000 mcm in size
Ex: gelatin, polyvinyl alcohol, ethylcellulose, cellulose acetate
phthalate and styrene maleic anhydride
 MICROENCAPSULATION
The process provides answers for problems such as:
masking the taste of bitter drugs;
a means of formulating prolonged-action dosage forms;
a means of separating incompatible materials;
a method of protecting chemicals against moisture or oxidation; and
a means of modifying a material’s physical characteristics
 MICROENCAPSULATION
National Cash Register Co (NCR) Process - is a chemical operation based
on phase separation or coacervation techniques
The NCR process, using phase separation or coacervation techniques,
consists of three steps:
Formation of three immiscible phases: a Liquid manufacturing phase.
a core material phase, and a coating material phase.
Deposition or the liquid polymer coating on the core material.
Rigidizing the coating, usually by thermal, cross-linking, or des­olvation
techniques, to form a microcapsule.
THANK YOU!