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04.Ph Capsule

Capsules can be solid (hard) or liquid-filled (soft) unit dosage forms. Hard capsules enclose powder or granules inside a hard gelatin shell, while soft capsules contain liquid or semi-solid fills within an elastic gelatin casing. Capsules offer advantages over tablets such as easier swallowing, masking of bitter tastes, and ability to encapsulate liquids, but require specialized manufacturing equipment. The production of hard capsules involves dipping pins in gelatin to form shells, drying, trimming, filling, and sealing. Soft capsules are filled and sealed as one-piece shells made of gelatin and plasticizers. Both types are widely used for oral and other drug delivery applications.

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123 views63 pages

04.Ph Capsule

Capsules can be solid (hard) or liquid-filled (soft) unit dosage forms. Hard capsules enclose powder or granules inside a hard gelatin shell, while soft capsules contain liquid or semi-solid fills within an elastic gelatin casing. Capsules offer advantages over tablets such as easier swallowing, masking of bitter tastes, and ability to encapsulate liquids, but require specialized manufacturing equipment. The production of hard capsules involves dipping pins in gelatin to form shells, drying, trimming, filling, and sealing. Soft capsules are filled and sealed as one-piece shells made of gelatin and plasticizers. Both types are widely used for oral and other drug delivery applications.

Uploaded by

Subha Shankaree
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© © All Rights Reserved
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Capsules

CAPSULES
Definition:

 Capsules are solid unit dosage form


of medicament in which the drug is
enclosed in a practically tasteless,
hard or soft water soluble container
or, shell made up of a suitable form
of gelatin.
Advantages
Disadvantages

• The requirement for specialised


manufacturing equipment.

• Problems regarding the homogeneity of


fill weight and Content may be
associated with capsule formulations.

• Potential stability problems associated


with capsules containing liquid fills.
Capsule advantages over tablets

1) Production advantages
2) Formulation advantages
3) consumer advantages
1.Production Advantages:

I. They require lesser number of instruments


for manufacturing.

II. The procedure for manufacturing is easier.

III. They need to undergo lesser number of


quality control tests.

IV. The steps for manufacturing are lesser.


2. Formulation Advantages :
I. Filling materials may be in the form of powders, pellets,
liquids, semi solids or small tablets. These ingredients may be
filled alone. or in combinations of two or more.

II. Filling materials include very few number of additives.

III. Hard gelatin shell decreases the problems of stability for


storing sensitive drugs.

IV. They are perfectly suitable for filling medicaments for delayed
release
3. Consumer Advantages :

I. Glossy/polished outer surface which helps


in easy swallowing.

II. Masking of bitter and acrid taste of


medicaments by the shells.

III. Distinct colours and shapes help in


intensifying the capsule identity.
1. Hard capsules

2. Soft capsules
CAP

BODY

11
Manufacture of empty Hard
gelatin capsules
Compositions of HGC
Gelatin is obtained by the partial
hydrolysis of collagen obtained from the
skin, white connective tissue, and bones of
animals.
Manufacture of empty Hard gelatin capsules

Steps involved in making empty gelatin


capsules…

1. Dipping
2. Spinning
3. Drying
4. Stripping
5. Trimming
6. Joining
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1. Dipping
 Pairs of the stainless steel pins are
dipped into the dipping solution
to simultaneously form the caps and
bodies.

 The dipping solution is maintained at


a temperature of about 50 C in a
heated, jacketed dipping pan.

 The dipping time to cast the film is


about 12 secs

17
2.Spinning or Rotation
 After dipping, the pins are withdrawn
from dipping solution. They are
elevated and rotated until they are
facing upward.

 This helps distribution of the gelatin


over the pins uniformly and to avoid
the formation of bead at the
capsule ends

 After rotation they are given a blast of


cool air to set the film
3. Drying

 The Pin Bars pass through the


upper and lower kilns of Capsule
Machine Drying System.

 Here gently moving air which is


precisely controlled for volume,
temperature, and humidity,
removes the exact amount of
moisture from the capsule halves.
4. Stripping :

 A series of bronze jaws strip the cap


and body portions of the capsules from
the pins.
5. Trimming

 Thestripped caps and bodies


are delivered to collects in
which they are firmly held

 As the collects rotate the


knives are brought against
the shells to trim them to the
required length
6. Joining

 After trimming to the right length, the cap


and body portion are joined in the joiner
blocks and then ejected from the
machine.
MANUFACTURING OF HARD GEL
CAPSULES

Perfect capsules are imprinted with


the client logo on high-speed.
Filling of Hard gelatin capsule
Capsule filling methods

 1. Manual filling

 2. Hand filling machines

 3. Fully automatic capsule filling machine


1. Manual Filling

 Method: Initially the ingredients to be


encapsulated are triturated to obtain uniform
sized particles.

 They are then placed on a sheet of clean paper


with the help of a spatula the triturated
ingredients are made into a cake such that the
height of the cake is almost one third the
height of the capsule.
1. Manual Filling

 Now, required number of empty capsules are taken


and their caps are separated from the bodies.

 A single body of the capsule is held in between the


thumb and the forefinger and is punched into the
cake of powdered drug repeatedly until filled.

 Finally the cap is placed over the filled body


2. Hand filling machines

1. The empty capsules filled in to the loading tray, which is then


placed over the bed.

2. By operating the handle, the bodies of the capsules are locked


and caps separated in the loading tray by operating the lever.

3. The weighed amount of the drug to be filled in the capsules is


placed in powder tray already kept in position over the bed.

4. Spread the powder by the help of a spreader to fill the


bodies uniformly.

31
32
2. Hand filling machines

5. Collect excess of the powder on the platform of the


powder tray.

6. Lower the pin plate and move it downward so as to press


the powder in the bodies.

7. Remove the powder tray and place the caps holding tray
in position.

8. Press the caps with the help of plate with rubber top and
operate the lever to unlock the cap and body of the
capsules.

33
2. Hand filling machines

9. Remove the loading tray and collect the


filled capsules in a tray.

10. With 200 hole machine about 5000


capsules can be filled per hours.
Sequence of Events
2.Fully automatic capsule filling machine

 Machines developed for industrial use automatically


separate the caps from empty capsules,

 fill the bodies,


 scrape off the excess powder,
 replace the caps,
 seal the capsules as desired, and clean the outside
of the filled

 capsules at up to 165,000 capsules per hour


Small amounts of
powder may adhere to
the outside of capsules
after filling.

The powder may be


bitter or otherwise
unpalatable and should
be removed before
packaging or
dispensing.

Cleaning and Polishing


Filling of Hard Gelatin Capsules
During filling of hard gelatin capsules, the following problems may be
encountered:

 Improper flow of the powder mixture during the filling operation: This problem
can be overcome by incorporation of suitable amount of glidants or lubricants
into the powder mixture.

 Segregation and homogeneity: This problem is generally encountered when


semiautomatic or automatic machines are used for filling the capsules.

 The vibration during operation of these heavy-duty machines can cause


segregation of particles and inhomogeneity.

 This segregation can be minimized by keeping particle sizes and densities of


the powders as uniform as possible.
Different sizes of hard gelatin capsule
Excipients used in the formulation
Some of the excipients commonly used in the filling of hard gelatin capsules may
include the following:

 Diluents to increase the overall working mass of the powder for easy and
accurate handling during filling operations. These diluents include lactose, corn
starch, and microcrystalline cellulose.

 Disintegrates to break up the powder mass when exposed to a liquid medium.


Corn starch, microcrystalline cellulose, sodium starchglycolate, and
croscarmellose are disintegrantsused in hard gelatin capsules.

 Glidants to lower the interparticle attraction and thereby reduce


agglomeration and enhance the flow of powder. Colloidal silicon and talc are
commonly used for this purpose.
Excipients used in the formulation

 Lubricants to reduce the interaction between powders


and components of the filling machine handling the
powder. Magnesium and other metallic stearates are
generally used as lubricants.

 Surface-active agents incorporated into the powder mix


to decrease surface tension and enhance wetting of the
powder with the release medium when hydrophobic
components are present in higher amounts. Sodium
lauryl sulfateis commonly used for this purpose.
Soft gelatin capsule

Definition:
Soft Gelatin capsules are one piece, hermetically sealed,
soft gelatin shells containing a liquid, a suspension, or a
semisolid.

Soft capsules are soft and elastic in nature which are


prepared from gelatin and water.

Soft gelatin is mainly composed of gelatin, plasticizers,


preservative, colouring and opacifying agents,
flavoring agents and sugars.
The shape of soft
gelatin capsule are
round, oval, oblong,
tube.

51
advantages

1) Soft gelatin capsules permit liquid medication


to be easily transportable and administered as a
solid dosage form.

2) They provide accuracy and uniformity of the


dose to be administered.

3) They provide better drug availability than


tablets and hard gelatin capsules.
Disadvantages
Pharmaceutical Applications of Soft Gelatin Capsules

1) Soft gelatin capsules are available as an oral dosage


form.

2) They are available as a suppository dosage form.

3) They are available as a single-dose application of


topical and ophthalmic preparations.

4) They are extensively used in the cosmetic industry to


dispense bath oil, perfume, skin creams, breath
fresheners, etc.
 Rotary die process
Rotary die process

1) Liquid gelatin is formed into two ribbons

2) The two ribbons are brought together

3) Metered fill material is injected between the ribbons

4) These pockets of fill-containing gelatin are sealed

These rotary die machines are produce 25000 to 30000


capsules per hour.
POWDERS w/ capseal GRANULES

BEADS TABLETS
CAPLETS PASTES

LIQUIDS w/ capseal

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