Capsulesfinalppt

"Capsules are solid dosage forms in which
one or more medicaments are enclosed in
a water soluble bio degradable shell
made up of gelatin"

Hard- shelled capsules
Soft-shelled capsules

“Hard-shelled capsules,
which are typically made
using gelatin and contain
dry, powdered
ingredients”
These are made in two halves:
 Lower-diameter "body" that is
filled
 Then sealed using a higher-
diameter "cap".

Soft-shelled capsules,
primarily used for oils
and for active
ingredients that are
dissolved or
suspended in oil.

1. Gelatin
2. Certified dyes
3. Sugar
4.Water - 12 to 16 % but may vary depending on the
storage condition
5.Sulfur dioxide (0.15%) - prevent decomposition
during manufacture
6 Opaquants /Opacifying agent - titanium dioxide

 Ease of use due to the fact that it is smooth,
slippery and easy to swallow.
 Suitable for substances having bitter taste and
unpleasant odor.
 As produced in large quantities it is economic,
attractive and available in wide range of colors.
 Minimum excipients required.
 Little pressure required to compact the
material.
 Unit dosage form.
 Easy to store and transport.

 Not suitable for highly soluble substances
like potassium chloride, potassium bromide,
ammonium chloride, etc
 Not suitable for highly efflorescent or
deliquescent materials.
 Special conditions are required for
storage.

Steps involved in making empty gelatin capsules
with peg/pin method…
1.Dipping
2.Spinning
3.Drying
4.Stripping
5.Trimming and Joining
6.Polishing
MANUFACTURING OF HARD
GELATIN CAPSULES
The process of capsule shell production with the pin method:
• Dipping→ Drying → Stripping→ Trimming→ Joining →
Polishing

• DIPPING :
Pairs of the stainless steel pins are dipped into the dipping solution to
simultaneously form the caps and bodies.
The dippin solution is maintained at a temperature of about 50 degree
centigrade in a heated ,jacketed dipping pan.
• SPINNING:
The pins are rotated to distribute the gelatin over the pins unifomly and to
avoid the formation of a bead at the capsule ends.
• DRYING :
The gelatin is dried by a blast of cool air to form a hard shells.
The pins are moved through a series of air drying kilns to removewater
• STRIPPING :
A series of bronze jaws strip the cap and body portions of the capsules
from the pins.

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.
POLISHING
Pan Polishing : Acela-cota pan is used to dust and polish.
Cloth Dusting : Capsule are rubbed with cloth.
Brushing : Capsule are feed under soft rotating brush.

CAPSULE FILLING MACHINE
It is the mechanical device that fills the powders
(active ingredients and the mixtures of active
ingredients with combinations of different
excipients) into hard or soft gelatin capsules.
Capsule filling machines are used commonly in
industrial and pharmaceutical purpose. Millions
of capsules can be filled by using different
varieties of capsule filling machines which are
provided by different manufacturers.

Hard capsule FILLING
1) Bench scale filling.(for small scale filling)
- Manual filling machine
eg: feton capsule filling machine
2) Industrial scale-filling.
Comes in varying shapes and sizes
- semi automatic machine
- fully automatic machine

• At present about 9 manufacturing companies supplies the
capsule filling machines with different models . The following
famous companies which provides capsule filling machines are
 Eli Lilly and company indianapolis IN
 Farmatic SNC, Bologna, Italy
 Macofar SAS, Bologna, Italy
 Hofliger and Karg, Waiblingen, Germany
 mG2 S.P.A., Bologna, Italy
 Osaka, Osaka, Japan
 Parke-Davis and company, Detroit, MI
 Perry Industries, Green BayWI
 Zanasi Nigris, S.P.A., Bologna, Italy
The largest number of total machines are supplied by Lilly and
Parke-Davis. The method of operation and the description of
the machines are similar in these two companies.

What is the common working principle of all capsule
filling machines?

 TAMPER-EVIDENTCAPSULESare made sealing the joint
between the two capsule parts.
 DISTINCTIVELOOKINGCAPSULEScan be made by sealing
capsules with a colored band of gelatin, which cant be
restored without expert sealing.
 HEAT WELDINGPROCESScan also be used, that fuses
capsules cap through the double wall thickness at junction
 LIQUIDWETTINGAGENTthat lowers the M.P in contact
areas of capsule cap & body & then thermally bonds the
two parts using low temperatures

 On small scale capsules may be cleaned
individually or in small numbers by rubbing
them with a clean guaze or cloth.
 On large scale many CAPSULE FILLING
MACHINES with a cleaning vacuum that
removes any extraneous material from the
capsule as they exit the equipment.
 (ACCELACOTA APPARATU..S)

 Hardgelatin capsulesare stored in atightly
closedglass or plastic containers, protected
from dust andextremes of humidity and
temperature.
 Mini
mum
Ideal Maximum
Relative humidity 40% 50% 60%
Temperature 15 0c 20oc 25oc

Thesecapsulescontain 12 - 16%water but water
content vary according to the storage conditions.
Capsulesbecomebrittle in low humidity butare
flaccid andlose their shapeif stored in high
humidity.
Theydonot protect hygroscopicmaterials from
atmosphericwatervaporasmoisture candiffuse
through the gelatin wall. Whenstorage temperature
condition is high the quality of the hardgelatin
capsulesare affected

The capsule shell is basically composed of Gelatin, a
plasticizer & water it may
contain additional ingredients such as preservative,
coloring & opacifying agents, flavorings, sugars, acids &
medicaments to achieve desired effects
1. Capsule shell WATER:
NOT MORE THAN 45% w/w the ratio
by weight of water to dry gelatin can vary from 0.7
to1.3(water) to 1.0(dry gelatin) depending on the
viscosity of the gelatin being used.
2. PLASTICIZER:
Used to make the soft gel shell elastic & pliable.
Ratio used is between 0.3 to 1.8 for soft to hard shell
ondry basis. E.g. glycerin ,
sorbitol

3.COLOUR:
Used in shell has to be darker than colour of
encapsulating material colours may be natural or
synthetic.
4.OPACIFIER:
Usually titanium dioxide, may be added to produce
an opaque shell ,when the fill formulation is a
suspension or to prevent photo degradation of light
sensitive fill ingredients. Concentration of opacifier
may be up to 0.5%
5.Chelating Agents:
Iron is always present in raw gelatin, & should
not contain iron more than 15 ppm.
Additionally chelating agent may be used for
preventing the reaction of iron with
materials or colours.

A typical gel mass formula for making soft
gelatin capsules would be:
 Gelatine 35-45%
 Plasticizer 15-25%
 Water ~40%
 Dye / Pigment as needed
 Opacifier as needed
 Other (flavor, sugar,) as needed
(((1 part gelatin, 1 part water, 0.4-0.6 part
plasticizer)))

 >The gel is prepared in a 300-litre stainless
steel vessel
 >Gelatin powder is mixed with water and
glycerine. Heating. Stirring. The molten gelatin
mass is formed
 >It is decanted into 200-kg mobile vessels
 >Turbine mixing where colours and flavours
can be added. It ensures consistency of gelatin
mass
 >This mass is kept at a constant temperature
until it is needed for the next stage of the
process

 Content may be liquid, or a combination of
miscible liquids
 Solution of a solid(s) in a liquid(s) or
Suspension of a solid(s) in a liquid.
 It can be a liquid like a volatile oil
composition E.g. Vegetable oils like arachis
oil or aromatic or aliphatic hydrocarbons,
ethers, esters, or alcohols.
 Solids that are not Sufficiently soluble in
liquids or in combination of liquids are
capsulated as Suspension. Suspending
agents used are Lecithin, Soyabean oil,
yellow wax

and uniformity1. gel ribbon thickness
across the ribbon
2. seal thickness
3. weight of capsule fill and its variation
from capsule to capsule
4. weight of capsule shell and its variation
from capsule to capsule
5. moisture level of the capsule shell
before and after drying

1. Permeability and sealing
2. potency and impurity content
3. average weight and weight variation
4. uniformity of content
5. disintegration
6. dissolution
7. moisture content
8. microbial content

 Drug present in these capsules may be suspension,
solution or emulsion
 Ingredients that are solid at room temperature can
also be encapsulated in softgels if they are at least
semisolids below 45degree.
 The softgels can be coated with enteric resistant or
delayed release coating material.

 Pharmaceutical Dosage Forms and Drug
Delivery, Second Edition By Ram I. Mahato
 http://www.pharmacopeia.cn/v29240/usp29
nf24s0_c711.html
 http://www.authorstream.com/Presentation/aSG
uest89715-887369-soft-gelatin-capsules/
 http://www.slideshare.net/Ramyapriya7/quality-
control-of-capsules

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