Capsule

Presented by
Heristiana Pratiwi
P130929

 Kapsul dapat didefinisiakn sebagai bentuk sediaan padat,

dimana satu macam obat atau lebih dan atau bahan innert
lainnya yang dimasukkan ke dalam cangkang atau wadah
kecil yang umumnya dibuat dari gelatin yang sesuai
(Howard C. Ansel, Pengantar Bentuk Sediaan Farmasi)
The European Pharmacopoeia (Eur. Ph.) describes capsules
as follows: 'Capsules are solid preparations with hard or soft
shells of various shapes and capacities, usually containing a
single dose of active ingredient.
Ada dua bentuk :
Hard Gelatin Capsule (HGC)
Soft Gelatin Capsule (SGC)

Kapsul

 The hard capsule is also called two piece as it consists

of two pieces in the form of small cylinders closed at one
end, the shorter piece is called the cap which fits over
the open end of the longer piece, called the body.
Composition of HGC :
Gelatin : the major component of the capsules and has been the
material from which they have traditionally been made.
Colorant : Color is used principally to identify a product in all
stages of its manufacture and use.
Wetting Agent : Sodium Lauryl sulfate.
Preservatives : sodium bisulfite or metabisulfite, sorbic acid or
the methyl propyl esters of para hydroxy-benzoic acid, and the
organic acids, benzoic and propanoic acids.

Hard Gelatin Capsule (HGC)

 Content : Gelatin and Hydroxypropyl methyl cellulose (alternative),

colorant (water soluble dyes or insoluble pigment), Preservatives
(sodium bisulfite, sodium metabisulfite, benzoic acid, sorbic acid),
Surfactant (sodium lauryl sulfate)
Properties : a significant amount of water that acts as a plasticizer for
the gelatin film and is essential for their function. The standard
moisture content is between 13 % w/w and 16 % w/w.
Capsules are readily soluble in water at 37 C. The most Pharmacopoeia
have set a limit of 37C 1C for the media for carrying out
disintegration test.
Types of materials for filling into hard gelatin capsules:
Dry solids powders, pellets, granules or tablets
Semisolids suspensions or pastes
Liquids non-aqueous liquids

Hard Gelatin Capsule (HGC)

Hard Gelatin Capsule

Hard Gelatin Capsule

Hard Gelatin Capsule

Hard Gelatin Capsule

Advantages and Disadvantages
Advantages :
Capsules mask the taste and odor of unpleasant drugs and can be easily administered.
They are attractive in appearance
They are slippery when moist and, hence, easy to swallow with a draught of water.
As compared to tablets less adjuncts are required.
The shells are physiologically inert and easily and quickly digested in the
gastrointestinal tract.
They are economical
They are easy to handle and carry.
The shells can be opacified (with titanium dioxide) or colored, to give protection from
light.
Disadvantages :
The drugs which are hygroscopic absorb water from the capsule shell making it
brittle and hence are not suitable for filling into capsules.
The concentrated solutions which require previous dilution are unsuitable for capsules
because if administered as such lead to irritation of stomach.

 A soft gel (a soft gelatin capsule) is a solid capsule (outer shell)

surrounding a liquid or semisolid center (inner fill). An active
ingredient can be incorporated into the outer shell, the inner fill,
or both.
Gelatin soft capsules are made from gelatin and water but with
the addition of a polyhydic alcohol, such as glycerol or sorbitol,
to make them flexible. Sorbitol is less hygroscopic than glycerol.
They usually contain a preservative, such as beta-naphthol.
Shapes of soft gelatin capsules :
Spherical 0.05 -5 ml
Ovoid 0.05 - 7 ml
Cylindrical 0.15- 25 ml
Tubes 0.5 - 0 ml
Pear shaped 0.3 - 5ml

Soft Gelatin Capsule

Soft Gelatin Capsule

Advantages and Disadvantages
Advantages of soft gel capsules:

Ease of use - easy to swallow, no taste, unit dose delivery, temper proof.

Versatile, Accommodates a wide variety of compounds filled as a semisolid,

liquid, gel or paste.

Wide variety of colors, shapes and sizes

Immediate or delayed drug delivery-can be used to improve bioavailability by
delivering drug in solution or other absorption enhancing media.
Disadvantages of soft gel capsules:

Requires special manufacturing equipment

Stability concerns with highly water soluble compounds, and compounds

susceptible to hydrolysis

Limited choices of excipients/carriers compatible with the gelatin

CAPSULE FILLING MACHINE FOR

LIQUID AND SEMISOLID

Capsule Filling Machine

for Liquid and Semisolid
RnD Scale : FLUIDOCAP 1000 : A semi-automatic machine
for liquid filling and band sealing. With an ouput of up to 1,000
capsules per hour.
Pilot Scale : ACCURA : Capable of measuring weight of each
capsule pre and post filling, speeds of upto 40,000 capsules per
hour, versatile weighing capability of any size and fill.
Production Scale: fully-automatic capsule-filling machines that
can fill a large variety of liquid and semi-solid formulations into
two-piece hard capsules.
FLUIDOCAP FILLING (F20, F40, F70)
FLUIDOCAP SEALING (S40, S70)

Capsule Filling Machine for Liquid and Semisolid

RnD Scale

Pilot Scale

Production Scale

FLUIDOCAP FILLING
With speeds up to 70,000 capsules per hour, the Fluidocap
Sealing technology offers a solution to prevent oozing of
liquid, avoid cross contamination, increase shelf life, and
effectively tamper-proof the capsule, along with robust
stability.
The Fluidocap seals the liquid filled capsules by applying a band
of gelatin at the joint of cap and body of the capsule in one
automatic operation.
Quick drying time (approximately 7 minutes)
Capsules coming out of exit chute are ready for packing with
minimal inspection
Can be used to band capsules filled with liquids, powders,
pellets, tablets and softgels
Can be integrated withAccura - 100% capsules checkweigher

FLUIDOCAP F70
Empty
Capsule
Hopper

Stations

Funnel

Homogenize
r

Pannel
Screen
Bulk Hopper

Filled
capsule
output
Capsule
rejectio
n
output

A technological breakthrough for liquid-filling in hard capsules.

Fluidocap technology is ideal for liquid and paste formulations including
hot melts and suspensions.
Fluidocap Filling machines are easy-to-operate liquid-filling equipment
that enables the filling of two-piece hard capsules with formulations
ranging in viscosity from 10 cps to 80,000 cps depending on formulation
characteristics.
Fluidocap is also capable of filling liquids in combination with pellets,
tablets and even a capsule with liquid combination into hard capsules.
With speeds up to 70,000 capsules per hour, the Fluidocap meets all
international safety and regulatory standards.
Customizations for hot melts, air sensitive products, combination
products and other innovative dosage forms are available.

FLUIDOCAP SEALING

FLUIDOCAP S70