Capsule Gp A

1. PRESENTED BY;
Umer tanveer. Roll No R-47 CMS 11-2019
Izhan Siddiqui. Roll No R-56 CMS 119-2019
Syed Bilal Hussain. Roll No R-89 CMS 38-2019
Zumair Ali. Roll No R-91 CMS 115-2019
Abdul hannan. Roll No. R-01 CMS 102-2019
TOPIC : PHARMACEUTICAL CAPSULES DOSAGE FORM

2. Introduction
• What is capsule?
Capsules are solid dosage forms in which drug and/or inert substances are enclosed in a
gelatin shell. The gelatin shell may be hard or soft depending on their composition. The
word capsule is derived from the Latin word capsula, meaning a small box. The shells may
be composed of two pieces, a body and a cap, or they may be composed of a single piece.
Two piece capsules are commonly referred to as hard-shell capsules, and one-piece
capsules are often referred to as soft-shell capsules.
advantages of capsules:
• They are slippery when moist and hence, easy to swallow with a draught of water.
• The shells are physiologically inert and easily and quickly digested in the GIT.
• The shells can be opacified with Tio2(titanium dioxide) or coloured to give protection
from light.
Disadvantages of capsules:
• Efflorescent cause capsules to soften & deliquescent may dry the capsule shell to
brittleness.
• Capsule are not suitable for liquids that dissolve gelatin. Such as aqueous or
hydroalcoholic solution.

3. Hard gelatin capsules
• Hard gelatin capsules also known as hard-shell gelatin capsules or two-piece capsules are solid dosage
forms in which one or more medicinal agents or inert materials are enclosed within a small shell.
• A hard gelatin capsule shell consists of two prefabricated, cylindrical sections a cap and a body each of
which has one rounded, closed-end and one open end. The body has a slightly lower diameter than the
cap and fits inside the cap.
Components:
Hard gelatin capsule shell is composed largely of gelatin. Other than gelatin, it may contain materials such as
plasticizer, colourants, opacifying agents, and preservatives which either enable capsule formation or
improve their performance. Hard gelatin capsules also contain 12–16% water, but the water content can vary,
depending on the storage conditions.

4. size and shape:
Empty hard gelatin capsule shells come in a variety of sizes
ranging from an arbitrary numbering of 000 to 5 with 000 being
the largest size and 5 being the smallest.

5. Manufacturing of hard shell capsules:
Hard gelatin capsules are manufactured using a dip-coating method and the various
stages involved are as follows:
• Step 1: Preparation of the gelatin solution (dipping solution)
• Step 2: Dip-coating the gelatin solution on to metal pins (moulds)
• Step 3: Rotation of the Dip-coated pins
• Step 4: Drying of the gelatin-coated pins
• Step 5: Stripping and trimming
• Step 6: Joining of the trimmed capsule shell
• Step 7: Printing

6. Filling of capsules
The basic steps in filling hard gelatin capsules include:
1. Rectification of capsules (placing empty gelatin capsules on the removable plate
with bodies facing downward).
2. Separation of caps from bodies.
3. Dosing of fill material (The body is filled with the formulation manually using a
plastic spatula, and the excess powder is removed).
4. Replacement of caps/ closing capsule shells and
5. Ejection of filled capsules

8. SOFT GELATIN CAPSULES
1. Soft gelatin capsules are made of gelatin to which glycerin or a
polyhydric alcohol such as sorbitol has been added.
2. Soft gelatin capsules, which contain more moisture than hard
capsules, may have a preservative, such as methylparaben and/or
propylparaben, to retard microbial growth.
3. Soft gelatin capsules may be oblong, oval, or round. They may be
single colored or two-toned and may be imprinted with identifying markings.
4. As with hard gelatin capsules, they may be prepared with opaquants
to reduce transparency and render characteristic features to the capsule shell.

9. MANUFACTURING OF SOFT GELATIN CAPSULES :
PLATE PROCESS
1. Place the gelatin sheet over a die plate containing numerous die
pockets.
2. Application of vacuum to draw the sheet in to the die pockets
3. Fill the pockets with liquid or paste.
4. Place another gelatin sheet over the filled pockets
5. Sandwich under a die press where the capsules are formed and
cut out.

10. ROTARY DIE PROCESS:
1. 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
other Hooper.
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.

11. 5. At this stage the measured quantity of the medicament is filled in
to it with the stroke of a pump with the subsequent movement of the
dies the other half capsule is formed.
6. The two halves' of the capsules are sealed together by the heat &
pressure of the rotating dies.
7. As the die rolls rotate, the convergence of the matching die pockets
seals and cuts out
the filled capsules.

12. USE OF SOFT GELATIN CAPSULES
Soft gelatin capsules are prepared to contain a variety of liquid, paste, and
dry fi lls. Liquids that may be encapsulated into soft gelatin capsules include the
following.
1. Water-immiscible volatile and nonvolatile liquids such as vegetable and
aromatic oils, aromatic and aliphatic hydrocarbons, chlorinated hydrocarbons,
ethers, esters, alcohols, and organic acids.
2. Water-miscible nonvolatile liquids, such as polyethylene glycols, and
nonionic surface active agents, such as polysorbate 80.
3. Water-miscible and relatively nonvolatile compounds such as propylene
glycol and isopropyl alcohol, depending on factors such as concentration used and
packaging conditions.

18. INSPECTION OF CAPSULES:
In order to ensure optimal appearance quality, capsules are inspected for a broad
spectrum of defects, including deformation, cracks, burrs, presence of foreign particl
and discoloration. One of the method for inspection is The Seidenader ATI which is
automatic machine. It inspects the surface of plain or coated tablets, the ACI to inspe
hard gelatin capsules, throughout the rate up to 3000 units/min depending on the
product.
During the inspection process, the
good capsule is compared with others
and termed rejected if they are;
. Undersize, oversize, de shaped
capsules, opaque, leaked, joint, air
bubble in gelatin shell, different color
shades.

19. COUNTING OF CAPSULES:
The method for counting and dispensing the capsules or tablets depends on simple
vibrating, sloped and concave shaped (V-shaped) trough, having a number of
descending steps. The vibration of trough is adjusted and controlled by a
microprocessor. The vibration in the trough, is patterned to provide a great vibratory
amplitude. The microprocessor electronically adjust the input vibration to the
trough, such that the flow of materials is adjusted for different type of materials.
This causes the capsules to align in accurately within the trough.

20. PACKAGING OF CAPSULES:
Drug packaging can be broadly classified into four categories – primary,
secondary, tertiary and quaternary packaging. Primary packaging is a
material that envelops the product, impart barrier from immediate
environment to protect its activity and holds it. Secondary packaging is
outside the primary packaging that group primary packs together.
Tertiary packaging is used for bulk storage and transportation, whereas
quaternary packaging utilizes huge containers for shipment to another
territory or port. Polyvinyl chloride is the most common used
packaging material due to its low cost, flexibility and ease of
thermoforming. Other than this, aluminum, cyclic olefin copolymers,
cellulose polymers are also used.

21. Blister packaging is most common and widely accepted world-
over as primary pack of tablets or capsules due to its efficacy
and safety considerations. Alternative to blister packs is strip
packaging or glass vial with a sealed cap. Blister packs are
convenient and cost effective as they offer optimization of dose
and manufacturing process thereby utilizing resources
effectively. It is useful for protecting drugs against external
factors, such as humidity and microbial contamination for
extended period of time as well as offers a degree of
mechanical resistance from physical tampering.

22. STORAGE OF CAPSULES:
Correct storage and packaging are important to achieve maximum product
shelf life and achieve target quality levels. A capsule is a very sensitive
product and it must be protected against excessive heat and humidity. For
storage a temperature between 15 to 25C and a relative humidity between
35 to 65% is to be maintained. At a very low humidity, capsule loses
moisture and becomes brittle. At a very high humidity, it becomes flaccid
and loses shape. For hard gelatin capsule a relative humidity of 45-55%
should be maintained to maintain the 12-16% of the moisture content of
capsule.