CASTOR OIL

CAPSULE
CASTOR OIL
༝ Castor oil is very pale yellow liquid that is
extracted from castor seeds
༝ It’s one of the best kept secret of nature
༝ This oil is rich in ricin oleic acid, which has a
powerful therapeutic effect.
༝ It is also an excellent anti-oxidant and anti-
inflammatory oil.
༝ It is also known as a stimulant laxative

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CAPSULE
༝ INTRODUCTION
༝ ADVANTAGES
༝ DISADVANTAGES
༝ QUALITY CONTROL OF CAPSULE
a. Physical Test
b. Chemical Test
༝ PACKAGING OF CAPSULES
༝ PHARMACEUTICAL ASPECTS

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 “
Capsule is the most versatile
of all dosage forms. These are
solid dosage form in which
the drug is enclosed in a hard
or soft soluble container,
usually of a form of gelatin.
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ADVANTAGES OF CAPSULES
༝ Capsule mask the taste and odor of unpleasant
drugs and can be easily administered.
༝ They are slippery when moist and hence easy
to swallow with draught of water.
༝ As compared to tablets less adjuncts are
required
༝ the shell are physiologically inert and easily
and quickly digested in the gastrointestinal
tract
༝ They are economical
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DISADVANTAGES OF
CAPSULES

༝ 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.

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Examples of official
capsule
 Quality
Control of
Capsules
produced on a small scale
all or large scale all of
them required to pass
through certain test i.e.,
quality test control to test
the quality of a finished
Quality test control is divided
into
Physical Test Chemical Test
 Disintegration test  Dissolution test
 Weight variation  Assay
 Content uniformity
 Stability testing
 Moisture
permeation test

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Disintegration test
༝ The disintegration of capsules is different
from those of tablets because the
determination of end point is difficult owing
to adhesive nature of shell.
༝ The shell pieces after disintegration may
agglomerate forming large mass of gelatin
taking more time to dissolve and may adhere
to the mesh thus, blocking the holes.
༝ According to USP, place one dosage unit in
each of the tubes of the basket with water or
any other specified medium maintained of 13
Disintegration test
༝ Attach a removable wire cloth with a plain square
weave of 1.8-2.2 mm of mesh aperture and a
wire diameter of 0.60-0.655 mm to the surface of
upper rack of the basket assembly.
༝ Observe the capsule for a time limit (specified in
individual monograph) at the end of prescribe
time, all of the capsule must have been
disintegrated excluding the fragments from the
capsule shell
༝ If 1 or 2 capsule fail, the test should be repeated
on addition of 12 capsules.
༝ then not fewer than 16 of the total 18 capsule 14
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Weight Variation Test
༝ Method
• Weight an intact capsule
• Open the capsules and remove the content
• Weigh the shell
• Determine the weight of filled material (difference
between the weightings)
• This done for all 20 capsules.
• Determine the average fill weight
• Note: not more than 2 of the differences are greater
than 10% of the ave. net content
• No case is the difference greater than 25% wt. 16
Dissolution Test
༝ The dissolution test is carried out using the
dissolution apparatus official in both the U.S.P
and LP
༝ The capsule is placed in a basket and the
basket is immersed in the dissolution medium
and caused to rotate at a specified speed
༝ The dissolution medium is held in a covered
1000 ml glass vessel and maintained at 37°Cby
means of constant temperature suitable water
bath.
༝ The stirrer speed and type of dissolution 17
 Result
༝ Six capsules are tested and are accepted if
each of them is not less than monograph
specified i.e., p +5%
༝ If it fails then additional six capsule are tested
the result is accepted if the ave of 12 capsules
is greater than or equal to p and none of them
is less than p-15%.
༝ If the capsule still fails the test the additional
12 capsules are tested and are accepted if the
ave of 24 is greater than to p, if not more than
2 less than p-15% and none of them is less 18
Content Uniformity
༝ 10 capsules are taken and subjected
to assay
༝ 9 of 10 capsules should be in the
range of 15% (85-115%)
༝ And 10th capsule are beyond + 15%
range then 20 capsules are assayed
༝ All capsules with in range of 25%
(75-125%)

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Moisture Permeation Test
༝ The degree and rate of moisture penetration is
determined by packaging the dosage unit
together with a color revealing desiccant pellet
༝ Expose the packed into unit to know relative
humidity over a specified time
༝ Observe the desiccant pellet for color change
༝ Any change in color indicates absorption of
moisture
༝ By measuring pre test weight and protest weight
of pellet amount can be calculated 20
BLOOM STRENGHT OF GELATIN
RAW MATERIALS-
The gelatin of the capsule shells should be assayed
for varies physical properties like bloom strength,
viscosity etc.

PROCEDURE
gelatin is weighed into water typically create a 6.67% solution
in standard bloom bottles
the mix is then stirred and keep it for 3 hours at room temp
bottles are placed in a 65°C bath for 20 minutes
allow the bloom jars to cool for 15 mins at room temp
they are then conditioned for 16 hrs in 10°C water bath
when conducting gelatin bloom test, the bloom jar is
centered with the probe just above the sample surface
the probe penetrates the gelatin to a target depth of 4mm
at a speed of 0.5mm/s and the retracts
The peak force is the gel strength in grams bloom
Packaging of
capsules
 Packaging and storage of
capsules
Capsules should be packed in a well-closed glass
or plastic containers and stored in a cool place
༝ These type of containers have advantages over
cardboard boxes that they are more convenient to
handle and transport and protect the capsules from
moisture and dust
༝ To prevent the capsule from rattling a tuft of cotton
is placed over and under the capsule in the vials
༝ In vials containing very hygroscopic capsules a
packet- containing desiccant like silica gel or
anhydrous calcium chloride
༝ May be placed to prevent the adsorption of
excessive moisture by the capsules
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༝ Plastic bottle with screw cap (most
popular packaging in USA)
༝ Clam shell blister (one piece plastic that
folds over and locks itself; no heating
required)
༝ Blister pack (heat sealed blister on a
cardboard)
༝ Plastic pail/bucket (economical bulk
package)
༝ Plastic pouch zip locked (for sale via
retail stores or route trucks must be 25
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PHARMACEUTICAL ASPECTS-
essentially capsules are solid dosage
form containing liquid medication
and therefore offer certain
advantages
1. They permit liquid medication to become
easily potable.
2. These capsules easily pass the appropriate
compendial tests and surpass other solid
dosage form, because liquid formulations
can be more accurately precisely
compounded, blended, homogenized and
measured or dispensed then can dry solid 27
3. Dissolution and disintegration
The majority of dugs were more
rapidly and completely available
for dissolution from the soft
gelatin capsule then from the
commercial tablets and capsules
in accordance to dissolution and
disintegration time
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QUESTIONS
 TABLET
༝ A tablet is a compressed
powder in solid form.
༝ Tablets can be cut into two
༝ Tablets are coated with sugar
or similar substances, which
means that the drug
contained in them will not
immediately enter the blood
stream
༝ Tablets are also known to
have more shelf life and also
retain its potential for a
longer period
༝ Tablets are available in
different sizes and shapes.
༝ Tablets are known to be less
expensive
CAPSULE
༝ A capsule consists of
powder or jelly enclosed
in a dissolvable plastic
container
༝ capsules cannot
༝ the drug in the capsule
is known to enter the
blood stream
immediately.
༝ Capsules dont
༝ Capsules have less
potential and do not
come in different
shapes.
༝ Than capsules
༝ capsules are easy to 30
 KINDS OF CAPSULE
capsules

Dry filled Liquid filled

Hard Hard Hard Soft gel

gelatin HPMC capsule capsule

gelatin HPMC
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༝ Hard gelatin capsules. The gelatin used in the manufacture of
most common capsules is obtained from collagenous material by
hydrolysis. Gelatin is a natural, safe, non-allergenic, clean, and
economical ingredient.
༝ HPMC capsules. HPMC capsules are stable at low humidity
levels, have low moisture content (3–8%), and low static charge.
1. HPMC capsules are suitable for highly reactive molecules
(because they have no cross-linking reactions).
2. Compared to hard gelatin, HPMC is more suitable for moisture-
sensitive products, hygroscopic products, and for low relative-
humidity applications.
3. HPMC is not of animal origin and does not pose a risk of
contamination with organisms that cause bovine spongiform
encephalopathy (BSE) or transmissible spongiform encephalopathy
(TSE).
4. HPMC capsules are used in a wide range of OSD pharmaceuticals
as well as nutraceuticals, dietary supplements, and herbal
products, due to the vegetarian nature of HPMC. 
༝ Fish gelatin capsules. Marine caps are made from fish gelatin
and do not pose risk of BSE or TSE. 32
༝ Starch capsules. Starch capsules are made from potato starch. Their
dissolution is pH independent, and they are suitable for enteric coating
༝ Pullulan capsules. These vegetarian capsules are made from tapioca, which is
naturally fermented into pullulan. They provide a high barrier to oxygen.
༝ Polyvinl acetate (PVA) capsules. Capsules made from PVA can be used for
filling insoluble drugs dissolved in polyethylene glycol (PEG) 400. PEG 400 when
used as single vehicle is not compatible with other hard capsules. The oxygen
permeability of PVA is low, resulting in a high barrier to oxygen.
༝ Liquid-filled hard capsules (LFHC). Two-piece hard capsules made of either
gelatin or HPMC can be used for filling and band sealing non-aqueous liquid,
paste, suspension, hot melts, and other vehicles that melt up to 70 °C and flow
easily.
1. LFHC can also be filled with tablets, pellets, or other capsules as combination fill.
2. LFHC can be used for moisture-sensitive drugs.
༝ Soft gelatin capsules (SGC). SGC have soft, globular, gelatin shells somewhat
thicker than that of hard gelatin capsules. The gelation is plasticized by the
addition of glycerin, sorbitol, or a similar polyol. It may contain preservative to
prevent the fungal growth. Large-scale production methods are generally
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required for the preparation of SGC.
 used in manufacturing
capsule
༝ Gelatin is an animal protein used to make capsules, which can
deliver measured amounts of products. The pharmaceutical
quality gelatin used in our two-piece hard-shell gelatin capsules
is obtained through the processing of collagen, a protein
composed of eighteen different amino acids found in the
connective tissues and bones of most animals, including
humans
༝ Our two-piece hard-shell gelatin capsules (powder filled) are
typically made of a combination of beef (bovine) and pork
(porcine) gelatins. By contrast, our softgel (liquid filled) gelatin
capsules are typically derived solely from beef gelatin, not
pork. Bovine sources must be BSE/TSE free. The gelatin is
generally sourced from North America, but in some cases may
also be sourced from Southeast or East Asia (primarily
Thailand, Indonesia, or Japan) or South America (primarily
Colombia ) 34
Different sizes of hand gelatin
capsules and their compounding
capacity

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Thank you!!
GROUP 5
Krizza Mae D. Pascual
Aiza Pundato
Kairah Respicio

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