Experiment 10

and submit 15ml eye drops.

im: To Prepare
Theory:
cu ss1

Opthalmic preparations
are sterile products, essentially free from foreign particles, suitably
to the eye lids or
formulated and packaged in suitable container for either topical application
between the andEye drops
lids. are sterile aqueous
instillation into the cu-de-sac eyeball eye
or suspension of one or more medicaments intended for
installation into the
or oily solutions
are less used but may
nevertheless
conjunctival sac for therapeutic purpose. Oily eye drops
in a drug, sterile form to be
occasionally be requested. Certain eye drops may be supplied label
use. In such cases the
reconstituted in an appropriate sterile liquid immediately before
and should include direction for
should state clearly on the container 'Powder for eye drop'
suitable antimicrobial preservatives at the
the use of eye drops. Aqueous eye drops contain
intended for use on more than one occasion. The
appropriate concentrations because it is
antimicrobial preservatives should be compatible with
the other ingredients of the
the shelf life of the eye drops. Eyes
preparation and should remain effective throughout
them and are only lubricating and tear-
drops sometimes do not have medications in
forms are solutions,
replacing solutions. The most commonly employed ophthalmic dosage
forms for ophthalmic drug delivery are: gels,
suspensions and ointments. The newest dosage
intravitreal injections and implants.
gel-forming solutions, ocular inserts,
Synonym: Oculum guttae
Structure:

CH

HSO4 H20
OC-ÇH-
CH2OH

dnples of eye drops: Zinc sulphate eye drop, Framycetin eye drop, Pilocarpine eye drop,
Silver nitrate eye
drop,

73
 74 P PRACTICAL (INDUSTRIAL

Formula:
RMACYA
PHARMACY
Table10.1: Formulation of eye drops
Ingredients Qty given Qty taken
Atropine sulphate 300mg
Sodium chloride
234mg
Sterile purified water
30ml

Apparatus: Beaker, glass stirring road, measuring

cylinder, autoclave, spatula.
Procedure:
1. Weigh and measure all the
required ingredients of
Separately.
eye drop properly and keep them
2 Take 50ml beaker and dissolve
sodium chloride in sterile
3 Add atropine sulphate and dissolve it by continuous purified water.
4 The eye drop is clarified shaking.
5.
by passing through membrane filter.
Sterilize the product by
autoclaving at 121C for 30 minutes.
Packing: 15ml plastic dropper bottles.
Bose:
1.
Usually 1 drop once, twice or three times day. a
Refraction: 1 drop twice a
day for 1-3 days prior to refraction depending on loca
practice.
3 Occlusion: 1 drop day, for a limited period only
once a

Storage: Store below 25°C. Protect from light.

Category: Eye drop. (Each 1 ml contains 10 mg
atropine Sulfate (1 %).
ses:
1. To induce mydriasis and cycloplegia.
2 It also acts on the blood vessels of the iris and natural

ciliary body to restore

permeability.

3 Conditions which cause intlammation of the anterior

segment e.g. iridocycn
is and

anterior uveitis.
 PRACTICAL (INDUSTRIALPHARMACY-) 75

Refraction in children.
4.

5. Occlusion (suppression amblyopia)

66. Thrombotic glaucoma.
. Iustruction: For external use only. The preparation is for ocular use and sterile until opened.
Precautions:

To avoid excessive systemic absorption, the lacrimal sac should be compressed by

digital pressure for two to three minutes after instillation.
To avoid inducing angle closure glaucoma, an estimation of the depth of the angle of the

anterior chamber should be made. Administration of atropine in infants requires great

caution.
Do not touch dropper tip to any surface, as this may contaminate the solution.

Shelf life: 2 years unopened

How to uses:

1. Wash hands with soap.

2 Pull lower eyelid down with one hand gently.
3. If dropper is separate, squeeze rubber bulb once while dropper is in the bottle to bring
the liquid into dropper.
4.. Holding dropper above eye, drop medicine inside lower lid while looking up
5 Do not touch dropper to eye or fingers.
6.
6. Lift lower lid and try keep eye open and do not blink for at least 30 seconds.
7. If dropper is separate, replace on bottle and tighten thecap
8.
5. Keep the dropper tip always down and never use drops that have change color.
9. After instillation of drops, do not close eyes tightly and try not to blink more than usual.

ide Effects:
Blurred vision
Conjuctival irritation
Follicular conjunctivitis
Increased intraocular pressure (especially in patients with closed-angle glaucoma).
Increased sensitivity to light
Swelling of eyelids.
 76 PU PRACTICAL (INDUSTRIAL
PHARMA
Contraindications: Atropine eye drops are contraindicated in the
presence of angle
glaucoma where angle closure glaucoma
or is suspected. Hypersensitivity nele dosure
tivity to anvi
any
in atropine eye
drops. ingredient
Warnings:
1. Keep this
preparation out of reach of children. Atropine is very potent, with
can last for up to two weeks. effectsH. tha:
2 For topical ophthalmic use only and not for injection. Excessive
use in Cor
individuals with a previous history of
susceptibility to belladonna alkaloids
produce systemic symptoms of atropine poisoning. nay ma-

3 Patient should be advised not to drive or

engage in other hazardous activities
pupils are dilated. Patient may experience whils
bright illumination during dilation.
to sensitivity light and should protect eves n

bervation:
Table 10.2: Observation of eye drops
Name of Test
Specification Observation
Appearance Clear, colorless
pH 6-8

Clarity test Free from particulate

matters
Sterility test Sterile

VResults: Eye drop is prepared and

submitted.
Experiment 11
Aim: To Prepare and submit 3 tubes each containing 4gm of eye ointment.

Aheory: Cut Cut

much progress, challengin8
The last fifty years, ophthalmic drug delivery research has made
this drug delivery approach. Antibiotics
scientists about the advantages and limitations of
Conventional ocular
used in solution or in ointment for the ophthalmic route.
are popularly
ointments are developed to improve
formulations such as emulsions, suspensions, and
with drops,
precorneal residence time and ocular bioavailability of drugs. Along
solubility,
are the most common way to treat many eye problems. Because they go right intob
ointments
start to work much faster than a medicine taken by mouth. Eye ointments
eyes, they can
warmth makes them melt. Once ointment applied
are drugs in agreasy, semisolid form. Body's
for a while. That's
These hang out between eyeball and eyelid
to eyes, it breaks into tiny drops.
carrier
ointments are another class of
what gives the medicine time to work. Ophthalmic
Ocular ointment of mixture of
comprises
systems developed for topical application. at physiological ocular
semisolid and a hydrocarbon (paraffin) that has a melting point
solid
Ointments
on biocompatibility.
(34°C). The choice of hydrocarbon is dependent
temperature ointment are
ocular bioavailability and sustain the drug release. Opthalmic
help to improve the eyelids,
medicaments on the outside and edges of
used to obtain the effect of a variety of
sterilized ingredients packed under rigid asceptic
conjunctiva, cornea and iris. It contains must
official sterility test. Opthalmic ointment
conditions and meets the requirement of the
substances to prevent growth of or destroy,
contain a suitable substance or mixture of
use. Most
introduced when the container is opened during
microorganisms accidentally
with
opthalmic ointments are prepared with a base of
white petroleum and mineral oil often
anhydrous lanoline.
Synonym: Oculentum
Xamples of eye ointments: Chloramphenicol ointment, Tetracycline ointment,

Hydrocortisone ointment

79
 PU PRACTICAL
80 (INDUSTRIAL PHAR
ACA
Formula:
Table 11.1: Formulation of eye ointment

Ingredients Qty given Qty taken

White soft paraffin 80gm
Wool fat (lanoline)
10gm
Liquid paraffin 10ml

APparatus: Beaker, glass stirring road,

measuring cylinder, water bath, spatula.
Procedure:
1.
Weigh and measure all the required ingredients of ointment
separately. properly and keep them
Add white soft
paraffin and wool fat in a beaker and
ingredients melt at 60Cc. Stir with
keep in a water bath till the
3 Add liquid glass road.
paraffin to the main preparation with continuous
4 Transfer the prepared ointment to
the suitable container stirring
and label it.
Pácking: Aluminium tube with
cap or
polyethylene screw cap and nozzle.
Dose: Apply eye ointment
every three hours or
Storage:
more
frequently as advised by docto
1. Stored below 25°C and
2 Keep this medicine out protect
2.
of the
from light.
3. You are
sight and
advised to dispose reach of children.
of the tube
treatment. once you have finished your 5 day irse o
co
Category: Eye ointment.
Uses:
1 Eye ointment use in acute or long-term
eye problems.
2. Eye infections

3 Inflammatory conditions

4 Soreness, with dry-eye syndrome

 81
Ay PRACTICAL
(INDUSTRIAL PHARMACY-1)
until opened.
nstruction: Forexternal use only. The preparation is
n : For for ocular use and sterile

Precautions:

can cause temporary blurring of vision after application. Wait until your
Eve Ointment
before driving or using machines.
vision is clear
contains wool fat (lanolin). May local skin reactions (for example
2. This product cause

contact dermatitis).

Do not wear contact lenses whilst you are using chloramphenicol eye ointment.
3.
2 unopened
Shelf life: years
How to uses:

1Wash
1 your hands well before you use the eye ointment.

Sit or stand in front of a mirror.

2
Remove the cap from the tube.
3.3.

Tilt your head back a little and pull the lower lid of your eye out to
form a pocket.

5. Hold the tube upside down near to your eye.

thin line of ointment along the inside of
release
Apply enough pressure to the tube to
a
6
do this.
the lower eyelid. Try not to touch your eye as you

and then blink a few times to spread the ointment

7. Close your eye for a moment or two

around the inside of your eye.

8. Your vision may become a little blurred after you eye ointment. If you blink
use an

should clear. Try not to rub

several times after you apply your eye ointment your vision
your eyes.
9 Repeat the process in your other eye if both eyes are affected.
0. When you have finished, remember to replace the cap on the tube in order to prevent
ne ointment from becoming contaminated. Try not to touch the top of the tube.

Side Effects:
Eyediscomfort
Eyelid swelling
Irritation
 Temporary blurred vision
RIAL PHARM
Warnings:
Talk to your doctor or pharmacist betore using eye ointment if

You have visual disturbances

You have severe pain in the eye
You are sensitive to light
Your eye is inflamed and you have a rash on the
Youreye looks cloudy scalp or face
Your black or coloured
part of the eye looks unusual
You have
foreign body in the eye
a

You have
an
eye infection that keeps
Youhave glaucoma (raised pressure incoming back
the eye)
Youhave dry eyes
You have eye
injury or eye surgery
You are
currently using any other eye drops or
eye ointment
9bservation:
Table 11.2: Observation of eye ointment
Test
Specification Observation
Appearance
Pale yellow colour
Leakage test No leakage
pH
6-8

Homogeneity
Homogeneous
and consistent
Texture
Smooth
Spreadability
Easily spreadable

Bésults: Eye ointment is prepared and

submitted.
 Ex'lo
EXperiment 12
Aim: To Prepare 20gm of cold cream.
cut se
Theory:
Creams are
semisolid dosage forms containing one or more drug substances dissolved or
dispersed in a suitablebase. Cold cream has been around for much longer than we assumed.
and
a nd
Its invention
invention is widely credited to century Greek physician
second
Your
nhilosopher Galen. With the arrival of winter season, skin problems gain prominence.
lines of crack develop
skin becomes dry and moisture deprived. It stretches and then faint
red.
cheeks. If proper is not taken, these cracks may further become
over lips and care
Cold
of skin problems during the cold season.
Application of cold cream avoids aggravation because breaking up
cream is water type of emulsion. Cold cream is called cold cream
in oil
effect. Cold
emulsion on application to skin leads to evaporation of water giving cooling
of
action and
used to prevent excessive drying of skin. It has emollient
cream is primarily
bees
key chemical constituent of cold cream is
wax.
skin. The
prevents dehydration of
Cold cream is mainly used for skin treatment (such as a lip balm), due to its
facial mask or

It can also be used to r e m o v e makeup

and as shaving cream. A
moisturizing properties.
of a relatively large amount of water
characteristic feature of true cold creams is the presence
modern
mixture. But, the final product would be unacceptable by
loosely held in w/o in
appearance and reproducibility. Inclusion of borax
standards due to instability, poor
as it reacts with free fatty
acids in beeswax to
formulations produce a m o r e stable product
in formulation is the mineral oil which
form sodium soap. Another important ingredient
Most
the stability and whiteness of final product.
aids in inhibition of rancidity and improve
to the user
in diferent percentage according
cold cream contains these ingredients
function of cleansing creams is to
preference; Borax, beeswax, and mineral oil. The main
consist of four
remove oil soluble and water soluble efficiently. A simple cold cream may
soil

ngredients: white beeswax, mineral oil (light liquid

petrolatum), water and borax. Beeswax
with small quantities of other
consists chiefly of free cerotic acid and myricyl palmitate
Mineral oil is colourless, oily
hgher fatty acids and alcohol, and about 10% of hydrocarbons.
and obtained from petroleum. Borax in
ixture of liquid hydrocarbons insoluble in water
and boric acid. Although, there are
water solution hydrolysesto form sodium hydroxide
sodium
acid from beeswax and the alkali,
ECOndary reactions, the reaction of cerotic
such as almond, violet or rose
arOxide, form a soap, sodium cerotate. Various fragrances
cold c r e a m s often
to cold cream, depending on the application. Modern day
4Ided
and jojoba oils and they will contain additional
Deeswax and olive oil with mineral
in creams and other
Ealents like borax (to whiten) and glycerin (to hydrate). Waxes used
85
 86 FU PRACTICAL (INDUSTRIAL
PHARMAC
cOsmetics include beeswax, carnauba wax, ceresin, ozokerite
japan wax and
thesebeeswax and spermaceti are of animal origin, while ce

ermaceti.
are trom carnauba,
vegetable kingdom. Since this preparation contains candelila and iarn waz
ptible to microbial attack. Hence a cold cream both oil and wa
preparation should
water. It
ld also be
also
adding preservatives be preserve
preserved by
Synonym: Face cream

Formula:

Table 12.1: Formulation of cold cream

Ingredients Quantity given
Liquid paraffin
Quantity taken
50gm
White bees wax
16gm
Borax
0.8gm
Methyl paraben
0.18gm
Propyl paraben
0.02gm
Rose water
q.8.
Purified water
33gm
Apparatus: Beaker, measuring cylinder, glass
spatula. stirring rod, thermometer, water bath,
pipette
Procedure:
1.
.Weigh and measure all the
separately. required ingredients of cold cream properly and keep
2 Add
nea
beeswax, liquid paraffin and
order of propyl paraben in 100ml beaker and melt them
increasing melting point. u
3 Add water in
another beaker and
dissolve methvl paraben and borax Fil it if
required. at 70.
Fue
4. Now, mix the aqueous
phase with oil phase. This is the most and
requires experience
and skill to execute. At
importae
form water in oil 70 C both the
phases are mix ana
o
to
type of emulsion. It is important to stir
aqueous phase to the oily continuously while adag
phase to get stable water in oil emulsion.
Keep stirring till tne
temperature comes down to room temperature.
 FU PRACTICAL (INDUSTRIAL PHARMACY-) 87

5.5. Sufficient quantity of perfume is added before packing the finished product to suitable
wide mouth container while hot. Provide a professional finish.

Packing: In a suitable wide mouth labeled container.

Storage: Store in a cool and dry place in air tight container.

-Category: Cold cream

Uses:
Cold cream can be used to clean and soften the skin.
Traditionally, cold cream used as a gentle makeup remover.
3. It can be used to protected skin from harsh winter weather and to soften tough skin on
areas like knees, elbows and feet.
4 Cold cream can also be used to erase temporary tattoos.
5 Cold creams act as emollient and produce a cooling sensation.

Instruction: For external use only. Not for ophthalmic, oral, or intravaginal use.

Precaution: If any sensitivity, irritation, or an adverse reaction develops, use of cold cream
should be discontinued.

Observation

Table12.2: Observation of cold cream

Name of Test Specification Observation

Appearance White

Odour Rose type

pH 5-8

Homogeneity Homogeneous
and consistent

Texture Smooth

Spreadability Easily spreadable

Emolliency No residue left

Washability washable

Results:Cold cream is prepared and submitted.

 EXperiment
Aim:
Preparation
Theory
13 of
11

20gm of
A
cream is
solid a
vanishing creamn.
creams
and
of preparation
emulsions preparation
usually
usuallyy
which are oil and water. for
a water-in-oil (W/O)
continuous conmposed of smallThey application
divided are
the skin.to

acceptable they oily phase.

as
creams which droplets of oil into two
types: Creams
Creamss
creams are
more
are
are
dispersed
less Oil-in-water composed of small in oil-in-water
a semi
semi-
are
seem to
difficult greasy and more creams continuous
droplets water (O/W)n
disaPpear
applied to skin when to
handle. easily
more
are
of
comfortable water phase,
other face maketo providespread on the Vanishing
creams washed off and dispersed in
their
pearly up.
a
smooth skin. It is also get their name using water. cosmetically
alkali, a sheen. Vanishing emollient
creams also base before known as from
foundation
Water-in-oil
the fact
skin polyol and water. Chemically
they known for their the
application
that
cream whichthey
One protectant which The cream are
oil-in-water smooth, of face
powder
are

characteristic
Rather than due prevents the helps the powder emulsions dry
consisting
feel on the
skin
and
thesedamaging effect caused
to
giving a cakedwhich
to
adhere to the of stearic acid,and
Vanishing Creams look to the vanishing
during the day and the advantage of face, they
has creams by the
skin and
also acts
an

makes it a choice by womnen with being give a

are
natural preferred environmental
is the 'sheen
as

factors.
as
oily
moisture is the key daily cream is the skin. The non-greasy attractive
which makes sheen to theeffect'.
eludes some element of a moisture magical quality of them suitable forskin.
women. It is healthy locking power. As vanishing cream use
constituent of the cream equally skin,
eftective for
the
mystical many women that
sallowness and freckles. is
Four hydroquinone. This
normal and power of vanishing know that
oily skin
vanish all the age perceent chemical types. One
cream still
spots. purpOse ot hydroquinone
is
spots or discolorations The well known important
on the skin.
the applied
vanishing cream is consistently
in
is dispelling
Synonym: Foundation cream, face cream to supposed to
lighten unnecessary dark

90
 (INDUSTRIAL PHARMACY-)
PRACTICAL 91
a

Eormula:
Table 13.1: Formulation of vanishing cream

Ingredients Quantity given Quantity taken

Stearic acid 18gm

Glycerin 3gm
Lanoline 2gm
Triethonalamine 1gm
Methyl paraben 0.18gm
Propylparaben 0.02gm
Rose oil 9.S.

Purified water 75.8ml

Apparatus: Beaker, measuring cylinder, glass stirring rod, thermometer, water bath, pipette
spatula.
Procedure
Weigh all the required ingredients of vanishing cream properly and keep them
separately.
2 Take stearic acid and lanoline in a beaker and melt them at 60°C.
Take another beaker and add glycerin, triethonalamine, water and heat up to 60C.
4. Add the preparation of first beaker in a second beaker drop by drop with continuous

stirring.
After cooling add methyl paraben, propyl paraben, rose oil and mix them thoroughly to
obtain uniform product. Provide a professional finish.
Packing: In a suitable closed collapsible tube is packed and labeled.
torage: Store in well closed container, in cool place. Do not freeze.
ses:
1. It helps to keep the skin moisturized.
2 It is sometimes used as the base for cosmetics and make-up and even just plain
foundation.
3 Vanishing creams are also helpful in keeping the skin afresh.
 92 PUPRACTICAL(INDUSTRIAL PHARMACY
4. Vanishing creams makes the pimples and spots appear less significant or make them

disappear.
mstruction: For external use only. Not for ophthalmic, oral, or intravaginal use.

Rrecaution: If any sensitivity, irritation, or an adverse reaction develops, use of vanishing

cream should be discontinued.

Category: Vanishing cream

General Instructions:

The fragrances in creams may irritate you.

Cream should be applied evenly to prevent clogging of pores.
3. Different creams are used for different weather.
Never apply heavy creams on dry skin as they will not let your skin breath.
5. Over use creams will block the skin pores.

Caution:
not to be used all the time and they do not remove marks of acne
Vanishing creams are

scarring
Observation:
Table 13.2: Observation of vanishing cream

Specification Observation
Name of test

White
Appearance
Rose type
Odour

5-8
pH
Homogeneous, and Consistent
Homogeneity
Texture
Smooth

Easily spreadable
Spreadability

Type of smear Non-greasy

No residue left
Emolliency
Easywashable
Washability
and submitted.
Results: Vanishing cream is prepared