Ophthalmic dosage are the preparation designed for application to the eye:- For treatment For symptomatic release of symptoms For diagnostic purpose As aid to surgical procedures They are the sterile products meant to instillation in to the eye in the space between eye lid and the eye ball They are also prepared as parenteral product. Example Eye drops, Eye lotion, Eye ointment, Eye suspension, Contact lens solution

1. Prepared by:
Ibrahim Mussa
CT University, India
ibramussa1994@gmail.com

2. CONTENTS
1. Introduction
2. Formulation consideration
3. Eye drop
4. Eye ointment
5. Eye lotion
6. Method of preparation
7. Labeling
8. Container

3. INTRODUCTION
Ophthalmic dosage are the preparation designed for application to the
eye:-
 For treatment
 For symptomatic release of symptoms
 For diagnostic purpose
 As aid to surgical procedures
They are the sterile products meant to instillation in to the eye in the
space between eye lid and the eye ball
They are also prepared as parenteral product. Example
Eye drops, Eye lotion, Eye ointment, Eye suspension, Contact lens
solution

4. Types of ophthalmic products
Liquid preparation,
For application to the surface of the eye. Example ,eye drop
and eye lotion
Semi solid preparation,
Introduced to the margin of eye lid or conjunctival sac.
example are eye ointment and cream and gel
Solid preparation
such as Ocular insert intended to be placed in contact with
the surface of the eye to produce prolong effect

5. Formulation consideration.
The preparation of ophthalmic should consider
the following properties:-
1.Foreign particles
2.Viscosity
3.Tonicity
4.pH of preparation
5.Sterility
6.Surface activity

6. Foreign particles
All the ophthalmic products should be clear and free from
foreign particles, fibers and filaments.
Ophthalmic solutions should be clarified very carefully by
passing through bacteria proof filters such as
membrane filters, sintered glass filters.
The particle size of the eye suspension should be in an
ultrafine state of subdivision to minimize irritation. A
separate filter should be used for different ophthalmic
products in order to avoid the contamination.

7. Viscosity
In order to prolong the contact time of the drug in the eye, various
thickening agents are added in the ophthalmic preparations.
Polyvinyl alcohol (1-4%), polyethylene glycol, methylcellulose,
carboxymethyl cellulose are some of the commonly used thickening
agents. These agents improve the viscosity of the preparation.
An ideal thickening agent should possess the following properties:
1) it should be easy to filter
2) It should be easy to sterilize.
3) It should be compatible with other ingredients.
Thickening agents are not included drops and eye lotions which are
required to be used during or after surgery due to some possible
adverse effects on the interior of the eye.

8. Sterility
Ophthalmic preparations must be sterile when prepared.
Pseudomonas aeroginosa is very common gram-ve bacteria which is
generally
found to be present in ophthalmic products. It may cause serious
infections of cornea. It can cause complete loss of eye sight in 24-48hrs
To maintain sterility in multi dose container, containing ophthalmic
products, a suitable preservative is added, The preservative should be
 non-toxic,
 non-irritant
 should be compatible with medicaments.

9. The ophthalmic products are generally
sterilized by autoclaving, filtration through
bacteria proof filters and addition of
bactericides at low temperature

10. Tonicity
 Ophthalmic products should be isotonic with
lachrymal secretions to avoid discomfort and
irritation.
It has been observed that eye can tolerate a
range of tonicity from 0.5-2% NaCI.
There are certain isotonic vehicles which are used
to prepare ophthalmic products like 1.9% boric
acid, sodium acid phosphate buffer.

11. Surface activity
Vehicles used in ophthalmic preparations must have good wetting
ability to penetrate cornea and other tissues. Certain surfactants or
wetting agents added which are found to be suitable for ophthalmic
products .
It should not cause any damage to the tissue of eye.
Benzalkonium chloride, polysorbate 20, polysoabate80, dioctyl
sodium sulpho succinate etc., are some of the surfactants which are
commonly used.

12. pH of the preparations
pH plays an important role in therapeutic activity,
solubility, stability and comfort to the patient. Tears
have a pH of about 7.4
Eye can tolerate solution having wide range of pH
provided they are not strongly buffered, since the tear
will rapidly restore the normal pH value of the eye.

13. Are sterile aqueous or suspension of drugs
that are instilled into the eyes with the help of
dropper

14. FORMULATION
1. Drug
2. Preservative
3. Sterilization
4. Isotonicity
5. Buffer
6. Viscosity
7. Container
8. label

15. 1)Drug
These contains drug of various categories including antiseptic,
anti-inflammatory agent, mydriatric or meiotic properties.
2) Preservative
Eye drop should be sterile and should contain preservatives to
avoid microbial contamination when the container is open. The
preservative for ophthalmic use includes Benzalkonium chloride,
Chlorbutanol , Phenyl mercuric acetate, Phenyl mercuric nitrate
3) Sterilization
Eye drops are sterilized by autoclaving at 121°C for 15 minutes or
by bacteria filter to avoid thermal degradation; for example-
Preservative chlorbutanaol hydrolyzes at high temperature.

16. 4) Isotonicity
All the solutes including drug contribute to the osmotic pressure
of the eye drop, therefore isotonicity of the formula should be
calculated and it is adjusted with sodium chloride, for example-
Sodium chloride 0.9% and boric acid 1.9% are iso-osmotic
5) Buffer
The buffer should be added to maintain solubility, stability and
activity of drug. For example-, the hydrolyzed chlorbutanol forms
hydrochloride acid making the drop acidic, whereas certain drug
like pilocarpine hydrochloride are acidic.. Boric acid, monobasic
sodium phosphate are the common buffers for eye drop.

17. 6) Viscosity
The size of drop and its residences in eye depends on viscosity of
eye drops. Methylcellulose, hydroxypropyl methylcellulose and
polyvinyl alcohol are common viscosity enhancer
7) Container
The commonly used container for ophthalmic solutions or
suspension is multi-dose container (5ml, 10ml). Glass container is
supplied with sterile plastic dropper. Plastic bottles are with built-
up nozzle.
8) Label
Not for injection. For external use only . Shake well before use
(if it is suspension)

18. The eye drops are prepared in 4 stages.
1)Preparation of bactericidal and fungicidal vehicle:
The aqueous or oily vehicle is used in preparation of eye drops.
The aqueous vehicle may support bacterial or fungal growth,
so one of the following bactericide may be used to prepare the
eye drops,
I. Phenyl mercuric nitrate/ acetate 002%
II. Benzalkonium chloride 0.01%
III. Chlorhexidine acetate-0.01%

19. 2) Preparation of solution of medicaments and adjuvant:
The medicaments are dissolved in the aqueous vehicle
containing suitable anti microbial agent. The adjuvants are
also dissolved in the vehicle at a stage to form a stable
preparation.
3) Clarification:
The eye drops are clarified by passing the solutions through
membrane filter having pore size of 0.8µm. The clarified
solution is immediately transferred in to final containers
and sealed to exclude microorganisms.
4) Sterilization :
the eye drops are sterilized by autoclaving or heating with
bactericide at 98° to 100cfor 30 mins . or filtration through
bacteria proof filter

20. Eye lotion are the sterile aqueous solutions used for
washing of the eyes. The eye lotions are supplied in
concentrated form and are required to be diluted with
warm water immediately before use. They are usually
applied with a clean eye-bath or sterilized fabric
dressing and a large volume of solutions is allowed to
flow quickly over the eye.

21. Cont……
lotions should be isotonic and free from
foreign particles to avoid irritation to the eye.
They are required to be prepared fresh and
should not be stored for more than two days
as the lotion may get contaminated include
sodium chloride, sodium bicarbonate, boric
acid, borax or zinc sulphate

22.  Eye lotions are simple solution.
 They are iso-osmotic with tears because they cause much greater dilution
of the lachrymal fluid and hence are more likely to cause discomfort if not
adjusted.
 The eye lotion should be sterile because the large volume is used to
irritation from the eye.
 While removing the irritation from the eye, it become more susceptible to
infection.
 The eye lotions are sterilized by autoclaving or by passing through bacteria
proof filters.
 Sodium chloride eye lotion and sodium bicarbonate eye lotion are
commonly used to remove foreign substance from the eye.

23. EXAMPLE:-
To prepare and submit ml of sodium chloride eye lotion B.P.C
Rx
Sodium chloride 9gm
Purified water to produce 1000m
Method:
 Dissolve sodium chloride in purified water and made the final volume by adding
more of purified water.
 Filter through sintered glass filter grade 4.
 The eye lotion is transfer to the bottle.
 Close and sealed the bottle sterilize it by autoclaving.

24. Eye ointments are sterile preparation meant
for application to the eye.
These are prepared under aseptic conditions
and packed in sterile collapsible tubes which
keep the preparation sterile until whole of it is
consumed.

25. How to Use Eye Ointments and Gels
Properly?
25

26.  The ointment based for an eye-ointment must be no-irritating to
the eye.
 The eye ointment base should melt near to the body temperature,
so as to permit the diffusion of the drug through the lachrymal
secretions of the eye.
 For the preparation of eye-ointment the following base is used:-
Yellow soft paraffin Liquid 80g
Paraffin 10g
Wool fat 10g

27.  Melt wool fat, soft paraffin on a water bath.
 Add liquid paraffin.
 Filter through coarse filter placed in heated funnel.
 It is sterilized by dry heat method (160°C for 2 hours).
 Incorporate the medicament with the eye ointment
base. Pack in sterile containers.

29. Evaluation is test of finish Parenteral product
are free from of micro-organism or not.
Evaluation of the ophthalmic product is done
by following tests
1. Sterility Test
2. Clarity Test
3. Leaker Test
4. Metal particles in ophthalmic ointment

30. 1. STERILITY TEST:
Two basic methods for sterility testing:
1.Direct Inoculation Method:
It involves the direct introduction of product test samples into the culture
media.
2. Membrane filtration Method:
Involves filtering test sample through membrane filter, washing the filter
with fluid to remove inhibitory property and transferring the membrane
aseptically to appropriate culture media. Detection of contamination used
to two culture media:-
A) Soybean-casein digest medium:- Incubated at 20 to 25C
B) fluid thioglycollate medium:- Incubated at 30 to 35°Con 7 Days

31. 2. CLARITY TEST:
Ophthalmic Solution by definition contain no undissolved
ingredients and are essentially free from foreign particles.
Visual Inspection:
Under a good light, baffled against reflection into the eye
and viewed against a black and white background with
contest set in motion with swilling action.
Instrumental method:
It is utilizing the principle of light Scattering, light
absorption and electrical resistance to obtain particle count
and size distribution - destruction of product units-only for
quality control testing

32. 3. LEAKER TEST: (defect)
1. Select 10 tubes of the ointment with seals applied when specified.
2. Thoroughly clean and dry the exterior surfaces of each tube with an
absorbent cloth.
3. Place the tubes in horizontal position on a sheet of absorbent paper in
an oven maintained at temperature of 60 for 8 hours.
4. No significant leakage occurs during or at the completion of the test.
1. If leakage is observed from one, but more than one of the tubes repeat
the test with 20 additional tubes of the ointment.
1. The requirement is met if no leakage is observed from the first 10 tubes
tested or if leakage is observed from not more than one of 30 tubes
tested

33. 4. METAL PARTICLES IN OPTHALMIC
OINTMENT
1. Extrude as completely as practicable the content of 10 tubes
individually into separate, clear, flat-bottom, 60-mm petri dishes
that are free from scratches.
2. Cover the dishes and heat at 85°c for 2 hours, increasing the
temperature slightly if necessary to ensure that a fully fluid sate is
obtained.
3. Taking precautions against disturbing the melted sample, allow
each to cool to room temperature and to solidify.
4. Remove the covers and invert each petri dish on the stage of
suitable microscope adjusted to furnish 30 times magnification
and equipped with an eye pieces micrometer disk that has been
calibrated at the magnification being used.

34. 5. Examine the entire bottom of the petri dish for metal particles.
6. Count the number of metal particles that are 50um on larger in
any dimension.
7. The requirements are met if the total number of such particles in
all 10 tubes does not exceed 50 and if not more than 1 tube is
found to contain more than 8 such particles. If these results are
not obtained, repeat the test on 20 additional tubes.
8. The requirements are met if the total number of metal particles
that are 50um on larger in any dimension does not exceed 150 in
all 30 tubes tested and if not mote than 3 of the tubes are found
to contain more than 8 such particles each.

36. CONTAINERS USED IN OPHTHALMIC
PRODUCTS
Currently almost all commercially available
ophthalmic products are packaged in plastic
containers.
advantages
ease of use,
less spillage,
little breakage-
have led to universal acceptance of these plastic
packaging components,

37. The plastic bottles for packaging of ophthalmic
products are generally made of Low Density
Polyethylene(LDPE), either with or without
any colorants or with opacifying agents.
Polypropylene(PP) or high density
polyethylene(HDPE) are also used to meet
specific product requirements.

38. Eye drops (Single- dose containers):
Plastic bottles(LDPE) are widely used.
Eye drops(Multiple- dose containers):
Traditionally, glass bottles with rubber teat dropper were
widely used. Now- a-days, plastic bottles(LDPE) are widely
used.
Eye ointments:
Flexible plastic or collapsible metal tubes are used.
Caps or closures
are generally made from Polypropylene(PP) and basically
seal the container to prevent contamination or leakage of
the product.

39. Glass container
• Neutral, Boro-silicate type glass(Type 1 glass) were
widely used as a container for ophthalmic preparations,
Plastic container
• Thermoplastic polymers have been established as
packaging materials for sterile preparations such as
large-volume parenterals, ophthalmic solutions and
increasingly, small-volume parenterals.
Ampoules
• A parenteral product container made entirely of glass
and intended for single use.

40. Vials
A glass or plastic container closed with a
rubber stopper and sealed with an aluminum
crimp.

42. LABEL SHOULD CONTAIN
THE FOLLOWING
1. The name of the pharmaceutical product.
2. The name(s) of the active ingredient(s).
3. The concentration of the active ingredients and the amount
or the volume of preparation in the container.
4. The batch number assigned by the manufacturer.
5. The expiry date, the utilization period, and, when required,
the date of manufacture.
6. Any special storage conditions or handling precautions that
may be necessary.
7. If applicable, the period of use after opening the container.