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

1. OPHTHALMIC
PREPARATIONS
BY
SRIRAM THIRUNAVUKKARASU,
PHARM.D,
PGP COLLEGE OF PHARMACY,
NAMAKKAL

2. 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

3. OPHTHALMIC PREPARATIONS
Liquid preparation
For application to the surface of
the eye. Example: eye drop and
eye lotion.
Semisolid preparation
Introduced to the margin of eye
lid or conjunctival sac.
example : 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
CLASSIFICATION:

4. CONSIDERATION OF OPHTHALMIC PREPARATIONS:
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.

5. 1.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.

6. 2. 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.

7. 3.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.
The ophthalmic products generally are sterilized by autoclaving, filtration through
bacteria proof filters and addition of bactericides at low temperature.

8. 4.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% NaCl.
There are certain isotonic vehicles which are used to prepare ophthalmic products like
1.9% boric acid, sodium acid phosphate buffer.
5.Surface Area:
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, polysoabatc80, dioctyl sodium sulpho
succinate etc., are some of the surfactants which are commonly used.

9. 6.pH of preparation:
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.

10. ANATOMY OF SKIN:

11. 1.Epidermis:
The outermost layer of the skin is called the epidermis. It is primarily composed of
epithelial cells and serves as a protective barrier against pathogens, UV radiation, and
dehydration. The epidermis contains several layers, including the stratum corneum,
stratum granulosum, stratum spinosum, and stratum basale.
2.Dermis:
Beneath the epidermis lies the dermis, a thicker layer consisting of connective tissue,
blood vessels, nerves, and appendages such as hair follicles and sweat glands.
Collagen and elastin fibers in the dermis provide strength, elasticity, and support to the
skin. Blood vessels in the dermis supply nutrients and regulate temperature

12. 3.Hypodermis (Subcutaneous Tissue):
The hypodermis is the deepest layer of the skin and is composed of adipose (fat)
tissue and connective tissue. It serves as insulation, padding, and energy storage. The
hypodermis helps regulate body temperature and provides a cushioning effect.
4.Appendages and Specialized Structures:
Within the skin, various appendages contribute to its functions. Hair follicles are
responsible for hair growth, sebaceous glands produce sebum to lubricate the skin and hair,
and sweat glands regulate body temperature by producing sweat. Nails, derived from
specialized epidermal cells, protect the fingertips.

14. OINTMENTS:
Ointments are homogenous, translucent, viscous semi-solid preparations, most
commonly a greasy, thick oil (oil 80% - water 20%) intended for external application to
the skin or mucous membrane.
They are used as:
- Emollients
- Protective
- Therapeutic
- Prophylactic purpose

15. Classification of ointments:
A- Epidermic ointments:
These ointments are intended to produce their action on the surface of the skin and produce
local effect, they are not absorbed.
They acts as protectives, antiseptics and parasiticides.
B- Endodermic ointments:
These ointments are intended to release the medicaments that penetrate into the skin. They
are partially absorbed and acts as emollients, stimulants and local irritants.
C- Diadermic ointments:
These ointments are intended to release the medicaments that pass through the skin and
produce systemic effects.

16. Preparation of Ointments:
Both on a large and a small scale, ointments are prepared by three general methods:
(1) incorporation method
(2) fusion method
(3) emulsification method
The method for a particular preparation depends primarily upon the nature of the
ingredients
(1) incorporation:
-The components of the ointment are mixed together by various means until a uniform
preparation has been attained.
- On a small scale, the pharmacist may mix the components of an ointment in a mortar
with a pestle, or a spatula and an ointment slab may be used to rub the ingredients together.

17. TRITURATION METHOD:
SIZE REDUCTION
LEVIGATION
MIXING WITH BASE
SPATULATION OR TRITURATION
MIXING BASE TO PRODUCE
FINAL WEIGHT
HOMOGENIZATION
FILLING

18. (2) Fusion method:
• By the fusion method, all or some of the components of an ointment are combined by
being melted together and cooled with constant stirring until congealed.
• Those components not melted are generally added to the congealing mixture as it is
being cooled and stirred.
• Naturally, heat-labile substances and any volatile components are added last when the
temperature of the mixture is low enough not to cause decomposition of volatilization
of the components.

20. (3) Emulsification:
In the preparation of ointments having an emulsion type of formula, the general
method of manufacture involves a melting process as well as an emulsification process.

21. Storage Conditions:
1.Environmental Sensitivity: Ointments are sensitive to environmental factors,
necessitating proper storage for stability.
2.Temperature Control: Store ointments in a cool, dry place to prevent changes in
consistency or degradation of active ingredients.
3.Sunlight Avoidance: Keep ointments away from direct sunlight, as exposure can impact
their composition.
4.Extreme Temperature Caution: Avoid storing ointments in areas with extreme
temperatures, as this can compromise their effectiveness.
5.Product-Specific Instructions: Some ointments may require refrigeration; always
follow specific storage instructions provided by the product.

22. Container Material and Design:
1.Non-reactive Materials: Use containers made of materials that do not react with the
ointment's components to maintain its integrity.
2.Glass or Plastic: Opt for glass or plastic containers with tight-sealing lids to prevent
contamination and ensure product longevity.
3.Dispensing Convenience: Choose a container design that facilitates easy dispensing,
promoting user convenience.
4.Labeling Importance: Ensure that the container is appropriately labeled with crucial
information to aid identification and proper usage.
5.Manufacturer's Instructions: Adhere to any additional recommendations from the
manufacturer regarding the container material and design for specific ointments.

23. Labeling Requirements:
•Accurate and comprehensive labeling is essential for ointments. The label should
include the following information:
• Name of the Ointment: Clearly state the name of the ointment for
identification.
• Active Ingredients: List all active components and their concentrations.
• Instructions for Use: Provide clear directions on how to apply the ointment.
• Storage Conditions: Specify temperature and humidity requirements.
• Expiry Date: Clearly indicate the expiration date for ensuring efficacy and
safety.
• Manufacturer Information: Include the name and contact details of the
manufacturer.

25. JELLIES
INTRODUCTION:
• Jellies are transparent or translucent non-greasy semisolid dosage form.
• They are less greasy compare with gel.
• They are mainly used for mucous lubricating, antiseptic purpose. membrane for
• Jellies are also used for lubricating surgical gloves, catheters & rectal thermometers.
• Vaginal jellies & contraceptive jellies are also commonly used.
Types of Jellies:
1. Medicated jellies: Medicated jellies contains a considerable amount of water therefore
those are suitable for water soluble medicaments & used for anesthetics, antiseptics and
spermicidal. After evaporation of water they produce cooling sensation to the skin.
2. Lubricating jellies:
3. Miscellaneous jellies: Patch testing: Used for allergens which are applied on skin to
check the sensitivity. Electro-cardiography:

26. Preparation of Jellies;
1. Usually prepared by adding thickening agent : Tragacanth, Carboxymethyl
cellulose
2. Thickening agent is added to aqueous solution in which drug has to be dissolved.
3. Mass is triturated in a mortar until a smooth product is obtained.
4. When colored drug to be incorporated glass mortar is used
5. Whole gum is preferred to powdered gum to get clear preparation of uniform
consistency

27. THANK YOU…..