All merged opthalmic - converted.ptyyutdf

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1. CONTENTS:
*Introduction
*Anatomy of eye and
adnexa
*Absorption of drugs in the
eye
Presented by:
1.Marium Khatun(1912026113)
2.Mahfuzur Rahman(1910826119)
3.Samaun Nahar(1912326151)
4.Saraban Tahura(1812526154)
5.Mubasshira Islam(1812026158)
Department of Pharmacy,University of Rajshahi

2. →onto the external surface of the eye
( topical)
→administered inside (intracular)
→adjacent to the eye (pericular)
→used into the eye in the space between
eyelids and eye balls in conjunction with
an opthalmic device

Opthalmic preparations are specialized sterile dosage
forms designed to be instilled
Introduction :

3. ★Solution
★Suspension
★ointments

The most
commonly used
opthalmic
dosage forms
are
N.B This preparation when installed
into the eye are rapidly drained away
from ocular cavity due to tear flow and
lacrimal nasal drainage.

4. To overcome the problems of solution, suspensions and ointments,
The newest dosage form that
are designed for opthalmic
drug delivery are
★★Gels
★★Gel- forming solutions
★★ocular inserts
★★Intraviteal injections and
implants

5. 1.Easily admistered by the patient himself
2.Less visual and systemic side effects
3.Have the quick absorption and show effects
4.Longer shelf life
5.Better patient compliance
6.Easily administered by the nurse
Advantage includes

6. .
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7. Disadvantage
1.Poor bioavailability
2.Need of using preservative
3.Careful Sterilization
4.Less but possible solution drainage
5.Retention time of the solution
in the eye is short

8. Anatomy and Physiology of The Eye
and Adnexa

9. Anatomy of Eye is divided into
3 major layers
a.Outer layer:: Consists of
→Sclera
→Cornea
→Conjuctiva c.Inner Layer:: Consists of
→Retina

b.Middle Layer:: Consists of
→Choroid
→Iris
→Ciliary body

10. Outer layers:
★★Sclera: The protective outer layer of the
eye which maintains the shape of the eye. It is
referred to as "White of the Eye".
★★Cornea: The fornt portion of the sclera, is
transparent and allows light to enter the eye. It is a
powerful refracting surface,providing much of the
eye's focusing power.
★★Conjunctiva: Thin transparent layer that covers
and protect the cornea.

11. Middle layers:
★★choroid: Part of second layer of the eye
that lies between the sclera and the retina. It
contains the blood vessels which provide
nourishment to the outer layer of the retina.
★★Ciliary body:Consists f two sets of ciliary
muscle and suspending ligaments and is
attached to lens that holds it in position. It's
function is to change the shape of lens by
contraction or relaxation of muscle

12. ★★Iris:It is the part of the
eye that gives it color.It
consists of muscular tissue
that responds to surrounding
light and controls the amount
of light entering into eye by
controlling the size of pupil.

13. Inner layer:
It is the innermost layer of the eye. It converts images into electrical
impulses that are sent along the optic nerve to the brain where the
images are interpreted.
The optic nerve enter retina at a point called
blind spot.It does not contain any rods or cone
cells.It is least sensitive to light and forms no
image where light falls on blind spot.
Retina

14. ABSORPTION OF DRUGS IN THE EYE
Absorption is the process through which
drugs enter into the systemic circulation
from its site of administration topically
i.e:eye,are absorbed through permeation
across the cornea from pre corneal tear film
or through local blood capillaries.

16. 1.Rapid solution drainage by gravity,induced
lachrymation, blinking reflex, and normal tear
turnover.
2.Superficial absorption of drug into the
conjunctiva and sclera and rapid removal by the
peripheral blood flow.
3.Low corneal permeability(act as lipid barrier)
Factors affecting drug absorption and
availability

17. In general:
- Hydrophilic and macromolecular drugs
transport Through sclera route
-Lipohilic and low Molecular drugs transport by
passive diffusion process
N.B. The drug should have dual solubility to
transverse the corneal epithelium then the
aqueous humour.

18. Drug delivery in occular route is a
challenging problem due to the following
reasons
Poor bioavailability
productive mechanism Anatomy of eye
Barrier properties of the cornea

19. Thanks
Everyone

20. OPTHALMIC PRODUCTS, CLASSIFICATION,
CHARACTERISTICS, FORMULATION
VEHICLES & ADDITIVES
Department of Pharmacy
University of Rajshahi
PRESENTED BY : (Group-5)
Rakib Khan (1911016129)
Munna Mondol (1911026142)
Mahmuda Nishat (1912426114)
Sakibur Rahman (1911026125)
Jahid Hasan (1910626104)

21. Opthalmic preparations are sterile, liquid, semi
solid or solid preparations that may contain one
or more active pharmaceutucal ingredients.
These products must be sterile and are prepared
under the same conditions and same methods
as other parenteral preparaton.
WHAT IS OPTHALMIC PRODUCTS?

22. TYPES OF OPTHALMIC PRODUCTS
1. Eye drops
2. Eye lotion
3. Eye ointment
4. Eye suspension
5. Contact lens solution
EYE SUSPENSION
EYE LOTION
CONTACT LENS
EYE DROPS

23. EYE DROPS
Eye Drops are sterile aqueous or oily
solutions or suspension of drug that are
installed in the eye with the help of dropper.

24. Lorem EYE LOTION
These are the sterile aqueous solutions used
for washing for the eyes.

25. EYE OINTMENT
Eye ointment are sterile preparations meant
for appication to the eye.

26. EYE SUSPENSION
It is a type of eye drop that is suspended in a
liquid, rather than being dissolved.

27. CONTACT LENS SOLUTION
Contact Lenses are usually made from
polymethyl methacrylate which is hard
hydrophobic plastic.

28. IDEAL CHARACTERISTICS
1. Sterile
2. Free from foreign particular matter
3. PH equal to 7.4
4. Optimum viscosity
5. Proper preservative

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

30. 1) DRUG :
2) PRESERVATIVE :
3) STERILIZATION :
These contains drug of various categories including antiseptic,
anti-inflammatory agent, mydriatric or meiotic properties.
Eye drop should be sterile and should contain preservatives to avoid
microbial contamination when the container is open. The preservative
for opthalmic use includes Benzalkonium chloride, Chlorbutanol,
Phenylmercuric acetate, Phenylmercuric nitrate etc
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.

31. 4) Isotonicity :
5) Buffer :
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.
The buffer should be added to maintain balance between comfort,
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.
On the hand certain drug such as alkaloids show precipitation at
lachrymal pH. Boric acid, monobasic sodium phosphate are the
common buffers for eye drop.

32. 6) Viscosity :
7) Container :
8) label :
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.
The commonly used container for opthalmic solutions or suspension
is multi-dose container (5ml, 10ml). Glass container is supplied with
sterile plastic dropper. Plastic bottles are with built-up nozzle.
Not for injection. For external use only. Shake well before use (if it is
suspension)

33. VEHICLES
Ophthalmic drop (using purifies water USP) as the solvent.
Purified water meeting USP standards may be obtained by :
Distillation, deionization, or reverse osmosis.
Oils have been used as vehicles for several topical eye drops
products that are extremely sensitive to moisture.
When oils are used as vehicles in ophthalmic fluids,
they must be of the highest purity.

34. TYPES OF ADDITIVES
1. Antioxidants: especially sodium bisulfate or metabisulfate and also,
ascorbic acid or acetylcysteine. It is used for prevention oxidation of
drug and inhibit free radical matters.
2. Surfactants : surfactant are often used to stabilize more
hydrophobic drugs. Nonionic surfactants, are used most often since
they generally less irritating than ionic surfactants. Polysorbate 80 is
used in preparation of ophthalmic emulsions. Polyoxyl 40 stearate
and polyethylene glycol has been used to solubilize a drug in an
anhydrous ointment. Cationic surfactants, are used gradually in the
eye solution but almost invariable as an antimicrobial preservative.

35. TYPES OF ADDITIVES
3. Preservative : Benzalkonium chloride as a preservative is used in large
quantities in commercial eye solution and suspension, preservative Should
be use in multi ophthalmic dose but in single dose they arent demand.
4. Chelating agents: Chelating agents are used in the formulation of
opthalmic preparation, to remove traces, of heavy metals. Disodium
edetate, is commonly employed as chelating agent in eye drops. It also
enhances the activity of preservatives that are included in the formulation.
5. Wetting agents: These are used for proper penetration of the products
into the cornea of the eye. Polysorbate 20 and polysorbate 80 are used as
wetting agent.

36. REFERENCE
Lachman/Lieberman's The Theory And Practice
Of Industrial Pharmacy, Chapter 22 : Sterile Products
https://en.wikipedia.org/wiki/Ophthalmic

38. PRESENTED BY:
KAZI MUHTASIM FUAD(1911026107)
SHIBLI RUBATUL ISLAM(1910426136)
AHASAN ULLAH AHAD(1910426106)
SK REDWAN ZAMAN(1810626110)
AYESHA TASNIM SINTHI(1912126121)
MANUFACTURING CONSIDERATION,ENVIRONMENT
,MANUFACTURING TECHNIQUE
A PRESENTATION ON OPHTHALMIC
PREPARATION

39. MANUFACTURING
CONSIDERATION OF
OPTHALMIC PRODUCTS
Ophthalmic products are subject to strict
regulations to ensure their safety and
efficacy. Manufacturers must adhere to
relevant regulations and guidelines
REGULATORY COMPLIANCE
01
Manufacturing processes should include
appropriate aseptic techniques and cleanroom
facilities to prevent contamination.
STERILITY AND CLEANLINESS
02

40. MANUFACTURING
CONSIDERATION OF
OPTHALMIC PRODUCTS
Biocompatible materials that do not
cause irritation or adverse reactions in
the eye should be chosen.
MATERIAL SELECTION
03
Advanced machinery and technologies may be
employed to ensure accurate measurements
and tolerances.
PRECISION MANUFACTURING
04

41. MANUFACTURING
CONSIDERATION OF
OPTHALMIC PRODUCTS
Robust quality assurance programs
should be in place, including thorough
testing at various stages of production.
QUALITY ASSURANCE
05
To avoid contamination, light, and moisture. Clear
instructions for use, warnings, and precautions should
be included on the packaging and product labeling.
Compliance with regulatory requirements for
packaging and labeling is essential.
PACKAGING AND LABELING
06

42. 2.LAMINAR-FLOW
1.SHOULD BE (STERILE AND PARTICLE-FREE)
Manufacturing Environment
3.MINIMUM PARTICLES PER CUBIC FOOT OF
SPACE
4.RELATIVE HUMIDITY (40 -60%)
5.SURFACE DISINFECTION
6.SEPARATE ENTRANCE FOR PERSONNEL
7.COMPATIBLE WALLS, CEILINGS AND FLOORS

43. EQUIPMENTAL CONSIDERTION OF OPTHALMIC PRODUCT
A dedicated sterile workstation should be set up within the cleanroom or laminar
flow hood. This workstation should be equipped with a sterile work surface,
including a sterile work mat or tray.
Ophthalmic preparations require a sterile environment to prevent contamination. A
laminar flow hood or a dedicated cleanroom with appropriate air filtration systems is
essential to maintain a sterile environment during compounding and packaging
processes.
1. LAMINAR FLOW HOOD OR
CLEANROOM
2.STERILE WORKSTATION
3. STERILE CONTAINERS
Use sterile containers specifically designed for ophthalmic preparations. These
containers should be made of materials that are compatible with the product and
ensure the integrity and sterility of the final preparation.

44. EQUIPMENTAL CONSIDERTION
Ophthalmic preparations may require temperature control during storage or manufacturing
processes. Equipment such as refrigerators, freezers, and incubators should be available to
maintain the required temperature conditions.
Various measuring and mixing equipment may be required, such as graduated
cylinders, pipettes, beakers, and glass or plastic stirring rods. Ensure that these items
are made of materials compatible with ophthalmic preparations and are sterile or
properly sanitized..
4.MEASURING AND MIXING
EQUIPAMENT
5.TEMPERATURE CONTROL
DEVICES
6.CLEANING AND DISINFECTION
EQUIPMENT
Proper cleaning and disinfection of equipment and surfaces are essential to maintain a
sterile environment. Autoclaves, sterilizers, or other appropriate disinfection systems
should be available for sterilizing reusable equipment.

45. MANUFACTURING TECHNIQUES
Aqueous ophthalmic solutions:
1. dissolution of the active ingredient and all or a portion of the excipients into all
or a portion of the water
2. heat sterilization & sterilizing filtration
3.sterile solution is then mixed with the additional required sterile component and the
bath is brought to final volume with additional sterile weter.
Aqueous suspensions:
Are prepared in much the same manner, except , the solid to be suspended is previously
rendered Sterile by:
✔heat,
✔exposure to ethylene oxide or
✔ionizing radiation (gamma or electrons),
✔dissolution in an appropriate solvent,
✔sterile filtration, and aseptic crystallization.

46. MANUFACTURING TECHNIQUES
Ophthalmic ointment:
UNPRESERVED FORMULATIONS OF ACTIVE DRUGS:
It is used for manufacture of unpreserved ophthalmic products, especially for
artificial tear products. In this process, the first step is to extrude polyethylene resin
at high temperature and pressure and to form the container by blowing the resin into
a mold with compressed air. The product is filled as air is vented out, and finally the
container is sealed on the Top
base sterilization
filter
placed into sterile steam jacket
addition of sterile API and excipient

47. The Blow/Fill/Seal method:

48. Thank you

64. the eye seems to tolerate hypertonic solution better than hypotonic ones
ChatGPT
The statement that the eye tolerates hypertonic solutions better than hypotonic
ones is generally accurate and aligns with the physiological properties of ocular
tissues.
In ophthalmology, solutions are often categorized based on their tonicity, which
refers to their osmotic pressure relative to that of the intraocular fluids (such as
tears in the eye). Here's a brief explanation of tonicity:
Isotonic solution: This has the same osmotic pressure as the intraocular fluids
and does not cause a net movement of water into or out of the ocular tissues.

65. hy should preservatives to be included in multiple doses soluation but not for unit dose package
atGPT
Preservatives are often included in multi-dose solutions, such as eye drops or nasal sprays, to prevent
microbial contamination and ensure the product remains safe for use throughout its intended shelf life, even
ter multiple openings and closings of the container. However, preservatives are typically not needed in unit-
dose packages due to their single-use nature.
Here are the main reasons why preservatives are used in multi-dose solutions but not in unit-dose packages:
Preventing Contamination in Multi-Dose Solutions: Multi-dose solutions are designed to be used multiple
times over an extended period, which increases the risk of microbial contamination each time the
container is opened and exposed to the environment. Preservatives help inhibit the growth of bacteria,
fungi, and other microorganisms that could contaminate the solution.
Prolonging Shelf Life and Efficacy: Preservatives extend the shelf life of multi-dose solutions, allowing them
to be used safely and effectively for a longer period. They help maintain the integrity and potency of the
active ingredients within the solution over time.
Cost-Effectiveness for Multi-Dose Containers: Using a multi-dose container reduces the amount of

67. lity of ocular drugs typically applied in eye drops is very poor how can you overcome it
f drugs applied via eye drops is often poor due to various anatomical and physiological factors associated with the
ntribute to the poor bioavailability of ocular drugs from eye drops include limited drug absorption, rapid clearance,
to drug penetration. To improve bioavailability and therapeutic effectiveness, several strategies and technologies
rmulations:
ancers: Increasing the viscosity of the eye drop formulation can prolong the residence time of the drug on the o
ing for better drug absorption.
Polymers: These can help the drug adhere to the ocular surface, extending drug contact time and enhancing
s and Liposomes: Encapsulation of drugs in nanoparticles or liposomes can protect them from rapid clearance
penetration into ocular tissues.
drugs, which are biologically inactive compounds that are converted into active drugs after administration. Prodrugs
drug penetration and absorption.
ystems: