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Ophthalmic Products

This document discusses the formulation and production of ophthalmic preparations such as eye drops. It notes that ophthalmic preparations must be sterile and free of particles to safely treat the delicate eye area. The preparations are categorized and can include solutions, suspensions, ointments, and others. Important components of eye drop formulations include active ingredients, vehicles, preservatives, and adjuvants to control properties like tonicity, viscosity and pH. Proper containers are also needed to maintain stability and prevent contamination. The highest quality standards are required to safely produce medications for use in the eyes.

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Amrit Gaire
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527 views17 pages

Ophthalmic Products

This document discusses the formulation and production of ophthalmic preparations such as eye drops. It notes that ophthalmic preparations must be sterile and free of particles to safely treat the delicate eye area. The preparations are categorized and can include solutions, suspensions, ointments, and others. Important components of eye drop formulations include active ingredients, vehicles, preservatives, and adjuvants to control properties like tonicity, viscosity and pH. Proper containers are also needed to maintain stability and prevent contamination. The highest quality standards are required to safely produce medications for use in the eyes.

Uploaded by

Amrit Gaire
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPT, PDF, TXT or read online on Scribd
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Ophthalmic Preparations

Introduction
The human eye is an amazing organ and the
ability to see is one of our most treasure
possessions. Thus the highest standards are
necessary in the compounding of ophthalmic
preparation and the greatest care is required
in their used. It is necessary that all
ophthalmic preparation are sterile and
essentially free from foreign particles.
The ophthalmic preparation may be
categorized as follows :
1. Eye drops including solution and suspension of active
medicament for instillation into the conjunctival sac.
2. Eye lotions for irrigation and cleaning the eye surface.
3. Eye ointment, creams, and gels containing active
ingredient(s) for application to the lid margins and/or
conjunctival sac.
4. Contract lens solution to facilitate the wearing and care
of contract lenses.
5. Parenteral product for intracorneal, intravitreous or
retrobulbar injection.
6. Solid dosage forms placed in the conjunctival sac and
designed to release active ingredient over a prolong
period.
Medicaments contained in ophthalmic
products including :
 Anesthetics used topically in surgical procedure.
 Anti-infective such as antibacterial, antifungal, and
antiviral.
 Anti-inflammatory such as corticosteroid and
antihistamine.
 Antiglucoma agent to reduce intraocular pressure,
such as beta-blocker.
 Astringents such as zinc sulphate.
Medicaments contained in ophthalmic
products including : ( Cont…)
 Diagnostic agents such as fluorescein which
highlight damage to the epithelial tissue.
 Miotics such as pilocarpine which constrict the
pupil and contract ciliary muscle increasing
drainage from the anterior chamber.
 Mydriatics and cycloplegics such as atropine
which dilate the pupil and paralysis the ciliary
muscle and thus facilitate the examination of the
interior of the eye.
Eye Drops
Formulation of The Eye Drops
 Active ingredient(s) to produce desired therapeutics effect.
 Vehicle, usually aqueous but occasionally may be oil e.g.
tetracycline hydrochloride.
 Antimicrobial preservative.
 Adjuvant to adjust tonicity, viscosity or pH in order to
increase the comfort in use and to increase the stability of
the active ingredient(s).
 Suitable container for administration of eye drops which
maintains the preparation in a stable form and protects
from contamination during preparation, storage and use.
Antimicrobial Preservatives
 Antimicrobial preservative to eliminate any microbial
contamination during use and thus maintain sterility.
 It is essential for multiple dose of eye drops.
 Normal healthy eyes are quite efficient at preventing
penetration by microorganisms. Eye that have damaged
epithelia have their defenses compromised and may be
colonized by microorganism.
 The lack of vascularity of cornea and certain internal
structures of the eye make it very susceptible and difficult
to treat once infection has been establish.
Antimicrobial Preservatives ( Cont …)

 No single substance is entirely satisfactory for use


as a preservative for ophthalmic solution. The
system that have been used.
 The eye drops supplied for use during intraocular
surgery should not contain a preservative because
of the risk of damage to the internal surface of the
eye.
 Preservative suitable eye drops such as
Benzalkonium chloride 0.1% w/v, chlorhexidine
acetate 0.01 % w/v, chlorbutol 0.5 % w/v,
phenylmercuric salts 0.001-0.04 % w/v, thiomersal
0.005-0.01 % w/v.
Tonicity
 may possible eye drops are made isotonic with
lachrymal fluid ( approximately equivalent to 0.9
% w/v sodium chloride solution ).
 The eye will tolerate small volumes of eye drops
having tonicities in the range equivalent 0.7 – 1.5
% w/v sodium chloride.
 The tonicity of hypotonic eye drops by addition of
the tonicity of the lachrymal fluid.
Viscosity Enhancers
 There is general assumption that increase the
viscosity of an eye drop increase the residence
time of the drop in the eye and results in increase
penetration and therapeutic action of the drug.
 Viscosity enhancers including polyvinyl alcohol 1.4
% w/v & methylcellulose derivative such as
hypromellose “ hydroxypropyl derivative of
methylcellulose” 0.5 – 2 % w/v.
pH Adjustment
 the best compromise is required after considering
the following factors:
 the pH offering best stability during preparation and
storage.
 The pH offering the best therapeutic activity.
 the comfort of the patient.
pH Adjustment ( Cont …)
 Most active ingredient are salts of weak bases and are
most stable at an acid pH but most active at a slightly
alkaline pH.
 The lachrymal fluid has a pH of 7.2 – 7.4 and also
possesses considerable buffering capacity. Thus a 50 mcl
eye drop which is weakly buffered will be rapidly
neutralized by lachrymal fluid. Where possible very acidic
solution, such as adrenalin acid tartrate or pilocarpine
hydrochloride are buffered to reduce stinging instillation.
 Suitable buffers for eye drops including Borate buffer,
Phosphate buffer, Citrate buffer.
Antioxidants
 Reducing agent are preferentially oxidizing and are
added to eye drops in order to protect the active
ingredient from oxidation.
 Active ingredient requiring protection including
adrenalin, sulphacetamide, phenylephedrine…etc.
Chelating Agent
 Traces of heavy metals can catalyse breakdown of
active ingredient by oxidation and other
mechanism. Therefore chelating agent such as
disodium edetate may be including to chelating the
metal ions and thus enhance stability.
 disodium edetate is a very useful adjuvant to
ophthalmic preparations at concentration of up to
0.1 % w/v to enhance antimicrobial activity &
chemical stability.
Container of Eye Drops
 Container should be regarded as part of the total
formulation.
 They should protect the eye drops from microbial
contamination, moisture and air.
 Container materials should not be shed or leached into
solution neither should any of the eye drop formulation be
sorbed by the container.
 If the product is to sterilized in the final container all parts
of the container must withstand the sterilization method.
 Container may be made of glass or plastic and may be
single or multiple dose. The latter should not contain more
than 10 ml.
Thanks

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