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2c. Opthalmic Preparations.

2c. Opthalmic Preparations.

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Published by Kustian Kohat

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Published by: Kustian Kohat on Jun 26, 2012
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12/06/2012

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CHAPTER # 2 (c)
FORMULATION OF OPHTHALMIC PREPARATIONS
Introduction:-
Ophthalmic preparations may be defined as;“These are the sterile preparations intended for installation into the eyes for the treatment of eyediseases, for the relief of symptoms, for diagnostic purposes, for washing of eyes & as an adjuvant inthe surgical procedures.” (or)“These are the sterile preparation that are compounded & packed for installation into the eye.”Drugs are commonly applied to the eye for the localized effect of the medication on thesurface of the eye or on its interior. Most frequently aqueous solutions are employed; however nonaqueous solutions, suspensions & ophthalmic ointments are also commonly used. Recentlyophthalmic inserts, impregnated with drug, have been developed to provide for the continuousrelease of medication. These inserts are of particular usefulness for those drugs requiring frequentday time & night time administration. Since the capacity of the eye to retain liquid & ointment preparations is limited, they are generally administrated in small volumes. Larger volumes of liquid preparations may be used to flush or wash the eye.The normal volume of tears in the eye is 7µl, whereas a non blinking eye can accommodate amaximum of 30 µl of fluid, blinking eyes can hold only 10µl. Excessive liquids both normally produced & externally added are rapidly drained from the eye.Thus the effective “dose” of medication administered by ophthalmic route can be varied bythe strength of medication administered, the volume administered, and the retention time of themedication in contact with the surface of the eye & the frequency of administration.
Types of Drugs Used Ophthalmically:-
The major types of drugs used ophthalmically are as follows:-
1.Miotics:-
Miotics are used primarily in the treatment of glaucoma. Miotics reduce intraocular pressureassociated with glaucoma. Among the miotics are physostigmine, pilocarpine, neostigmine,methacholine, carbachol etc.
2.Mydriatics & Cycloplegics:-
Mydriatics allow examination of the fundus of the eye thought the dilatation of the pupil. Thestronger mydriatics having a long duration of action are called cycloplegics.Among mydriatics & cycloplegics are Atropine, hyoscyamine, scopalamine, hematropine, Cocaine& cyclopentolate etc.
 
3.Local Anesthetics:-
Local anesthetics allow for the relief of pain pre-operatively, post operatively, following trauma &during ophthalmic examination.Among the local anesthetics used opthalmically are Tetracaine, benoximate, proparacaine, cocaine,dyclonine & phenacaine etc.
4.Anti-InflammatoryAgents:
-
These agents combat inflammation of the eye. Most prominent among these arehydrocortisone, prednisolone & dexamethsone salts.
5.Local Antiseptics:-
Local antiseptics are employed topically to reduce microbial presence on the eye. Among these arecertain organic mercury compounds as trimerosal & ammoniated mercury & silver nitrate.
6.Anti-Microbial Agents:-
Antimicrobial agents are used specifically to combat infection of the eye. They are frequentlyemployed both systemically & locally for their effect. Among those applied topically to the eye arechloramphenical, sulfacetamide sodium, Gentramycin, Tetracyclline & Neomycine.
7.Astringents: -
These agents are generally used in the treatment of conjunctivitis (inflammation of the conjunctivacharacterized by redness and often accompanied by a discharge). Most preparations for this purposeutilize Zinc-compounds, particularly Zinc Sulfate, as the astringent.
8.Topical Protectants:-
These agents are employed as artificial tears or as a contact lens fluid. Examples of agents used inthese solutions are methylcellulose & hydroxypropyl-methylcellulose.
Formulation of Ophthalmic Preparations:-
The primary requirement for the ophthalmic preparation is that it should be sterile. As most of theophthalmic preparations cannot be sterilized in the final containers due to the sensitivity of the activeingredients &/or excipients or package to the elevated heat, therefore these products are sterilizedindividually. They are blended aseptically, filled aseptically in pre-sterilized containers using asepticcapping technique.Due to these restrictions of sterility & purity the ophthalmic products are prepared in completelysterile environment using aseptic techniques to minimize the chances of contamination during the preparation & filling. Thus for the preparation of safe, sterile & therapeutically active product, thefollowing factors must be controlled: -1.Environment2.Manufacturing Techniques3.Raw Material4.Machinery (equipment)
 
1)Environment:-
The environment required for the preparation of ophthalmic product is same as that for parenterals.Ophthalmic preparations are manufactured & processed in aseptic area which needs the requirementsof class-100 space. Class-100 space is an area having not more than 100 particles (living & nonliving) larger than 25µm. Now this aseptic area is constructed of hard, impervious material. Theceiling, walls & floor are such that they can be washed easily with disinfectant after each cycle. Theair supplied to that area must be sterile i.e. air is passed through the HEPA Filters. A positive pressure is maintained in the rooms (i.e. inside pressure is more than outside) so that when the door is opened the air flows outside rather than coming inside. The personnel working in that area mustwear the sterile gowns, gloves & foot covers. The inward & outward traffic should be mini
mum.
2)Manufacturing Techniques:-
In case of eye drops water soluble ingredients are dissolved in water & then they are sterilized either  by heat or filtration process.In case of suspension, which cannot be sterilized by filtration process, dry powder is either heatsterilized or ethylene oxide or by radiation. If dry powder is sensitive to heat & radiation then it isdissolved in suitable solvent, sterilized by filtration & then crystallized aseptically.In case of ophthalmic ointments, the base is first melted, heat sterilized & then filtered to removelarge particles. Then pre sterilized active ingredients & excipients are mixed aseptically with molten base. Then this molten mass is passed through sterilized colloidal mill & then it is filled in previously sterilized container.3)
Raw Materials:-
The raw materials used for the ophthalmic preparation (i.e. Active ingredients & excepients) must beof highest purity & quality. Specifications for the raw material of every product should beestablished & each lot of material purchased should be checked for the established specifications.4)
Machinery (Equipments):-
Equipments used for the ophthalmic preparation have same requirements as those used fo parenterals. All parts of the equipments coming in contact with the product are made up of corrosionfree material, which can easily be disassembled, cleaned & sterilized. Preferably they are made up of high grade stainless steel. Moreover machinery used should be cleaned regularly in order to avoidthe risk of contamination.
Additives Used In Ophthalmic Preparations:-
In addition to the active drug, the ophthalmic preparations contain the following excepients(additives).1.Vehicle2.Tonicity Modifiers3.Buffers4.Stabilizers (Antioxidants)

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