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OPTHALMIC PREPARATIONS,[object Object],SHUBHRAJIT MANTRY,[object Object],Asst.Prof,[object Object],Kottam Institute of Pharmacy.   A.P,[object Object]
SYLLABUS,[object Object],[object Object]
Formulation
Methods of preparation
Containers
Evaluation,[object Object]
Opthalmic products are the sterile products meant to instillation in to the eye in the space between eye lid and the eye ball. ,[object Object],These products must be sterile and are prepared under the same condition and by the same methods as other Parenteral preparations.,[object Object],opthalmic products includes:,[object Object],Eye drops,[object Object],Eye lotion,[object Object],Eye ointment,[object Object],Eye suspension,[object Object],Contact lens solution,[object Object],EYE LID,[object Object],EYE BALL,[object Object]
Opthalmic preparation
EYE,[object Object],DROPS,[object Object]
EYE LOTION,[object Object]
EYE OINTMENT,[object Object]
How to Use Eye Ointments and Gels Properly?,[object Object]
EYE SUSPENSION,[object Object]
CONTACT LENSE,[object Object]
Types of opthalmic products,[object Object],Opthalmic products may be categorized into a number of groups:,[object Object],Liquid preparations for application to the surface of the eye such as eye drops and eye lotions.,[object Object],Semi solid preparations such as eye ointments, creams and gels for application to the margin of eye lid or for introduction in to the conjuctival sac.,[object Object],Solid preparations such as Ocular inserts intended to be placed in contact with the surface of the eye to produce modified release of medicament over a prolonged period.,[object Object],Parenteral products for sub conjuctival or intra ocular injection.,[object Object],Liquid products for irrigation of the eye during surgical procedures.,[object Object],		All opthalmic products are required to be sterile and free from extraneous particulate matter. Solutions used during surgery should not contain any preservative.,[object Object]
O,[object Object],C,[object Object],U,[object Object],L,[object Object],A,[object Object],R,[object Object],I,[object Object],N,[object Object],J,[object Object],E,[object Object],C,[object Object],T,[object Object],I,[object Object],O,[object Object],N,[object Object]
REQUIREMENTS,[object Object],Opthalmic preparations should possess the following properties:,[object Object],Foreign particles,[object Object],Viscosity,[object Object],Tonicity,[object Object],pH of preparations,[object Object],Sterility,[object Object],Surface activity,[object Object]
Foreign particles: ,[object Object],	All the opthalmic products should be clear and free from foreign particles, fibers and filaments.,[object Object],	Opthalmic solutions should be clarified very carefully by passing through bacteria proof filters such as membrane filters, sintered glass filters. ,[object Object],	The particle size of the eye suspension should be in an ultrafine state of subdivision to minimize irritation. ,[object Object],	A separate filter should be used for different opthalmic products in order to avoid the contamination.,[object Object]
Opthalmic preparation
2) Viscosity:,[object Object],in order to prolong the contact time of the drug in the eye, various thickening agents are added in the opthalmic preparations. ,[object Object],Polyvinyl alcohol (1-4%), polyethylene glycol, methyl cellulose, carboxy methyl cellulose are some of the commonly used thickening agents. These agents improve the viscosity of the preparation. ,[object Object],An ideal thickening agent should possess the following properties:-,[object Object],it should be easy to filter.,[object Object],It should be easy to sterilize.,[object Object],It should be compatible with other ingredients.,[object Object],It should possess requisite refractive index and clarity level.,[object Object],		Thickening agents are not included in the formulation of eye 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.,[object Object]
3) Tonicity: ,[object Object],Opthalmic products should be isotonic with lachrymal secretions to avoid discomfort and irritation. ,[object Object],	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 opthalmic products like 1.9% boric acid, sodium acid phosphate buffer.  ,[object Object]
4) pH of the preparations: ,[object Object],  	pH plays an important role in therapeutic activity, solubility, stability and comfort to the patient. ,[object Object],	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. ,[object Object],	Alkaloid salt solutions are stable at pH 2-3 but this pH is irritant to eye. ,[object Object],	The alkaloids get precipitated at pH above 7 and creates a number of formulation problems.,[object Object]
5) sterility:,[object Object],Opthalmic preparations must be sterile when prepared. ,[object Object],Pseudomonas aeroginosa is very common gram –ve bacteria which is generally found to be present in opthalmic products. It may cause serious infections of cornea. It can cause complete loss of eye sight in 24-48 hrs.,[object Object],	To maintain sterility in multi dose container, containing opthalmic products, a suitable preservative is added. The preservative should be non-toxic, non-irritant and should be compatible with medicaments. The opthalmic products are generally sterilized by autoclaving, filtration through bacteria proof filters and addition of bactericides at low temperature.,[object Object]
6) Surface activity: ,[object Object],Vehicles used in opthalmic preparations must have good wetting ability to penetrate cornea and other tissues. ,[object Object],	Certain surfactants or wetting agents added which are found suitable for opthalmic products. ,[object Object],	It should not cause any damage to the tissue of eye. ,[object Object],	Benzalkonium chloride, polysorbate 20, polysoabate 80, dioctyl sodium sulpho succinate etc., are some of the surfactants which are commonly used.,[object Object]
Opthalmic preparation
EYE DROPS,[object Object],	Eye drops are sterile aqueous or suspensions of drug that are instilled in to the eye with a dropper. They usually contain drugs having anti septic, anti anesthetic, anti inflammatory, mydriatic or meiotic properties.,[object Object]
FORMULATION,[object Object],Drug,[object Object],Preservative,[object Object],Sterilization,[object Object],Isotonicity,[object Object],Buffer,[object Object],Viscosity,[object Object],Container,[object Object],label,[object Object]
Drug,[object Object],These contains drug of various categories including antiseptic, anti-inflammatory agent, mydriatric or meiotic properties.,[object Object],2) Preservative,[object Object],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,[object Object],3) Sterilization,[object Object],Eye drops are sterilized by autoclaving at 1210C for 15 minutes or by bacteria filter to avoid thermal degradation; for example- Preservative chlorbutanaol hydrolyzes at high temperature.,[object Object]
4) Isotonicity,[object Object],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.,[object Object],5) Buffer,[object Object],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.,[object Object],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.,[object Object]
6) Viscosity,[object Object],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.,[object Object],7) Container,[object Object],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.,[object Object],8) label,[object Object],Not for injection. For external use only. ,[object Object],Shake well before use (if it is suspension),[object Object]
PREPARATION,[object Object], The eye drops are prepared in 4 stages. These stages are as under—,[object Object],Preparation of bactericidal and fungicidal vehicle: ,[object Object],The aqueous or oily vehicle is used in preparation of eye drops. The aqueous vehicle may support bacterial or fungal growth, ,[object Object],	so one of the following bactericide may be used to prepare the eye drops :,[object Object],Phenyl mercuric nitrate/ acetate – 0.002%,[object Object],Benzalkonium chloride – 0.01%,[object Object],Chlorhexidine acetate-0.01%,[object Object]
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.,[object Object],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 micro organisms.,[object Object],4) Sterilization : the eye drops are sterilized by autoclaving or heating with bactericide at 98⁰ to 100⁰C for 30 mins., or filtration through bacteria proof filter.,[object Object]
5) Containers: ,[object Object],The eye drops should be packed in neutral glass containers or  in suitable plastic containers. ,[object Object],In olden days the eye drops are stored in vertically fluted amber colored glass bottles fitted with a Bakelite cap carrying a dropper. The bottle must confirm to limit test for alkalinity of glass.,[object Object], Now a days neutral glass small bottles having capacity of 4ml to 8ml are used. ,[object Object],It has two poly propylene screw caps, one for attaching a silicone rubber teat to the container and the other for covering the teat. ,[object Object],The plastic squeeze bottles having ridged plastic cap and polythene friction plug containing baffle that produces uniform drops are also used these days. ,[object Object],These are very handy. These bottles are sterilized by gaseous sterilization method.,[object Object]
Eye lotion,[object Object]
INTRODUCTION,[object Object],Eye lotion are the sterile aqueous solutions used for washing of the eyes. ,[object Object],The eye lotions are supplied in concentrated form and are required to be diluted with warm water immediately before use.,[object Object],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. ,[object Object]
Eye lotions should be isotonic and free from foreign particles to avoid irritation to the eye.,[object Object],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,[object Object]
FORMULATION OF EYE LOTION,[object Object],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. ,[object Object],The eye lotion should be sterile because the large volume is used to irritation from the eye.,[object Object],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. ,[object Object],Sodium chloride eye lotion and sodium bicarbonate eye lotion are commonly used to remove foreign substance from the eye.,[object Object]
PREPARATION OF EYE LOTION,[object Object],EXAMPLE:-,[object Object], To prepare and submit ml of sodium chloride eye lotion B.P.C,[object Object],       Rx,[object Object],	Sodium chloride                 9gm,[object Object],         Purified water to produce   1000ml    ,[object Object],Method:- ,[object Object],	Dissolve sodium chloride in purified water and made the final volume by adding more of purified water. Filter through sintered glass filter grade 4. ,[object Object],               The eye lotion is transfer to the bottle. Close and sealed the bottle sterilize it by autoclaving.      ,[object Object]
EYE OINTMENTS,[object Object]
Eye ointments are sterile preparation meant for application to the eye.,[object Object],These are prepared under aseptic conditions and packed in sterile collapsible tubes which keep the preparation sterile until whole of it is consumed.,[object Object],Nowadays eye applicaps are available which contain only one application of the eye-ointment preparation.,[object Object]
Formulation of Eye Ointments,[object Object],The ointment based for an eye-ointment must be no-irritating  to the eye.,[object Object],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. ,[object Object],For the preparation of eye-ointment the following base is used:- ,[object Object],Yellow soft paraffin                  80g,[object Object],    Liquid paraffin                          10g,[object Object],    Wool fat                                    10g,[object Object]
Methods of preparation,[object Object], of ,[object Object],Eye Ointments,[object Object],Melt wool fat, soft paraffin on a water bath. Add liquid paraffin.,[object Object],Filter through coarse filter placed in heated funnel. It is sterilized by dry heat method (1600C for 2 hours). Incorporate the medicament with the eye ointment base. Pack in sterile containers.,[object Object]
EYE SUSPENSION,[object Object]
INTRODUCTION,[object Object],Ophthalmic suspensions are also easily placed into the eye.,[object Object],In general, suspensions produce a longer effect than do solutions. Suspensions do have one disadvantage; it is difficult to ensure that the suspension does not contain particles large enough to produce eye irritation.,[object Object],Eye suspensions are not commonly used as compared to eye-drops. They are prepared only in those cases, when the drug is insoluble in the desired vehicle or unstable in liquid form.,[object Object]
Opthalmic preparation
CONTACT LENSES ,[object Object],Contact lenses are usually made from ,[object Object],polymethyl- methacrylate, a hard hydrophobic plastic, but some softer hydrophilic lenses have been developed and are coming to use.,[object Object],Types of contact lenses:,[object Object],1- Hard contact lenses,[object Object],2- Soft contact lenses,[object Object]
HARD CONTACT LENSES:,[object Object],Wearers of hard contact lenses generally use two solutions ,[object Object],[object Object]
A storage solution, which is used for overnight cleansing, soaking and storage.,[object Object]
They may contain,[object Object], A wetting agent:,[object Object], An antimicrobial agent:,[object Object], A substance for adjusting the osmotic pressure:,[object Object], A buffering agent:,[object Object], A thickening agent:,[object Object]
A wetting agent :,[object Object],polyvinyl alcohols, which are strongly hydrophilic, and polysorbate 80 , a non-ionic surfactant in which hydrophilic groups predominate, are examples.    ,[object Object],	Polyvinyl alcohols are obtained from polyvinyl acetate by hydrolysis and may contain traces of the parent compound from which irritating amounts of acetic acid may be liberated at neutral or alkaline pHs. ,[object Object],Hence, solutions are often adjusted to a pH between 5 and 6.                                           Polysorbate 80, at concentrations of 0.5 percent and above, inactivates Benzalkonium chloride and chlorhexidine acetate and at lower concentrations may increase or decrease their activity according to the conditions.,[object Object]
An antimicrobial agent:,[object Object],prolonged use f solutions containing the concentrations of antimicrobial agents recommended for eye-drops may cause irritation or allergic reactions. Consequently, lower levels are used in lens solutions; e.g. Benzalkonium chloride 0.004 percent, chlorhexidine acetate 0.005 to 0.006 % and chlorbutol 0.3 to 0.4 percent.          ,[object Object], Using more than one antimicrobial agent is a way of reducing the concentration of each and , at the same time, maintain an acceptable level of preservative activity.,[object Object], For example, disodium edentate(0.1 to 0.2 %) may be combined with Benzalkonium chloride, Benzalkonium chloride and chlorbutol or Benzalkonium chloride and chlorhexidine acetate.  ,[object Object],                     Richards points out that phenyl ethyl alcohol enhances the activity of all bactericides commonly used in eye solutions and is not inactivated by up to 1 percent of polysorbate 80;  but so far this compound has not been used in wetting solutions. ,[object Object]
A substance for adjusting the osmotic pressure:,[object Object], it is customary to adjust wetting solutions to approximately the same osmotic pressure as lachrymal secretion by adding sodium chloride alone or with potassium chloride. ,[object Object],Wearing contact lenses seems, by interfering with corneal metabolism, to increase the sensitivity of the eye to solutions that are not iso-osmotic with tears. ,[object Object]
A buffering agent:,[object Object],Hind and Goyan  found that solutions of pH 8.0  to 8.8 were best tolerated by the eye while more alkaline or acid preparations caused smarting or fogging. ,[object Object],Hypromellose Eye Drops B.P.C., which is sometimes used as a contact lens solutions, is buffered to pH 8.4 to 8.6 with boric acid and borax. Sodium bicarbonate 2 per cent , an early contact lens solution, has a pH of about 8.2 and is well tolerated.,[object Object]
A thickening agent:,[object Object],Comfort is significantly increased if the solution contains a substance that raises the viscosity, e.g. polyvinyl alcohols or the cellulose derivatives.,[object Object], The thickener must be compatible with the preservative(s) and produce a clear solution that does not interfere with vision.  ,[object Object],Generally, the vehicle for lens solutions is properly stored purified water; tap water is unsuitable because it contains salts, that may cause deposits, and chlorine, which may be irritating.,[object Object]
Storage solutions:,[object Object], Hydrophobic lenses attract hydrophobic substances from the eyelids, fingers, etc. and, therefore, require cleaning after use. ,[object Object],After removal they are wetted with the wetting solution and rubbed between well-scrubbed fingers until they appear clear after rinsing with purified water. ,[object Object],Then they are stored in a soaking solution intended to continue the cleaning process and prevent dehydration.,[object Object],Polymethyl methacrylate, although hydrophobic, does absorb a little water and it is undesirable for this to be taken from the eye.,[object Object]
Storage solutions usually contain ,[object Object],[object Object]
A mixture of antimicrobial agents. The concentrations can be greater than in wetting solutions because storage solutions are not used in the eye.  The solution is changed every few days because the preservatives may be partially inactivated by organic debris.,[object Object]
SOFT CONTACT LENSES:,[object Object],These are soft flexible type of lenses.,[object Object],Certain medicaments from wetting and storage solutions are strongly absorbed by the soft contact lenses.,[object Object],                                                                                                                              Due to this reason patients wearing soft lenses should be advised to remove them before instilling eye-drops,[object Object]
For cleaning soft contact lenses are heated in 0.9% sodium chloride solution. ,[object Object],The Wetting and storage solutions formulated for hard lenses must never be used. Special proprietary storage solutions are available. Wetting is not a problem because of the hydrophilic nature of lens.              ,[object Object],The wetting of soft contact lenses is not a problem because of hydrophilic nature of the lens.,[object Object],Contact lens solutions should be sterile.,[object Object]
EVALUATION,[object Object],OF ,[object Object],OPTHALMIC PREPARATION ,[object Object]
Evaluation is test of finish Parenteral product are free from of micro-organism or not.,[object Object],Evaluation of the opthalmic product is done by following tests:,[object Object],Sterility Test,[object Object],Clarity Test,[object Object],Leaker Test,[object Object],Metal particles in opthalmic ointment ,[object Object]
 STERILITY TEST :,[object Object],Two basic methods for sterility testing:,[object Object],Direct Inoculation Method:,[object Object],     It involves the direct introduction of product test samples into the culture media.,[object Object],II) Membrane filtration Method:  ,[object Object],      It 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.,[object Object],   Detection of contamination used to two culture media:-,[object Object],    A) Soybean-casein digest medium:- Incubated at 20to 250C,[object Object],B) fluid thioglycollate medium:- Incubated at 30 to 350C on 7 Days,[object Object]
2. CLARITY TEST :,[object Object],Opthalmic Solution by definition contain no undissolved ingredients and are essentially free from foreign particles .,[object Object],[object Object],Under a good light, baffled against reflection into the eye and viewed against a black and white background with contect set in motion with swilling action.,[object Object],[object Object],Instrumental method utilizing video image projection detects moving particles without destruction of product units-used for inline detection.,[object Object]
3. LEAKER TEST :,[object Object],[object Object]
 Thoroughly clean and dry the exterior surfaces of each tube with an absorbent cloth.
 Place the tubes in horizontal position on a sheet of absorbent blotting paper in an oven maintained at temperature of 60 ± 3 for 8 hours.
 No significant leakage occurs during or at the completion of the test.
 If leakage is observed from one, but more than one of the tubes repeat the test with 20 additional tubes of the ointment.

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Opthalmic preparation

  • 1.
  • 2.
  • 6.
  • 7.
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  • 64.
  • 65. Thoroughly clean and dry the exterior surfaces of each tube with an absorbent cloth.
  • 66. Place the tubes in horizontal position on a sheet of absorbent blotting paper in an oven maintained at temperature of 60 ± 3 for 8 hours.
  • 67. No significant leakage occurs during or at the completion of the test.
  • 68. If leakage is observed from one, but more than one of the tubes repeat the test with 20 additional tubes of the ointment.
  • 69.
  • 70. Cover the dishes and heat at 850C for 2 hours, increasing the temperature slightly if necessary to ensure that a fully fluid sate is obtained.
  • 71. Taking precautions against disturbing the melted sample, allow each to cool to room temperature and to solidify.
  • 72.
  • 73. Count the number of metal particles that are 50µm on larger in any dimension. 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.
  • 74.
  • 75.
  • 78.
  • 79.
  • 80. Weight loss by water vapor transmission
  • 81.
  • 82.
  • 83.
  • 84.