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OPHTHALMIC PRODUCTS
Sukanta satapathy
Asst.professor
Centurion University of Technology and
management
OPHTHALMIC PRODUCTS
 Ophthalmic products are sterile products
meant for instillation into the eye.
 Ophthalmic products includes
Eye-drops
Eye-lotions
Eye ointments
Eye suspension
Contact lens solution
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CONTACT LENS SOLUTION
 CONTACT LENS SOLUTIONS
 a Contact lenses are usually made from polymethyl methacrylate which is a
hard hydrophobic plastic.
 Nowadays, some softer hydrophilic lenses are also used.
 Hard Contact Lenses Wearers generally use two solutions.
損 1-Wetting solution
損 2- Storage solution
 1. Wetting solution :
 It is used primarily for treating the lenses before insertion in to the eye.
 The formulation of contact lens solution may contain a
 wetting agent,
 thickening agent (cellulose derivative),
 antimicrobial agent (benzalkonium chloride, chlorohexidine),
 isotonicity adjusters (sodium chloride) .
2. Storage solution
It is used for overnight cleansing, soaking and storage.
The contact lenses after its removal from the eye are
cleaned with wetting solution and rinsed with purified
water.
Then they are stored in a storage solution to prevent
dehydration.
The formulation of storage solution contains a non-ionic
surface active agent which will help in cleaning the contact
lenses.
It also contains preservatives to prevent the microbial
growth.
EYE DROPS
Eye drops are sterile aqueous or oily soultions or suspensions
of drugs that are instilled into the eye with a dropper.
They usually contains drugs like antiseptics,anaesthetics,anti-
inflammatory properties.
Essential characteristics of eye-drops
 It should be sterile.
 They should be iso-osmotic with lachrymal secretions.
 Should be free from foreign particles, fibres and filaments.
 They should have almost neutral pH.
 They should be preserved with a suitable bactericide.
 . They should remain stable during its storage.
Formulation of Eye-drops
 The eye drops are prepared in 4 stages.
 1. Preparation of bactericidal and fungicidal vehicle : The aqueousus
or oily vehicle is used in the preparation of eye-drops.
 The aqueous vehicle may support bacterial or fungal growth, so one of the
following bactericide may be used to preserve the eye-drops:
 (i) Phenylmercuric nitrate/acetate 0.002%
 ii) Benzalkonium chloride 0.01%
 (iii) Chlorohexidine acetate 0.01%
 benzalkonium chloride is not suitable as preservative for eye-drops
containing local anaesthetics.
2 Preparation of solution of medicament(s) and adjuvants :
 rnedicament(s) are dissolved in the aqueous vehicle containing-
antimicrobial agent. The adjuvants are also dissolved in this stage to form a
stable preparation.
 3-Clarification
 The eye drops are clarified by passing the solution
through membrane filter with pore size 0.8 袖m
 4-Sterilisation
 The eye drops are sterilised by
Autoclaving,
Filtration through bacteria proof filter.
Heating with bactericide at 98-100 c for 30
minutes
 Containers
 The eye drops packed in neutral glass containers of 4-8
ml .
 Plastic squeeze bottles with rigid plastic cap and
polythene friction plug containing baffle that produces
uniform drops.
 These are sterilised by gaseous sterilisation method.
 Labelling
 should be 'For External Use Only along with storage
conditions to maintain full activity.
adjuvants used in the preparation of
eye-drops :
 adjuvants used in the preparation of eye-drops :
 The following adjuvants are used in the preparation of eye drops:-
 1. Thickening agent : The thickening agents, such as, methyl cellulose. carboxy
methyl cellulose, polyvinyl alcohol, polyethylene glycol are used to increase the
viscosity of eye-drops. It will also help to prolong the contact time of the drug in
the eye.
 2. Buffers : Buffers are added to adjust and maintain the pH of the eye-drops.
 The pH of the eye drop is adjusted to maintain chemical stability to reduce
discomfort and to improve clinical response.
 The boric acid, sodium acid phosphate, sodium citrate are commonly used as
buffers.
 3. Anti-oxidants : They are added in several eye-drops to provide protection from
oxidation.
 Sometimes the eye-drops are protected from oxidation by replacing the air in the
container with an inert gas.
 Sodium metabisulphite (0.05 to 0.5%) and sodium thiosulphate (0.1 to 0.2%) are
commonly used as antioxidants.
4.Wetting agents
 These are used for penetration of eye drops into
the cornea of the eye.
 Polysorbate 20 and polysorbate 80
5.Isotonicity adjustment substance
 Eye drops are made isotonic with lachrymal
secretion with buffers.
 Examples of eye drop
 Atropine eye drop, physostigmine eye drop
EYE LOTION
 These are the sterile aqueous solutions used for washing of the
eyes.
 The eye lotions are supplied in concentration form and diluted with
warm water before use.
 They are usually applied with a clean eye-bath or sterilised fabric
dressing and a large Amount of solution is allowed to flow quickly
over the eye.
 Eye lotions should be isotonic and free from foreign particles to
avoid irritation to the eye.
 They are required to be prepared fresh and should not be stored
for more than two days as the lotion may get contaminated with
micro-organisms.
 The drugs used for preparing eye solutions include sodium chloride,
sodium bicarbonate, boric acid, borax or zinc sulphate.
Formulation of Eye Lotions
 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.
 The eye-lotions should be sterile.
 The eye lotions are sterilised by autoclaving or by
passing through bacteria proof filters.
 Sodium chloride eye lotion and sodium
bicarbonate eye lotion are commonly used to
remove foreign substances from the eye.
EYE OINTMENT
 Eye ointment are sterile preparations meant
for application to the eye.
 These are prepared under aseptic condition
and packed in sterile collapsible tubes .
 Eye applicaps contain only one application of
the eye ointment preparation.
FORMULATION OF EYE OINTMENT
 The ointment base selected for eye-ointment
should be non-irritant to the eye.
 The ointment base should melt near to the
body temperature to permit the diffusion of
the drug in the eye.
 Yellow soft paraffin should be used instead of
white soft paraffin .(because white soft
paraffin contain bleaching agent may lead to
irritation.
Container
 Eye ointment should be supplied in metal or
plastic collapsible tubes.
 The tube must be fitted with a nozzle of
suitable shape for application of ointment into
the eyes without contamination.
 Eye ointment should be stored in a cool place.
EYE SUSPENSION
 The eye suspensions are prepared when the drug
is insoluble in the desired vehicle or unstable in
liquid form.
 Prepared for sustained action of the preparation.
 Essential characteristics-
 They should be sterile
 Isotonic
 Desired viscosity
 Fine particle size
 Suitably packed in a container.
References
 Pharmaceutics-2 R.M MEHTA vallabh
prakasan.
THANK YOU

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Ophthalmics

  • 1. OPHTHALMIC PRODUCTS Sukanta satapathy Asst.professor Centurion University of Technology and management
  • 2. OPHTHALMIC PRODUCTS Ophthalmic products are sterile products meant for instillation into the eye. Ophthalmic products includes Eye-drops Eye-lotions Eye ointments Eye suspension Contact lens solution
  • 10. CONTACT LENS SOLUTION CONTACT LENS SOLUTIONS a Contact lenses are usually made from polymethyl methacrylate which is a hard hydrophobic plastic. Nowadays, some softer hydrophilic lenses are also used. Hard Contact Lenses Wearers generally use two solutions. 損 1-Wetting solution 損 2- Storage solution 1. Wetting solution : It is used primarily for treating the lenses before insertion in to the eye. The formulation of contact lens solution may contain a wetting agent, thickening agent (cellulose derivative), antimicrobial agent (benzalkonium chloride, chlorohexidine), isotonicity adjusters (sodium chloride) .
  • 11. 2. Storage solution It is used for overnight cleansing, soaking and storage. The contact lenses after its removal from the eye are cleaned with wetting solution and rinsed with purified water. Then they are stored in a storage solution to prevent dehydration. The formulation of storage solution contains a non-ionic surface active agent which will help in cleaning the contact lenses. It also contains preservatives to prevent the microbial growth.
  • 12. EYE DROPS Eye drops are sterile aqueous or oily soultions or suspensions of drugs that are instilled into the eye with a dropper. They usually contains drugs like antiseptics,anaesthetics,anti- inflammatory properties. Essential characteristics of eye-drops It should be sterile. They should be iso-osmotic with lachrymal secretions. Should be free from foreign particles, fibres and filaments. They should have almost neutral pH. They should be preserved with a suitable bactericide. . They should remain stable during its storage.
  • 13. Formulation of Eye-drops The eye drops are prepared in 4 stages. 1. Preparation of bactericidal and fungicidal vehicle : The aqueousus or oily vehicle is used in the preparation of eye-drops. The aqueous vehicle may support bacterial or fungal growth, so one of the following bactericide may be used to preserve the eye-drops: (i) Phenylmercuric nitrate/acetate 0.002% ii) Benzalkonium chloride 0.01% (iii) Chlorohexidine acetate 0.01% benzalkonium chloride is not suitable as preservative for eye-drops containing local anaesthetics. 2 Preparation of solution of medicament(s) and adjuvants : rnedicament(s) are dissolved in the aqueous vehicle containing- antimicrobial agent. The adjuvants are also dissolved in this stage to form a stable preparation.
  • 14. 3-Clarification The eye drops are clarified by passing the solution through membrane filter with pore size 0.8 袖m 4-Sterilisation The eye drops are sterilised by Autoclaving, Filtration through bacteria proof filter. Heating with bactericide at 98-100 c for 30 minutes
  • 15. Containers The eye drops packed in neutral glass containers of 4-8 ml . Plastic squeeze bottles with rigid plastic cap and polythene friction plug containing baffle that produces uniform drops. These are sterilised by gaseous sterilisation method. Labelling should be 'For External Use Only along with storage conditions to maintain full activity.
  • 16. adjuvants used in the preparation of eye-drops : adjuvants used in the preparation of eye-drops : The following adjuvants are used in the preparation of eye drops:- 1. Thickening agent : The thickening agents, such as, methyl cellulose. carboxy methyl cellulose, polyvinyl alcohol, polyethylene glycol are used to increase the viscosity of eye-drops. It will also help to prolong the contact time of the drug in the eye. 2. Buffers : Buffers are added to adjust and maintain the pH of the eye-drops. The pH of the eye drop is adjusted to maintain chemical stability to reduce discomfort and to improve clinical response. The boric acid, sodium acid phosphate, sodium citrate are commonly used as buffers. 3. Anti-oxidants : They are added in several eye-drops to provide protection from oxidation. Sometimes the eye-drops are protected from oxidation by replacing the air in the container with an inert gas. Sodium metabisulphite (0.05 to 0.5%) and sodium thiosulphate (0.1 to 0.2%) are commonly used as antioxidants.
  • 17. 4.Wetting agents These are used for penetration of eye drops into the cornea of the eye. Polysorbate 20 and polysorbate 80 5.Isotonicity adjustment substance Eye drops are made isotonic with lachrymal secretion with buffers. Examples of eye drop Atropine eye drop, physostigmine eye drop
  • 18. EYE LOTION These are the sterile aqueous solutions used for washing of the eyes. The eye lotions are supplied in concentration form and diluted with warm water before use. They are usually applied with a clean eye-bath or sterilised fabric dressing and a large Amount of solution is allowed to flow quickly over the eye. Eye lotions should be isotonic and free from foreign particles to avoid irritation to the eye. They are required to be prepared fresh and should not be stored for more than two days as the lotion may get contaminated with micro-organisms. The drugs used for preparing eye solutions include sodium chloride, sodium bicarbonate, boric acid, borax or zinc sulphate.
  • 19. Formulation of Eye Lotions 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. The eye-lotions should be sterile. The eye lotions are sterilised by autoclaving or by passing through bacteria proof filters. Sodium chloride eye lotion and sodium bicarbonate eye lotion are commonly used to remove foreign substances from the eye.
  • 20. EYE OINTMENT Eye ointment are sterile preparations meant for application to the eye. These are prepared under aseptic condition and packed in sterile collapsible tubes . Eye applicaps contain only one application of the eye ointment preparation.
  • 21. FORMULATION OF EYE OINTMENT The ointment base selected for eye-ointment should be non-irritant to the eye. The ointment base should melt near to the body temperature to permit the diffusion of the drug in the eye. Yellow soft paraffin should be used instead of white soft paraffin .(because white soft paraffin contain bleaching agent may lead to irritation.
  • 22. Container Eye ointment should be supplied in metal or plastic collapsible tubes. The tube must be fitted with a nozzle of suitable shape for application of ointment into the eyes without contamination. Eye ointment should be stored in a cool place.
  • 23. EYE SUSPENSION The eye suspensions are prepared when the drug is insoluble in the desired vehicle or unstable in liquid form. Prepared for sustained action of the preparation. Essential characteristics- They should be sterile Isotonic Desired viscosity Fine particle size Suitably packed in a container.
  • 24. References Pharmaceutics-2 R.M MEHTA vallabh prakasan.