Ophthalmic product

This PPT file for Pharmacy

1. O phthalmic P roduct Bushra F. Deshpande M. Pharm (Pharmaceutics)

2. What is ophthalmic product………… ? Ophthalmic product ( Eye Product) are sterile, liquid, semi- solid product that may contain one or more active pharmaceutical ingredient intended for application to the conjunctive, the conjunctival sac or the eyelids.

3. Eye drop Ophthalmic product Eye lotion Eye ointment Eye suspension Contact lens solution

4. Essential characteristics of different ophthalmic preparations 1. Foreign particles 2. Viscosity 3. Tonicity 4. pH of the preparation 5. Sterility 6. Surface activity BFD

5. 1. Foreign particles All the ophthalmic products should be clear and free form foreign particles, fibres and filaments. Ophthalmic solution should be clarified very carefully by passing through bacteria proof filters Membrane filters Sintered glass 2.Viscosity In order to per long the contact time of the drug in the eye, various thickening agents are added in the ophthalmic preparations. 3. Tonicity Ophthalmic product must be isotonic with lachrymal secretions to avoid discomfort and irritation

6. 4.pH of the preparation pH plays an important role in therapeutic activity, solubility, stability and comfort to the patient. Tears have a Ph of about 7.4. 5. Sterility Ophthalmic preparation must be sterile when prepared. 6. Surface activity Vehicles used in ophthalmic preparation must have good wetting ability to penetrate cornea and other tissue.

7. Eye Drops Eye drops are sterile aqueous or oily solutions or suspensions of drugs that are instilled into the eye with a dropper.

8. Essential characteristics of eye drop: They should be sterile. They should be iso -osmotic with lachrymal secretions. They 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.

9. Formulation of Eye drops 4 stages 1. Preparation of bactericidal and fungicidal vehicle 2. Preparation of solution of medicaments and adjuvants 3. Clarification 4. Sterilization : BFD

10. 1. Preparation of bactericidal and fungicidal vehicle: The aqueous or oily vehicle is used in the preparation of eye drop. The aqueous vehicle may support bacterial or fungal growth, so used to preserve the eye drop e.g : Phenylmercuri, Benzalkonium 2. Preparation of solution of medicament and advents: The medicament are dissolved in the aqueous vehicle containing suitable antimicrobial agent. The adjuvant are also dissolve in the vehicle at this stage to form a stable preparation. 3. Clarification: The eye drop are clarified by passing the solution through membrane filter having pore size of 0.8 µ. The clarified solution is immediately transferred into final containers and sealed to exclude micro-organism 4. Sterilization: The eye drop are sterilized by autoclaving or heating with bactericide at 98° C to 100°C for 30 minutes or filtration through bacteria proof filter. 5. Containers: The eye drop should be packed in neutral glass containers or in a suitable plastic container. Now days, neutral glass small bottles having capacity of 4ml to 8ml are used. It has two polypropylene screw caps, one for attaching a silicon rubber teat to the container and the other for covering the teat.

11. Labelling Eye drop should be labelled ‘ For External use only’ along with storage conditions to maintain full activity

12. Adjuvants used in the preparation of eye drop Thickening agent 2. Buffer 3. Anti-oxidants 4. Wetting agents 5. Isotonicity adjustment substances

13. Thickening agent: The thickening agent, such as, methyl cellulose, carboxyl methyl cellulos are used to increase the viscosity of eye drop. 2. Buffer: Buffer are added to adjust and maintain the pH of the eye drop. 3. Antioxidant : They are added in several eye drop to provide protection from oxidation 4. Wetting agent: These are used for proper penetration of eye drop into the cornea of the eye. 5. Is tonicity adjustment substances: Eye drop are made iso tonic with lachrymal secretion with the help of various buffers and other solution.

14. If the dropper is separate, always hold it with its tip down. Never touch the dropper surface. Never rise the dropper Never use eye drop that have changed colored When the dropper is at the top of bottle, avoid contaminating the cap when removed. After instillation of drop, do not close eyes tightly or blink more often than usual as this may remove the medicine from the place where it is needed. Precaution used in handling eye drop

15. Example: Prepare and dispense 100ml of atropine eye drops B.P.C Atropine sulphate 1g Phenyl mercuric nitrate 50.0ml Solution 0.002% Purified water, add up to 100ml Make an eye drop Direction: To be used as directed Method: Dissolve phenyl mercuric nitrate in purified water and prepare 0.002% solution. Dissolve atropine sulphate in 50ml of phenyl mercuric nitrate solution. Add purified water to make 100ml. Filter the solution through membrane filter. Transfer the solution to final container and sterilize it by autoclaving at 115° C for30 minutes. Clean the bottle, label and dispense. ℞

16. These are the sterile aqueous solution used for washing of the eyes. The eye lotions are supplied in concentrated from and are required to be diluted with warm water immediately before use Eye lotions

17. Formulation Of Eye Lotions Eye lotion are simple solution. They are iso osmotic with tears because they cause much greater dilution of the lachrymal fluid and are more likely to cause discomfort if not adjusted. The eye lotions should be sterile because the large volume is used to remove the irritant from the eye.

18. Example: Prepare and dispense 100ml of sodium chloride eye lotion B.P.C Sodium chloride 9g Purified water to produce 100ml Method: Dissolve sodium chloride in purified water and made the final volume by adding more of purified water. Filter through sintered glass filter grade 4. The eye lotion is transferred to 5the bottle. Close and sealed the bottle sterilize it by autoclaving clean the bottle, label and dispense. Storage: Eye lotion are supplied in amber colored screw capped fluted bottles. The contamination during use discard any unused part after 24 hours. ℞

19. Eye ointments Eye ointments are sterile preparation meant for application to the eye

20. Formulation of eye ointments The ointment base selected for an eye ointment must be non irritating to the eye. The ointment base should melt near to the body temperature, so as to permit the diffusion of the drug through the lachrymal secretion of eye. For the preparation of eye ointment the following base Example: Yellow soft paraffin 80g Liquid paraffin 10g wool fat 10g Method: Melt wool fat, yellow soft paraffin on a water bath. Add liquid paraffin. Filter through coarse filter paper placed in heated funnel. It is sterilized by dry heat method. Incorporate the medicament with the eye ointment base. Pack in sterile containers. White soft paraffin is not used in the preparation of ointment base because it is prepared by bleaching the yellow soft paraffin. Some of the bleaching agent any remain sticking to the base eve after careful washing which when used in the eye may lead to irritation ℞

21. Contact lenses are usually made from polymethyl methacrylate which is a hard hydrophobic plastic. Hard contact lenses Wetting solution Storage solution Contact Lens Solutions

22. It is used primarily for treating the lenses before insertion. Due to its hydrophobic nature, polymethyl methacrylate is poorly wetted by lachrymal fluid of the eye. The contact lenses required moistening with a wetting agent to make the insertion easy and comfortable. The contact lenses solution are required to be used daily for years together, therefore, they should be prepared carefully and all the ingredients used should be of good quality. The formulation of contact lens solution may contain a wetting agent, thickening agent (cellulose derivative), antimicrobial agent ( benzalkonium chloride) 1. Wetting solution

23. 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 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. The solution should be changed after every few days because the preservatives may be practically inactivated by the organic materials present in the form of debris.

24. Soft Contact Lenses These are soft flexible type lenses. Certain medicaments from eye drop and preservatives from wetting and storage solution are strongly absorbed by the soft contact lenses. Due to this reason patients wearing soft contact lenses should be advised to remove them before instilling eye drops.

25. Containers Contact lens solutions are packed in containers designed to minimize the chances of microbial contamination of the product. The solution are generally stored in plastic container with inbuilt dropper which prevent the return of used or excess solutions to the container.