Opthalmics Preparation and its Evaluation parameters

Contented and Precise, opthalmic preparation , preparation and evaluation of opthalmics

1. PACKAGING AND EVALUATION OF OPHTHALMIC PRODUCTS By S.KAVYA M.PHARMACY SRMC&RI

2. CONTAINERS PLASTICS . It has Sorption & Permeability characteristics .There are LDPE & HDPE GLASS .It is employed as the container of choice .Type1:Neutral borosilicate & Type2,3&4

3. GLASS Type 2 : Treated Soda lime Type 3 : Regular soda lime glass of limited Alkalinity.. Type 4 : Soda lime glass not suitable for containers for parenterals..

4. COLOUR CODING

5. TYPES

6. EYE DROPS Traditionally , Glass bottle with Rubber teat dropper were widely used… Example : Atropine eye drops ..

7. EYE drops

8. Eye Lotion Eye lotions are packed in LDPE or HDPE bottles Either it has a “Brush “ Or it has a “roller” for administration.. Eg : sodium chloride eye lotion

9. Eye lotioN

10. Eye Ointment.. Flexible “ Plastic or Collapsible Metal tubes ’’ Eg : Neosporin E ye Ointment & Tetracycline Eye O intment.

11. EYE OINTMENT

12. O cular Inserts Ocular inserts: prep meant for treating ophthalmic diseases like GLAUCOMA Eg : Pilocarpine ocuserts ..

13. OCULAR INSERTS

14. Contact lenses A thin plastic lens placed directly on the surface of the eye to correct visual defects Packed in Polyester bags then 2* packing is done by packing in a wide mouth bottle..

15. CONTACT LENS

16. EVALUATION PARAMETERS Its Ophthalmics

17. Evaluation Evaluation of the Opthalmic product was done by the following tests . 1) Sterility test 2) Clarity test 3) Leakage test 4) Metal particles in opthalmic products. 5) Assay 6) pH 7) Viscosity

18. Sterility tesT 1 . Direct inoculation method : The test samples are test using culture media. 2. Membrane filtration method : * Filtering of test samples using membrane filter. * Wash the membrane filter. * Transfer it to the media Eg : Soya digest media.. * Then check for microbial growth

19. Membrane filter & soya bean digest medium

20. Clarity test Visual inspection : Bottles are viewed in light & dark background. Instrumental Method : * A light ray is passed * The light gets scattered into t he Product * The instrument images all the undissolved particles in the product ..

21. Clarity test Light & D ark Background.

22. Leakage test. Take 10 opthalmic ointments Wipe it well at both the ends It should be sealed Keep it in hot air oven for 60 degree celsius for 8 hours If there is no leakage the opthalmic preparation passes the test..

23. Leakage test.. For all opthalmic products …

24. Metal partices in opthalmic products. 10 g of 10 ml of opthalmic preparation is taken in a petri dish Then it is heated at 85 degree celsius for 2 hours Then cool at room temperature to solidify Slightly invert the petridishes in he stage o a suitable microscope Observe he metallic compounds in it .

25. Metal detector

26. Assay & p H The sample is titrated against the standard. pH : The ph of the opthalmic preparation should be equal to that of the lachrymal secretions.. OPTIMUM PH : 7.4 The pH is tested usind the ph paper or ph meter

27. p H meter .

28. viscosity In the preparation of O phthalmics various thickening agents are used… OPTIMAL VISCOSITY : 15 – 25 Centipoise They are added to increase the ocular contact time. And to reduce the surface tension Viscosity is measured by Brookfield’s viscometer & Rolling ball viscometer ..

29. Brookfield’s viscometer

30. Stability Stability study can be done by 2 methods.. Accelerated stability study. Freeze thaw method.

31. Stability chamber

32. summary The total summary of ophthalmics includes 1)Definition & its types 2)Ideal properties of the ophthalmic products 3)Formulation 4)Preparation 5)Sterility testing And packaging & evaluation…

33. Definition Ophthalmic prep are sterile & specified dosage forms designed to be instilled onto the external or internal surface of the eye with a help of a ophthalmic device .

34. Structure of eye…

35. Ideal properties of Ophthalmic preparations.

36. Ideal properties

37. Sterility testing

38. Formulation of ophthalmic products Basically a ophthalmic preparation should contain Tonicity modifier – Dextrose & Nacl &Kcl surfactants - polyethylene sorbitane mono oleate (0.1-0.5%) sorbitane mono oleate (0.05-0.25%) Antioxidants – Ascorbic acid - 0.02-1 Sodium bisulphite - 0.1-0.15

39. formulation Solubilizing agent : Alcohol Glycerine Polyethylene glycol Lecithin Buffers : Acetates Citrates Phosphates Chelating agent : EDTA, Citric acid & Tartaric acid.

40. Formulation of eye drop Prepare the vehicle containing the preservative. Then add antioxidant , surfactant , tonicity modifier buffer Add the active ingredient Vehicle is made up to the volume. Then it is clarified using sintered glass filter then sealed

41. Eye ointment Ointment base is sterilized by heat Remove the foreign matter when it is molten It is placed in Steam jacketed kettle Previously sterilized active ingredient is added The above all are carried in aseptic condition Then it is passed through a previously sterilized colloid mill to attain uniformity.

42. Contact lenses Soft contact lenses: made up of hydrophilic transparent plastic “ hydroxy ethyl methacrylate’’ It contains 30 -80% of water. It is of 2 types Daily wear Extended wear..

43. Thank you