Ciplox Eye Drops – Evaluation
Eye drops are sterile medicaments that contain a liquid solution. The eye drops are administered directly into the eye with the help of a special device called a dropper. There are various reasons that eye drops may be used such as redness of eyes, itching, and dryness of the eyes.Eye drops are also used for the treatment of many infections, and to reduce the pressure in the eyes that are caused due to different conditions like glaucoma.
There are a few eye drops that may also contain medicaments that dilate the pupil or minimize the inflammation.
As eye drops are sterile preparations so they should be stored and handled properly to avoid contamination as well as other complication that may also cause during the storage.
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There are the following types of tests that are performed during the evaluation of ciplox eye drops.
The eye drops or the ophthalmic preparations are tested for their sterility.
There are the following criteria that should be followed while performing sterility testing.
1) For the determination of aerobic and anaerobic bacteria and fungi there are two types of sterile culture media is to be prepared.
2) Now the test sample is transferred into the test tube that contains a clear medium.
3) The medium becomes turbid if the test sample contains microorganisms.
4) The medium remains clear if the sample did not contain microorganisms.
There are the following types of tests that are performed during the evaluation of ciplox eye drops.
(a) Test for Sterility
All ophthalmic preparations should be free from the viable organism as well as spores means should be completely sterile. The aseptic conditions should be carried out while performing the test.The eye drops or the ophthalmic preparations are tested for their sterility.
There are the following criteria that should be followed while performing sterility testing.
1) For the determination of aerobic and anaerobic bacteria and fungi there are two types of sterile culture media is to be prepared.
2) Now the test sample is transferred into the test tube that contains a clear medium.
3) The medium becomes turbid if the test sample contains microorganisms.
4) The medium remains clear if the sample did not contain microorganisms.
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(i) Membrane Filtration Method (Method A)
This method is generally followed for those products that are easily filtered and also performed in aseptic conditions.Step 1- The apparatus is composed of a sterilized filtration unit with a 0.45 pore size sterile membrane filter.
Step 2- A single membrane filter is separated into two halves.
Step 3- The membrane filter is used for filtering the test solution.
Step 4- For 7 days, one-half of the membrane will be placed in fluid thioglycollate medium at 30-35°C and the other half in soybean casein digest medium at 20-25°C.
Result
If there is no development in the medium, the sample solution passes the test.
If the medium grows, the experiment is repeated.
If the growth appears again, then the sample solution fails the test.
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Now incubate it at a specific temperature for 14 days and mixed it with the medium.
A part of the medium is transferred to a new medium between the third and seventh days of incubation; if it indicates turbidity, both the old and fresh media are incubated for 14 days.
Result
If there is no development in the medium, the sample solution passes the test.
If the medium grows, the experiment is repeated.
If the growth appears again, then the sample solution fails the test.
(ii) Direct Inoculation Method (Method B)
A specific amount of the solution to be evaluated is drawn with a clean syringe or pipette.Now incubate it at a specific temperature for 14 days and mixed it with the medium.
A part of the medium is transferred to a new medium between the third and seventh days of incubation; if it indicates turbidity, both the old and fresh media are incubated for 14 days.
Result
If there is no development in the medium, the sample solution passes the test.
If the medium grows, the experiment is repeated.
If the growth appears again, then the sample solution fails the test.
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(b) Test for Ocular Toxicity and Irritation
The isotonicity of the preparation is measured with the help of this test.Procedure
- Five albinoes (white) rabbits are selected.
- The iridal vessels of these rabbits can be easily examined for toxicity and irritation.
- The medicament is extracted using cottonseed oil or saline depending on the type of dosage form.
- Small amounts of the extract are administered into one eye of each rabbit, while the sterile saline solution is administered into the other eye.
- After one hour, all rabbits are examined for ocular irritation, swelling, or shrinking of an eye.
If there is no change in the eye into which the preparation is administered, the preparation under evaluation is satisfactory to use.
(c) Test for Preservative Efficacy
The culture of microorganisms that contains about 10,000-10, 00,000 organisms per ml is selected and these microorganisms are Candida albicans, Escherichia coli, Aspergillus niger, and Pseudomonas aeruginosa.In a sterilized test tube, three to four samples of each preparation are collected and inoculated with a few ml of each culture individually.
They are kept for 28 days and incubated at 20-25°C and are checked weekly for the development or appearance of turbidity.
If there is not occur any growth of microorganisms then it shows that the preservative is completely effective.
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Using a dialysis membrane, in vitro release was tested in compositions containing varying amounts of gelrite.
At 37°C ±0.5°C, the diffusion medium of 26 ml of synthetic tear fluid was agitated or stirred at 50 rpm.
With the help of a dialysis membrane, one end of the diffusion tube is covered.
The 1 ml solution is applied to the dialysis membrane, and the membrane is positioned so that it only contacts the diffusion medium in the receptor section.
The drug samples are taken out from the diffusion medium at one-hour intervals for an 8-hour time period and analyzed by a UV spectrophotometer at 261 nm with simulated tear fluid used as a blank.
Water at 25°C circulates through the adaptor's jacket.
Finally, the value of the viscosity is recorded.
I hope that you have liked the article on the evaluation of ciplox eye drops. In this article, I have talked about the various types of tests that are being performed during the evaluation of eye drops. If you have any points, please ask in the comment.
(d) Clarity
Visual inspection of the formulations under light against white and black backdrops determines the clarity of the formulations before and after gelling.(e) pH
The pH of each formulated ophthalmic formulation is measured using a pH meter. (equip-Tronics). Before each use, the pH meter is calibrated with standard buffer solutions of pH 4, 7, and 9.2.(f) In-vitro Diffusion Studies
By the use of bichambered donor recipients compartment mode, the in-vitro release studies are performed.Using a dialysis membrane, in vitro release was tested in compositions containing varying amounts of gelrite.
At 37°C ±0.5°C, the diffusion medium of 26 ml of synthetic tear fluid was agitated or stirred at 50 rpm.
With the help of a dialysis membrane, one end of the diffusion tube is covered.
The 1 ml solution is applied to the dialysis membrane, and the membrane is positioned so that it only contacts the diffusion medium in the receptor section.
The drug samples are taken out from the diffusion medium at one-hour intervals for an 8-hour time period and analyzed by a UV spectrophotometer at 261 nm with simulated tear fluid used as a blank.
(g) Determination of Viscosity
A specific amount of prepared ophthalmic solution is transferred in a sample cell that is very carefully positioned within the adaptor.Water at 25°C circulates through the adaptor's jacket.
Finally, the value of the viscosity is recorded.
I hope that you have liked the article on the evaluation of ciplox eye drops. In this article, I have talked about the various types of tests that are being performed during the evaluation of eye drops. If you have any points, please ask in the comment.
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