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Ophthalmic preparations
If anyone know about ophthalmic solution preparation I need a help … thanks in advance
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21 Replies
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This is a product that would need to be produced under sterile conditions such as a laminar flow hood.
This is not a simple product nor would it be a Cosmetic, (I am assuming it is meant to be applied to the eye itself).
This would be a Pharmaceutical product and if you don’t have the training nor the proper equipment, you would be reckless, foolish and dangerous to attempt such a product.
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okay I am a Pharmaceutical formulator and it is my first time to prepare such a solution and read about it a lot … and I have an ask in calculating NaCl eq. value so I want a help …
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@Mary24 That is likely outside of the scope of this forum. My background started in Pharmaceutical manufacturing. As I said, it will need to be done in a Pharmaceutical setting with a laminar flow hood.
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Okay thanks a lot
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pharmaceutical or medical device
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unfortunately jeremien I haven’t the device (Osmometer) till now and I have to calculate it theoretically before starting any trial
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@mary24, you have a lot to learn.
Calculating the NaCl quantity necessary is very easy. But this is the last step in the formulation. Do you have a stable formulation yet?m={[0.2308-(c*i+c1*i1+c2*i2+….)]M}/i’
m-> NaCl needed for 1000 ml solution
i’ -> dissociation degree (Van ‘t Hoff factor) for NaCl, in this case is 1.5
M -> NaCl molecular mass
i, i1, i2 etc -> is the dissociation degree (Van ‘t Hoff factor) for each substance in your formulation
c, c1, c2 etc -> is the concentration ‰ of each substance divided by the molecular mass of the respective substanceYou need a supervisor for this kind of formulation!
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You don’t need a supervisor, you don’t need a hood, you don’t need a medical device qualification, but you do need to compound standard saline solution (0.90% w/w NaCl) which every MD in the world uses, then you need to either package it aseptically or run the packaged goods through gamma radiation treatment to assure sterility. Plus, do not forget to apply tamper-evident seal to the package. Oh, and make sure you product liability insurance is paid up. You will likely need it, depending on the business volume.
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Just by using NaCl 0.9% solution instead of water, doesnțt mean you are good to go.
@chemicalmatt stop giving bad advices. -
thanks for everyone .. I searched well and got it … I am ready to apply the formula if there is anyone need a help in such preparations I am here
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@chemicalmatt
package it asepticallyIn this case you do need a laminar flow hood!
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In College we completed several credit hours before attempting any sterile products. To attempt this without specific training and “searching well” as ones sole credential is both reckless and dangerous. Hopefully you have the training and access to a laminar flow hood.
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I agree with @Doreen81 and @Microformulation you need a laminar flow and even with that you need to sterilize the whole container (preferably glass) after packaging with gamma ray.
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@Microformulation
To attempt this without specific training and “searching well” as ones sole credential is both reckless and dangerous.I am in full agreement.
Usually if people say ‘they’ve read about it a lot’ they’re not the slightest bit trained/educated in basic chemistry, let alone in microbiology or specialized (pharmaceutical) preparations. Using a laminar flowhood without exactly knowing what one is doing is indeed both reckless and dangerous.I’m still not sure what to think of it. You’ve come to a cosmetic forum to get help for an ophthalmic solution. If you’re a pharmaceutical formulator already, what point is there for us to give basic instructions? If there is still need for utter basic knowledge about aseptic preparations, such as the need for laminar airflow during aseptic preparations, I wonder if it’s wise at all? Haven’t you been an intern at the end of your study? I’ve spent four obligatory weeks as an intern before I prepared aseptic preparations individually.
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I’m a pharmacist and I was scared when I red about the OP having so limited info about sterile preparation, but still getting fully involved.
Again, I insist about the supervisor! -
My background is in Pharmacy and we used to compound specialty ophthalmic preparations. Cyclosporine for dry eye comes to mind, although it is available commercially now. We did it in a laminar flow hood using aseptic technique, To really get good with aseptic technique takes training and practice. Honestly much of it is driven home by days and weeks of experience in the hood. It becomes muscle memory.
I also did QA at a large Pharmaceutical manufacturer are well and they manufactured these products in a clean room under sterile condition’s and irradiated the containers for sterility.
Again, this is not something you learn on line. Otherwise it is a therapeutic misadventure waiting to happen.
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@Microformulation
To really get good with aseptic technique takes training and practice.Exactly. And perform (annual) broth/agar infusions for individual quality tests.
@em88
I was scared when I red about the OP having so limited info about sterile preparation, but still getting fully involved.I have no idea what you’re talking about?
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What exactly don’t you understand? Should I reformulate my statement again? @Doreen81
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@em88
I got it later on. You meant you were still worried about Mary24 being serious about it. -
Yes.
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well , guys it’s all about theoretical calculations, not at all about manufacturing , I appreciate your worry about the sterility and other precautions but It is not what I asked for.
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