Expert: Joe Haynes, R.Ph., MBA - 3/5/2009

Question
QUESTION: working with a contract manufacturing company to make an ear drying product for water clogged ears. There is all ready two products on the market using the same active ingredients 95% isopropyl alcohol and 5% anhydrous glycerin.
I need to find the manufacturing directions/formula/preperations for it. Or they will charge me $3500 bucks to formulate it. It seems rather silly to pay that much when the formula has all ready been done.
Help. :-)

ANSWER: Hi Dawn-
Wow, that's a tough one. I did a general Google search under the general topics topics of medicinal chemistry, synthetic chemistry, and pharmaceutical manufacturing. I would suggest starting there. If there is a pharmacy school near you, you could speak to their pharmaceutics or medicinal chemistry departments for help as well.
Unfortunately, even though ethanol/glycerin combination products have been around for awhile it is not likely that the proprietary synthetic processes will be published.

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QUESTION: Hi Joe,
Can you explain what you mean by proprietary SYNTHETIC PROCESSES? Meaning there are other ingredients to the product or does that mean there is a certain way you mix the alcohol and glycerin together?
Thank you for your answers they are helpful. I have actually sent an email to U of SAN FRAN they have a pharm school. (do you think it might be possible to have or find students formulate this mixture for me? Or at the very least write waht they manufacturing instructions would be so I could then send THAT to contract co and all they have to do is mix it?? ALSO I just talk to another lab they said they want $65k to do it. What ever happen to the "generic" version the name brand(s) have gone before me and done the hard expensive work, it works for RX drugs why can't the same rule apply to OTC remedies??

Answer
Hi Dawn-
Yes, most proprietary products contain ingredients other than the active ingredients to help with dissolution, lubrication, adjustment of pH, etc. When I say synthetic I am referring to the "synthesis" or creation of the final product. I wouldn't recommend mixing lab grade components together just to have something to make or sell. Things that go in the ear should also be sterile because the moist environment of the ear canal can grow bacteria and fungi.

Your best bet with USF would be to find a medicinal or pharmaceutical chemistry grad student to help you. Questions from the community can help drive some of their research so you will be helping them out too.

As for the research for OTC's, they still have to be proven safe and effective in some form of a clinical trial. Since you would be making a version of something that already exists, you wouldn't have to go through that. You would just have to show that your product is comparable in efficacy and safety against the innovator product (if you are planning to mass produce and market it. If this is just for your own personal use, then no).