Microformulation
Forum Replies Created
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Making Cosmetics is simply repacking a Lincoln Fine Ingredients Preservative; Linnatural MBS-2. http://www.lincolnfineingredients.com/products/133-Caprylic+Acid%2C+1%2C3+Propandiol+%28Natural%29%2C+Lauric+Acid%2C+Potassium+Sorbate.htm
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This is an area that I have some experience in.
Firstly, an ingrown toenail and toenail fungus. Different causes, presentation of symptoms and treatment.
An ingrown toenail is a physical condition where the toenail grows into the nail bed abnormally and causes pain. The most common cause is too aggressive trimming of the nails. In this case it is usually a minor outpatient procedure. A local anesthetic is applied, the nail removed in a sterile manner, antibiotics are prescribed, a dressing is applied and wound care follow-up is completed.
Toe nail fungus (also known as Onychomycosis or Tinea unguium) is an actual fungal infection of the nail. It is characterized by discoloration and thickening of the nail. The treatment centers around the use of Prescription or OTC topical products. The FDA has a monograph that will designate which anti-fungal actives can be used for the indication. Not every anti-fungal is approved. I have seen some “homeopathic” and/or “Natural” alternatives sold but I feel they encroach upon the OTC monograph in spirit. Also this is a case where an OTC or Physician involvement is warranted. NOT EVERYTHING HAS TO BE A NATURALLY INSPIRED PRODUCT. This is a case where established medicine has a strng history of effectiveness.
Tinea ungium also is unique to other fungal infections. Most fungal infections (Tinea pedis, Tinea cruris) will have a “cosmetic” resolution well before they are fully eliminated. What this means is the redness, irritation and itching will resolve well before the fungus is fully cleared up. This is why most products are recommended to be used for a period of time after the cosmetic symptoms abate. Tinea ungium is the exception. The fungus can be totally eradicated but you will still see the “cosmetic” appearances for the most part until the nail is replaced through normal growth. The changes in the appearance (yellowing, thickened nails) can be addressed by nail care (filing, trimming, routine care) and many nail shops will provide this service.
I see numerous “Cosmetic” products looking to treat this condition but I think we are remiss to provide these products. This is really a case where an OTC product is most warranted. While there is a strong belief in Natural Medicine and “natural” remedies we have an obligation to not interfere with appropriate Medical Management when warranted.
I suppose your only recourse would be to make an OTC product but generally this requires a higher level of documentation, experience and Registartion with the FDA as an OTC Labeler.
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Feel free to email me at markfuller@microformulation.com. My contact info and capabilities are on my website http://www.microformulation.com. I formulate only and will assist you in sourcing out Production.
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Great discussion! I see these Ingredient lists abused in the smaller Markets. You couldn’t guess how many times I have to delete out the “Organic” this and “wildcrafted” that in the ingredient deck before I can even begin to start breaking it down. Keep the INCI names only in the listings! You have all the rest of the label for marketing!
Many people are reluctant to disclose their ingredient lists despite what the law requires. They feel that it just makes their product easier to copy. Firstly, with some extra work someone can replicate the performance of your product. That is what we do. Secondly it is the law and if we can’t do things right, don’t do them at all.
Perry makes a great point. We have workable Cosmetic Regulations. We just have to learn them and follow them.
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Grant also supplied Dimethyl isosorbide (Gransolve DMI).
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Global 4075 from Stepan thickens with the addition of Na Stearate. Pretty easy to use and lots of Formulation guidance.
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You could consider an easier Salicylic acid such as Salvona’s product. Much easier to work with especially at the lower level you need.
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Generally when they claim a high level of Vitamin C (I call it chasing the Perricone dragon) they are using a more stable form of Vitamin C. L-Ascorbic acid is a HUGELY flawed Cosmetic active in the fact that in an aqueous product you will have oxidation and hence browning unless you can isolate the product (many ways). For water based Vitamon C look at Sodium Ascorbyl Phosphate or Magnesium Ascorbyl Phosphate. For the lipid phase you have Ascorbyl Palmitate or many other forms.
Unfortunately I have seen products imply that 1 part Ascorbyl Phosphate equals 1 part Ascorbic acid. This is not true.
It is common to see these products used that high. But in my experience I see that the Vitamin C certainly peaks in activity at much lower levels. In many cases they lose the advantage of using other actives as well when they “chase the Perricone Dragon.” -
Here is the definition. It is a colloquialism for an ointment not a Technical term. Sorry I jump on the work “pill” also. That isn’t recognized under USP either. It is either a tablet or a capsule and subcategories thereof.
salve
sav,säv/nounnoun: salve; plural noun: salves1.an ointment used to promote healing of the skin or as protection.synonyms: ointment, cream, balm, unguent, emollient; -
You could try for a nonaqueous silicone base much like this article;
https://drive.google.com/file/d/0BwuqL_fQzYhiZjB5SFFDZ2JaU3c/edit?usp=sharing
As a Pharmacist and a purist, what is a salve? I don’t believe that it is a recognized dosage form. Were you referring to an ointment?
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I have used Ben at Cosmetic Test Labs and sent clients his way. He has nothing but ringing endorsements. Definitely the way to go.
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RT Vanderbilt
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Only thing I know of is FillTech, but in Charlotte.
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Client gets pricing, go back 4 spaces and reformulate.
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Do you mean I need to stop using my Cosmetic grade Magic Eight Ball?
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You do see it come up often. I give limited advice and guidance. I share others issue when someone posts “I need Formula X and it needs to be unique, safe, Natural…” (Add adjectives here.
Many of us do this for a living. You wouldn’t call a mechanic and ask him to walk you through how to fix your car for free. You wouldn’t call a plumber and ask him to tell you how to repair your sink for free. You wouldn’t call your Doctor and ask for free advice (successfully at least).
That said I think there is a great deal of advice and guidance given on this website up to that point. You just need to be aware that most of us WORK in this area.
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@palaquin I am glad it worked out. Feel free to send me a message so I know who did a good job. I get inquiries from all over the World and I like to have good sources and people to send them onto. Due to the differences in Suppliers and Regulatory issues I generally pass on any clients outside of the US. For example I designed a great cleanser for a client. He (unbeknowst to me) took it to India and couldn’t get any of the materials. It really pays to use someone regional.
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I have worked with DavidW in the past and he is very good. He is dead on though about needing Formulas or simply going Private Label.
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Do you already have validated Formulations?
If so I would recommend talking with DavidW on here. Like for most of us he is pretty busy but he does great work.
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I would place an advertisement with the Carolinas Chapter SCC. I believe they have a newsletter coming out pretty soon. The Chapter is very active in your area.
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Those stick tests are for the presence of bacteria/yeast/mold as a “snapshot” in a fixed point in time. Very analogous to APC Testing but less accurate. USP 51 is a totally different test. As such the comparison is flawed. I have used those test “stick” in plant sanitation monitoring but again I prefer to send tests out when need be. The concept of “Third Party Validation” is critical in a QA Program.
Nobody is doing home PET. The sticks roughly allow them to do an analogous test to APC. That is ok for a home tester. It doesn’t pass the level of scrutiny for a Contract Manufacturer.
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I have used the SAP and gotten a stable product. I believe we added Sodium metabisulfate.
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No offense, but I would leave the micro testing to the pros. It is an involved test that is best done by a specialist. Also, using an outside lab gives you third party validation.
With a well thought out and designed preservative system you should be able to feel comfortable sending your samples for USP 51 testing without attempting the test in-house.
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An inline speed regulator will not work with a solid state mixer. Believe me I once saw someone try one with an Arde Barrinco drop-in homogenizer with disasterous results.
Saw Tooth impellers will give you some shear, but remember sometimes you have to mix without shear. For example after you have neutralized a carbomer, high shear will tear it up.