Microformulation
Forum Replies Created
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If you are creating this product for Commercial use, your number one biggest mistake is using drops as a measurement rather than wt./wt.%. Measuring by weight ALWAYS is the only way to ensure consistency. If you had used this process, it would be much easier to determine the accuracy of your processes.
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I agree with @MarkBroussard in every aspect. This is a project that can not ethically be called “natural” but perhaps “nature identical.”My question (and I already know the answer), is it absolutely critical that you call this “natural?” With every line claiming “natural” (no legal definition, don’t be naive of that fact), would such a claim set you apart from the market? Or will you need a better marketing story?An effective product balances price (in line with the market), performance and the “sustainability/natural” aspects as well. Like a three-legged stool, you need to balance these three aspects. To simply bang away on “natural” creates a poorly selling one-legged stool.
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No, Honestly I would never make this claim ever. You are not 100% Natural arguably. The Federal Trade Commission (not the FDA) will hammer you for this if they have to weigh-in. There have been several issues in the past 3 years for this claim, which is one dimensional and of lesser value than a coherent material standard. Keep the preservative. Never compromise safety for a “buzzword.” Never.
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Go to Youtube and search for the Sucragel. They have great videos. The issue for me is that the rate at which the phases are added. You must go super slow. Also, they show a way to make the oil gel without a Homogenizer. In my experience, it is nearly impossible to get a stable gel that way.
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MarkBroussard said:Yes, you can make some interesting products with it, but generally it is way too finicky, requires special process so is difficult for contract manufacturers to scale up. I do you use it, but only in certain circumstances.Exactly my experience as well. I got pretty good at dealing with its issues in the lab with a great deal of experience and you can produce some great products. However, they are difficult to ramp-up for most manufacturers.
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I was able to try Sucragel AOF and the Sucragel AOF Bio when it was first released. It does require some tricks to overcome the stickiness, but that is achievable. It was very process dependent. They had recommended low speed mixing processes, it worked best with a homogenizer.
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I would have to read the initial press release, but I believe that they have altered the molecule slightly, thus making it more effective and a new compound. I will look later.
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Pharmaceutical grade is really not even a term that has a wide usage. I would imagine that ultimately they could seek a USP or NF designation, but this is a way down the road as these are Federal responsibilities.Developing a new drug is a huge endeavor. It is not likely in the reach of many in the Cosmetic field. It would approach 7 figures and is slow to get approved. I did the samples for such a study years ago and the company is waiting for approval.One could make an argument that CBD in CA is treated as a drug in many aspects. The 135 plus page Law they published last December sets these responsibilities. Honestly, in my opinion, if you want to promote it like a drug, you better produce, test and substantiate it like a drug.The FDA did prove a specific cannabinoid derivative for seizures this year.“The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.”THAT is the GW Pharmaceutical Product. I doubt after the money they spent on research, they would be happy with a client piggybacking on their patented product.I would caution not to take any advice in here as the final word. In my opinion, you have multiple reasons to consult with a Regulatory Expert.
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The FDA is NOT working with any companies. In fact, the FDA seems to be doing their best to avoid weighing in at this point. This was covered at length at a Seminar I attended on this topic.
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That is really something that would have to be discussed via Emails and on the phone. Honestly, I will rarely work with lines that manufacture themselves for various reasons. We are really positioned more for assisting moving smaller lines to the market. As you grow, you will not be able to manufacture and operate day to day operations.
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Will you be buying wholesale quantities of materials? Kilograms at a time? To be honest. That is the audience for UL Prospector. Companies participate as a sales tool with the intent of selling amounts larger than many small lines or crafters can afford. So, that is the background behind it all.
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ULProspector has become much stricter in qualifying people. I spoke with them regarding a separate issue (I am trying out a new version as a beta tester) and they said that a few years ago they were lax and many companies complained that they were getting sample requests but zero follow-up commercial material purchases. Remember, companies sample so that they can sell.The other resources (HAPPI, C&T, Personal Care Magazine) you can request access with a Gmail or yahoo account. However, it takes just a few minutes and less than 10 USD to park a website and set-up a mail server, thus giving you a company email.
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Off the top of my head, I have seen numerous examples of similar products. Lubrizol has a Biphasic Formulation that is nearly exactly what you are working with. Also, in the “Formulary” of “Formulating” columns of HAPPI, Cosmetics, and Toiletries and Personal Care Magazine as well. You should be able to access these Formulations easily or in some cases get free online access.
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I understand. (above should be $1293.27 per kilo.)
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We always avoided high levels of Shea and Cocoa Butters or added ingredients to prevent the crystallization. Tempering these raw materials in large-scale manufacturing is very difficult.A great mini-knock-out would be to smell (or taste a small amount if so willing) and see how the raw Shea contributes to this negative taste. Many lines would look at adding a sweetener such as saccharin, aspartame, monk-fruit, etc.You have learned a valuable lesson regarding scale-up. It requires some experience to scale-up and there are even Process Chemists who do this much of their time.
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I see that you are looking at other materials Ingredient Declarations which is helpful but you could get some benefit at looking at starting Formulations and some of the Journal documents that address this Market niche. It would be more effective in my opinion to look at fully defined Formulas and the accompanying Process instructions. As many can tell you, these starting Formulations are rarely useful as final Formulations in my experience, but great starting points. Ingredient lists are helpful, but only a small part of Formulation Design.
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What can you find? This could be a learning experience in either the HLB with more widely available Nonionic emulsifiers. or (if available) to try other superior emulsifiers.
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Or, as I have seen done numerous times, sell out the old product and containers and then reintroduce the product as a “new” product or version. In my opinion, unless the new product was revolutionary, I wouldn’t even try to relabel in any way. This assumes the revised product is already on the market, an assumption I made since packaging exists.It all comes down to comfort with risk. Mine is pretty low having started in Pharmaceuticals.
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Cream going down? Please don’t eat Cosmetics. But seriously…I don’t do peoples research for them since I truly feel it robs them of the Professional Development that they would otherwise obtain. I like to teach and mentor and I believe simply answering a question. I apologize if you are offended, but hey, it has worked for 30 years with staff, so it is time-proven.Search any of the credible raw material resources such as Cosmetic and Toiletries CBR Directory, the PCPC Material search site or Prospector (you have to be in the Industry and approved to join).Be careful. Cellulose is like Dimethicone in a way. One INCI describes several different products with different functions and forms.
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Honestly, I have always reserved the higher visocoity Dimethicones for skin protectants under the US FDA OTC Monograph. I have found that the 100 cps or even lower are best for lubricity and shine.Not to complicate the issue, but there are haircare benefits that are achieved with the lower volatile silicones.
There are offsets for these products if there is limited availability. I have used and seen used the LexFeel series from Inoloex used widely. -
Off topic, I would ensure that you get a proper diagnosis of the skin condition by a vet. Veterinary Dermatology (yes, it is a specialty, I have such a client) is even more difficult than human Dermatology. I had a general Vet misdiagnose an allergic pruritic condition for several months until it was properly treated with an oral antihistamine. It cleared up immediately after we established a loading dose with the anti-pruritic treatment.Animal Pharmacology is a vastly different animal than the Human Pharmacology I learned. So very different in elimination and the subsequent toxicities which can occur.Not a reflection on the Original poster who is experienced, but a caveat so that readers don’t start using raw materials (Essential oils especially) and cause a therapeutic misadventure.
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1. It is Folic acid I believe that was mentioned, but I don’t put much past over auto-correct. Ferulic acid is a totally different animal.2. Bulk supplements have an oral grade (Supplements, not Cosmetic) at 10 grams for almost 13 dollars. That brings your cost to $587.85 per pound or $1293.27 per pound. That is a lot of raw material cost for an item with minimal benefit.
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DSM has Folic acid available but is expensive, in large quantities and in the few cases I have used it, the results were really minimal at best.
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That is a lot of Shea Butter and it could be contributing to the taste. Also, you will have a hard time tempering that much Shea without issues in a manufacturing setting of any real size whatsoever.