Microformulation
Forum Replies Created
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I found some botanical extracts but they way too expensive. Any thoughts?
Is this a Product which will be sold commercially? If so, and you are having an issue with costs of raw materials, you may be underfunded. It sounds like a small issue, but it is not as it will have an effect on the entire process from beginning to end.
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The Heat and Hold technique was never intended to increase the quality of your water or to provide any measure of increased sterility.
In some emulsifiers (nonionics come to mind), the product was held at heat and mixed AFTER the oil and water phases were combined. It was felt to decrease the size of the micelles, leading to a more stable emulsion. It is a valid technique in some cases.
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My only experience with them wasn’t negative or positive but rather null. I stopped by a lab once that had a Chinese Lab Homogenizer and it was not being used. They couldn’t get any replacement parts after they broke the machine and it was gathering dust.
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I keep hammering on the proper source. (Cannabis based CBD with THC in 1 10-20:1 CBD:THC ratio). It really is important. I am a bit defensive since this emerging Industry keeps presenting it as a “medicine” that cures all. If they want credibility we need to disregard all the marketing based Cosmetic bull hockey and engage in real studies.
Otherwise just buy a wagon and peddle your product from town to town with an accompanying assortment of salves, balms, tinctures and healthy elixirs.
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First, unless you can get Cannabis based CBD (with the accompanying THC), it is just marketing. Use Hemp Seed Oil and make it all marketing.
Next, you need to have an assay of the CBD/THC in the product. Like any plant-based material, it must be standardized.
Once you have the CBD content. it is simple mat. Let’s say 1 gram of an extract contains 10mg of the active product. Then it is based on a simple ratio.
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@Belassi Hope you ate the leftovers.
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Here are some links I can access without being on my server. There is a discussion of THC/CBD in Dermatology. https://drive.google.com/drive/folders/16ca1zcgWpThKlLa_SQ16FqOxh_gjX1l6?usp=sharing
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I still haven’t found time to get into the office, but it is on my to-do list. So much lab work.
There is still so much up in the air with the regulations. The FDA has yet to make any definitive answers. For example, one person told me that it is the DEA that regulates the THC and that the FDA will still evaluate any drug claims for monograph compliance. Another I asked had no idea.
Honestly (and I hope I am wrong), I think we will find very little valid use for CBD typically unless it is processed for some sort of absorption. I have one client using an ultrasonic system to form a nanoemulsion. I do however think though that there is so much pressure to give it credibility.
So, I guess people need to stop overreaching regarding its proven uses. If you just want to get it traction so it can be used recreationally, just say that.
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I will send links when I get into the office as I am in the lab.
Also, if I wasn’t under NDA’s, I could share about 40 Formulas based up 25-50mg.
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IT is wholesaled by MORRE-TEC (http://www.morretec.com/) but I don’t believe it is available retail in the US.
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I have to agree with @”DRBOB@VERDIENT.BIZ” in an important respect, that being that would have to address which particular diagnosis you would be assessing the comparative testing towards. I think in this case, in order not to risk being an obstacle to Medical intervention (fluid replenishment, secondary bacterial infection), you would have to restrict the evaluation to first degree burns ( pain and reddening of the epidermis). By definition, this would eliminate Silver Sulfadiazine (Silvadene Cream) since Pfizer does not endorse it for first degree burns but rather second and third-degree burning wherein there is a full or partial thickness compromise of the dermis. So, in summary, I believe that a simple dermatological erythema grading of the products side by side in first burns would be your evaluation criteria.
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This would be an easier situation to test versus many others. Dermatological grading of erythemic response is common in sunscreen testing. Treated skin versus untreated skin could be graded over a set period of time.
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1. Even though the Hibiscus grows there, it is a false savings as you CAN NOT use it. I have lavender in my front yard. I buy lavender.
2. Honey is self-preserving, but not a preservative for a product. Honey in its harvested state has very little free water. Dilute it in a water phase and it becomes a food source for contamination.
3. The preservative in the Aloe preserves the Aloe. They are NOT at a level that will preserve a Formula.
Please don’t take offense, but I have to agree with DRBOB@VERDIENT.BIZ. I believe you could benefit with some further credible education. In my opinion, only, the fact that you are addressing the honey as a preservative leads me to believe that you may be referring to some unreliable online sources.
Preservation can be tricky. Also, your product seems a bit all over the place. You make a point to use “organic” materials but also use materials that would not be allowed under an Organic or Natural standard.
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In that case, you would be better off buying standardized extracts. One of the root characteristics of a credible product is that it is consistent from batch to batch. Preservation is based upon a consistent product, especially if you are referencing challenge testing. Botanical products by definition vary due to numerous environmental factors. An MSDS and TDS are basic documents used for Occupational Safety and Analytical standards. As your line grows, some sales outlet or buyer will require you to provide this documentation. The MSDS would be required for shipping, especially through Customs.
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Would you be selling the product?
If so, Infused oils without batch to batch testing for consistency with the lack of proper documentation will be an issue. Eventually, you will need a TDS and MSDS.
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If it isn’t the whole plant extract with the CBD, THC, and terpenes it is a waste of time, period regardless of how you try and market it. If it is the whole plant extract with CBD, THC and the terpenes, it can’t be shipped across state lines. You are proposing a market-driven product with no functionality.
Taking that another step, part of a well designed and credible product is a realistic Cosmetic claim. What Cosmetic claim are you proposing from the CBD oil? If it is a drug claim, it becomes an OTC at the minimum. The Federal Government (even if you could ship it across State lines) is not entertaining NDA’s on the cannabis-based products. Now, you could say that it is going to be only sold in the State the raw material is authorized, but you would still have a difficult time skirting regulatory oversight.
https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm
I would posit that any Cosmetic claims you make regarding the CBD oil could be more affordably delivered with Hemp seed oil as well.
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You could contact the distributor, BASF.
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It is actually Cosmedia ACE from BASF. https://knowledge.ulprospector.com/4810/pcc-cosmedia-ace-basf-care-cosmetics/
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10 mg of CBD in 16 fl oz is 0.02mg/ml and 20 mg of CBD in 16 fl oz is 0.04mg/ml. This are extremely low doses even if you disregard the need for THC and the terpenes.
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@Bill_TogeI observed the shear thinning of Cetearyl alcohol in past Formulas. However, like many fatty alcohols, I saw rebound from this effect at 24-48 hours. Anyone who has ever seen one of these products thicken post manufacturing can weigh-in on this effect.
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1. The Topical dosage is 25-50mg per dose. This is established in several British studies and is the level that topicals strive for in WA, OR, CO and CA.
2. First described in 1998 by Israeli scientists Shimon Ben-Shabat and Raphael Mechoulam, the basic idea of the entourage effect is that cannabinoids within the cannabis plant work together, or possess synergy, and affect the body in a mechanism similar to the body’s own endocannabinoid system.
This theory serves as the foundation for a relatively established principle within the pharmacology community, that in certain cases whole plant extractions serve as better therapeutic agents than individual cannabinoid extractions.
The entourage effect theory has been expanded in recent times by Wagner and Ulrich-Merzenich, who define the four basic mechanisms of whole plant extract synergy as follows:
- Ability to affect multiple targets within the body.
- Ability to improve the absorption of active ingredients.
- Ability to overcome bacterial defense mechanisms.
- Ability to minimize adverse side effects.
3. “Most of the marketing is 0% THC.” I think we can weigh-in on the disconnect between marketing and Science.
4. 20 mg would be just for label copy. Marketing the presence at a subtherapeutic level. I guess this would add a whole other aspect to “greenwashing!”
As a disclaimer, I do not partake in THC containing products since my state does not allow it Recreationally or even widespread for Medical uses. When CA announced its proposed new law, many companies were forced to step up their documentation standards. I was recommended to one company who in turn passed my name on to several others. We discussed the cGMP and recordkeeping requirements for making a product “X” where I was consulting vaguely. My feeling here is that if it is going to gain any ground it must be researched as an active with better studies (more data points) and if made should be made as an active where it is consistent batch to batch and tested as such. These over-reaching Cosmetic claims are seen as marketing and by many as a barrier to a more credible product.
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It is to a great respect marketing. I know that the topical products go for 25-50mg’s per DOSE to try and claim efficacy based on the credible studies. In that case, it is 10 mg of CBD per what volume? Also, remember that the credible studies (especially the Israeli study that is often cited) showed that to be effective CBD must have a 10:1 or 20:1 ratio of CHD: THC. This is called the entourage effect. This only occurs in CBD harvested in a recreational/medical approved state. Hemp has 3.5% of the equivalent CBD in cannabis-based plant material. THC cannot be transported across State lines and in the US the DEA requires that it must have less than 0.3% total CBD.
(Clarification, I did a great deal of cGMP consulting last quarter 2017 in the California market and one company even flew me out for a 2-day course by the STtate Cannabis Board).
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I really couldn’t disagree with you there. The Skin barrier is likely not compromised as much as inflamed, the raw materials would likely price you out of the market as we all can recall a representative product and the effect would just not be marked. Then, I think it would be a hard sell for marketing to “upsell” this product at a higher price due to these “unique” materials.