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Formulating for the Vagina
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This may be of interest:
Recently, Technavio reported the personal lubricant market will expand at a CAGR of ~7% between 2016 and 2020. Water-based lubricants in particular are forecast at a 6.75% CAGR for the same time frame. This projection is higher than the anticipated CAGR from 2017–2022 for global skin care or face cream, at 4.7% and 4.9%, respectively. What’s behind this rise?
The ‘What’
Mynewsla.com discussed
this Technavio report in depth, attributing the anticipated expansion
to a broader acceptance for products to enhance sexual health and
experience. Interestingly, the report added this segment has been
growing since the 2008 recession, when people spent more time indoors
(*wink*).Additional drivers include a growing awareness for the sensory
benefits personal lubricants can provide. Attractive websites,
educational content and search engine-optimized marketing are also
influencing purchase patterns, especially since consumers of products in
this segment seek anonymity, privacy and convenience.The ‘Where’
In 2015, the personal lubricants market was led by APAC due to large
customer bases in India, China, Japan, Singapore, Indonesia and
Thailand; this trend is expected to continue through 2020. High Internet
penetration is also responsible for an increasing demand for sexual
wellness products in these countries.The ‘How’
As mynewsla.com reported, silicone-based lubricants come out
on top due to their long-lasting moisturizing properties, which are
used by an increasing number of women who experience vaginal dryness.
However, they can be stickier and messier than oil- or water-based
lubricants, and are reportedly not compatible with silicone sex toys.Water-based lubricants have been available for years and are
compatible with condoms but some of their ingredients are suspected to
cause irritation. In contrast, oil-based lubricants, which are primarily
used in developing countries, are not compatible with latex condoms.
Could this pose a market opportunity?‘Shear’ Pleasure
Then again, whose to say “sticky and messy” is a bad thing? As one study from
the Centre for Industrial Rheology demonstrates, broad technical
differences exist between equally successful lubricant brands.Here, the rheology and bio-tribology of three personal lubricants
were assessed: brand A, described as “slippery,” having “good glide” and
“light, intimate feel”; brand B, having “poor glide,” “stick/slip” and
being “silky”; and brand C, described as “thick”, “heavy” and “sticky.”Three parameters were tested: viscosity under shear, elasticity under
shear and frictional force over varied sliding speeds. Results showed
major differences in product behavior, revealing brand success was
driven more by consumer behavior and preferences.All in all, it seems market researchers have a good feeling for growth in this most personal of personal care categories.
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@johnb this is of interested. Thank you so much.
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@Mark - Can I trouble you to elaborate on the body cavity/510K comment? Are Vaginal rinses classified similarly? What about anal cleansers/wipes?
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Certainly, Personal Lubricants are regulated at 510K Medical Devices since they are intended to be used in the vagina as opposed to on the vagina … this is the same regulation as for lubricated condoms and the testing required of of Personal Lubricants is actually the same as the testing for lubricants on condoms. Your personal lubricant is applied to 800 condoms and the same tests are repeated 800 times.
Vaginal Rinse … I am not certain, but I would suspect they would likewise fall under a 510K classification as they are designed to be used in the vagina.
Anal Cleanser/Wipes … I suspect these would be similar to Vaginal Stimulation Gels which are regulated as cosmetics since they are designed to be use on the the surface of the vagina/clitoris as opposed within the vagina.
Now, if your anal cleanser/wipe is intended to be used by someone actually inserting their finger in their butt … well, that’s probably a different story. But, anal wipes should be under cosmetic category unless your wipe solution contains an OTC drug ingredient.
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Question: I am still a newbie… My water phase has Natrosol, PG, and water.
I have noticed that in previous formulations that small tiny lumps have been apart of the final products. I totally want to avoid this.
Should I heat the water phase to 65-70 let it then adjust pH with NaOH to approx 8-8.5.
OR
mix my water phase at RT adjust pH to 8-8.5?
In either case this will be slowly added to a silicone phase to complete the lube.
Typical vagina pH is 3.8- 5.0 do I need to correct the pH before the addition to the silicone phase or afterward?
Another silly question…. would final pH would be N/A because this is a W/S emulsion? Just want to make sure my thinking is correct. I am alone in the wilderness … thanks!
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You’ll want to first disperse the Natrosol in the water phase and then adjust the pH after the Natrosol is dispersed to activate the cross-linking, then heat. What specific variant of Natrosol are you using?
It will help to reduce lumps if you first pre-disperse the Natrosol in PG. Combine the PG and Natrosol and mix to form a slurry, then drizzle that slurry into your water phase while stirring @ 500 RPM or so. Let it stir for 10 to 15 minutes, then adjust the pH and begin heating.
You would make an additional pH adjustment as your final step in the formulation. If your product has water in it, it has a pH.
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I am using Natrosol 250 HHR.
My real question is do I have to adjust pH for use in the vagina at the end? Vagina pH is 3.8 -5.0 range.
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Of course.
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Yes, you should adjust pH for the vaginal environment at the end.
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thanks! Learning after high school never ends!
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@Mark - Much appreciated!!
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This is more about stability of the before mentioned vaginal lube formulation. Please correct me if I am wrong…
I made 3 versions of the water in silicone lube. I placed the samples in a 55°C for a quickie stability check before doing “real” stability.
Sample #1 showed no signs of separation @ 55°C for 5 days
Sample #2 showed showed signs of separation @55°C after 2 days
Sample #3 immediately separated after a few hours on the same day @55°C.Question is would my Sample #1 be deemed acceptably stable formulation for the market place? Are samples #2 & #3 acceptable with limits?
I know that 45°C for approx a month represents a year. Thanks!
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No. This isn’t a proper stability test. You can’t test a formula for 5 days at any temperature to predict a year or even 6 months of stability.
Also, 45C for 2 months (8 weeks) is indicative of 1 year.
There is no super short cut for stability testing.
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I plan to do proper stability testing with out a doubt. I am not suggestion that what I am doing is in place of real stability. I am trying to get my current employers to understand that too.
At a previous employment, they would make a lab batch and place a samples in ovens of various degrees (40, 45,50,55, f/t) to see if this would separate. It was not fool proof or in place of real stability but it gave idea of the potential stability.
They want to launch this product fairly quickly and I noticed 2 of my samples were separating in the 55°C oven. Is there no conclusion that could be ascertained at this moment?
Thanks for the correction of the 45 and 2 months.
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The only conclusions you can make at this point is that one of your products is stable for 5 days at 55C and two of them aren’t.
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Okay this formula is the gift that keeps on giving….
Now my hybrid formula keeps thickening on me. I have reduced the natrosol 250 HHR to 55%. and I have changed out the my silicones to be of lower viscosity. (PMX 200-0.65 cst @5% and PMX 200 - 0245 @ 10%)
I have notice the thickening happening at the end of the batch when I have to adjust for clarity using my refractometer. slightly hazy clear is acceptable. It needs to be around 3000 cps more on the “running side.” Not sure what to do next.
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I assume 55% HHE is a typo but, that aside, my view is that you would be better off using a lower viscosity grade (H or even M rather than HH) at a higher concentration. You will than get a product with more controllable viscosity at small variatons of Natrosol concentration.
I don’t really understand why you are including silicones. I just see that (from a simplistic point of view) just introduces unnecessary stability difficulties.
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You could make your life a whole lot simpler by using a mid-range Hyaluronic Acid as your thickener and gelling agent as opposed to Natrosol and Silicones. It’s natural, it will be slippery (or slippery enough for your purposes) and it’s simple to use relative to the approach you are not taking.
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@markbroussard and @johnb
Thank you gentleman.
Understand this is still all new to me and I don’t have the guidance of a on staff mentor. So what may be a simpler method for you (after years of experience) doesn’t come as elementary for me. In some of my experience, R&D Chemists can be down right snobby about being helpful. I am very grateful each of you and for this website to as a helpful source of sharing knowledge…
My benchmark is a competitor hybrid lubricant and I am using similar chemicals as listed on the ingredient deck and what is available to me at this time. I am trying to reproduce what the last chemist was working on.
@johnb
I will be looking into getting another grade of natrosol today! Hybrid lubes right now are the “hip” thing in personal lubes. However I am totally open into doing something differ@johnb@MarkBroussard
I am extremely in doing what you are suggesting. My boss has her heart set on a water/silicone because that is what other companies are offering. What gelling agent would you suggest with hyaluronic acid.Again thanks.
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Something tht strikes me as the ideal for your end use is polyethylene oxide (Polyox). I have mentioned it several times recently on this forum.
Certain grades of Polyox approach the ideal in terms of slipperiness and lubricity. Have a look at http://www.dow.com/dowwolff/en/industrial_solutions/resources/literature/index.htm using the first pdf hit in the list.
The problem may be obtaining a sample of the material - Dow are rather reticent in providing samples if they cannot see a prospect of reasonably large sales.
I have offered elsewhere on this forum some links (use the search box) to obtain small amounts of a single grade of the material which you could use for a tryout.
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Pity that your boss has her heart set on following her competitors instead of paving your own path with a unique product offering. You don’t need a gelling agent with a mid-weight Hyaluronic Acid … the Hylauronic Acid IS the gelling agent.
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Gentleman thank you again.
My boss is a sales woman and not a scientist. What ever is trending is what she wants….
I am sure my boss is open to new things but right now she wants this as apart of our line of products. Some of our clients have been asking for it too. It is the “buzz word” for lubes right now. -
Synovial fluid is made of hyaluronic acid and lubricin, proteinases, and collagenases.
Normal synovial fluid contains 3-4 mg/ml hyaluronan (hyaluronic acid), a polymer of disaccharides composed of D-glucuronic acid and D-N-acetylglucosamine joined by alternating beta-1,4 and beta-1,3 glycosidic bonds.
Synovial fluid also contains lubricin secreted by synovial cells. It is chiefly responsible for so-called boundary-layer lubrication, which reduces friction between opposing surfaces of cartilage.Now if you could get hold of some lubricin to add to hyaluronic acid you would have the perfect product, completely natural and perfectly compatible with all body tissues.
A while ago I damaged a toe joint and as a result had a leakage of synovial fluid from the joint. It was a transparent clear medium with the consistency of light petroleum jelly and very very slippery. It’s perfect for a lube…
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@Belassi
That is ingenius. You got my brain working on something… Thanks for the tip! -
Shhhh … I’m working on an all-natural SlipperyClit Hot Gel.
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