[Herbnerd]

Abdullah said:

I don’t know about toothpaste but we are sanitizing with 100 ppm hypochlorite solution. 
Much cheaper than alcohol.

It would make a lot of sense - I would run that past QA and the production manager. 

[Herbnerd]

Other example of carelessness (off cosmetic topic) I’ve heard of was when a pharmacist was developing a dog biscuit and almost used grape seed flour by mistake. This is a (potencial) highly toxic ingredient for dogs, unlike golden flaxseed, coconut and green banana.

I was developing an oral hydration product for dogs. I was asked to turn the raw data into a nutritional premix to be added to other ingredients to make up the hydration beverage.

The specifications for the finished product was given by the vets (at the local veterinary school) engaged to develop the nutritional premix.

One ingredient required was “Potassium (from potassium iodide) 40 mg/serve” (I forget the exact figure now). I had to point out to the vets that 40 mg from potassium iodide was over 129 mg of Iodine - which is pretty toxic at that dose.

The vet hadn’t considered the iodine portion at all - and left me to determine the best potassium source for myself (along with any other adjustments) that may be required.

[Herbnerd]

Surely you will be adding some preservatives to the formula?

[Herbnerd]

Richard said:

Herbnerd said:

My most challenging aspect of any formulation work is a micromanaging boss (only experience is in alcoholic beverages and ice-cream) micromanaging down to the point of ‘advising’ what ingredients he wants increased/decreased.

The other big challenge I have is a marketing team changing the brief constantly. We are literally 2 weeks away from the first production run of 6 new products - all stability tests completed, micro, abrasion, fluoride stability etc - and now they want to add natural colour and other ingredients to the range - and bring in new international markets for products where we have already completed regulatory checks and formulation changes to accommodate.

I love this one. Give them MBA and suddenly they know everything. Micro managing bosses, no thanks. And the ever responsive marketing team - another of my past challenges. Do what I did and don’t work for anyone again and those problems go away but perhaps replaced by some others such as who is my next client.

That is very much the plan. I want to see the launch of these products then quit - working on the exit-plan in the background.

[Herbnerd]

My most challenging aspect of any formulation work is a micromanaging boss (only experience is in alcoholic beverages and ice-cream) micromanaging down to the point of ‘advising’ what ingredients he wants increased/decreased.

The other big challenge I have is a marketing team changing the brief constantly. We are literally 2 weeks away from the first production run of 6 new products - all stability tests completed, micro, abrasion, fluoride stability etc - and now they want to add natural colour and other ingredients to the range - and bring in new international markets for products where we have already completed regulatory checks and formulation changes to accommodate.

[Herbnerd]

We used SGS to audit a manufacturer in India. Went smoothly and they were professional. You just need to define what you want audited - aside from the usual stuff - we wanted modern day slavery and child labour audits included too.

[Herbnerd]

PhilGeis said:

There is no gold technical standard - in a regulatory sense these tests are validated in their respective authority.

Fair comment re gold standard. However, meeting BP is tougher to meet than USP or ISO

[Herbnerd]

Mixed results here.

I am developing toothpaste, which admittedly has a low water activity and adds to the inherent preservation and aside from some essential oils there for flavour (but seem to contribute to antimicrobial activity) our toothpaste  is self-preserving and we can back this up with PET testing results conducted to British Pharmacopoeial standards.

Those products that have failed BP PET testing have been the newer silica gel based toothpastes.

That said, those gels that failed BP PET have also passed USP and ISO PET standards showing that our products are safe without additional preservatives needed. However, testing to BP is the gold standard - and those products that failed BP test methods do have some preservatives in them.

[Herbnerd]

I was asked to work on flavoured lubes for a dominatrix customer. The product may not be particularly weird - it’s how she wanted to ‘pay’ me that was the decider to not continue any further.

[Herbnerd]

@Pharma - great explanation. Thank you.

[Herbnerd]

@Perry Thank you so much; and for linking to the relevant regulations. Still trying to get a handle on the US Regs - and this is appreciated too.

[Herbnerd]

@Pharma The way I understand your post is that multilamellar emulsion is similar to the structure of the cell?  As in bi-layer structure (hydrophilic head/hydrophobic tail  layered so the hydrophilic head is both inside the vesicle and outside such as that of a mamallian cell)?

Would that be a fair assessment or am I totally on the wrong track here?

[Herbnerd]

Looking at thegoodfaceproject.com website it treats Californian regulations differently to the rest of the USA regulations.

Can anyone advise what these differences are? I can only assume California has other requirements on top of the FDA regs.

[Herbnerd]

I calibrate the lab pH meter first thing in the morning before use. 

[Herbnerd]

Ryan23294 said:

Hi @Herbnerd, you’re absolutely correct. I live in the USA but would still be open to working with people overseas if cheaper. Thanks!

By the time you factor in international couriers to get your samples to NZ, you may find it is far cheaper to do this in USA. However, I have no contacts in the USA.

[Herbnerd]

Abdullah said:

@Herbnerd are you in china? 

No - New Zealand. But I do work with a number of regs in China and the rest of Asia.

[Herbnerd]

For which market?

China for example, max 1% on leave on products, but no limit on rinse off products.

[Herbnerd]

Might be useful to advise people in which country you are looking - I can suggest a couple in Australia & New Zealand. But this may not be what you are after.

[Herbnerd]

MariaGarcia said:

Thank your again, Herbnerd. I suppose they work like the mixture of baking soda and lemon juice to remove the stubborn dirt from the bottom of the skillet or the oven  ????, I feel these tablets very efective as dentifrice! My teeth are brilliant and smooth ????

Certainly you could. But then again, knowing your interest in formulation a toothpaste/tooth powder, you could just formulate your own.

[Herbnerd]

We use 90-150 micron (described by supplier as ‘coarse granular’) baking soda and have an RDA of about 100 (medium abrasive according to Indiana/ISO). Our calcium carbonate toothpastes using a 7 micron powder is around RDA of 120 - which is considered highly abrasive

Baking soda is far less abrasive to teeth. Silicon dioxide is far better as an abrasive being able to target specific RDA.

[Herbnerd]

Probably not harmful to teeth as a solid dentifrice - the bicarbonate would neutralise the tartaric and citric acids. It will effervesce nicely (basic formula for effervescent tablets and bathbombs). As long as the baking soda is in excess (not just enough to neutralise the acid) it should leave enough abrasive to clean the teeth too.

From experience, baking soda has a fairly low RDA (Relative Dentin Abrasivity, also known as Radioactive Dentin Abrasivity) and a good PCR (Pellicle cleaning Ratio) giving a fairly respectable CEI (Cleaning efficiency Index).

Speaking with other colleagues in the dental health area, the RDA is considered the least valuable of the tests, whereas many put greater weight on the PCR. 

CEI is just a calculation between RDA & PCR to give an overall value.

As a mouthwash, this is just an effervescent tablet used as a carrier for the flavours. There seems to be no surfactant, so on sitting, the oils would come out of solution.

[Herbnerd]

Tried any of the flavourhouses - Sensient, IFF, Givaudan etc? They would be your best bet. You can give them a brief of what is required and they will (hopefully) deliver you samples to assess.

[Herbnerd]

tecnico3vinia said:

Herbnerd said:

I’m currently developing products to Natrue standard. A number of compounds seem to influence preservation whilst not being on the approved preservative list under Annex 4 of the standard.

If you check out various suppliers - such as this one (and there are many more) they offer a number of other ‘multifunctionals’ that offer antimicrobials that are based on flavour compounds and other molecules. 

https://cosphatec.com/en/products/

Often you will get clues to what others are using from reading the labels.

Thank you!
I discovered these Cosphatec’s preservatives while I was doing some research days ago. I’ve found out that Alverde uses a lot of Levulinic Acid and Sodium Levulinate, which are also flavour/fragrance compounds. While I’m skeptical about these ‘multifunctional’ allegations, I really want to test them and see how (and if) they work. 

The toothpastes I am working on mostly do not have any preservatives added to them - the various compounds in the essential oils do the job effectively. We have tested this to BP/EP preservative efficacy testing/micro challenge and we have demonstrated that the formula works well and passes all testing.

A couple of formulae did fail BP/EP preservative testing (only on Aspergillus brasiliensis, all other micro passed) and these used ISO 9235 compliant flavours rather than essential oils; however, based on the results, these would USP preservative testing and definitely pass ISO testing. We did decide to use potassium sorbate in these formulae. That said, we do plan to trial other compounds to see if it is possible to remove the potassium sorbate.

I’m open to trying them. I wouldn’t say I am entirely skeptical about them - but I would need to test and prove them. These compounds may not be suitable for everything - Inolex have some compounds, but have advised against their use in oral care. Symrise have offered other products including raspberry ketone. I;ve not tried the symrise products because the raspberry ketone would definitely impact the flavour

[Herbnerd]

I’m currently developing products to Natrue standard. A number of compounds seem to influence preservation whilst not being on the approved preservative list under Annex 4 of the standard.

If you check out various suppliers - such as this one (and there are many more) they offer a number of other ‘multifunctionals’ that offer antimicrobials that are based on flavour compounds and other molecules. 

https://cosphatec.com/en/products/

Often you will get clues to what others are using from reading the labels.

[Herbnerd]

@PhilGeis Thanks for that. We seem to be getting bogged down (mostly by a micromanaging manager) who is insisting we compare BP, EP, USP, ISO/TR 19838 etc. 

I’ll see if I can get hold of a copy.