[Herbnerd]

Fantastic - thank you

[Herbnerd]

Does anyone know if this seminar be recorded and streamed?

Sounds useful - but in another seminar at the same time.

[Herbnerd]

I develop toothpaste - and I do make toothpaste for my own use. It allows me to play around and work with either the flavours or ingredients I want.

I like Euthymol from UK - but it is bloody expensive in New Zealand - so I make my own version because I like the flavour.

Also, I can make my own theapeutic products and not have to buy them - such as Fluoride 5000 ppm. It is available, but prescription only through dentists and not cheap either.

I also play around with fun concepts for my colleagues kids - such as for a Harry Potter fan, I made a green, salty flavoured toothgel can labelled it ‘troll bogies’. Kids loved it - but I can’t see the marketing team going with it.

[Herbnerd]

I can’t say for everyone, but I have conducted stability programs with lab samples and with scale up production trials and our quality program extends this to the first three production runs and one production run per product per year.

However, we may not do all tests at all stages: For example, I have been developing toothpaste. RDA/PCR/Fluoride studies have so far only been on the scale up production samples owing to the cost of this test. Preservative efficacy tests too.

Ambient stability and accelerated stability and micro have been on everything.

[Herbnerd]

perhaps flag @Perry and see if he is able to assist you since he is admin of this site.

[Herbnerd]

Joy said:

 Vegans are only about 2% of the population. 

Assuming this is the USA then vegan being 2% of the population is still almost 7 million people (based on 332 million people in USA according to google).

This is still enough people to support a brand - even if you were only reach 10% of those. Vegans don’t support any animal exploitation and see bees being exploited for honey and beeswax (though many conveniently ignore the bee exploitation to product almond milk!).

Coming from a country of around 5 million, there are a couple of vegan brands doing quite well.

Not pro or anti vegan. But technical challenges of trying to meet vegan, cruelty free, Natural/organic standards etc is what keeps the job interesting to me.

[Herbnerd]

Most natural colours are highly pH sensitive. Chlorophyll for example, is only stable in alkali media, it starts going yellow to clear once the media is acidic. 
Whilst the blue spirulina is based on phycocyanins, I understand that this too is affected by pH as well as light and chemical degradation.

I tried this in a silicon dioxide gel toothpaste - the colour disappeared during manufacturing.

[Herbnerd]

If you are using other essential oils, such as peppermint, menthol will dissolve into it easily (a bit of heat will help), more slowly, menthol will dissolve into other vegetable oils too. Once it is dissolved, it is unlikely to precipitate out.

I’m using this at 0.3-0.6% in toothpaste for flavour; however, for topical applications you may want to start at 0.01% and see what the feedback is like - and either increase or decrease from there.

[Herbnerd]

@MapX
What is your formulation? 

Whilst I can get a nice clear gel in the lab, production seems to be a hit and miss - though it seems that the vacuum pump wasn’t drawing enough vacuum and not de-aerating properly.  It also seems we can’t manufacture multiple batches without a thorough clean-down between.

We went from 1 kg lab trials straight to 800 kg trial batches (no equipment to do scale-up trials) so lots of trouble-shooting during production at the moment.

[Herbnerd]

@PhilGeis Definitely stainless (I would have to find the technical specs of the equipment to find out what type of stainless). But cleaning is neither pickled or passivated - literally mechanical scrubbing.

[Herbnerd]

@chemicalmatt Thank you - very helpful. I will discuss with the team here regarding your comments

[Herbnerd]

Patents also expire. Check the original patent date and see if it has expired or if it is due to expire.

Also, and this one has caught me, patents can be challenged and overturned in many countries, but still exist in other countries. They chap doing my job before me used Monk fruit (Mogrosides) to sweeten toothpaste - only to find the material was under patent in New Zealand, but this patent had been challenged and overturned elsewhere.

[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.