iformula

By David Calvert, December 2022

Reflecting back on 12 months ago, here in the UK we were facing the Omicron COVID variant and – due to government advice – entering another pseudo-lockdown. I remember thinking at that time, where would we be in a year’s time – and would life, both personal and business, ever return to “normal”? Well times have changed and as the saying goes, we have now entered a “new normal”.

Although we had participated in a few in-person events in 2021, exhibitions, courses and conferences returned properly in 2022. We attended several exhibitions and presented in-person at ChemUK 2022 in Birmingham and then I attended an in-person networking event on “Sustainability in Cosmetics” in York in February. It seemed somewhat surreal going back to “business speed-dating” but the smiles of all participants (the majority without masks) were something special.

As the year progressed, more familiarity returned with exhibitions such as “Making Pharmaceuticals”, “SCS Formulate” and “Surfex” and we continued our efforts to help educate the next generation of formulators by delivering lectures at both the University of Lincoln and the University of York, as well as contributing to the activities of the SCI Formulation Forum.

Our in-person training courses picked up with Formulation – The Basics being sold out on its first appearance in London in September and the Spray Drying course with the University of Leeds was well received. There has been a noticeable change in attitudes to on-line training though and we saw this with the second live online edition of Informa’s “Introduction to Agrochemical Formulation Strategies” which saw participation from companies in Malaysia, South Africa, the US and all around Europe. In our projects, we have noticed that there has been a trend towards hybrid projects where we have delivered on-line training tailored to a company’s activities, together with an element of consultancy. This “Trainsultancy” looks like it is here to stay.

We have carried out a number of projects and conference presentation on agrochemicals with an emphasis on biopesticides, or BioControl Agents (BCAs) as they are the industry now prefers to call them. Following presentations at the World Bioprotection Forum event in Birmingham and running a formulation session at the inaugural IBMA UK/University of Swansea conference on “New IPM”, we also recently ran a workshop at the Annual Biocontrol Industry Meeting (ABIM) in Basel. This event had over 1500 attendees and combined an exhibition, with a conference and workshop programme. We were invited to lead an interactive workshop on “Formulating for Biology” and with over 50 attendees this was a challenge and experiment which I am pleased to say was received well. The exhibition demonstrated the massive growth potential of biocontrol agents and formulation has a key role to play in delivering the growth potential. As would be expected, the conference programme had an emphasis on regulations, and this is still hindering the introduction of BCAs in Europe especially. This may change with the EU’s “Farm to Fork” strategy but there is still a long way to go to match the progress seen in Brazil where it has been recently reported that from 107 biological pesticide registrations in 2013, there are now 433 registered through March 2022 with over 500 expected by March 2023[1]. So, what do we expect in 2023 for formulation in general? Well, change is always to be expected and formulators cannot ignore the cost-of-living crisis which people around the globe are facing. We would expect a formulation “evolution” rather than revolution both in terms of technology and delivery but the importance of formulation will continue to grow – and with that we wish you all a happy Christmas and successful 2023.  

Free Stock Photos by Vecteezy

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[1] https://www.agribusinessglobal.com/biopesticides/biopesticide-registrations-have-skyrocketed-in-brazil-heres-why/

By Jim Bullock, December 2022

Formulations are complex systems with numerous variables. Quite apart from the numerous functional ingredients found in most formulations, a wide variety of different processing operations and conditions can be used when making formulations in order to achieve the desired product microstructure and the end performance. This all means that making changes in your formulation can have unexpected consequences. So, what happens if you want to make changes to an existing formulation and need to predict the impact of replacing a particular ingredient with another one, for instance on grounds of cost or environmental sustainability? Similarly, what happens if you have developed a formulation in the laboratory and would like to know how it would perform once scaled up to pilot or full manufacturing scale? The complexity of formulated products and formulation processes is such that this can conventionally be a tricky task.

Well, this is where a “digital twin” of your process could be invaluable. In the context of formulations, a digital twin is a digital simulation of, for instance, your product, your manufacturing process or your supply chain system. It can be used to help design products or processes, or to optimise them once they are up and running. In the latter case a digital twin can be furnished with real-time data from the process in order to help monitor and predict what happens if changes are made. Although the initial focus on digital twins might have been in the engineering sector, they are becoming more prominent in industries closer to home, such as pharmaceuticals and the food industry where processes such as fluid dynamics, heat transfer and mass transfer are modelled. Examples of digital twins in pharmaceutical manufacturing have been presented, and here the use of Process Analytical Technologies (PAT) to collect and report critical process and product data is a key component of the model. Moving on from production and into the use of formulated products, a digital twin of human skin has been developed and it is being used to predict the effect on the skin of cosmetic and pharmaceutical products, potentially reducing the need for animal testing.

Apart from optimising costs and performance of formulated products, digital twins can be used to predict the impact of changing processes from a sustainability point of view. So, in that context, it was interesting to see a real-life example reported in the recent Green Special edition of BBC Click (note that this may not be available to view in your country). In the programme, the consumer products company, Reckitt, explained how they had used a digital twin of their manufacturing and supply chain systems (developed by Risilience) in order to model the environmental impact of replacing an active ingredient in one of their headline disinfectant brands (Dettol®) with lactic acid. As well as the fact that it is derived from renewable raw materials, the use of lactic acid was found to reduce the overall carbon footprint of the product. A description of the Risilience collaboration with Reckitt on sustainable supply chains can be found on the Risilience website as well as in this video.

Formulated products and formulation processes have long been thought to be too complex for useful predictive models to be developed. However, as we have seen in these few examples, recent developments in sensing, measurement, scientific understanding, data processing and simulation – as embodied in the newest digital twins – have brought the dream of truly predictive formulation closer than ever to reality.

Image created by the author using DALL-E 2 AI art software.

By Dr Jim Bullock, January 2022

Regulations abound in the chemical-using industries and although most companies are aware of the main laws that apply to their products and market, it seems that many companies still get caught out. Although compliance with regulations can be costly and time-consuming for companies, at the same time we are all consumers and the majority of chemicals regulations (however imperfect) have been implemented in order to benefit us by reducing risks to human health and to the environment.

We hear a lot about regulations and the requirements of regulatory bodies, but not so much about enforcement. So far there isn’t a formulation equivalent of Interpol but a recent report from the European Chemicals Agency (ECHA) describes how the majority of products inspected in a recent enforcement activity were not compliant in at least one respect. This activity had consequences – more than 5000 enforcement actions were initiated.

Of interest to formulators is the fact that 81% of the products inspected were mixtures (i.e., formulations), the rest being chemical substances or articles. The inspections related specifically to:

• REACH (the EU’s main chemical regulation) where 78% of products were non-compliant;
• the BPR (Biocidal Products Regulation), where 77% of products fell-foul of regulations on advertising and illegal sale of biocides and
• CLP (which relates to classification and labelling of hazardous substances and mixture), where 75% products did not comply with advertising obligations.

As a result of the enforcement activity, 53% of non-compliant products were removed from the market and, in 23% of cases, advertising material was brought into compliance.

The consequences of non-compliance can be costly and the regulations described above are just a few examples of the many regulations to which companies making and selling formulations are subject worldwide. Other examples of regulated markets include crop protection products, cosmetics and medicines. Whether, or how, a regulation applies can depend quite subtly on the intended market, use and product claims being made. In new product development, this can restrict the ingredients used in a formulation and can make the whole process more complex and costly.

At iFormulate, we assist our clients with formulation development across all of the markets mentioned in this article, as well as many others. We can’t be regulatory experts in all of these markets but, in all of our assignments, we do ensure that our clients recognise where regulatory advice is likely to be needed. At that point, if required, we can bring in a regulatory expert into the assignment. We then work alongside them to find solutions which are going to not only comply with the regulations, but also meet the client’s requirement for formulations with the required technical performance and cost-effectiveness. If you’d like to ask us about how iFormulate can help you with your formulation development activities, just contact us at info@iformulate.biz.

By David Calvert, December 2021.

As the festive period approaches, we thought it would be appropriate to look back at how formulations have influenced, or could influence, our Christmas times past present and future.

For many, celebrations include a little tipple and we are in that respect no different. To bring something special to my wife’s favourite tipple of gin and tonic last year, I bought her a small jar of “Blue Pearl Shimmer for Gin” (Figure 1) and thought I would reflect on the formulation design process for this.

So, if you were to apply iFormulate’s “Design for Formulation” approach to this product the customer promise would include phrases such as “shimmers when dispersed in gin”, “does not impact on taste of the drink” and “contains only food approved ingredients”.

The business brief and the technical brief would expand on the regulatory status and include cost targets as well as details on manufacturing process. This would subsequently lead to identifying critical quality attributes, critical material properties and critical process parameters. Incidentally, amongst the elements which should be defined are shelf life and absence of caking of the powder. I guess the manufacturers assumed their product would be used quickly, but as with many Christmas gifts, the Blue Pearl Shimmer made its way to the back of the cabinet and after one year some caking can be observed (Figure 2).

Moving on to Christmas present, perhaps we can only mention the hot topic of the day, and indeed the last 18 months, and reflect on the success of innovative formulation in playing a key role in delivering COVID vaccines into billions of arms. Formulation science and technology was used to stabilise the mRNA vaccines which are formulated in lipid nanoparticles – and we can only expect that this technology will be further developed and enhanced as the use of such vaccines to treat viral conditions is widened further.

Moving forward to Christmas future, it is time to get out our crystal ball. As with drink, food is an important part of the celebration for many and in particular I’m a big fan of the gravy formulation and I’m strongly of the opinion that family recipes for Yorkshire Pudding* (Figure 3) need to be maintained to prevent the move towards frozen Yorkshire Puddings. Perhaps a controversial wish may be to see 3-D printing develop so that we can personalise perhaps our sage and onion stuffing or even the Christmas puddings? Well, on reflection maybe we need to be careful what we wish for and that technology advances do not go too far and replace long-held traditions.

We wish all our clients and followers a very merry Christmas and let’s all hope for a better 2022. 

 

*For those unfamiliar with the finer points of British cuisine, Yorkshire Pudding isn’t actually a dessert, but a savoury accompaniment to a traditional Sunday roast dinner. See here for more detail on the formulation and key performance criteria for Yorkshire Pudding.

For those unfamiliar with the finer points of British geography, Yorkshire is a large English county and its inhabitants are famed for their generosity and modesty. 

 

By Dr Jim Bullock and Dr David Calvert. Taken from Agropages News, 7th December 2021

Outside the recent COP 26, Greta Thunberg bemoaned the lack of action and spoke of commitments being simply “Blah, Blah, Blah” and demanded that everyone took action to reduce global emissions and prevent climate change spiralling out of control. In this article, we reflect on whether these comments apply to agrochemical companies as we take a look at a selection of the sustainability reports which companies now regularly publish.

As a greater number of companies started to report on their sustainability credentials, they were often criticised for lacking consistency and for not using a standard format. When we looked at the reports from the last couple of years, it became clear that this has been addressed and many of the sustainability reports are issued according to the Global Reporting Initiative (GRI) and the Sustainability Accounting Standards Board (SASB). The latter has some specific industry guidance for classifications created by SASB and the majority of companies in agrochemicals are in “Resource Transformation”…

To read the rest of this article go to Agropages.

By Jim Bullock, January 2021.

Over the last year, the prolonged pandemic has caused all of us to ask ourselves new questions. For instance, there has been a lot of valuable discussion and learning on various topics of science and statistics. The recent start of the coronavirus vaccination campaign has meant well-deserved praise for those scientists who have worked tirelessly to devise, test and scale-up several different vaccines. For those of you able to view it, the recent BBC documentary which focuses on the Oxford-AstraZeneca vaccine designed by Professor Sarah Gilbert, is highly recommended.

For formulators amongst us, vaccine formulation and stability are very interesting topics. For instance, the Pfizer-BioNtech and Moderna vaccines are based on novel mRNA which has to be protected in a lipid nanoparticle (LNP) formulation containing a number of lipids as well as salts and sucrose. Despite the use of this nanoformulation, these vaccines still have to be stored at very cold temperature. In contrast, the Oxford-AstraZeneca vaccine is based on more conventional vaccine technology that does not require protection by lipid particles and the vaccine can be stored under conventional refrigeration. Could formulations do even more for vaccines? Just today, as I was writing this article, the head of the UK’s vaccine task force called for improved coronavirus vaccine formulations (e.g. oral, buccal, nasal or patch formats) which could avoid the need for injections and cold storage.

Another topic of interest to formulators has been sanitisation. Suppliers have stepped up and provided huge quantities of various different sanitiser formulations. Those of you with an interest in sanitiser formulation, application, efficacy and regulations should take a look at “Sanitising the World”, an upcoming online event (free of charge) on these topics from the SCI’s Formulation Forum.

Those of us who wear spectacles have probably also encountered another formulation issue. When worn together with a face covering, our specs can become severely fogged as exhaled water vapour condenses on cold lenses. While this might seem like a “first world problem” in comparison to some other coronavirus challenges, anything that makes it more likely for people to wear face coverings properly has to be a good thing. And masks do help to reduce the risk of coronavirus transmission as Dr Josh Robinson from the University of Bristol pointed out recently in another Formulation Forum event.

Faced with this foggy problem myself, my first move was to try out (using an old pair of specs) the trusty anti-fog spray that I normally use for my swimming goggles (swimming being a distant memory at the moment). A field trial on my weekly supermarket trip was successful. I shouldn’t have been surprised; the anti-fog formulation contains non-ionic surfactants which act to reduce the surface tension of water droplets forming on the lens. This causes droplets to coalesce, spread and form a thin transparent film instead of allowing condensed droplets – which would scatter light – to remain.

Emboldened by this, I tried out the spray on my new glasses. This time however, the spray totally failed to wet the lenses and dried as a patchy mess. Needless to say, this treatment failed to prevent fogging. The reason: my new specs have an anti-reflection coating on them. These coatings are typically made of an inorganic material such as magnesium fluoride which is highly hydrophobic and therefore conventional surfactants aren’t up to the job of wetting the lens surface. Luckily my esteemed colleague, David Calvert came to my rescue and recommended an alternative product which works successfully on anti-reflection lenses. On further investigation, I discovered that this formulation contained tetrafluoropropanol and perfluoroopolymethylisopropyl ether, both of which are much more effective at wetting highly hydrophobic surfaces than conventional surfactants.

So, what conclusions can we draw from this? Well for the formulator – make sure you know and understand the surfaces you are working with and the limitations of your surfactants. And for everyone – wear a mask!

November 2020

From IHS Market Agribusiness

IHS Markit’s Crop Science Formulations 2020 is concerned with the formulation of crop protection products, in particular the features of the commercially important formulation types in the market. We also examine the products and companies active in formulation in this market and review the latest technological developments via the available patent and academic literature.

To learn more about crop formulations and technological developments take a look at our short video presentation below.

For further details of the IHS Markit Special Report Crop Science Formulations 2020 have a look here.