Creating a successful product is a lot more than creating a list of ingredients that mix well together.

NaturPro has a broad base of knowledge in product development and production of dietary supplements, healthy foods and natural products, spanning from raw material to finished consumer product.

We guide our clients in the right direction, by helping to manage all or parts of the process for natural product formulation and development — from seed to shelf — for dietary supplement and health food products.

The sky is the limit for healthy food and supplement product development

Dietary Supplement Formula Development

Our client list includes folks of all shapes and sizes, from startup to large corporation.

No two clients or projects are the same, but there are some common approaches found in our Product Development Toolbox:

Product Development Toolbox: Top 10 Product Development Tools:

Product development requires a ‘toolbox’ of analysis including the following

1. Market Analysis, Competitive Analysis and Positioning
2. Regulatory Status / Safety Assessment
3. Claims Development and Substantiation
4. Product Costing and Financials
5. Ingredient Readiness, Supplier Qualification
6. GMP’s, Specifications, and Analytical Testing
7. Intellectual Property Development
8. Manufacturing Feasibility
9. Contract Manufacturer Qualification and Negotiation 

In food and supplement product development, it’s sink or swim.

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Emerging sources and technologies for omega-3, omega-6 and healthy fats:

We didn’t need to add butter to coffee to demonstrate the importance of fats as energy in the diet, but maybe it helped. The concept that there are healthy fats other than omega-3’s and 6’s may present a challenge to market growth. Fortunately, the quality problems that plagued the sector for years have moved on. We no longer need to worry how to clean up fish oil, and make it taste like key lime pie.  But where to go from here?

Hopefully the benefits of omega-3’s will continue to be found from the hundreds of clinical studies in progress.  But no dietary ingredient exists in a vacuum, and there are ways to further optimize omega-3’s beyond the old standbys.  For example, phospholipids naturally present in krill oil have been shown to increase the absorption of DHA, allowing for a lower dose substantiated for phospholipid-rich krill oil. This is nature’s way of optimizing absorption. Both phospholipids and omega-3 are stored in cell membranes, where they serve similar roles.  It is reasonable to think there might be a benefit to consuming both together, beyond the increased bioavailability. Are there better optimized combinations of phospholipids and cofactors which closer represent the nutrient profile of salmon, and may be even more beneficial?  Perhaps.

Meanwhile, man continues to create products based on nature, inspired by milk emulsions and small intestine micelles, developing ways that (at least theoretically) increase the body’s ability to assimilate nutrients.  But some caution is to be given with the re-emergence of New Dietary Ingredient guidance. If NDI’s are to be taken literally, any dietary ingredient having a different composition than one marketed before 1994 requires a notification to FDA. So, it’s probably a good idea to start putting together the safety assessments that will be required for omega-3 ingredients and technologies that were not around before 1994.

Back to the clinicals. In addition to the hundreds already published, there are more than 250 clinical trials listed on clinicaltrials.gov for omega-3, which are just getting started.  You name the health condition and it’s probably represented.  Add on the current study conducted by the U.S. Army, to determine if krill oil improves cognitive performance of soldiers. Out of all the supplements (and likely drugs) possible for a study like this, omega-3’s were selected.  With all this interest, there must be some evidence that the stuff works.

For product development, in case a high-quality omega-3 source is not sexy enough on it’s own, the literature is abound with examples of combinations of omegas with other nutrients.  DHA with EPA and GLA have led to improvements in multiple studies on people with cognitive impairment.  Look for the combinations of omega-6 to be balanced with omega-3 sources like flax and krill. And stearidonic acid (18:4 n-3) from echium and Buglossoides arvensis may be a cofactor to help improve absorption of DHA and other omega-3’s.

Combinations of omega-3 with ingredients that are not necessarily fat soluble may be trending. In a 2014 placebo-controlled study, a probiotic blend and omega-3 combination increased HDL and lowered insulin resistance better than either alone.  The addition of Vitamin E and C to DHA has been researched in clinical trials, and several studies have observed the benefits of statins with omega-3.  Omega-3 blood levels may also affect whether B-vitamins can slow the brain’s decline during aging.  And their addition with Vitamin D has been shown to improve symptoms in people with mental illness. So there is some basis to believe omega-3’s are able to potentiate the effects of both water-soluble and fat-soluble nutrients, likely in different ways.

Our understanding of the relationships between PUFA, fat metabolism and inflammation has created many connections with pathways regulated by other nutrients. Thinking in terms of focused nutrition, a combination of omega-3’s with other sources of healthy fats such as MCT, at a certain dose and balance could provide optimal brain nutrition for certain people.   The addition of other cofactors along the arachidonic acid and inflammatory pathways, in addition to mediators along the endocannabinoid pathways may provide systemic support for the pathways which rely on a steady stream of fatty acids as signaling molecules.

New sources of omega-3 are likely to pop up as they always have. Perilla, new types of microalgae, and plants like canola bred to produce greater amounts of omega fatty acids are in the pipeline.  And a few consumer product categories are starting to emerge as opportunities for fortification with omega-3. Meal replacement powders and liquids are beginning to see omegas being added successfully, benefitting from new powdering and emulsion technologies.  The infusion of omega-3 into food products like eggs, chickens and even prepared foods has been achieved through integration of DHA-rich algae or flaxseed into animal feed.  Thanks to long-term and growing interest, the omega-3 rich products of today don’t look or taste anything like grandmother’s cod liver oil, but are just as healthy.

By: Blake Ebersole

First published in Natural Products Insider, October 2016

References

1. http://www.hindawi.com/journals/mi/2014/348959/tab1/
2. http://www.eurekalert.org/pub_releases/2014-05/bawh-nss050114.php
3. http://www.ncbi.nlm.nih.gov/pubmed/12837515
4. http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1676-26492011000400007
5. http://content.iospress.com/articles/journal-of-alzheimers-disease/jad150777
6. http://www.hindawi.com/journals/ije/2013/361895/
7. https://www.army.mil/article/172714/omega_3_study_aims_to_give_soldiers_a_cognitive_advantage
8. http://www.foodingredientsfirst.com/news/Waitrose-Launch-Omega-3-Rich-Chicken-As-Alternative-To-Unpopular-Oily-Fish.html
9. http://www.fasebj.org/content/26/1_Supplement/125.6
10. http://www.ncbi.nlm.nih.gov/pubmed/26793308

The gut is by nature one of the best machines imaginable for chemical conversion of food into energy. As a result, the majority of what we consume is changed into something different with incredible efficiency. The stomach begins this process with the pH of battery acid, plus enzymes. Then, the intestines—25 feet long and filled with hungry bacteria and more enzymes— do the rest. Considering the environment, it is surprising that anything we consume actually absorbs into our bloodstream intact.

Bioavailability, often defined as the amount of a compound put into the body compared to the amount reaching blood circulation, is an unexpectedly complex subject. Luckily, the pharmaceutical scientific literature has given us some good tools to understand it adequately.

In order to be bioavailable, a compound must first remain stable and retain its identity in the gut, which is no small order. Assuming it stays intact, its bioavailability can be divided into four main classes, categorized by the Biopharmaceutics Classification System (BCS). According to the BCS system, there are only two chemical factors driving bioavailability: its solubility and its permeability. Water-soluble compounds like ascorbic acid are considered class I (high solubility and permeability), the ideal scenario for bioavailability. However, many fat-soluble compounds such as curcumin are considered BCS Class IV, possessing low solubility and permeability. With the potential of curcumin and its more than 6,700 published studies, this means a lot of opportunity in the face of a lot of challenge.

For Class I to III compounds, dose delivery is often fairly easy to solve. Optimizing these based on pH, particle size, solid dispersions, crystallization or salt forms can be enough to ensure adequate absorption. But what to do about the difficult Class IV compounds?

The water solubility of a compound is based on its chemical polarity, which depends on the electric charge of a compound (given by the presence of charged atoms like oxygen) and its asymmetry. Water (H₂O) is polar, because it’s an asymmetric molecule containing mostly oxygen by weight. On the other hand, fats and oils, generally symmetric compounds with a lot of uncharged carbons, are nonpolar and not very water soluble.

The spectrum of polarity includes some compounds called amphiphilic (meaning both-loving) which are able to interact with both polar and nonpolar compounds. As a result, they are ideal to include in many dose-delivery systems. Because ‘like dissolves like’, amphiphiles can dissolve both fat- and water-soluble compounds; detergents like soap, which dissolves grease into water, are one everyday example of this type of compound.

The use of amphiphiles to improve bioavailability has already been perfected in our gut. High-purity phospholipids are the key components used by the small intestine to absorb dietary fat. Phospholipids are also a main part of cell membranes, whose critical function is to separate the cell from its environment while at the same time allowing both polar and nonpolar nutrients to pass through. In the past few years, science has harnessed these unique and interesting properties of phospholipids to better deliver active compounds to target tissues.

To date, thousands of studies have been published on improved bioavailability technologies such as solid-lipid particles, nanoparticles, micelles, liposomes, emulsions, microparticles and others. Phospholipids are one common factor among these technologies, which ultimately stabilize and solubilize compounds of a class IV nature. Curcumin, resveratrol and other fat-soluble compounds all clearly benefit from some of these advanced dose delivery systems.

Yet challenges remain. In the view of the literature and medical use, reliable human efficacy is achieved infrequently; the number of successful human studies using these advanced technologies pales in comparison to the number of successful test tube or animal studies. Why? From a dose delivery view, it is also well understood that there is an ideal concentration of active in the body: too little is ineffective, while too much may be counterproductive. Striking that balance is a difficult task.

The human body and how exactly it works remains much of a mystery, still with vast areas of uncharted territory. And some big differences exist in how we absorb, metabolize and excrete what we consume, due to genetics, diet, what we consume it with and other variables. Plus, each active compound is an individual chemical entity with unique physicochemical characteristics and bioavailability. Hence, the need for good and rigorous science.

Also, our current capabilities and standards for measuring bioavailability are sometimes not relevant to efficacy. For example, bioavailability of fat-soluble compounds is generally measured in blood plasma, because plasma is mostly water-based and the best medium to measure water-soluble compounds. However, plasma data often does not reflect actual bioavailability of fat-soluble compounds, because plasma does not generally attract these compounds like blood cell membranes and organ tissues do. Many dose-delivery technologies work magnificently in the test tube, but may not survive stomach acid or the small intestine intact. And some delivery systems may appear to improve bioavailability but only for an inactive metabolite like a glucuronide.

In these cases, the chemical identity of what we measure in the blood, in addition to what part of the blood we are measuring, proves to be more important than the amount we are measuring. When the science of a bioavailability study is off-kilter, it can ultimately lead to the selection of poor clinical study material and a failure to show efficacy. Good science in the early stages of development is critical, and while oil and water can mix, dose delivery is ultimately just a means to promoting health.

By: Blake Ebersole

This article was originally published in Natural Products Insider in August 2014