Standardized Botanical Powders (SBPs): Part 5 of 5

Dr Raina Raj PicIn the last decade, the worldwide organic food market has developed at an exponential rate. Consumers’ attention has shifted from cost-effective products to quality-effective products. This has sparked an organic revolution, which, according to market forecasts, is here to stay. From $15.01 billion in 2021, the worldwide organic meat products market is predicted to reach $20.83 billion in 2025. This demonstrates that a natural lifestyle, and thus nature-based products, are the market’s future. The poultry business must hunt for non-synthetic dietary supplements to improve the health quotient of their flocks to satisfy this high-quality, efficient product demand. With this in mind, we created a series of articles on standardized botanical powders (SBPs), outlining the importance of SBPs, the advantages of using SBPs, the factors that affect their manufacture, and factors to consider when procuring raw material for their manufacture, among other things.

Natural Remedies is the number 1 veterinary herbal healthcare company in India with presence in more than 30 countries across the globe. Through its world-class Research and Development centre, Natural Remedies offers a category of science-based Phytogenic feed additives, called Standardised Botanical Powders (SBPs). In this series of articles, Dr. Raina Raj, Head of Marketing at Natural Remedies, provides in-depth knowledge of what SBPs are, and their benefits in the poultry diet.

A need for standardization of herbal products exists due to the inherent variation of endogenous phytochemicals found in plants. Farming practices, plant age, soil conditions, geographical location, weather conditions, harvest time, post-harvest processing, and a range of other factors can all affect the phytochemical signature of a given species of plant, resulting in uneven final herbal product outcomes. Standardization ensures the herbal powders’ consistent quality and, as a result, their biological health effects.

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The process of standardizing is not limited to the manufacturing plant but starts at the farm where the herbs are grown. One of the strategies we outlined in this series for procuring superior quality raw botanicals with the least variability in their phytoconstituents is through contracted supervised farming. We have also detailed the process of how an SBP comes into being through aggressive scrutinization through the stage-gate innovation process. The stage-gate innovation process can be segmented as the ideation stage, concept stage, feasibility stage, developmental stage, scale-up stage, launch stage, and post-marketing surveillance. The SBPs are evaluated for their biological efficacy throughout the stage-gate process. In the current issue, we shall highlight the importance of studying the biological impact of the SBPs from the performance of the birds to genomic level.

In the feasibility stage, the herbs that would address the specific issue are screened using in-vitro and in-vivo assays. If an SBP has been conceptualized, the potential herbs should undergo preliminary evaluation in cell lines and in experimental animals first to evaluate their biological efficacy. For instance, when formulating an SBP to maintain healthy microbiota and hence prevent loose litter in chickens, the astringent properties of the herb combination must be examined by in-vitro bioassays such as protein precipitation assay and half maximal effective concentration (EC50) values analysed followed by ex-vivo assays such as ileal loop assay to evaluate its effect on hypersecretion. Other relevant assays can be performed for the biomarkers of interest, such as inhibition of cAMP release response to Forskolin in HT-29 cell line (specific for enterocytes), as illustrated in Figure 1. Only those phytochemicals that pass this preliminary evaluation should be considered candidates for the developmental stage.

Figure 1. Results of an in-vitro assay
Figure 1. Results of an in-vitro assay to assess anti-hypersecretory property (a) Schematic representation of Cl− and H2O release from the enterocyte. (b) Experimental results of cAMP inhibition by an SBP

Next, in-silico assays can used to discover the best match among the possible herbs that passed the feasibility test. Phytochemicals showing synergistic effects should be tested in the biological systems for their efficiency. Specific animal disease models should be used to test the efficacy of the SBPs. The animal models may vary depending on the specific condition being addressed by the SBP. If the desired biological effect of the SBP is to be anti-diarrheal, the SBP should be tested in a well-established animal disease model such as magnesium chloride-induced, castor oil-induced, or non-saturated polysaccharides (NSPs) induced diarrhoea animal models, comparing the effect with a control group to test the efficacy of the SBP for fluid retention and zootechnical parameters as shown in Table 1.

 Table 1: Results of the zootechnical parameters of broiler birds with induced diarrhoea with NSPs and supplemented with SBP.

Table 1: Results of the zootechnical parameters of broiler birds with induced diarrhoea with NSPs and supplemented with SBP.

Following that, the herb formulation should be assessed for safety in smaller groups of target species in a controlled environment. The animals should be observed for any adverse reactions to the consumption of the SBP.

Only when the formulation passes this stage should it move to the scale-up stage, where larger populations of target animals are evaluated in the field conditions in different parts of the country and world. In this stage, the SBP is assessed for both its efficiency and its performance in response to the SBP, and zootechnical parameters such as body weight gain and feed conversion ratio (FCR). These parameters may vary depending on the SBP. The SBPs can also be evaluated for their effect on a single organ system through serological biomarkers, at the structural level through histological studies as shown in Figure 2, and at the molecular level using Omics studies as illustrated in Figure 3.

Figure 2: Histopathological slides to assess the effect of an SBP on the structure of hepatocytes.

Omics studies

Omics studies are high throughput studies, comprising of proteomics, metabolomics, transcriptomics, etc. An in-depth understanding of pharmacodynamics, pharmacokinetics, and toxicological characterization of the active ingredients of a herbal product is gained through these research. The goal of omics studies is to identify and quantify large groups of biological molecules that are transformed in the structure, function, and dynamics of an organism.

Every material that is supplemented to an animal to achieve the intended result has a mechanism of action in the body, and it is critical to understand why and how it works. And, to answer the question, what genes, proteins, and metabolites in the body are affected by the substance in question? Omics studies are essential. This would provide scientific support and proof for the phenotypes displayed by the animals.

Considering natural compounds take a holistic approach to healing an animal, rather than focusing on a single molecule, a systems biological approach using OMICs studies is required to examine the herb’s effect on the complete system. Figure 3 illustrates the results of nutrigenomics in broiler breast muscle and liver after supplementation on Standardized Botanical Powders. Inferences on mechanism of action of the SBP can be drawn based on the gene alterations noticed in the treatment (SBP supplemented) group as compared to the disease (no supplementation) group.

Figure 3: OMICs study results from the Lipid genomics study on ACLY gene expression.
Figure 3: OMICs study results from the Lipid genomics study on ACLY gene expression.

Batch-to-batch consistency must be evaluated to assess the efficiency of the standardization process. This can be verified with the help of chromatographic techniques where the products manufactured are compared against reference material of the product using an appropriate test method. As shown in Figure 4, high-performance thin-layer chromatography (HPTLC) is used to assess the phytochemical constituent pattern for batches manufactured during different periods.

Figure 4: Assessment of consistency in the SBPs in each batch.
Figure 4: Assessment of consistency in the SBPs in each batch.

To have a highly efficient and high-performing Standardized Botanical Powders, they must be scientifically assessed and evaluated thoroughly before and after their launch into the market.

To conclude, standardization is an essential process that ensures that active phytochemical concentrations are maintained with minimum fluctuation, ensuring efficient phyto-active function in the animal’s body. This helps monitor the product for consistency batch after batch so that it provides the expected results and the best performance in the animals.

 

Previous articles in this Series

PART 1: Standardized Botanical Powders : What? Why? How?
PART 2: Standardized Botanical Powder – To Be Or Not To Be
PART 3: Standardization Of Botanical Powders Starts At The Grassroots
PART 4: Check, Assessment & Revalidation Of SBPs

Standardized Botanical Powders (SBPs):  Part 4 of 5

Environmentally conscious consumers place a premium on global sustainability, animal welfare, and obtaining better food for their families, driving them to solely purchase organic items. This Dr Raina Raj Picsegment of the population has grown at an exponential rate over the last decade, and their numbers are continuing to rise. According to reports published by BusinessWire, the global organic meat products market is expected to grow from $14.38 billion in 2019 to $20.39 billion in 2023. To meet this market demand, manufacturers must take on the task of producing higher-quality, consistently efficient, value delivering sustainable herbal products.

In this series of articles, Dr. Raina Raj, Head of Marketing at Natural Remedies Pvt. Ltd., provides in-depth knowledge of what SBPs are, and their benefits in the poultry diet.

Natural Remedies is the number 1 veterinary herbal healthcare company in India with presence in more than 30 countries across the globe. Through its world-class Research and Development centre, Natural Remedies offers a category of science-based Phytogenic feed additives, called Standardised Botanical Powders (SBPs).

In previous articles of this Series, we explored what standardised botanical powders (SBPs) are, their value, and the benefits they give to the poultry farming community. SBPs are herbal powders whose specific phytochemical active concentrations are standardized with minimal variation, to ensure efficient Phyto active function in the animal’s body. Through standardization of botanical powders, the product can be monitored for consistency, and it provides the expected and desired results for the animals.

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Consistency in efficacy is crucial in today’s poultry sector, and the usage of SBPs will help with that. In previous articles, we discussed the scientific foundation to produce SBPs as well as the protocols that must be followed to ensure that the active phytoconstituents remain of high quality. It’s crucial to keep the herbal constituents stable in a poly-herbal composition. Environmental factors such as humidity, air, light, and temperature can affect stability. Stability is further affected by factors such as particle size, pH, the characteristics of water and other solvents used during manufacturing, the nature of the container, and the presence of other chemicals resulting from contamination. Maintaining an SBP’s stability ensures that the product’s strength, quality, and purity remain consistent as per specifications.

In the current article, we shall shed light on the desired botanical, organoleptic, physical, chemical, and biological properties of SBPs that make them stable and maintain high quality.

SBPs should be assessed and documented for their properties

SBPs should be thoroughly studied for their inherent properties as shown in Figure 1.

Figure 1: The many assessments that an SBP must go through are depicted in this schematic representation.

Botanical properties such as physical shape, external appearance, and markings should be documented.

Organoleptic properties are properties that create an individual experience through the senses of the consumer. These properties are colour, odour, texture, taste, and fracture.

Physical attributes such as pH, moisture content, ash value, which is the inorganic residues obtained after complete combustion of a compound, and extractive values are used to assess quality, purity, and to detect adulteration.

Chemical properties should be assessed through high-performance liquid chromatography (HPLC), high-performance thin-layer chromatography (HPTLC), thin-layer chromatography (TLC), and gas chromatography (GC). The SBPs should be analysed both qualitatively and quantitatively for their chemical properties.

Biological properties should be studied for microbial contamination, toxicological and pharmacological residues.

The next sections go through some of the key attributes that contribute to the making of an efficient SBP.

Assessment of the particle size of the SBPs

Poultry are simple stomached animals largely dependent on the repertoire of endogenous enzymes for their nourishment. One of the most critical aspects that determine feed utilisation in these animals is particle size distribution. Finer particle size provides for better contact with digestive enzymes, which results in optimal nutrient absorption and improved animal performance. However, the fineness of the particle size has limitations. Increased incidences of gizzard dysfunction are seen in the flock when the particle size is very fine. Hence, during the manufacture of SBPs, the particle size of the product plays an integral role. Particle size can be assessed using a particle size analyser, as in Figure 2, which works on the principle of laser diffraction.

Figure 2: Particle size analyser results
Figure 2: Particle size analyser results

Large particles scatter light at small angles as compared to that of the laser beam, whereas small particles scatter light at a much larger angle. The angular scattering intensity is used to determine particle size. The flow of the SBP particles should be assessed for parameters such as the angle of repose, which is a characteristic related to inter-particulate friction or resistance to movement between particles, the compressibility index, and Hausner ratio.

Figure 3: Particle size of different products shown at higher magnification.

In Figure 3, the particle sizes of three products, A, B, and C, are compared. While they are all in powder form, higher magnification reveals that product A has the best particle size when compared to B and C. The ability of a product to be homogeneously blended into the feed mixture is also influenced by particle size. Hence, as indicated in Figure 4, an SBP must be examined for its capacity to be uniformly mixed.

Figure 4: Assessment of uniform mixing of the SBP with other feed ingredients.
Figure 4: Assessment of uniform mixing of the SBP with other feed ingredients.

Thermostability assessment

It has been observed that, under higher temperatures, many of the constituents present in poly-herbal formulations may react with each other, raising serious concern about the stability and efficiency of the formulation. Natural products are often susceptible to deterioration, especially during storage, leading to the production of metabolites with no activity, loss of active phytoconstituents, and, in extreme cases, the production of toxic metabolites. Hence, qualitative, and quantitative evaluation of SBP stability at higher temperatures is essential. In Figure 5, the product under test doesn’t show any change in the active ingredient composition before and after being autoclaved at 121͒ C, indicating that the compound is thermostable. These results ensure that the SBP is stable and will have the desired biological activity in the target animal.

Figure 5: Thermostability assessment for the SBP both qualitatively and quantitatively. SBPs should be thermostable.
Figure 5: Thermostability assessment for the SBP both qualitatively and quantitatively. SBPs should be thermostable.

Microbial Load assessment

Herbal plants may be associated with a broad variety of microbial contaminants transmitted through soil or air as illustrated in Figure 6.

Figure 6: Schematic representation of the possible pathways of microbial contamination of medicinal plants
Figure 6: Schematic representation of the possible pathways of microbial contamination of medicinal plants

They could be bacteria, fungi, or viruses. Multiple environmental conditions influence the microbial load, which has a significant impact on the overall quality of herbal goods and preparations. According to study reports, the most found pathogens are enterobacteria such as E. coli and Salmonella. Hence, microbial assessment of medicinal plants on procurement and SBPs after manufacturing is essential. ISO guidance suggests standardized protocols for aerobic mesophilic bacteria, yeasts, and moulds, E. coli, and Salmonella in herbal medicines as shown in Figure 7.

Figure 7: Microbial analysis of herbal products
Figure 7: Microbial analysis of herbal products

Assessment for toxic contaminants

Contaminants such as heavy metals, pesticides, and mycotoxins, if not maintained below safe levels, can lead to life-threatening toxicity in animals. To ensure the SBPs are safe, they should be tested for these contaminants. The samples can be tested for pesticide residues with Gas Chromatography – Electron Capture Detector (GC-ECD) and Gas Chromatography-Tandem Mass Spectrometry (GC-MS/MS). Heavy metal contamination can be detected using an inductively coupled plasma mass spectrophotometer (ICP-MS). Aflatoxin and mycotoxins can be detected using high-performance liquid chromatography with fluorescence detection (HPLC-FLD).

Assessment of Hygroscopicity

The SBPs should be non-hygroscopic, among other physical qualities. The ability of a substance to absorb moisture from its surroundings is known as hygroscopicity. It’s an unfavourable feature since it might cause lumps and prevent correct mixing with other feed ingredients. As a result, the SBPs must be designed to be non-hygroscopic. Figure 8 depicts a method for determining hygroscopicity. Product A is less hygroscopic as compared to B since it doesn’t form lumps.

Figure 8: A test for the hygroscopicity of products A and B after 7 hours of storage under high humidity.
Figure 8: A test for the hygroscopicity of products A and B after 7 hours of storage under high humidity.

The efficiency of a feed supplement can be attributed to its physical properties as well as its functional efficacy based on the performance of the birds. Here we elaborately provided evidence of the physical attributes necessary to be tested in an SBP, which would keep the product stable and efficient for a prolonged period as well as make management of the product easy.

In our next article, Productivity Check of SBPs in the Field, we shall elaborate on the scientific assessment of functional efficiency through their biological effects.


Previous articles in this Series

Dr Raina Raj PicStandardized Botanical Powders (SBPs): Part 3 of 5

The organic revolution in the food industry has taken the world in its stride. The consumer awareness of the health benefits of natural products shall keep this revolution going. There has been tremendous growth in the global organic animal food industry. The global organic poultry market alone is expected to make $7.67 billion in 2021. Although there have been several discussions to meet the desired market demand, there is little talk around the quality and consistency of natural products. With this in mind, we have designed this series of articles, which sheds light on the importance of standardization in botanical powders. In the last two issues, we have discussed with evidence what standardized botanical powders (SBPs) are, and how an SBP comes into being.

The current article emphasizes the importance of procurement of high-quality raw material by focusing on its authenticity, safety, and documentation to keep good consistency in the concentration of the phytoconstituents. Finally, these would result in high-quality SBPs.

The medicinal property of a plant is determined by the natural phytoactive chemicals they possess. Phytochemicals, such as alkaloids, terpenes, phenolic compounds, and flavonoids are encapsulated by a specialized membrane known as tonoplast. A tonoplast is a semipermeable membrane surrounding a vacuole in a plant cell. Once the SBP is fed to the animal, the tonoplast disintegrates in the gut of the animals, releasing the phytochemicals. These phytoconstituents have been reported to exhibit various biological effects for instance adaptogenic, hypoglycaemic, antioxidant, immunomodulatory, anti-inflammatory, anti-cancer, and gut enhancing properties. However, the biosynthesis of phytochemicals is significantly affected by several factors such as environmental stress conditions like seasonal changes, geographical location, plant maturity, soil type, farming practices, genetic make-up, and post-harvest processing to mention a few.

Natural Remedies is the number 1 veterinary herbal healthcare company in India with presence in more than 30 countries across the globe. Through its world-class Research and Development centre, Natural Remedies offers a category of science-based Phytogenic feed additives, called Standardised Botanical Powders (SBPs). In this series of articles, Dr. Raina Raj, Head of Marketing at Natural Remedies, provides in-depth knowledge of what SBPs are, and their benefits in the poultry diet.

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In India, manufacturers can purchase crude botanicals from local Bazaar, where 52% of their stock comes from temperate and tropical forests, 25% from wild-grown regions, and 20% from farms or plantations. Scientifically, harvesting botanicals from wild sources not only damages the biodiversity of the region but also there is no accountability to the variation in their phytochemical constituents, which poses an issue when botanical compounds need to be standardized. Therefore, it is important to ensure that plants selected for their medicinal uses contain relatively fewer variations in phytochemical constituents. Standardization is essential to maintain consistency in the biological outcome when consumed by animals. Hence to overcome these issues the standardization process begins at the farm where the medicinal plants are cultivated under supervision and can be harvested at the optimum time of growth for the best utility of the phytochemicals.

Contracted supervised farming

One of the strategies to procure superior quality raw botanicals with the least variability in their phytoconstituents is through contracted supervised farming. This helps monitoring of the raw product for its authenticity, safety, and least variability in the desired phytochemical; ensuring organic methodology is used in the plant cultivation process; harvesting at the specific age of maturity, when the phytochemicals are at their peak; to the farming community this generates a steady source of income; this generates gainful employment in rural communities; they receive support and guidance throughout the cultivation process; they receive input after analysis of the soil and water samples for pH, conductivity, organic carbon, phosphorus, potash, and residual pesticides. Since the plants are grown organically, pesticide use is avoided, which in turn helps the environment. However, to ensure that the crops receive sufficient nutrients the manure used as fertilizer is also assessed, for physical and chemical properties such as colour/odour, moisture percentage, pH, conductivity, organic carbon, N-P-K, CN ratio, micronutrients like Fe, Mn, Zn, etc. A technical team supervises the land for soil waterlogging, major weed infestation, and irrigation and assists the farmers to solve any issues in the field. In general, it is a win-win situation for both the contracting herbal company and the farmer.

Figure 1
Figure 1: Farmers receive support and guidance from land preparation until the time of harvest

Assessment of authenticity

The herb samples collected from the farm should be evaluated extensively for their genuineness at the physical, microscopic, and molecular levels (Figure1). The authenticity of the herbs is already established at the seed level during collection. Ultimately, all these assessments are necessary for the standardization process of the SBPs and to provide consistency in each batch to give the desired biological effect.

Figure 2: Herbal authentication
Figure 2: Herbal authentication

Assuring safety

To ensure the SBPs are safe, the herbs are collected from a pristine area where there is no heavy presence of contaminants. Also, the safety is ensured with the harvested raw herbs through testing for pesticides, heavy metals, and mycotoxins/aflatoxin. The samples can be tested for pesticide residues with Gas Chromatography – Electron Capture Detector (GC-ECD) and Gas Chromatography-Tandem Mass Spectrometry (GC-MS/MS) as shown in Figure 3. Heavy metals such as Cadmium, Arsenic, Lead, and Mercury are evaluated with an inductively coupled plasma mass spectrophotometer (ICP-MS) as shown in Figure 4. Heavy metal, pesticides and mycotoxins occurrences in herbs, if not maintained below safe levels can lead to life-threatening toxicity in animals. Aflatoxin and mycotoxins are detected using high-performance liquid chromatography with fluorescence detection (HPLC-FLD) as shown in Figure 5.

Figure 3
Figure 3: Pesticide Residues in the raw material are evaluated by GC-MSMS/GC-ECD

Figure 4

Figure 4: Heavy metals in the raw material are detected by ICP-MS

Figure 5
Figure 5: Aflatoxins in the raw material can be detected through HPLC-FLD

Traceability of the raw material to its origin

The whole process of cultivation to harvest should be well documented, just as travel information in a passport Figure 6. Supervised farming helps maintain scientific recording that gives details at each stage of growth, if at all there are any untoward variations noticed in the performance of the product, it can be traced back and re-evaluated with scientific data. Post-harvest the product should be well labelled too (Figure 7). So that finished goods can be traced to which farm they originated from. The whole raw material procurement process becomes more science-based which helps in the standardization of SBPs and is eco-friendly, by maintaining the biodiversity of the forests, avoiding pesticides, and ensuring customers a safe end product free of synthetic constituents.

Figure 6
Figure 6: Passport data of Ocimum, authenticated by a botanist.
Figure 7
Figure 7: Post-harvest the raw material is labelled so that its origin can be traced back

In our next issue, we shall elaborate on theCheck, Assessment, and Revalidation of SBPs.”

Standardized Botanical Powders (SBPs):  Part 2 of 5

The demand for organic and natural foods has grown over the past decade. The desire for better overall health among consumers and the awareness of the harmful effects of synthetic ingredients has fueled an organic revolution. This is evident from the global market estimations; “the organic food market generated $162,036.7 million in 2019 and is predicted to make revenue of $416,049.7 million by 2027.”

Dr. Raina Raj pic

To be a front player in the future of the organic revolution, consistency in quality and biological results shall be essential. Keeping this in mind, we have designed a series of articles describing the importance of the standardization of botanical powders. Standardization here refers to neutralizing the natural variability to deliver consistency and uniformity in the quality assessment parameters. According to the National Institutes of Health (NIH), standardization is a process that manufacturers use to ensure batch-to-batch consistency of their products. Standardization involves identifying specific phytochemicals (also known as markers) that can be used to manufacture a consistent product.

In our first article, we discussed What, Why and How standardization is done  in standardized botanical powders (SBPs).

In this current article, we shall discuss how an SBP comes into being. What are the process and aggressive scrutinization that occurs at each step of its formulation from when it is an idea to its launch into the market? Shakespeare’s hamlet phrase “to be or not be” fits in aptly here. The well-known stage-gate process for innovative products can be used as a basis with slight modifications (Figure 1). At each stage a committee would review the process and approve or disapprove the SBP from entering the next stage.

SBP: The steps in the stage-gate process
Figure 1: The steps in the stage-gate process

Ideation stage: In the ideation stage, an idea of a product is proposed to address a pain point or an issue, in the poultry industry. Either to bring in a new supplement or to find a natural, and safe alternative to an existing synthetic supplement in the market.

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Concept stage: A clear customer value proposition for the idea is made through a business case. What would the impact of this SBP be in the market? A library of plants is created based on availability, biodiversity, patentability, and cost. If the Standardized Botanical Powder passes this stage, it goes to the feasibility stage.

Feasibility stage: The potential plants that would address the issue are screened. Medicinal plants are screened with bioassays in vitro or in vivo. Traditional and modern scientific literature is curated for botanical constituents that can be used to address and solve the issue. The phytochemistry laboratory develops commercially viable processes for the optimum extraction of medicinal plants, where active constituents, otherwise known as markers, are already known. The phytochemistry lab is where the creation of a Standardized Botanical Powder starts, with the preparation of different formulations. The SBPs are prepared through scientific evaluation of the phytochemicals required for the formulation and the right selection of the raw materials. The phytochemistry lab also establishes the essential reference marker or the phytochemical that would be necessary to be standardized in each batch of SBPs (Figure 2).

Reference phytochemicals are selected to be standardized in SBPs.
Figure 2 : Reference phytochemicals are selected to be standardized in SBPs.

 

Developmental stage: Leads generated in the feasibility stage are examined and combined to form formulation prototypes. This is performed with computational models such as orthogonal array composite design (OACD) (Figure 3), which helps look for interactions between the different components of the tentative formulations. These results simulate the interaction between the components and give a scientific insight regarding the interaction between the constituents. They could either be synergistic, additive or antagonistic. Additivity means that the activity of the ingredients is adding up, synergy means the activity of the components when combined is enhanced, and antagonism means that the ingredients would nullify the effects of each other. Only those combinations that show synergistic predictions in a formulation are prioritized and selected to be taken further.

A series of biological studies are conducted to find the best herb(s) for the desired biological activity. The Standardized Botanical Powder formulation is then tested in a small group of the target species in a controlled environment. It is assessed for safety in the animals. Only if these studies show promising results they move to the scale-up stage.

Taguchi Orthogonal Array Method
Figure 3: Taguchi Orthogonal Array Method

 

Scale-up stage: The challenges during manufacturing are addressed in this stage, where the product is scaled in quantity from kilograms to tons. Then, the beta-testing phase begins, where a larger number of target species is tested. Farm trials in field conditions are conducted in different parts of the country and the world. If the results are encouraging at the scale-up stage, the product is launched to a segment of the market.

Launch stage: In the launch stage the SBP is evaluated for its safety, effectiveness and checked if it meets all the end attributes that were desired in the conceptual stage. Later on, it is taken to full-scale marketing.

Post-marketing surveillance: Test to examine how the SBP fairs. Is the SBP efficient in showing the desired biological effects? Its mechanisms of action at the phenotypic, molecular, and genome level are evaluated.

Only when an SBP can pass through each stage with satisfactory performance, the process is furthered to the next stage, if not the journey of the SBP is halted; to iterate its formulations and the journey begins from the start with new constituents.

In our next article, we shall elaborate on when the standardization process begins “Standardization of SBP starts at the grassroots

The future of the animal food industry is invested in the organic revolution, due to the worldwide awareness of the Authorhealth benefits associated with holistic living. The natural supplement industry is foreseeing a huge surge for evidence-based scientific herbal products. This growing market demands exceptionally high-quality and consistently efficient natural products.

One of the major issues in assuring the consistent quality of herbal products is the natural variation of endogenous phytochemicals that occur in plants. The phytochemical “fingerprint” of a particular species of plants can vary drastically depending on the age of the plant, soil conditions, weather conditions, farming practices, time of harvest, geographical location, post-harvest processing, and many other factors, leading to inconsistent results of the final herbal products. The solution to this is by standardization of the product during manufacturing. Our intention through a series of articles is to provide evidence on what is? And why is it? There is a mandatory need for standardization of herbal powders to ensure high efficiency and consistency in each batch.

This article series will take the readers through a journey of rigorous standardization process of standardized botanical powders (SBPs) that begins at the grass-root through the procurement of raw material by supervised contract farming or other means; assurance of evidence-backed consistency in quality until its packaging before reaching the end-user. The current article shall provide in-depth knowledge of what SBPs are; and their benefits in the poultry diet.

What are Standardized Botanical Powders (SBPs)?
Standardized Botanical Powders (SBPs) are herbal powders whose specific phytochemical active concentrations are standardized with minimal variation, to ensure efficient phyto-active function in the animal’s body. Through standardization of botanical powders, the product can be monitored for consistency and it provides the expected results in the animals.

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Processing of Standardized Botanical Powders
Botanicals are processed in different ways as shown in Figure 1 depending upon the end-use and also, sometimes, depending on the inherent nature of the botanical itself. Let us take the example of Withania somnifera known as “Ashwagandha” in Ayurveda; the phyto-actives are present in its roots. The dried roots are powdered finely to produce Ashwagandha straight powder. This powder is then standardized with reference to the phytochemical markers chosen; this would also be the constituent that is responsible for its botanical effect in the body. The standardization process of the phytochemical assures consistency in its biological effects in each batch, and these are referred to as SBPs.

Schematic representation of processing of botanicals during manufacture
Figure1: Schematic representation of processing of botanicals during manufacture

Why are SBPs a more holistic way to approach phytochemical supplementation?

Schematic representation of the Tonoplast
Figure 2: Schematic representation of the Tonoplast

Phytochemicals like alkaloids, terpenes, phenolic compounds, and flavonoids are produced by the plants for self-defence and are stored in a specialized organelle known as the vacuole, which is encapsulated by a membrane known as tonoplast. Once the SBP is fed to the animal, the tonoplast disintegrates in the gut of the animals, which in turn releases the phytochemicals present in it. The natural encapsulation that nature provides to plants to protect its phytochemicals is preserved during manufacture. This ensures optimum phytochemical delivery to the animals.

How are the Standardized Botanical Powders different from botanical extracts?
The SBPs are simple straight powders of the botanical plant part which have scientific evidence of health benefits associated with their use. Unlike extracts, the manufacturing of SBP does not involve any extraction, elimination, or concentration of individual components. They can be used as functional food ingredients just as the herbal extracts are used. Generally, SBPs require larger oral doses to attain the health benefits. Extracts are often preferred only when the volume of the oral dose is an issue. Technically the SBPs are as good as extracts because the extracts are produced from the same herbs.

Table 1
Table 1: Compared to other phytogenic, SBPs are more holistic since they contain all the constituents of a plant which assist in bringing about the desired results in animals.

Biological advantages of using SBP

  1. SBPs have multiple modes of action with a systemic effect on different organ systems in a synergistic manner, due to different composite of phytochemicals inherently present in them. SBPs show synergistic and/or additive effects due to a composite number of phytochemicals in them.
  2. SBPs contain high fibre content that provides several benefits, in digestion and feed absorption. They are also useful to the gut microflora.
  3. The raw materials for SBPs are produced by supervised, responsible, and sustainable farming, to assure good quality. Hence, we possess the capability to trace them back to their origin up to the supplier level.
  4. Secondary metabolites (the potent phytochemicals) are present in their natural packaging, known as the tonoplast.
  5. SBPs are assessed for their physical properties such as particle size, for uniform mixing; Thermo-stability at 120°C for 5 minutes at 15 psi pressure; chemical consistency from batch to batch; and microbial analysis for safety.
  6. SBPs are manufactured with the holistic principles of Ayurveda and modern scientific technologies.

Currently marketed SBPs contain a combination of botanicals, whose desired phytochemicals are standardised to give specific biological effects in the animals.

Figure 3: Beneficial Effects of Using SBPs
Figure 3: Beneficial Effects of Using SBPs

In the next issue, we shall discuss how an SBP comes into being, titledTO BE or NOT to be an SBP”.

Author:
Dr. Raina Raj, Marketing Head
Natural Remedies Pvt Ltd