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How to add powdered fruit, vegetable and herbal extracts to cosmetic formulasHerbal and botanical extracts -
This article outlines some of the lessons learned over 3 decades of practical experience in the formulation of complex herbal medicinal tea infusion products, when combining botanical substances of varying physical properties and performance characteristics. Meadowsweet Filipendula ulmaria L. Dunal , licorice Glycyrrhiza spp.
and Maxim. and reishi Ganoderma lucidum Karst extracts will exemplify specific extract characteristics in the following. Traditional principles of formulation for herbal infusions emphasize clinical efficacy, combining the primary and secondary actions of their components to achieve desired therapeutic outcomes Hoffmann, Single herbs with their diverse pharmacological components can provide a balanced complement of actions for a given therapeutic outcome: for example, meadowsweet herb yields key active constituents, including salicylates and quercetin-derived polyphenolic glycosides, into a simple aqueous infusion at 90—°C steeped for 10—15 min Harbourne et al.
As a result, a teabag infusion made from 2 g of comminuted meadowsweet herb per day can be expected to be effective, as noted by the European Medicines Agency EMA in its therapeutic labeling monograph European Medicines Agency, For reference, typical total teabag weights in commerce range from 1.
This, however, may not be the case for more complex mixtures or for ingredients that are not traditionally suitable for simple infusion as above. Although the amounts can vary depending on the specifics of a formulation, the doses required to achieve therapeutic efficacy for polyherbal formulations can in some cases exceed those that a teabag infusion product can deliver, requiring an impractical number of teabags to be consumed on a daily basis.
Even single herbal ingredients, such as echinacea above-ground parts, may require a dose too high to be practical in a teabag indicated for infusion. Additionally, certain ingredients, such as medicinal mushrooms, or certain plant parts, such as roots or barks, present a challenge to infusion and are traditionally prepared by decoction long-term simmering Green, This makes them poor candidates for inclusion in an herbal tea infusion, which is typically steeped in hot water for about 10 min and not simmered.
Extracts of medicinal herbs and mushrooms can serve as a viable option for addressing these challenges when formulating for delivery in double-pouch filter teabags. Extracts may be used as active components of the formulation, or as flavor corrigents to modify the final sensory experience of the infusion.
The authors have found that the following are important considerations when formulating teabag infusion products with extracts:.
Extracts can be obtained using a variety of techniques, solvents, and extraction parameters. At its most basic, extraction involves exposing comminuted or powdered plant material to a solvent, under variable conditions of time, temperature, and pressure depending on the extraction system.
Solvents used can be highly variable, with their unifying characteristic being an ability to penetrate fibrous tissues and cell walls to allow constituents to dissolve down their concentration gradients into a homogeneous, equilibrated solution List and Schmidt, This extract is concentrated, through evaporation of the solvent, to a thick, soft substance extractum spissum , the native extract, which can be further dried into a powder extractum siccum.
The ratio of the mass of initial material to the mass of native extract is known as the drug extract ratio DER , and is roughly indicative of the degree of concentration of the extract List and Schmidt, The solvents used for extraction vary widely. The choices of solvent, extraction time, and pressure, are determined in large part by the traditional use record and modern insight into the polarity of the chemical constituents of interest for the ingredient s being extracted Abubakar and Haque, Mixtures of water and ethanol hydroalcoholic solvents allow for extraction that favors a range of chemical constituents with differing polarities both polar and slightly non-polar.
Carbon dioxide, under different conditions of temperature and pressure, can yield different non-polar fractions from a given ingredient. A notable example is hemp, using supercritical carbon dioxide at varying conditions of temperature, pressure, and solvent flow rate, extracts with high cannabinoid or, conversely, high terpene content can be obtained Baldino et al.
For the purposes of formulation, matching the polarity of the desired chemistry of the extract with the polarity and extraction parameters of the solvent yields an extract that best matches the desired phytochemical profile.
This can be useful in the production of standardized extracts which require a consistent, quantified amount of certain marker compounds. This can be seen in the production of TCM aqueous dry extracts. After extraction, the extractum siccum is compressed into granules with a defined DER range.
This enables practitioners to make a dosage correlation between the traditional preparation decoction of the raw ingredients and the modernized extract granules. For example, a TCM formulation known as Biyan Pian [consisting of xanthium fruit Xanthium sibiricum Patrin ex Widder ; magnolia flower Magnolia biondii Pamp.
Baill; Platycodon root Platycodon grandiflorus A. ex Hoffm. and Hook. ex DC. Chinese Pharmacopoeia Commission, is indicated for rhinosinusitis and respiratory congestion. It is traditionally prepared by combining the herbal ingredients and decocting, or simmering, the mixture for a prolonged period, making it impractical for use in teabag infusion products both because of its preparation and the mass of herbal ingredients required.
A dry aqueous extract using water as the only solvent of Biyan Pian with an average DER of addresses both these concerns by pre-extracting the herbal ingredients so that prolonged simmering is no longer required, and by concentrating the extract roughly eight-fold through evaporation of the water solvent.
In this way, by using the extract in a teabag, approximately 8-times the amount of herb equivalents is delivered into the aqueous infusion when the teabag is steeped for 10—15 min at 90—°C. While the example above uses water as the only extraction solvent, other choices are available for other herbal ingredients.
This solvent is selected for two reasons: first, historical evidence emphasizes the use of the hydroalcoholic tincture as an effective medicinal preparation of this herb King and Felter, Second, modern analytical chemistry emphasizes the non-polar phenolic and alkamide fractions of the root Spelman et al.
After extraction in the hydroethanolic solvent, a dry extract is produced, which is incorporated into teabag infusion products designed to stimulate immunologic function European Medicines Agency, In this case, the use of the extract allows for delivery of an efficacious amount of constituents among them, phenolic compounds and alkamides from fibrous roots in a non-traditional format.
For example, the root of ashwagandha is traditionally ingested as a powder i. While aqueous extraction at high temperature and pressure may yield an extract rich in compounds considered medicinally relevant Hooda et al.
However, this extract is wholly insoluble in water, and does not disperse through a teabag. Due to natural variability of the herbal ingredients used to manufacture extracts Pant et al. This can be accomplished by blending the native extract with an excipient such as maltodextrin.
This allows for a consistent level of phenolic compounds and alkamides, which are assayed for compliance with internal specifications based on pharmacopoeial standards before the extract is used to manufacture finished products.
Beyond the process of normalization and standardization described above, a native extract can undergo additional processing after extraction.
Emulsification of these native extracts significantly improves their performance in an infusion and can be achieved by micro-encapsulating the soft extract into micelles.
Previous research has identified phospholipids, such as those obtained from sunflower Helianthus annuus L. Komaiko et al. The types and characteristics of suitable extracts, including the use of different excipients for different types of extracts and applications, are summarized in Table 1.
TABLE 1. Types and characteristics of extracts suitable for use in teabag infusion products. Native extracts often present a range of DERs due to natural variability of the starting material.
Depending in part on the specific herb to be extracted and its content of water- or ethanol-soluble extractives, these can range from averages of 4—, up to Monagas et al.
Normalized extracts offer a consistent DER by adding variable amounts of excipients. Standardized extracts offer a consistent, quantified amount of marker compound s.
Teabag-ready extracts, which may be normalized or standardized before processing, blend the extract with excipients and emulsifiers to aid in their infusibility. Dried or concentrated liquid extracts require preparation before they can be incorporated into blends destined for use in teabag infusion products.
Dried extracts extractum siccum have very small particle sizes which are defined as microfine powders Pharmaceutical Guidelines, Size spectra are around 1—3 µm by number though they can range widely from 1— µm depending on types of extracts and drying processes Ulyantsev et al.
On the other hand, herbs used for bagged teas are bulk solids with particle sizes ranging from a few millimeters to a fraction of a millimeter, typically between US.
mesh 10 2 mm and US. mesh 60 0. Mixing microfine extract powder with TBC herbs widens the particle size distribution of the blend, which can impact blend homogeneity. Particle size influences the flowability of material. Flowability is the ratio between the cohesive forces making particles stick together and the normal forces breaking them apart Lawrence, Coarse particles have a better flowability than finer particles.
Blending microfine extract powders with TBC herbs also increases the differences in flowability between the components, which leads to higher segregation of a mixture Savage and Lun, Furthermore, microfine powder tends to stick on machine surfaces, which increases the friction between the dosing parts of a tea packaging machine, generates heat, and can seize the packaging machine.
Consequently, the efficiency of tea packaging operations decreases. Therefore, one must take measures to agglomerate powder extract into machinable particle size to mitigate undesirable physical properties and yield a homogeneous mixture with good machinability. There are multiple technologies for converting a powder extract into a TBC particle size depending on the extract in question.
Dry granulation utilizes two rollers that revolve towards each other to form solid compacts or sheets by hydraulic pressure which are then milled and granulated to TBC particles. Figure 1 shows samples of licorice root aqueous extract powder, licorice root aqueous extract granules, and licorice root TBC to illustrate how licorice root aqueous extract granules have a similar particle size to TBC licorice roots.
FIGURE 1. Samples of licorice extract powder, licorice root extract granules and licorice root TBC. The hardness of granules is proportional to compression force. Appropriate granule hardness is critical.
The granulation can be processed with excipients such as maltodextrin, sugars, gum acacia, and starch for standardization, or to mitigate the separation of the ingredients in a solid mixture during blending and material handling and improve the flow of the mixture in the tea packaging machine.
When granules are too hard, they may not disintegrate and dissolve sufficiently for full release during the allotted brewing time Lira Soares et al.
A widely used practice is to agglomerate such an extract with appropriate excipients with emulsifying properties and homogenize the slurry before drying and milling to TBC size.
Desai et al. reviewed various techniques for producing dry emulsions Desai and Jin Park, Depending on the polarity of extract active components, different excipients can be used.
For an extract with constituents of very low polarity, emulsifiers are often used to make it dispersible in water. For example, supercritical CO 2 hemp extract is hydrophobic and dissolves in fat, not in water.
It needs the help of excipients with strong emulsifying properties, such as sunflower lecithin, to become dispersible in water. Another example is vanilla pod Vanilla planifolia Andrews hydroalcoholic extract, which has a lipid-rich nature.
Concentrated liquid extracts extracta spissa can sometimes be sprayed onto plant parts TBC prior to drying to become incorporated with the plant parts.
For example, an elderberry juice extract Sambucus nigra L. can be applied to echinacea aerial parts TBC before drying, which normalizes particle size and mitigates the hygroscopicity of the extract. Finally, when an herbal mixture contains a very low percentage of aqueous extract, a dry extract can be directly sprayed onto herbal leafy materials TBC while mixing.
The mechanism consists of coating extract microfine particles onto the surface of comparatively large herbal leaflets. Since the attractive force between two microfine particles in contact is greater than the weight of a microfine particle, the particles stick together on the TBC leaflet, and segregation will not occur Rhodes, If necessary, adding a small amount of liquid while spraying helps achieve a better mixing quality.
Agglomeration helps reduce the surface areas of microfine extract particles and improves its hygroscopicity Gallo et al. However, agglomerated extract granules for tea infusion can readily absorb water, form clumps, and become sticky over time when exposed to a moist and warm environment.
For example, Eleuthero root aqueous extract granules are free-flowing material. Clearly, temperature and humidity accelerate the process, and the higher the temperature, the higher the relative humidity, the less desirable the granules become.
FIGURE 2. Changes of eleuthero aqueous extract granules when exposed to high temperature and high humidity over time. In a humid and warm environment, a hygroscopic extract can absorb water during both storage and processing, raising its moisture content enough to make it slightly sticky and more likely to adhere to the components of the machinery to dose the blend into tea bags , which hampers performance and causes production loss.
One must take adequate precautions when weighing and handling extract materials. Once open, the package containing unused extract material must be sealed well and quickly and stored in a cool environment.
Furthermore, the hygroscopic nature of an extract also impacts the quality of the finished product during shelf life.
Therefore, it is essential to package herbal teas containing extracts in a substrate with excellent moisture and oxygen barriers and store them in a cool dry environment to maintain the good organoleptic quality of finished products.
The solubility of active constituents in an infusion is vital to deliver efficacious products for consumers to experience therapeutic benefits. Theoretically, granules made from an aqueous water extract should be water soluble, but the authors found this is not always the case.
Granules often require more time and effort to get solubilized than powder as they must go through a process of disintegration and dissolution Farakte et al.
Disintegration is achieved by the penetration of water into the compacted powder, disrupting the particle-particle bonds which maintain the structural integrity of granules. For example, eleuthero aqueous extract once compacted to granular form showed decreased solubility in water, as demonstrated in Figure 3.
The infusion prepared by steeping the granules in a teabag in freshly boiled water was lighter than was seen with the powder, and the teabag of the granules retained more extract than that of the powder. Any amount of extract left in the teabag directly reduces the efficacy of a product.
Therefore, it is sensible to control the granulation processes to optimize the particle size and hardness of granules. This can help ensure final product efficacy, beyond supporting the homogeneity and machinability of herbal blends. For hydroalcoholic or CO 2 extracts agglomerated with emulsifiers, active constituents must be dispersible for bioavailability regardless of their low polarity.
This requires the use of emulsifiers to create oil-in-water emulsions and stabilize the suspension of small droplets to prevent them from coalescing or coming together to grow larger droplets. Emulsifiers form physical barriers to prevent droplets from coming together.
Such emulsions can easily be dispersed in water, though the resultant tea infusions may look cloudy. A good example is to apply oil-in-water emulsions to hemp extract for tea infusions.
Hemp extract is totally insoluble in water, and sunflower lecithin, a phospholipid molecule, is an effective and popular food emulsifier. By agglomerating hemp extract with emulsifiers such as lecithin, gums and other saponin-containing plant materials, an oil-in-water emulsion can be created, which makes hemp extract disperse across the fiber of the teabag and into an aqueous infusion.
Figure 4 depicts the power of this emulsification technology on converting oil-soluble material to water-dispersible emulsions. As shown in the pictures on the left, when hemp extract, extracted by supercritical carbon dioxide, was steeped in a teabag in freshly boiled water for 10 min, a few drops of the extract floated on the top of water, and most remained in the teabag.
Conversely, the pictures on the right show that, when the emulsified hemp extract flakes went through the same steeping process, essentially all the hemp extract was dispersed into the water with little left in the teabag.
The formation of oil-in-water emulsions enabled cannabinoids to disperse into water, increasing the bioavailability of the hemp extract. Quality testing of botanical extracts, the raw materials from which they are derived, and finished products into which they are formulated is paramount to establishing safety and efficacy.
Quality testing requirements, governed by national and international regulations, evaluate identity, purity, strength, composition, and limits on contaminants. The establishment of pharmacopoeial-based specifications is an effective strategy for the assurance of medicinal grade ingredient quality.
Confirmation of identity is critical to botanical quality testing, as is widely reflected in regulations governing the manufacture and marketing of dietary supplements and herbal medicinal products European Commission, ; United States Food and Drug Administration, HPTLC allows for comparative visualization of multiple chemical fingerprints chromatograms across a single plate.
The opportunity for inclusion of a variety of sample types along with botanical and chemical references, makes it the analytical method of choice for establishing identity of botanical extracts. Figure 5 shows HPTLC plate images of the United States Pharmacopoeia USP monograph method for the identification of elderberry dry extract by HPTLC United States Pharmacopoeia Convention, Visualized at different wavelengths prior to and following derivatization, the plate compares a variety of elderberry extract sample types: alcoholic, juice concentrate liquid vs powder relative to raw fruit at various levels of processing whole, TBC, and ground.
Chemical and authenticated botanical reference materials were included for the purpose of establishing identity, along with references for a distinguishable alternate species.
FIGURE 5. Chromatograms for the identification of elderberry. Chemical reference standards: 1 caffeic acid, hyperoside, chlorogenic acid, rutin; botanical reference materials BRM : 2 Sambucus nigra AHP whole fruit ; 3 S.
nigra Chromadex ground fruit ; 4 S. nigra Dry Extract USP alcohol extract ; commercial samples: 5 elderberry extract lot ; 6 elderberry juice powder lot ; 7 elderberry juice liquid lot ; 8 elderberries, TBC lot ; 9 elderberries, ground lot ; 10 elderberries, whole lot ; 11 elderberries, TBC lot ; BRM 12 S.
cerulea AHP whole fruit ; 13 S. cerulea Chromadex ground fruit. The comparison of extract samples to references by HPTLC demonstrates consistency of the chemical fingerprint across extract preparations as well as the presence of marker compounds such as rutin and chlorogenic acid see Figure 5.
HPTLC can be a powerful tool for distinguishing alternate species or plant parts as potential adulterants, in addition to detection of other sources of adulteration of known or unknown origin.
For example, with increased pandemic-related demand for elderberry products, there is growing concern over economically motivated adulteration with black rice Oryza sativa L.
extract Gafner et al. Availability of extract-specific methods in pharmacopoeias can present a potential challenge, as botanical monographs are often focused on the raw botanical. While extract-specific monographs are commonly provided within the USP and becoming increasingly available from pharmacopoeias, issues related to incongruency of the extract type may still arise.
As previously discussed, aqueous extracts are common herbal tea ingredients due to their water-soluble properties. Botanical extract monographs; however, are often developed based on alcoholic or hydroalcoholic extracts.
We find that monograph methods developed for a raw botanical or alternate extract type can often be adapted for use with an aqueous extract. The inclusion of proper samples aids in confirming the method as fit for purpose. Extract suppliers able to provide retain samples of their raw materials are of value to the herbal tea manufacturer for the purpose of method adaptation as well as traceability throughout processing.
HPTLC analysis of these samples combined with authenticated references confirmed continuity of identity throughout processing while also aiding in pharmacopoeial method evaluation in a case where extract-specific monographs were unavailable Figure 6.
FIGURE 6. Chromatogram reishi. PPRC HPTLC ID Method 2: BRM: 1 G. lucidum AHP whole fruiting body ; 2 G. lucidum fruiting body Dry Extract USP; Samples: 3 Reishi whole raw material; 4 Reishi powdered raw material; 5 Reishi aqueous extract powder; 6 Reishi aqueous extract granules.
In addition to identity testing of single ingredient extracts, HPTLC is a valued technique for determination of extract identity when combined with other herbal ingredients Reich and Frommenwiler, ; Frommenwiler et al.
An elderberry juice extract applied to a substrate of echinacea aerial parts to regulate particle size and mitigate hygroscopicity requires an identification method capable of distinguishing both herbal components of the combined ingredient.
HPTLC analysis of the combined ingredient compared with the individual components accomplishes this by determining the chromatographic contribution of each component to the combined chemical fingerprint and determines diagnostic bands for each component.
The same principle is possible for detection of extract ingredients within a more complex multi-herb tea blend; however, the possibility of matrix interference increases with blend complexity.
In evaluation of finished product composition, challenges with matrix interference and the detection of herbal extract ingredients may arise. Limits of detection by HPTLC may contribute to identity challenges as well. Due to machinability constraints and concentrated nature, extracts are often formulated in blends at low levels.
In addition, when assessing identity in a finished blend, we have experienced HPTLC limitations when trying to qualitatively distinguish a raw botanical and an extract of the same botanical Reich and Frommenwiler, A solution we have employed uses a quantitative technique such as HPLC and a marker compound.
The pharmacopoeial strength marker compound glycyrrhizic acid in licorice root was quantified by HPLC in a multi-herbal tea blend containing both raw licorice root and a licorice root dry extract standardized for glycyrrhizic acid content. In this case, HPTLC would not distinguish the two ingredients in a chromatogram generated on the blend.
Assaying for glycyrrhizic acid content in the finished blend was performed as indirect confirmation of the extract ingredient based on overall content level. It has been the experience of the authors of this paper that the procurement of an extract, one that is suitable for use as one component of a medicinal herbal tea formulation in combination with dried herbs , generally requires the development of a special extract.
The standard offerings of extraction houses are produced with an aim towards usage in solid dosage forms, i. While extraction houses servicing the phytopharmaceutical sector may produce extracts using pharmacopeial quality starting materials under pharmaceutical drug GMP conditions, that may also meet quality and ingredient performance requirements, such companies are generally less experienced in the production of extracts that conform to the requirements of sustainability standards, such as use of purified water and certified organic ethanol as extraction solvents, and, if needed, certified organic and non-GMO verified excipient materials.
On the other hand, extraction houses that target the sustainable products sector e. The target customers for organic and fairtrade herbal extracts are generally natural cosmetic and natural food product companies, and not necessarily herbal medicinal product companies.
We have also found that Sourcing personnel at the herbal tea brand may need to become involved and coordinate with the Procurement personnel at the extraction house. That is because, in some cases, the commercial supply of herbal starting material is for the most part produced and traded in the conventional market, without sustainability documentation such as fairtrade, non-GMO, and organic.
In such cases, sustainable supply chain development work becomes necessary. Once the estimated annual demand of the special extract and the theoretical native DER range are known, the annual requirement for starting materials may be calculated. Secondly, if the producer operation is not in the certified sustainable ingredient sector, financial and technical support to assist the producer with successful implementation of certain voluntary sustainability standards towards audit and certification may be necessary.
Depending on the crop, whether an annual crop or a multi-year root crop or tree bark crop, the product development timeline must take into consideration the transition period of the producer to organic production control and certification.
As an example, in the early s, the authors contacted a European phytopharmaceutical extraction house to gauge their interest in producing a pharmacopoeial quality dry hydroalcoholic extract that would be both certified organic and kosher. The annual quantity was sufficient to consider co-development of a special extract, one that would not be offered to other customers.
The extraction house was willing to have areas of their facility controlled for organic and kosher certified production of special extracts. The Procurement personnel at the extraction house were generally procuring conventional, not certified organic herbal material, for their standard extracts.
Initially we suggested certain certified organic medicinal plant farms for them to qualify and add to their network of producers. Because the herbal material is produced as a 3-year root crop, the farmers require, annually, that all parties, the herbal tea brand, the extraction house, and the farm, agree on the quantity to plant each year for harvest in 3 years.
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