Method of forming extract of mitragyna speciosa using acetone

Abstract

The present disclosure relates to the development of a standardized acetone extract of Mitragyna speciosa, commonly known as kratom, specifically designed for use in beverages, dietary supplements and natural health products. This extract is standardized to contain a precise concentration of mitragynine, the primary active alkaloid in kratom, ensuring consistent potency and efficacy in enhancing energy, alertness, and alleviating minor pain associated with physical exertion. The disclosed technology outlines an extraction process that not only maximizes the yield of mitragynine but also ensures the removal of undesirable compounds, thereby enhancing the safety profile of the final product. This process involves the use of environmentally friendly extraction methods that are both efficient and scalable, suitable for commercial production. The standardized extract may be easily incorporated into various beverage formulations, dietary supplements and natural health products providing a reliable and effective herbal supplement option.

Description

74000-53 METHOD OF FORMING EXTRACT OF MITRAGYNA SPECIOSA USING ACETONE CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 705,645, filed on October 10, 2024. The entire disclosure of the above application is incorporated herein by reference. FIELD

[0002] The present technology relates to a botanical extract and, more particularly, to a standardized acetone extract of Mitragyna speciosa or use in a beverage, dietary supplement, and natural health product. INTRODUCTION

[0003] This section provides background information related to the present disclosure which is not necessarily prior art.

[0004] Mitragyna speciosa, commonly known as kratom, is a tropical tree native to Southeast Asia, which has been used for centuries as an herbal remedy and in cultural ceremonies. The leaves of the Mitragyna speciosa plant are known for containing various alkaloids, primarily mitragynine, which have been reported to produce stimulant and sedative effects depending on the dosage. Traditionally, the Mitragyna speciosa leaves are chewed fresh or dried, brewed as tea, or prepared as decoctions. More recently the leaves of Mitragyna speciosa have been converted into dry powdered extracts, leaf powders, and other forms for consumption.

[0005] Despite its well documented uses, the extraction and standardization of Mitragyna speciosa have posed significant challenges. Traditional methods of preparation often result in products with inconsistent potency and purity. This variability may lead to products that are either ineffective or, conversely, pose safety risks due to unexpectedly high concentrations of active compounds or oxidation products of the analytes. Furthermore, traditional extraction methods are often inefficient, failing to extract the full spectrum of beneficial compounds from the leaves.74000-53

[0006] Moreover, the regulatory landscape for kratom is complex and varies significantly by region, partly due to these inconsistencies in product quality and safety. In some areas, kratom is classified as a controlled substance, while in others, kratom remains a legal herbal supplement or is considered a food. The regulatory inconsistency can be attributed in part due to the lack of standardized, high-quality kratom products that may be reliably safe for consumer use.

[0007] Additionally, the existing extraction processes often use solvents that may not be environmentally friendly or could leave harmful residues in the final product, raising further safety concerns for consumers and challenges for manufacturers aiming to comply with health and safety regulations.

[0008] There is a continuing need for improved methods and compositions in the field of kratom extraction and standardization. Desirably, such advancements would address the inconsistency in the potency and purity of kratom extracts, provide safer and more environmentally friendly extraction methods, and result in products that meet regulatory standards for safety and quality. SUMMARY

[0009] In concordance with the instant disclosure, an improved method and composition in the field of kratom extraction and standardization, and which addresses the inconsistency in the potency and purity of kratom extracts, provides safer and more environmentally friendly extraction methods, and result in products that meet regulatory standards for safety and quality, have surprisingly been discovered.

[0010] The present technology includes articles of manufacture, systems, and processes that relate to the standardized extraction and formulation of Mitragyna speciosa for the creation of consistent, safe, and effective botanical beverages, dietary supplements and natural health products designed to enhance energy, alertness, and alleviate minor pain.

[0011] In one embodiment, a method for extracting and standardizing Mitragyna speciosa leaf product includes steps to optimize the yield and consistency of the active compounds, primarily mitragynine. The method begins with the provision of high-quality Mitragyna speciosa leaf material, which may be subjected to a process involving acetone, temperature control, and constant stirring to facilitate the extraction of desired alkaloids, preserving integrity. Subsequent steps may include a filtration process to remove solid residue,74000-53 followed by a concentration phase under reduced pressure to remove the solvent and produce an extract at a predetermined mitragynine concentration. The method includes a purification step to remove an undesired compound, promoting the production of a standardized and high-quality kratom extract.

[0012] In another embodiment, the Mitragyna speciosa extract produced by the method is standardized to contain from 2-10 %(w / w) mitragynine, depending on the intended application, and is substantially free from detectable levels of 7-hydroxymitragynine, a short-lived human metabolite and oxidation product of mitragynine that poses a safety risk when consumed. The Mitragyna speciosa extract may be particularly advantageous for use in various formulations, including beverages, dietary supplements, and natural health products, due to its consistent potency and enhanced safety profile. The standardized Mitragyna speciosa extract offers potential benefits such as improved alertness, energy restoration, and alleviation of minor pain, making the Mitragyna speciosa extract a valuable component in health and wellness products. Additionally, the stability and purity of the Mitragyna speciosa extract are maintained through careful storage conditions, ensuring its efficacy and quality over time.

[0013] In an exemplary embodiment, the present disclosure pertains to a method for extracting and standardizing Mitragyna speciosa leaf product, designed to produce a high-quality extract with consistent levels of the active alkaloid mitragynine while substantially eliminating undesired compounds, such as 7-hydroxymitragynine. The method may include several steps: starting with the selection and provision of high-quality Mitragyna speciosa leaf material, the Mitragyna speciosa leaves may be added to acetone to facilitate the extraction process. Following this, a two-step filtration process may be employed to remove solid residues, ensuring the clarity and purity of the extract. The filtered mixture may undergo evaporation using an evaporator under reduced pressure to remove the solvent and produce a dry extract that may be typically 5.0±0.5% w / w mitragynine but may fall within a specific range of 2% to 10%, depending on the intended application. This provides for a standardized native extract with a targeted mitragynine concentration and a full spectrum of plant secondary metabolites from the leaf material, enhancing the safety profile of the final product. Additional enhancements may include the optional use of an ultrasonic bath for pre-treating the leaf material to increase yield, the incorporation of natural flavor enhancers and antioxidants to improve taste and stability, and the addition of natural preservatives during concentration to extend shelf life. The method may74000-53 also include microfiltration for higher purity and encapsulation in biodegradable capsules for controlled release. The resulting dry powdered extract of fluidized extract of Mitragyna speciosa leaves, that may be dried, characterized by its full spectrum of plant phytochemicals, consistent mitragynine content and absence of detectable levels of 7-hydroxymitragynine, and offers significant potential for use in beverages, dietary supplements, and natural health products, providing benefits such as enhanced alertness, restored energy, and alleviation of minor pain, all while ensuring user safety and product reliability.

[0014] In another exemplary embodiment, the powdered Mitragyna speciosa extract may be fluidized and combined with co-ingredients, such as linear or cyclic polysaccharides, to enhance the physicochemical properties, such as solubility, stability and bioavailability.

[0015] Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. DRAWINGS

[0016] The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations and are not intended to limit the scope of the present disclosure.

[0017] FIG.1 is a flowchart illustrating a method for extracting, according to some embodiments of the present disclosure; and

[0018] FIGS.2A-2C is a flowchart illustrating a method for extracting, according to another embodiment of the present disclosure. DETAILED DESCRIPTION

[0019] The following description of technology is merely exemplary in nature of the subject matter, manufacture and use of one or more inventions, and is not intended to limit the scope, application, or uses of any specific invention claimed in this application or in such other applications as may be filed claiming priority to this application, or patents issuing therefrom. Regarding methods disclosed, the order of the steps presented is exemplary in nature, and thus, the order of the steps may be different in various embodiments, including where certain steps can be simultaneously performed, unless expressly stated otherwise. “A” and “an” as used herein74000-53 indicate “at least one” of the item is present; a plurality of such items may be present, when possible. Except where otherwise expressly indicated, all numerical quantities in this description are to be understood as modified by the word “about” and all geometric and spatial descriptors are to be understood as modified by the word “substantially” in describing the broadest scope of the technology. “About” when applied to numerical values indicates that the calculation or the measurement allows some slight imprecision in the value (with some approach to exactness in the value; approximately or reasonably close to the value; nearly). If, for some reason, the imprecision provided by “about” and / or “substantially” is not otherwise understood in the art with this ordinary meaning, then “about” and / or “substantially” as used herein indicates at least variations that may arise from ordinary methods of measuring or using such parameters.

[0020] Although the open-ended term “comprising,” as a synonym of non-restrictive terms such as including, containing, or having, is used herein to describe and claim embodiments of the present technology, embodiments may alternatively be described using more limiting terms such as “consisting of” or “consisting essentially of.” Thus, for any given embodiment reciting materials, components, or process steps, the present technology also specifically includes embodiments consisting of, or consisting essentially of, such materials, components, or process steps excluding additional materials, components or processes (for consisting of) and excluding additional materials, components or processes affecting the significant properties of the embodiment (for consisting essentially of), even though such additional materials, components or processes are not explicitly recited in this application. For example, recitation of a composition or process reciting elements A, B and C specifically envisions embodiments consisting of, and consisting essentially of, A, B and C, excluding an element D that may be recited in the art, even though element D is not explicitly described as being excluded herein.

[0021] As referred to herein, all compositional percentages are by weight of the total composition, unless otherwise specified. Disclosures of ranges are, unless specified otherwise, inclusive of endpoints and include all distinct values and further divided ranges within the entire range. Thus, for example, a range of “from A to B” or “from about A to about B” is inclusive of A and of B. Disclosure of values and ranges of values for specific parameters (such as amounts, weight percentages, etc.) are not exclusive of other values and ranges of values useful herein. It is envisioned that two or more specific exemplified values for a given parameter may define endpoints for a range of values that may be claimed for the parameter. For example, if Parameter74000-53 X is exemplified herein to have value A and also exemplified to have value Z, it is envisioned that Parameter X may have a range of values from about A to about Z. Similarly, it is envisioned that disclosure of two or more ranges of values for a parameter (whether such ranges are nested, overlapping or distinct) subsume all possible combination of ranges for the value that might be claimed using endpoints of the disclosed ranges. For example, if Parameter X is exemplified herein to have values in the range of 1–10, or 2–9, or 3–8, it is also envisioned that Parameter X may have other ranges of values including 1–9, 1–8, 1–3, 1–2, 2–10, 2–8, 2–3, 3–10, 3–9, and so on.

[0022] When an element or layer is referred to as being “on,” “engaged to,” “connected to,” or “coupled to” another element or layer, it may be directly on, engaged, connected or coupled to the other element or layer, or intervening elements or layers may be present. In contrast, when an element is referred to as being “directly on,” “directly engaged to,” “directly connected to” or “directly coupled to” another element or layer, there may be no intervening elements or layers present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.). As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0023] Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

[0024] Spatially relative terms, such as “inner,” “outer,” “beneath,” “below,” “lower,” “above,” “upper,” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. Spatially relative terms may be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in74000-53 the figures is turned over, elements described as “below,” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the example term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0025] The present technology improves the extraction and standardization processes of Mitragyna speciosa leaves, ensuring that the resulting botanical extracts maintain consistent levels of active compounds, particularly mitragynine. Additionally, the present technology can minimize the amount of 7-hydroxymitragynine present in the final product, which is beneficial given the harmful nature of 7-hydroxymitragynine. This advancement not only enhances the efficacy and safety of the final product but also addresses environmental concerns by utilizing greener, more sustainable extraction methods. By providing a reliable and standardized product, the present disclosure significantly mitigates the risks associated with the variability of traditional kratom preparations and paves the way for broader acceptance and regulatory compliance of kratom-based products in various markets.

[0026] The manufacturing process may generally include the following steps: the Mitragyna speciosa leaves can be dried, crushed and may transferred to an extraction vessel and partitioned with acetone by agitation; the spent crushed Mitragyna speciosa leaves may be removed by mechanical filtration using an inert filter (50 micron nylon mesh); the liquid may be then left to cool to room temperature; and the liquid may be evaporated to dryness to obtain the dietary ingredient, a dry powdered native extract of kratom leaves.

[0027] As shown in Figures 1 and 2A-2C, the present disclosure includes a method for extracting and standardizing Mitragyna speciosa leaf product, referred to herein as method 200. The method 200 may be designed to produce a standardized extract of Mitragyna speciosa, commonly known as kratom, which may be particularly useful for incorporation into a beverage, dietary supplement, and natural health product. The method 200 promotes consistent levels of the primary active alkaloid, mitragynine, while militating against oxidation (chemical alteration) of key alkaloids and removing / militating against the formation of undesired compounds, thereby enhancing both the safety and efficacy of the final product.

[0028] The present technology includes articles of manufacture, systems, and processes that relate to the standardized extraction and formulation of Mitragyna speciosa for the creation74000-53 of consistent, safe, and effective botanical beverages designed to enhance energy, alertness, and alleviate minor pain. In one embodiment, a method for extracting and standardizing Mitragyna speciosa leaf product includes steps to optimize the yield and consistency of the active compounds, primarily mitragynine. The method 200 generally includes the provision of high- quality Mitragyna speciosa leaf material, which may be subjected to a process involving acetone, precise temperature control, and constant stirring to facilitate the extraction of a desired alkaloid. Subsequent steps may include a meticulous filtration process to remove solid residues and an evaporation phase under reduced pressure to achieve a predetermined mitragynine concentration. The method 200 may conclude with a purification step to remove undesired compounds, facilitating the production of a standardized and high-quality kratom extract.

[0029] In an exemplary embodiment, the present disclosure pertains to the method 200 for extracting and standardizing Mitragyna speciosa leaf product, designed to produce a high- quality extract with consistent levels of the active alkaloid mitragynine while substantially eliminating undesired compounds such as 7-hydroxymitragynine. The method 200 may involve several steps: starting with the selection and provision of high-quality Mitragyna speciosa leaf material, the leaves are added to acidified acetone to facilitate the extraction process. The mixture may be constantly stirred for about two hours to optimize the alkaloid extraction. Following this, a two-step filtration process is employed to remove solid residues, ensuring the clarity and purity of the extract. The filtered mixture may undergo an evaporation step using an evaporator under reduced pressure to produce a dry Mitragyna speciosa extract standardized to a mitragynine content within the range of 2.0-10.0± 0.5% (w / w). To further refine the Mitragyna speciosa extract, undesired components may be removed using a selective chromatographic technique, enhancing the safety profile of the final product.

[0030] Method 200 may begin with a step 210 of providing Mitragyna speciosa leaf material. The Mitragyna speciosa leaf material used may be selected based on quality and mitragynine content, ensuring that only high-quality Mitragyna speciosa leaves may be used in the extraction process. The initial selection may be important as the quality of the Mitragyna speciosa leaf material impacts the overall yield and quality of the final Mitragyna speciosa extract. In certain embodiments, the method 200 may include a step 212 of pre-treating the Mitragyna speciosa leaf material with an ultrasonic bath prior to extraction. The pre-treatment74000-53 step 212 may increase the yield of mitragynine by disrupting the cell structure of the Mitragyna speciosa leaves, making the alkaloids more accessible for extraction.

[0031] In step 220, the provided Mitragyna speciosa leaf material may be added to acetone, which may help in the extraction of mitragynine and other desirable alkaloids from the Mitragyna speciosa leaf material. The modification to the extraction process, specifically the replacement of water with acetone, may be intended to improve the efficiency and effectiveness of the alkaloid extraction from Mitragyna speciosa leaves. Acetone, being a more potent solvent than water, may enhance the extraction of volatile and lipophilic compounds, potentially yielding a fuller spectrum extract. However, it is necessary to handle and dispose of acetone with care due to the volatile and flammable nature, ensuring that all safety and environmental regulations are strictly followed during the extraction. Using acetone instead of water in the extraction process of Mitragyna speciosa offers several specific benefits, particularly in terms of efficiency and effectiveness of extracting alkaloids such as mitragynine.

[0032] Some key advantages of using acetone during the extraction process include, but are not limited to, increased solubility of alkaloids, faster extraction rates, reduced risk of degradation, enhancing purity and selectivity, and efficiency in dehydrating the plant material. More specifically, acetone is more similar to water, with respect to polarity, than other organic solvents yet acetone is also more potent as an organic solvent compared to water. In this way, acetone may be particularly effective in extracting volatile non-polar and lipophilic compounds. Alkaloids like mitragynine are partially lipophilic, which means they dissolve better in acetone. Accordingly, the use of acetone during extraction may lead to a higher yield of these active compounds in the Mitragyna speciosa extract.

[0033] Additionally, acetone has a lower boiling point (56°C) compared to water (100°C). This property may be advantageous as it allows for quicker evaporation and concentration processes, potentially speeding up the entire extraction procedure. Faster extraction not only saves time but may also reduce energy consumption during the process.

[0034] Further, the aqueous extraction process may result in degradation of the extract due to the sensitivity of the compound to high temperatures, which may be required for aqueous extraction. Since acetone evaporates at a lower temperature, acetone may be used to extract compounds at a lower temperature, thereby reducing the risk of thermal degradation and / or74000-53 isomerization of heat-sensitive alkaloids to undesirable, un-natural, chemically altered alkaloid products.

[0035] Another advantage of utilizing acetone is that acetone may sometimes provide a more selective extraction, pulling out desired alkaloids while leaving behind more polar impurities that are more soluble in water. This selectivity may lead to a purer extract, reducing the need for extensive purification steps later in the process. Acetone may further increase the accessibility of alkaloids during the extraction process due to its effectiveness as a dehydrating agent. By utilizing acetone, more water may be removed from the plant materials and help in breaking down cell structures, potentially increasing the accessibility of alkaloids during the extraction process.

[0036] The step 220 also involves constant stirring, which facilitates the release of the alkaloid into the solution. The stirring in step 220 may be conducted with constant stirring that may be maintained for about a predetermined duration, for example, approximately 2 hours, ensuring that the Mitragyna speciosa leaf material may be evenly exposed to the acetone. A skilled artisan can select a suitable predetermined duration within the scope of the present disclosure.

[0037] Another refinement in method 200 may be the adjusting of the temperature of the acetone solution during the extraction. The temperature range of the extraction may be adjusted to between 10 to 50 °C to suit specific formulation requirements. A further refinement of the method 200 may be adjusting the time of stirring during the extraction. The time of stirring may be adjusted to between 1 to 5 hours to suit specific formulation requirements. A skilled artisan can select a suitable temperature and duration within the scope of the present disclosure.

[0038] Following the stirring process, the method 200 may include variations in the duration to accommodate different batch sizes or specific strains of Mitragyna speciosa that may have varying alkaloid profiles. For instance, stirring may be extended or reduced based on preliminary tests that indicate optimal extraction efficiency for specific leaf material. These adjustments are considered non-limiting examples of how the process may be tailored to achieve the best results while maintaining the integrity of the active compounds. One of ordinary skill in the art may also select different temperatures and stirring durations as desired to suit specific extraction needs or to optimize the process for commercial scale-up.74000-53

[0039] Following the stirring step 220, the method 200 includes a step 230 of filtering the mixture to remove solid material. The step 230 may be crucial as it purifies the mixture by separating the liquid extract from the residual Mitragyna speciosa leaf material. The filtration process employed may include a two-step filtration system, in a step 232, enhancing the clarity and purity of the filtered mixture. For example, the two-step filtration system may utilize a coarse filter to remove large particulate matter, followed by a finer filter to ensure the removal of finer particles. The purpose of the two-step filtration approach is to ensure the clarity and purity of the Mitragyna speciosa extract by systematically removing particles of different sizes with first the larger particulate matter, then the finer particles, which is crucial for producing a high- quality, standardized Mitragyna speciosa extract suitable for beverage and supplement applications.

[0040] For applications requiring extremely high purity, a microfiltration step 234 may be included after the initial filtration to further purify the final extract. The step 234 ensures that the final product meets stringent quality standards.

[0041] To extend the shelf life of the extract, a natural preservative may be added during a step 236, prior to evaporation. The addition ensures that the final product remains stable and effective over a longer period. A skilled artisan can select a suitable natural preservative within the scope of the present disclosure.

[0042] Additional enhancements to method 200 may include the addition of a defoaming agent in a step 238, prior to evaporation, to militate against foaming, which may interfere with the evaporation process. The defoaming agent, typically a dimethylpolysiloxane solution, may be added in an amount ranging from 45 mL to 75 mL of a 10% solution per 150 L of extract. A skilled artisan may select a suitable defoaming agent within the scope of the present disclosure.

[0043] Step 240 of method 200 may include evaporating the filtered mixture to produce a crude mitragynine extract. The evaporation step 240 may be performed using an evaporator under reduced pressure, for example, in a step 242, which may efficiently evaporate the solvent to a dry extract without significant loss of volatile compounds.

[0044] In addition to using an evaporator under reduced pressure, additional methods that can also be used may include reverse osmosis or other drying techniques, which could offer additional advantages such as reduced energy consumption or enhanced preservation of sensitive compounds. Furthermore, the target concentration of mitragynine might be adjusted based on the74000-53 intended use of the extract, whether for more potent medicinal formulations or for milder consumer health products. These variations are non-limiting examples that demonstrate the flexibility of the concentration step to accommodate different production requirements and goals. One of ordinary skill in the art may also select alternative concentrating methods and adjust the mitragynine concentration as desired to optimize the efficacy and stability of the product.

[0045] In step 250, undesired compounds, such as a bittering constituent, lipophilic component, or artefact of processing, such as degradation or oxidation products, may be removed from the Mitragyna speciosa extract and the Mitragyna speciosa extract may be concentrated to a targeted mitragynine concentration of typically 5.0±0.5 % mitragynine, but the targeted concentration can fall within a specific range of 2.0% to 10%, depending on the intended application with a ±0.5% precision. This provides for a standardized Mitragyna speciosa extract with a targeted mitragynine concentration. The purification step 250 may also be critical for ensuring the safety of the final Mitragyna speciosa extract. The step 250 may be achieved using a chromatographic technique that selectively binds an undesirable compound, in a step 252, allowing for their separation from the desired mitragynine. A skilled artisan can select a suitable purification method and chromatography method within the scope of the present disclosure.

[0046] Another refinement in method 200 may involve adjusting the pH of the extract after concentration in a step 260. The pH adjustment step 260 may be crucial for stabilizing the extract and enhancing the solubility of mitragynine. The pH range may be adjusted to between 2.4 to 3.9 to suit specific formulation requirements. A skilled artisan can select a suitable pH for adjustment within the scope of the present disclosure.

[0047] The method 200 may also include the addition of natural flavor enhancers to improve the taste of the extract without altering the efficacy of the active compounds in a step 270. Additionally, natural antioxidants may be supplemented in the acetone to preserve the stability of mitragynine during the extraction process. A skilled artisan may select a suitable natural flavor enhancer and natural antioxidant within the scope of the present disclosure.

[0048] In certain embodiments, the Mitragyna speciosa extract may be complexed or encapsulated with linear or cyclic polysaccharides or encapsulated in biodegradable capsules for enhanced physicochemical properties such as enhanced solubility, stability, bioavailability, and controlled release to provide a convenient and precise dosage form for consumers in a step 280. The encapsulation process may utilize various biodegradable materials to ensure environmental74000-53 compatibility while maintaining the integrity of the active compounds. The encapsulated extract may maintain the standardized mitragynine concentration within the 2.0% to 10% range with ±0.5% precision while remaining substantially free from detectable levels of 7- hydroxymitragynine.

[0049] The standardized Mitragyna speciosa extract produced by method 200 may be characterized by consistent mitragynine concentration within 2.0% to 10%, depending on the intended application with a ±0.5% precision (20-100 mg mitragynine per gram dry weight) and the absence of detectable levels of 7-hydroxymitragynine. The standardized Mitragyna speciosa extract may be used in the formulation of beverages, dietary supplements, and natural health products, offering benefits such as improved alertness, restored energy, and alleviation of minor pain associated with physical exertion. The extract may be stored in sealed containers at a room temperature, protected from moisture and light to maintain its stability and efficacy.

[0050] Overall, method 200 provides a comprehensive and efficient approach to producing a high-quality, standardized extract of Mitragyna speciosa, addressing the needs and challenges associated with traditional kratom products.

[0051] Advantageously, the present method addresses the significant challenges identified by providing a method for extracting and standardizing Mitragyna speciosa that ensures consistent levels of the active compound mitragynine and prevents the formation of oxidation products, such as 7-hydroxymitragynine. The method 200 not only enhances the safety and efficacy of the resulting extract but also ensures product reliability and consistency, which have been major issues with various kratom products. By incorporating steps such as precise acidification, meticulous filtration, and selective chromatographic techniques, the method 200 reduces variability in the active compound concentrations. Furthermore, the addition of natural preservatives and antioxidants during the extraction process improves the stability and shelf life of the extract, addressing the problem of degradation and inconsistency found in naturally sourced products. The standardized approach to producing Mitragyna speciosa extract provides a safer, more reliable product for consumers, making it a superior solution compared to the unpredictable and often unsafe products available in the prior art. EXAMPLES74000-53

[0052] Example embodiments of the present technology are provided below and are non- limiting.

[0053] Example 1:

[0054] The following sections are an in-depth description of the specifications for one embodiment of the technology used to produce a Mitragyna speciosa extract standardized to 5.5±0.5% (w / w) mitragynine.

[0055] Assessment CategorySpecification Acceptable Level Testing method0000001Unidentified Mitragynine speciosa alkaloids checked against the NIST database to determine putative identities.74000-53 Assessment CategorySpecification Acceptable Level Testing method00000 0 0 0 n > >74000-53 Assessment CategorySpecification Acceptable Level Testing method>w material used for manufacturing standardized extract of Mitragyna speciosa are listed below. Copies of the validated GC-MS and HPLC method are also provided herein. All USP and AOAC contaminant testing methods are as per pharmacopeial standards using official methods of analysis compliant with USP.

[0057] AOAC2017.14

[0058] Used for the determination of the alkaloid HPLC profile and quantify the alkaloids mitragynine, speciogynine, paynantheine and speciociliatine, and the determination of presence or absence of 7-hydroxymitragynine. Performed on raw material, standardized extract of Mitragyna speciosa, and dietary supplement finished products. HPLC method using DAD detection.

[0059] SOP-ATM-02-00

[0060] Used for the detection of alkaloids and to determine their relative percentages. Performed on raw material, standardized extract of Mitragyna speciosa, and dietary supplement finished products. GC-MS method. Peaks detected by the method are checked against the NIST database to determine their putative identities. The peak areas of all alkaloid signals are used to determine relative alkaloid content.

[0061] SOP-ATM-03-00

[0062] Used for the detection and quantification of flavonoids in the sample. Performed on raw material, standardized aqueous extract of Mitragyna speciosa, and finished products. HPLC method using DAD detection.

[0063] AOAC 984.27

[0064] Used for the detection and quantification of elemental impurities. Performed on raw material, standardized extract of Mitragyna speciosa, and dietary supplement finished products. ICP-MS emission spectrometry method.

[0065] AOAC 986.3274000-53

[0066] Used in the detection and quantification of total microbial load in the material. Performed on standardized extract of Mitragyna speciosa and dietary supplement finished products.

[0067] USP <61>

[0068] Used for the detection and quantification of coliforms present in material and to determine their relative percentages. Performed on standardized extract of Mitragyna speciosa and dietary supplement finished products.

[0069] AOAC 985.21

[0070] Used for the detection and quantification of yeasts and molds in the material. Performed on standardized extract of Mitragyna speciosa and dietary supplement finished products.

[0071] USP-NF <2022>

[0072] Used for the detection and quantification of specific coliforms in the material. Performed on standardized extract of Mitragyna speciosa and dietary supplement finished products.

[0073] Example 2: Preparation of Standardized Mitragyna speciosa Extract

[0074] In this example, the process of extracting and standardizing Mitragyna speciosa leaf product using the method 200 is demonstrated. High-quality Mitragyna speciosa leaves were sourced and verified for their mitragynine content using high-performance liquid chromatography (HPLC). The leaves were then added to acetone. This mixture was stirred constantly for two hours to ensure optimal extraction of mitragynine and other alkaloids.

[0075] Next, the mixture underwent a two-step filtration process. Initially, a coarse filter was used to remove large particulate matter, followed by a finer filter to ensure the removal of finer particles. The resulting clear liquid was then transferred to an evaporator where it was evaporated under reduced pressure to produce the crude extract. This evaporation process also involved the addition of a dimethylpolysiloxane solution as a defoaming agent to militate against foaming during evaporation.

[0076] The purified extract was tested again using HPLC to ensure that it met the predetermined specification of being substantially free from detectable levels of 7- hydroxymitragynine and at the desired mitragynine concentration. The final standardized extract74000-53 was stored in amber glass containers at 4°C to maintain its stability and integrity until further use.

[0077] Example 3: Application in Beverage Formulation

[0078] In this example, the standardized Mitragyna speciosa extract prepared as described in Example 1 was used to formulate an herbal beverage intended to improve alertness and restore energy. The beverage formulation involved dissolving sufficient extract into an acidified aqueous liquid formulation to achieve a final concentration of 40 mg of mitragynine per 60 mL container for 2 servings. Natural flavor enhancers and a small amount of natural sweetener were added to improve the taste profile of the beverage without compromising the efficacy of the active compounds.

[0079] The beverage was subjected to stability testing to ensure that the active mitragynine content remained stable over time. Accelerated stability testing was conducted by storing the beverage at various temperatures for up to six months. The mitragynine content was periodically measured using HPLC, and the results confirmed that the active compound remained within 95% of its initial concentration throughout the testing period, demonstrating good stability.

[0080] Consumer testing was also conducted to assess the acceptability and perceived efficacy of the beverage. Participants reported increased alertness and energy after consuming the beverage, with no adverse effects reported. This example demonstrates the practical application of the standardized extract in a consumer product and highlights its potential benefits as a natural health product.

[0081] Example 4: Enhancement of Extraction Yield

[0082] In this example, an enhancement of the extraction yield of mitragynine from Mitragyna speciosa leaves was explored by pre-treating the leaves with an ultrasonic bath prior to the extraction process described in Example 1. Leaves were submerged in acetone and subjected to ultrasonic waves for 30 minutes, which was intended to disrupt the cell walls and increase the release of alkaloids during the subsequent extraction process.

[0083] Following the ultrasonic pre-treatment, the leaves were processed according to the method 200 described in Example 1. The yield of mitragynine was measured and compared to a control batch of Mitragyna speciosa leaves that were not subjected to ultrasonic pre-treatment. The results indicated a significant increase in the yield of mitragynine in the ultrasonically pre-74000-53 treated batch, demonstrating the effectiveness of this pre-treatment step in enhancing the efficiency of the extraction process.

[0084] Further analysis was conducted to ensure that the ultrasonic pre-treatment did not adversely affect the quality or stability of the extracted mitragynine. The stability of the extract from the pre-treated leaves was monitored over a period of three months, and no significant degradation of mitragynine was observed. This example illustrates an effective method to enhance the yield of active compounds from botanical materials, potentially reducing the cost and increasing the efficiency of the production of standardized extracts.

[0085] Example embodiments are provided so that this disclosure will be thorough and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms, and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well-known processes, well-known device structures, and well- known technologies are not described in detail. Equivalent changes, modifications and variations of some embodiments, materials, compositions and methods may be made within the scope of the present technology, with substantially similar results.

Claims

74000-53 CLAIMS What is claimed is:

1. A method for extracting and standardizing Mitragyna speciosa leaf product, the method comprising steps of: providing Mitragyna speciosa leaf material; adding the Mitragyna speciosa leaf material to an acetone mixture and with constant stirring to provide a mixture; filtering the mixture to remove solid material and provide a filtered mixture; evaporating the filtered mixture to produce a Mitragyna speciosa concentrated extract; and removing an undesired compound from the Mitragyna speciosa concentrated extract to produce a standardized Mitragyna speciosa leaf extract.

2. The method of Claim 1, further including pre-treating the Mitragyna speciosa leaf material with an ultrasonic bath prior to adding the Mitragyna speciosa leaf material to the acetone mixture.

3. The method of Claim 1, wherein the step of adding the Mitragyna speciosa leaf material to an acetone mixture includes maintaining constant stirring for approximately 2 hours.

4. The method of Claim 1, wherein the step of adding the Mitragyna speciosa leaf material to an acetone mixture includes adjusting the temperature of the acetone solution to between 10°C to 50°C.

5. The method of Claim 1, wherein the step of filtering the mixture includes employing a two- step filtration process to remove solid residues.74000-53 6. The method of Claim 5, wherein the two-step filtration process comprises using a coarse filter to remove large particulate matter followed by a finer filter to remove finer particles.

7. The method of Claim 1, further including performing microfiltration after the initial filtration step to further purify the filtered mixture.

8. The method of Claim 1, further including adding a natural preservative to extend shelf life of the standardized Mitragyna speciosa extract.

9. The method of Claim 1, further including adding a defoaming agent prior to evaporation to militate against foaming during the evaporation step.

10. The method of Claim 1, wherein the step of evaporating the solvent includes using an evaporator under reduced pressure.

11. The method of Claim 1, wherein the step of removing undesired compounds comprises using a chromatographic technique that selectively binds undesirable compounds.

12. The method of Claim 1, further comprising adjusting the pH of the extract after concentration to between 2.4 to 3.

9.

13. The method of claim 1, further including adding natural flavor enhancers to improve taste of the standardized Mitragyna speciosa extract.74000-53 14. The method of Claim 1, further including adding natural antioxidants to the acetone to preserve stability of mitragynine during the extraction process.

15. The method of Claim 1, further including encapsulating the extract in biodegradable capsules for controlled release.

16. The method of Claim 1, wherein the step of removing undesired compounds from the concentrated mixture to produce a standardized Mitragyna speciosa leaf extract includes removing detectable levels of 7-hydroxymitragynine from the Mitragyna speciosa leaf material.

17. A standardized Mitragyna speciosa extract as made by the method of Claim 1.

18. The standardized Mitragyna speciosa extract made by the method of claim 1, wherein the standardized Mitragyna speciosa leaf extract is standardized to contain mitragynine concentrations of 2.0-10.0% with a ±0.5% precision and is substantially free from detectable levels of 7-hydroxymitragynine.

19. A consumable product containing Mitragyna speciosa extract as made by the method of Claim 1.

20. A beverage containing Mitragyna speciosa extract as made by the method of Claim 1.

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