TURKESTERONE HYDROXYPROPYL B-CYCLIC DEXTRIN COMPLEX AND METHOD OF MANUFACTURING THEREOF

Abstract

The present invention provides an advanced absorption and delivery system to an ecdysterone-based nutritional supplement, specifically a turkesterone-based nutritional supplement, a turkesterone hydroxypropyl β-cyclic dextrin complex manufactured using a co-precipitation technique, the manufacturing process including a fluid bed drying system wherein the complex is dried using hot air blown into contact with a fluidized bed.

Claims

1. A nutritional supplement comprising a complex of an ecdysterone and cyclodextrin, the complex comprising a one-to-one ratio of the ecdysterone and the cyclodextrin.

2. The nutritional supplement complex of claim 1, wherein the ecdysterone is turkesterone.

3. The nutritional supplement complex of claim 2, wherein the turkesterone is derived from ajuga turkestanica extract standardized to 10% turkesterone.

4. The nutritional supplement complex of claim 3 further comprising a thickening excipient.

5. The nutritional supplement complex of claim 4, wherein the thickening excipient is an organic, food grade gum.

6. The nutritional supplement complex of claim 4, wherein the complex is manufactured using a fluid bed drying and complexing process.

7. The nutritional supplement complex of claim 6, wherein the fluid bed drying and complexing manufacturing process comprises the steps of: mixing, using a mixer, the ajuga turkestanica extract, the cyclodextrin, the thickening excipient, and hot water; heating the mixture of the ajuga turkestanica extract, the cyclodextrin, the thickening excipient, and hot water to a predetermined temperature and for a predetermined period of time; cooling the mixture of the ajuga turkestanica extract, the cyclodextrin, the thickening excipient, and hot water to cause precipitation; separating, using a filtration system, and collecting the precipitant resulting from the precipitation during cooling; drying the precipitant using a fluid bed drying system, resulting in dried granules of precipitant; testing the dried granules of precipitant for potency and moisture concentration, and accepting for further processing only those dried granules of precipitant with a moisture concentration between three and five percent; milling the dried granules of precipitant until they pass a predetermined granule size filtration system; and packaging the dried, filtered granules of precipitant into a final product for distribution.

8. The fluid bed drying and complexing manufacturing process of claim 7, wherein the predetermined granule size filtration system comprises a 16-20 mesh.

9. The fluid bed drying and complexing manufacturing process of claim 7, wherein the fluid bed drying system comprises: an air inlet filtration system comprising one or more of a course filter, a fine filter, a dehumidifier, a heater, and a hepa filter; a planium chamber for receiving air filtered through the air inlet filtration system; a product container for containing the precipitant, the product container comprising a product sampling port providing access to the precipitant held within the product container; an expansion chamber comprising an explosion port, a telescoping cylinder assembly, and an exhaust system, the expansion chamber containing one or more filter bags, the telescoping cylinder assembly operating to agitate the one or more filter bags within the expansion chamber, and the exhaust system comprising: a chimney with a damper and a damper actuator to control the flow of fluid up the chimney; a blower casing containing one or more blower fans operated by one or more electric motors; and an exhaust spout releasing the exhaust into the ambient environment.

10. The fluid bed drying and complexing manufacturing process of claim 9, wherein: the fluid bed drying system further comprises one or more inflatable gaskets located in one or more of the following: between the planium chamber and the product container, between the product container and the expansion chamber, and within the expansion chamber; the planium chamber of the fluid bed drying system further comprises an air inlet temperature sensors; the product container of the fluid bed drying system further comprises a product temperature sensor, a bowl earthing, a ss clamp for locking a bottom mesh of the product container, and one or more glass viewing ports; the expansion chamber of the fluid bed drying system further comprises one or more glass viewing ports; and the chimney of the exhaust system of the fluid bed drying system further comprises an outlet temperature sensor and a sensor for solid flow monitoring, each located on the chimney between the damper and the expansion chamber.

11. A process for manufacturing a turkesterone hydroxypropyl β-cyclic dextrin complex comprising the steps of: obtaining ajuga turkestanica extract standardized to 10% turkesterone, cyclodextrin, and an organic, food grade thickening excipient; mixing, using a mixer, the ajuga turkestanica extract, the cyclodextrin, and the organic, food grade thickening excipient with hot water, wherein the ajuga turkestanica extract and the cyclodextrin are added to the mixer using a one-to-one ratio; heating the mixture of the ajuga turkestanica extract, the cyclodextrin, the thickening excipient, and water to a predetermined temperature and for a predetermined period of time; cooling the mixture of the ajuga turkestanica extract, the cyclodextrin, the thickening excipient, and water to cause precipitation; separating, using a filtration system, and collecting the precipitant resulting from the precipitation during cooling; drying the precipitant using a fluid bed drying system, resulting in dried granules of precipitant; testing the dried granules of precipitant for potency and moisture concentration, and accepting for further processing only those dried granules of precipitant with a moisture concentration between three and five percent; milling the dried granules of precipitant until they pass a predetermined granule size filtration system; and packaging the dried, filtered granules of precipitant into a final product for distribution.

12. The process for manufacturing a turkesterone hydroxypropyl β-cyclic dextrin complex of claim 10, wherein the predetermined granule size filtration system comprises a 16-20 mesh

13. The process for manufacturing a turkesterone hydroxypropyl β-cyclic dextrin complex of claim 10, further comprising the step of extracting samples for quality control and to ensure adherence with good manufacturing practices throughout the process.

14. The process for manufacturing a turkesterone hydroxypropyl β-cyclic dextrin complex of claim 10, further comprising the step of transferring the dried granules of precipitant with a moisture concentration between three and five percent into poly-lined tote bins, which undergo labeling for tracking and compliance with good manufacturing practices and requirements.

15. The process for manufacturing a turkesterone hydroxypropyl β-cyclic dextrin complex of claim 10, further comprising the step of adding the dried, filtered granules of precipitant to a rotary mixer for final processing before packaging the dried, filtered granules of precipitant into a final product for distribution.

16. The process for manufacturing a turkesterone hydroxypropyl β-cyclic dextrin complex of claim 10, wherein the mixer comprises a reaction progress monitoring system and a temperature indicator, the reaction progress monitoring system obtaining data about the mixture of the ajuga turkestanica extract, the cyclodextrin, the thickening excipient, and water from the mixer, and the temperature indicator providing the reaction progress monitoring system with temperature information about the mixture of the ajuga turkestanica extract, the cyclodextrin, the thickening excipient, and water in the mixer.

17. The process for manufacturing a turkesterone hydroxypropyl β-cyclic dextrin complex of claim 10, wherein the fluid bed drying system comprises a flow indicator and at least one temperature indicator, the flow indicator operating to prevent over-supply of precipitant into the fluid bed drying system, and the at least one temperature indicator monitoring the temperature of hot air introduced to fluid bed drying system, which should be between 50 and 70 degrees Celsius.

18. The process for manufacturing a turkesterone hydroxypropyl β-cyclic dextrin complex of claim 10, wherein the fluid bed drying system comprises: an air inlet filtration system comprising one or more of a course filter, a fine filter, a dehumidifier, a heater, and a hepa filter; a planium chamber for receiving air filtered through the air inlet filtration system; a product container for containing the precipitant, the product container comprising a product sampling port providing access to the precipitant held within the product container; an expansion chamber comprising an explosion port, a telescoping cylinder assembly, and an exhaust system, the expansion chamber containing one or more filter bags, the telescoping cylinder assembly operating to agitate the one or more filter bags within the expansion chamber, and the exhaust system comprising: a chimney with a damper and a damper actuator to control the flow of fluid up the chimney; a blower casing containing one or more blower fans operated by one or more electric motors; and an exhaust spout releasing the exhaust into the ambient environment.

19. The process for manufacturing a turkesterone hydroxypropyl β-cyclic dextrin complex of claim 18, wherein: the fluid bed drying system further comprises one or more inflatable gaskets located in one or more of the following: between the planium chamber and the product container, between the product container and the expansion chamber, and within the expansion chamber; the planium chamber of the fluid bed drying system further comprises an air inlet temperature sensors; the product container of the fluid bed drying system further comprises a product temperature sensor, a bowl earthing, a ss clamp for locking a bottom mesh of the product container, and one or more glass viewing ports; the expansion chamber of the fluid bed drying system further comprises one or more glass viewing ports; and the chimney of the exhaust system of the fluid bed drying system further comprises an outlet temperature sensor and a sensor for solid flow monitoring, each located on the chimney between the damper and the expansion chamber.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0059] FIG. 1 depicts a schematic representation of a manufacturing process for a turkesterone hydroxypropyl β-cyclic dextrin complex according to exemplary embodiments of the present invention.

[0060] FIG. 2 depicts a schematic representation of a fluid bed drying system according the exemplary embodiments of the present invention depicted in FIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

[0061] The following detailed description illustrates the technology by way of example, not by way of limitation of the principles of the invention. This description will enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives, and applications of the invention, including what is presently believed to be the best mode of carrying out the invention. The present invention is not limited to that described hereafter, however, and those of skill in the art will recognize other manners of carrying out the invention without departing from the principles thereof.

[0062] Described herein are preferable embodiments of nutritional supplements employing an advanced absorption and delivery system. The present invention applies this advanced absorption and delivery system specifically to Ecdysterones, and more specifically to Turkesterone. Preferable embodiments of the present invention thus provide a turkesterone hydroxypropyl β-cyclic dextrin complex manufactured using a co-precipitation technique. The Turkesterone is preferably derived from ajuga turkestanica extract standardized to 10% turkesterone and then complexed with the hydroxypropyl-beta-cyclodextrin complex. A per-dose delivery of 500 milligrams is preferable.

[0063] The turkesterone hydroxypropyl β-cyclic dextrin complex preferably employs a one-to-one formulation of ajuga turkestanica extract with hydroxypropyl-beta-cyclodextrin, with preferable amounts of 250 milligrams of each per dose. The complex is preferably delivered orally into the user's system, and preferably takes the form of a capsule or pill. Other user intake methods may also include providing a powder that a user mixes with a liquid, as is well known in the nutritional supplement industry.

[0064] To achieve the one-to-one ratio complexing of the ajuga turkestanica extract with the hydroxypropyl-beta-cyclodextrin complex, the preferable manufacturing process 10 depicted in FIG. 1 is employed in preferable embodiments of the present invention. The process 10 begins by combining the ajuga turkestanica extract 12, cyclodextrin 14, and an organic, food grade thickening excipient 16 with hot water in a mixer 20 for heating and combination. The organic, food grade thickening excipient 16 may be any known agent, such as xanthem gum or the like, as will be known by persons of skill in the art. The cyclodextrin may be held in a storage unit 18, as depicted, before being introduced into the mixer 20.

[0065] The mixer 20 heats and agitates the mixture for a period of time sufficient to ensure proper combination. Preferable embodiments of the mixer 20 are equipped with a reaction progress monitoring system 22, which obtains data about the mixture's status, and at least a temperature indicator 24, to determine when the mixture is sufficiently heated and processed to ensure proper combination. The mixture is then slowly cooled to create precipitation, and samples of the precipitant are preferably obtained to ensure combination has been achieved and for quality control 26.

[0066] The precipitant now contains ajuga 12 embedded in cyclodextrin 14 together with the organic, food grade thickening excipient 16. The precipitant is next introduced to a precipitate filtration system 28, which separates out any remaining solids from the mixture, leaving only the precipitant. From the precipitate filtration system 28, the precipitant is next pumped to a tank for storage 30, and further samples are preferably obtained from the tank 30 and tested.

[0067] Following the second set of sampling, the precipitant is pumped into the fluid bed drying system 32. The fluid bed drying system is preferably equipped with a flow indicator 34 and a temperature indicator 36 of its own. The flow indicator 34 keeps track of the amount of precipitant being introduced to the fluid bed drying system 32 to ensure it is not over-supplied, while the temperature indicator 36 tracks the temperature of the precipitant to ensure it maintains a temperature range necessary for the fluidized bed drying process. The temperature indicator 36 also preferably verifies the temperature of the hot air being introduced into the fluid bed drying system 32.

[0068] A bag filter 38 is provided, in preferable embodiments as depicted in FIG. 1, to assist in releasing exhaust fumes 40 from the fluid bed drying system 32 when the drying process is in progress. And hot air 42 is continually introduced to the fluid bed drying system 32, as needed, during the drying process. In preferable embodiments, the hot air is heated to between 50 and 70 degrees Celsius before being introduced into the fluid bed drying system 32.

[0069] Once the drying process is completed, the dried granules of precipitant 44 are removed, and a third round of sampling occurs for quality control. At this stage the quality control process 46 ensures that the moisture levels in the dried granules of precipitant 44 are between three and five percent (3-5%). The quality control process 46 will either accept 48 or reject 50 the samples if they fall or do not fall in the required range.

[0070] After the quality control process 46 and acceptance 48 of the product output, the dried granules of precipitant 44 are transferred into polylined tote bins 52, which preferably undergo labeling 54 for tracking and compliance with good manufacturing practices and requirements. The dried granules of precipitant 44 are next introduced to filtration 56 based on granule size, preferably using a 16-20 mesh, though other filtration practices are also possible, as those of skill in the art will understand.

[0071] Any oversized 58 dried granules of precipitant 44 are milled 60 and reintroduced to the filtration 56. The filtered granules 62 are next introduced to a rotary mixer 64 for final processing before packaging into final product form 66 and prepared for shipment 68. As noted, sampling and testing is preferably undertaken throughout the process for quality control and to adhere to good manufacturing practices and requirements.

[0072] Referring now to FIG. 2, an exemplary embodiment of a fluid bed drying system 32 is depicted. The fluid bed drying system 32 preferably includes an air inlet filtration system 70 with a number of filters and other processing features to ensure the air introduced into the fluid bed drying system 32 is hot, dry, and free of contaminants. The filters and processing features include, in preferable embodiments, one or more of a course filter 72, a fine filter 74, a dehumidifier 76, a steam radiator and/or heater 78, and a hepa filter 80. The course filter 72 and fine filter 74 operate to remove contaminants from the intake air. The dehumidifier 76 removes moisture to ensure dry heat is used in the fluid bed drying system 32. The steam radiator and/or heater 78 heat the air up, preferably to within the 50 to 70 degrees Celsius range. Finally, the hepa filter 80 removes any additional particles or contaminants not filtered previously.

[0073] Once the intake air has passed through the air inlet filtration system 70, it is funneled 82 into the fluid bed drying system's 32 planium chamber 84. Preferable embodiments also include an inlet temperature sensor 86 to confirm the intake air is in the required temperature range. Above the planium chamber 84 is the product container 88, which holds the precipitant. A product temperature sensor 90 may be included to determine the temperature of the precipitant within the product container 88. An inflatable gasket 92 may be provided between the planium chamber 84 and the product container 88, in some preferable embodiments.

[0074] Also preferably included in the walls of the product container 88 is one or more viewing ports 94. The viewing ports 94 are covered by glass to maintain a fully enclosed environment within the product container 88 but allowing visibility of the precipitant within. Preferable embodiments of the product container 88 also include a product sampling port 96, as depicted in FIG. 2, that allows a user to access the precipitant held within.

[0075] A bowl earthing 98 is also preferably provided in the side of the product container 88 to assist in discharging built up electrical energy from the drying process. And an SS clamp 100 may be provided for locking the bottom mesh of the product container 88.

[0076] Above the product container 88 preferably resides an expansion chamber 102. The expansion chamber 102 contains one or more filter bags 104, and an explosion port 106 is preferably provided on at least one side of the expansion chamber 102. Also within the expansion chamber 102 is another inflatable gasket 92, in preferable embodiments, which preferably separates the one or more filter bags 104 from the remainder of the expansion chamber 102. Another inflatable gasket 92 may be provided between the product container 88 and expansion chamber 102, in some preferable embodiments, as depicted in FIG. 2. One or more viewing ports 94 may also be provided in the sides of the expansion chamber 102.

[0077] Provided in the top of the expansion chamber 102 is a telescoping cylinder assembly 108, which can operate to shake and agitate the one or more filter bags 104 during the drying process. The telescoping cylinder assembly 108 is preferably electronically operated, although those of skill in the art will recognize other approaches to providing the ability to agitate the one or more filter bags 104.

[0078] An exhaust system and assembly 110 is preferably provided to manage exhaust 112 created within the fluid bed drying system 32 during the drying process. The exhaust system and assembly 110 is preferably provided in the top of the expansion chamber 102 and includes a chimney 114 and a blower fan 116 provided within a blower casing 118 to facilitate removal of the exhaust 112 from the fluid bed drying system 32. The blower fan 116 is preferably operated by one or more electric motors 120. The chimney 114 is preferably provided with a damper 122 with an actuator for adjusting the damper 122. Some preferable embodiments of the chimney 114 are also provided with an outlet temperature sensor 124, preferably located between the expansion chamber 102 and the damper 122 to provide the most accurate temperature measurements. Some preferable embodiments of the chimney are also provided with a sensor for solid flow monitoring 136.

[0079] In the preferable embodiment depicted in FIG. 2, the fluid bed drying system 32 is located near a wall of the structure 132 such that the explosion port 106 can extend through the wall of the structure 132 to reach outside or into another room, for example. Likewise, the air inlet filtration system 70 and/or the funnel 82 may be provided outdoors or in another room, as depicted. And at least portions of the exhaust system and assembly 110 may extend upwardly through the roof of the structure 132 to reach the outside or another room, facilitating release of exhaust 112.

[0080] In such preferable embodiments, features of the fluid bed drying system 32, such as the exhaust system and assembly 110, may be mounted to the walls/roof of the structure 132 using mounting features 126, as depicted in FIG. 2. Preferable embodiments of the fluid bed drying system 32 may also employ a trolley system 128 to facilitate positioning and orientation of the fluid bed drying system 32 or portions thereof. As depicted in FIG. 2, such trolley systems preferably employ lockable wheels 130 to roll the fluid bed drying system 32, or portions thereof, along the ground. One or more feet 134 may also be provided extending from the bottom of the planium chamber 84 to stabilize the fluid bed drying system 32 once it is positioned and at rest.

[0081] While the present invention has been described with reference to particular processes, methods, embodiments, and arrangements of parts, features, and the like, it is not limited thereby. Indeed, modifications and variations will be ascertainable to those of skill in the art, all of which are inferentially and inherently included in these teachings.