MONITORING AND EVALUATION
To use the standard evaluation and monitoring methods of a systematic nature of identifying the intermediary, final, and precursors.
To maintain a viable development program into the inquiry of the bodies of knowledge in malarial therapies.
To maintain quality control and quality evaluations in the ISO standards.
To maintain quality assurance in the evaluation of compliance to ISO standards.
Saturday, October 27, 2007
ORGANIZATION AND CAPACITY
To be subsequently determined although to be assessed within the 18 month time frame and within the 501(c)(3) organizational capacity. Final capacity will be determined within the yield of the product, within the environmental factors effects upon Arteminisia annua yields, and within the supporting economic milleu. An assessment will be made as to the situational status of these factors, the maintenance of the mission and objective, the adherence and any accepted modification to the concept of the operation, the maintenance of attention and reliance on any modifying variables to the concept of the operation, and the adherence to the resource logistics.
To be subsequently determined although to be assessed within the 18 month time frame and within the 501(c)(3) organizational capacity. Final capacity will be determined within the yield of the product, within the environmental factors effects upon Arteminisia annua yields, and within the supporting economic milleu. An assessment will be made as to the situational status of these factors, the maintenance of the mission and objective, the adherence and any accepted modification to the concept of the operation, the maintenance of attention and reliance on any modifying variables to the concept of the operation, and the adherence to the resource logistics.
PROJECT DESIGN AND IMPLEMENTATION PLAN
To take approximately an acre and one-half of real-estate, add a product line of two vessels--one for extraction and one for separation--and one re-dissolution tank for resolubilized product in the hemi-succinate form for reconstituting for use with a 5 % sodium bicarbonate weight to volume.
By establishing a market for the raw product, this would lead to independent national resource from the locally cultivated Arteminisia annua flora.
This would allow the source to be available without relying on the uncertainty of worldwide or international supply in the event of interruptions.
With integrated approaches to the agronomy of Arteminisia annua, to the methodology of processing and to the developments in malarial control, the reliability of combination medicinal treatments, therapeutics, and care can be accomplished with a significant contribution.
This project design can be accomplished with an economy of investment and effort on real-estate already available, can be implemented from a standpoint of established and already existent resources, and can have a viable planned effort of completion.
To take approximately an acre and one-half of real-estate, add a product line of two vessels--one for extraction and one for separation--and one re-dissolution tank for resolubilized product in the hemi-succinate form for reconstituting for use with a 5 % sodium bicarbonate weight to volume.
By establishing a market for the raw product, this would lead to independent national resource from the locally cultivated Arteminisia annua flora.
This would allow the source to be available without relying on the uncertainty of worldwide or international supply in the event of interruptions.
With integrated approaches to the agronomy of Arteminisia annua, to the methodology of processing and to the developments in malarial control, the reliability of combination medicinal treatments, therapeutics, and care can be accomplished with a significant contribution.
This project design can be accomplished with an economy of investment and effort on real-estate already available, can be implemented from a standpoint of established and already existent resources, and can have a viable planned effort of completion.
BACKGROUND AND RATIONALE
ARTEMINISIN is being shown by itself and in combination therapies or treatments to provide a broad spectrum contribution to control in the malarial, Plasmodium falciparum, life cycle's infectious stages. It has been previously shown also that when the cultivated biologic source, Arteminisia annua, at bi-annual yields up to a 1% - 2% by weight of the Arteminisin active malariacide. Arteminisin is a double lactone phytochemical that when used by itself and in combination antiresistant treatment of fulminating neural malaria has been shown to be the therapy of choice. Recognizing that cultivation can be the primary source of this needed therapy, Arteminisia annua, can be harvested in a haystack bale by baler; the separatory process for the Arteminisin active molecule follows on a straightforward known procedure. Recent genetic engineering (GM) additions of the genome in E. coli have proven mainly the production of precursors to Arteminisin. Some of these precursors may be available for organic synthesis to deriviatives of Arteminisin--as Arteminisinic acid, and di-hydro Arteminisin though the active molecule shows the most effect. Because of double lactone ring structure in Arteminisin that must be active in malaria therapy--understood as very likely introducing an ozone like free radical intermediary into the Plasmodium falciparum. The actual extraction in acidic ethanol and into hexane would be accepted other track for Arteminisin availability followed by hemi-succinate esterifying to the hemi-succinate form allowed to precipitate. This becoming part of the agribusiness economy would integrate a supplemental agronomy study in engineering and economics. Furthermore any international uncertainties interrupting the supply of anti-malarials will be avoided with the source kept within American purview or western hemi-spheric bio-availability.
ARTEMINISIN is being shown by itself and in combination therapies or treatments to provide a broad spectrum contribution to control in the malarial, Plasmodium falciparum, life cycle's infectious stages. It has been previously shown also that when the cultivated biologic source, Arteminisia annua, at bi-annual yields up to a 1% - 2% by weight of the Arteminisin active malariacide. Arteminisin is a double lactone phytochemical that when used by itself and in combination antiresistant treatment of fulminating neural malaria has been shown to be the therapy of choice. Recognizing that cultivation can be the primary source of this needed therapy, Arteminisia annua, can be harvested in a haystack bale by baler; the separatory process for the Arteminisin active molecule follows on a straightforward known procedure. Recent genetic engineering (GM) additions of the genome in E. coli have proven mainly the production of precursors to Arteminisin. Some of these precursors may be available for organic synthesis to deriviatives of Arteminisin--as Arteminisinic acid, and di-hydro Arteminisin though the active molecule shows the most effect. Because of double lactone ring structure in Arteminisin that must be active in malaria therapy--understood as very likely introducing an ozone like free radical intermediary into the Plasmodium falciparum. The actual extraction in acidic ethanol and into hexane would be accepted other track for Arteminisin availability followed by hemi-succinate esterifying to the hemi-succinate form allowed to precipitate. This becoming part of the agribusiness economy would integrate a supplemental agronomy study in engineering and economics. Furthermore any international uncertainties interrupting the supply of anti-malarials will be avoided with the source kept within American purview or western hemi-spheric bio-availability.
GOALS AND OBJECTIVES
To within 18 months utilize the commonly accepted method and procedure of producing Arteminisinic hemi-succinate derivative by extraction from a separatory process. It is generally reported that the Arteminisia annua can be extracted with an acidified ethanol fraction and this acidic solution will yield Arteminisinic acid in an acidified low pH ethanol. This fraction can then be further refined with a hexane separation in a separatory containment vessel. From this point succinic acid anhydride in aqueous hydroxide yields the hemi-succinate. This can be later reconstituted in a phosphate buffered (PO4, HPO4, H2PO4) to 5% weight to volume.
To within 18 months utilize the commonly accepted method and procedure of producing Arteminisinic hemi-succinate derivative by extraction from a separatory process. It is generally reported that the Arteminisia annua can extracted with an acidified ethanol fraction and this acidic solution will yield Arteminisinic acid in the low pH ethanol. This fraction can then be further refined with a hexane separation in a separatory containment vessel. Le chatelier's and braun principle is employed when allowing of the hexane to evaporate. The resulting crystalline precipitate is then added into a saponified succinic acid at high pH and the arteminisinate hemi-succinate allowed to re-precipitate in crystalline form. The active ingredient can be reconstituted in a 5% aqueous sodium bicarbonate solution.
And within a similar time frame to allow a local cultivation of Arteminisia annua, in silt clay loam soils by commonly accepted agronomy methods.
By preparation of a seed bed, a drill similar to those used with wheat, milo, oats, barley, flax seed, or soybeans will place the seed properly and in optimum agronomic conditions. By controlling competing flora, within the objective's time, these can be cut, raked or windrowed as necessary and baled in haystack bale form. Following the carrying of these haystack bales to the separatory and processing facility, the Arteminisia annua can be rolled exposing an extrapolated surface area and placed into the extraction vessel, filled with low pH ethanol solution, and agitated for a period of time until the extraction is drained or transfered off into the final hexane separation container.
TO WORK WITHIN THE PARADIGM OF A HUMANITARIAN HEALTH CARE OBJECTIVE TOWARD THE DEVELOPMENT OF MALARIAL MEDICATIONS, OF A FRAMEWORK OF MINISTERING OF THE GLOBAL OUTREACH OF PROFESSIONAL CARE-GIVERS, AND TO SHOW STEWARDSHIP IN ADVANCING WORLD HEALTH ORGANIZATION (WHO), GENEVA, SWITZERLAND, OBJECTIVES IN INTERNATIONAL PUBLIC HEALTH.
To within 18 months utilize the commonly accepted method and procedure of producing Arteminisinic hemi-succinate derivative by extraction from a separatory process. It is generally reported that the Arteminisia annua can be extracted with an acidified ethanol fraction and this acidic solution will yield Arteminisinic acid in an acidified low pH ethanol. This fraction can then be further refined with a hexane separation in a separatory containment vessel. From this point succinic acid anhydride in aqueous hydroxide yields the hemi-succinate. This can be later reconstituted in a phosphate buffered (PO4, HPO4, H2PO4) to 5% weight to volume.
To within 18 months utilize the commonly accepted method and procedure of producing Arteminisinic hemi-succinate derivative by extraction from a separatory process. It is generally reported that the Arteminisia annua can extracted with an acidified ethanol fraction and this acidic solution will yield Arteminisinic acid in the low pH ethanol. This fraction can then be further refined with a hexane separation in a separatory containment vessel. Le chatelier's and braun principle is employed when allowing of the hexane to evaporate. The resulting crystalline precipitate is then added into a saponified succinic acid at high pH and the arteminisinate hemi-succinate allowed to re-precipitate in crystalline form. The active ingredient can be reconstituted in a 5% aqueous sodium bicarbonate solution.
And within a similar time frame to allow a local cultivation of Arteminisia annua, in silt clay loam soils by commonly accepted agronomy methods.
By preparation of a seed bed, a drill similar to those used with wheat, milo, oats, barley, flax seed, or soybeans will place the seed properly and in optimum agronomic conditions. By controlling competing flora, within the objective's time, these can be cut, raked or windrowed as necessary and baled in haystack bale form. Following the carrying of these haystack bales to the separatory and processing facility, the Arteminisia annua can be rolled exposing an extrapolated surface area and placed into the extraction vessel, filled with low pH ethanol solution, and agitated for a period of time until the extraction is drained or transfered off into the final hexane separation container.
TO WORK WITHIN THE PARADIGM OF A HUMANITARIAN HEALTH CARE OBJECTIVE TOWARD THE DEVELOPMENT OF MALARIAL MEDICATIONS, OF A FRAMEWORK OF MINISTERING OF THE GLOBAL OUTREACH OF PROFESSIONAL CARE-GIVERS, AND TO SHOW STEWARDSHIP IN ADVANCING WORLD HEALTH ORGANIZATION (WHO), GENEVA, SWITZERLAND, OBJECTIVES IN INTERNATIONAL PUBLIC HEALTH.
Subscribe to:
Posts (Atom)