US2009238899A1PendingUtilityA1

Method for rapid identification of pharmacologically active chemical entities associated with the efficacy of ethnobotanical substances

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Individually held — no corporate assignee on recordPriority: Mar 24, 2008Filed: Mar 24, 2008Published: Sep 24, 2009
Est. expiryMar 24, 2028(~1.6 yrs left)· nominal 20-yr term from priority
Inventors:Mangala P. Bajpai
G01N 33/5044G01N 33/94G01N 33/5067C12Q 1/00G01N 33/5038
32
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Claims

Abstract

The method includes the steps of performing in-vitro liver, intestinal and/or expressed enzyme assays with selected ethnobotanical substances, for both humans and a variety of animal species, to produce an array of resulting chemical entities, such as metabolites, for the human and the animals. Comparisons are then made between the chemical entities from the human in-vitro studies and the animal in-vitro studies to determine the closest match. The animal with the closest match is then used for an in-vivo study. If a match is present between the animal in-vivo results and the human in-vitro results, the matched chemical entity is isolated or synthesized and then further tested to determine the suitability of the matched chemical entity as a treatment drug.

Claims

exact text as granted — not AI-modified
1 . A method for identifying medicinally active chemical entities in ethnobotanical substances, comprising the steps of:
 performing an in-vitro assay with an ethnobotanical substance using human intestinal and/or liver and/or enzyme expression preparations to produce an array of human chemical entities;   performing an in-vitro assay of said ethnobotanical substance using animal intestinal and/or liver and/or enzyme expression preparations from at least one selected animal species to produce an array of animal chemical entities;   determining any matches between the human chemical entities and the selected animal chemical entities to identify a matched animal species;   performing an in-vivo dosing of the ethnobotanical substance with the matched animal species; and   performing an analysis of a biological fluid from the matched animal species to determine any matches between the in-vitro human chemical entities and the in-vivo matched animal chemical entities.   
   
   
       2 . The method of  claim 1 , including the further step of synthesizing or isolating those in-vitro human and in-vivo animal chemical entities that match for use in follow-on studies to confirm the suitability of the matched chemical entities as a treatment drug. 
   
   
       3 . The method of  claim 1 , wherein in-vitro testing is performed on a plurality of animal species, with those species producing the closest match of animal chemical entities to human chemical entities being used as the matched animal species for the step of animal in-vivo dosing. 
   
   
       4 . The method of  claim 1 , wherein the steps of determining matches are accomplished using pre-established standards. 
   
   
       5 . The method of  claim 4 , wherein the steps of determining matches are carried out automatically. 
   
   
       6 . The method of  claim 4 , wherein the steps of determining matches are carried out manually. 
   
   
       7 . The method of  claim 4 , wherein the steps of determining matches are carried out with a combination of automatic and manual steps. 
   
   
       8 . The method of  claim 1 , wherein the human and animal in-vitro assays are liver microsomal assays. 
   
   
       9 . The method of  claim 1 , wherein the human and animal in-vitro assays are intestinal microsomal assays. 
   
   
       10 . The method of  claim 1 , wherein the human and animal in-vitro assays are liver hepatocytes assays. 
   
   
       11 . The method of  claim 1 , wherein the human and animal in-vitro assays are enzyme expression assays. 
   
   
       12 . The method of  claim 1 , wherein the biological fluid is whole blood and/or plasma. 
   
   
       13 . The method of  claim 1 , wherein the chemical entities are metabolites. 
   
   
       14 . The method of  claim 1 , wherein the human and animal in-vitro assays are liver microsomal assays, wherein the chemical entities are metabolites and wherein the biological fluid is whole blood or plasma. 
   
   
       15 . The method of  claim 2 , wherein the follow on studies include pharmacology in-vitro studies, pharmacology in-vivo studies and toxicology studies to determine the suitability of the chemical entities. 
   
   
       16 . The method of  claim 1 , wherein the biological fluid testing includes the use of LC-MS and/or GC-MS data. 
   
   
       17 . A method for identifying medicinally active chemical entities in ethnobotanical substances, comprising the steps of:
 performing an in-vitro assay with an ethnobotanical substance using human intestinal and/or liver and/or enzyme expression preparations to produce an array of human chemical entities;   performing an in-vivo dosing of at least one selected animal species with said ethnobotanical substance;   performing an analysis of a biological fluid from the selected animal species to determine a match between the in-vitro human chemical entities and the in-vivo animal chemical entities;   performing an in-vitro assay of said ethnobotanical substance using intestinal and/or liver and/or enzyme expression preparations from the selected animal species if there is not an in-vitro human/in-vivo animal match; and   determining any matches between the in-vitro animal chemical entities and the in-vitro human chemical entities.   
   
   
       18 . The method of  claim 17 , including the step of synthesizing or isolating those in-vitro human and in-vivo animal and in-vitro animal chemical entities which match for use in follow-on studies to confirm the suitability of said matched chemical entities as a treatment drug. 
   
   
       19 . The method of  claim 17 , wherein in-vivo dosing is performed on a plurality of animal species. 
   
   
       20 . The method of  claim 17 , wherein the steps of determining matches are accomplished using pre-established standards. 
   
   
       21 . The method of  claim 20 , wherein the steps of determining matches are carried out automatically. 
   
   
       22 . The method of  claim 20 , wherein the steps of determining matches are carried out manually. 
   
   
       23 . The method of  claim 20 , wherein the steps of determining matches are carried out with automatic and manual steps. 
   
   
       24 . The method of  claim 17 , wherein the human and animal in-vitro assays are liver microsomal assays. 
   
   
       25 . The method of  claim 17 , wherein the human and animal in-vitro assays are intestinal microsomal assays. 
   
   
       26 . The method of  claim 17 , wherein the human and animal in-vitro assays are liver hepatocytes assays. 
   
   
       27 . The method of  claim 17 , wherein the human and animal in-vitro assays are enzyme expression assays. 
   
   
       28 . The method of  claim 17 , wherein the biological fluid is whole blood or plasma. 
   
   
       29 . The method of  claim 17 , wherein the chemical entities are metabolites. 
   
   
       30 . The method of  claim 17 , wherein the human and animal in-vitro assays are liver microsomal assays, wherein the chemical entities are metabolites and wherein the biological fluid is whole blood or plasma. 
   
   
       31 . The method of  claim 18 , wherein the follow-on studies include pharmacology in-vitro studies, pharmacology in-vivo studies and toxicology studies to determine the suitability of the chemical entities. 
   
   
       32 . The method of  claim 17 , wherein the biological fluid testing includes the use of LC-MS and/or GC-MS data. 
   
   
       33 . A method for identifying medicinally active chemical entities in ethnobotanical substances, comprising the steps of:
 performing an in-vitro assay with an ethnobotanical substance using human intestinal and/or liver and/or enzyme expression preparations to produce an array of human chemical entities;   performing an in-vivo dosing of a selected animal species with said ethnobotanical substance; and   performing an analysis of a biological fluid from the selected animal species to determine any matches between the in-vitro human chemical entities and the in-vivo animal chemical entities.   
   
   
       34 . The method of  claim 33 , including the step of synthesizing or isolating those in-vitro human and in-vivo animal chemical entities which match for use in follow-on studies to confirm the suitability of said matched chemical entities as a treatment drug. 
   
   
       35 . The method of  claim 33 , wherein in-vivo testing is performed on a plurality of animal species. 
   
   
       36 . The method of  claim 33 , wherein the steps of determining matches are accomplished using pre-established standards. 
   
   
       37 . The method of  claim 36 , wherein the steps of determining matches are carried out automatically. 
   
   
       38 . The method of  claim 36 , wherein the steps of determining matches are carried out manually. 
   
   
       39 . The method of  claim 36 , wherein the steps of determining matches are carried out with a combination of automatic and manual steps. 
   
   
       40 . The method of  claim 33 , wherein the human in-vitro assay is a liver microsomal assay, wherein the chemical entities are metabolites and wherein the biological fluid is whole blood and/or plasma. 
   
   
       41 . The method of  claim 33 , wherein the follow-on studies include pharmacology in-vitro studies, pharmacology in-vivo studies and toxicology studies to determine the suitability of the chemical entities as a treatment drug. 
   
   
       42 . The method of  claim 33 , wherein the biological fluid testing includes the use of LC-MS and/or GC-MS data.

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