Method of providing customized drug delivery correlating to a patient's metabolic profile - Patents

Method of providing customized drug delivery correlating to a patient's metabolic profile

Agent: William S. Parks - Havre De Grace, MD, US
Inventors: Robert Scott Wedinger, Dev Kumar Mehra, Wendy Ivy Wilson
Class: 435006000 (USPTO)
Related Patents: Chemistry: Molecular Biology And Microbiology, Measuring Or Testing Process Involving Enzymes Or Micro-organisms; Composition Or Test Strip Therefore; Processes Of Forming Such Composition Or Test Strip, Involving Nucleic Acid
#20060078897
04/13/06
A novel method of correlating the disposition of a specific drug in an individual patient to a controlled and modulated delivery system for optimizing therapeutic response of orally ingested dosage forms is provided. Such a method broadly encompasses a first determination of an individual's metabolic rate in terms of absorption of pharmaceutical materials from within the gastrointestinal tract measured as blood plasma concentration over a specific period of time after ingestion or by other commercially available methods and subsequent determination: 1) predicting a proper pharmaceutical compositions, in terms of amount of active available for absorption by the target patient; and 2) amount of such active pharmaceutical ingredient (API) to be formulated within a drug-delivery device that will take into account the unique metabolic profile of the drug (or drugs) in a specific patient. As a result, the API may be formulated as beads, pellets, minitablets, powders, granules, suspensions, and/or emulsions present within the drug-delivery source. As one potentially preferred embodiment, such beads and/or pellets, which may be coated with different polymers and differing levels of coatings, are selected in response to the initial determination of the patient's metabolic profile in order to ensure the specific targeted patient receives the most efficient dosage of the active drug at a rate unique to that individual.
FIELD OF THE INVENTION
[0001] A novel method of correlating the metabolic profile of a specific drug or combination of drugs in an individual patient to a controlled and modulated delivery system for optimizing therapeutic response of orally ingested dosage forms is provided. Such a method broadly encompasses a first determination of an individual's metabolic rate in terms of absorption of pharmaceutical materials from within the gastrointestinal tract measured as blood plasma concentration over a specific period of time after ingestion or by methods commercially available, as a non-limiting example, from companies such as Genelex Corp of Seattle, Wash., and subsequent determination of: 1) predicting a proper pharmaceutical composition, in terms of amount of active available for absorption by the target patient; and 2) amount of such active pharmaceutical ingredient (API) to be formulated within a drug-delivery device that will take into account the unique metabolic profile of the drug (or drugs) in a specific patient. As a result, the API may be preformulated as beads, pellets, minitablets, powders, granules, suspensions, and/or emulsions present within the drug-delivery source. As one potentially preferred embodiment, such beads and/or pellets, which may be uncoated or coated with different polymers and differing levels of coatings, are selected in response to the initial determination of the patient's metabolic profile in order to manufacture a customized final formulation to ensure the specific targeted patient receives the most efficient dosage of the active drug at a rate unique to that individual.
SUMMARY AND OBJECTS OF THE INVENTION
[0012] Therefore, it is an object of this invention to provide a more therapeutically beneficial, safe and reliable pharmaceutical delivery system for individual patients through customization of the formulation based on the individual's metabolic and/or genetic profile for a specific active. Another object of the invention is the ability to dose a target patient to achieve optimized absorption of the particular pharmaceutical active or actives delivered in order to provide salutary treatment. Yet another object is to provide an effective pharmaceutical delivery system as above, but also permitting simultaneous administration and eventual effective treatment by a plurality of pharmaceutical actives that may generally exhibit incompatibility when homogeneously blended into a single drug delivery system or may provide synergism via different mechanism.
[0013] Accordingly, this invention encompasses a method of providing a pharmaceutical formulation delivered in a form selected from the group consisting of a capsule, a tablet, and any combinations thereof, wherein said method comprises the following sequential steps: [0014] a) initially determining a target patient's individual metabolic and/or genetic profile (Bioavailability and Pharmacokinetics/Pharmacodynamics parameters) for at least one pharmaceutical active; [0015] b) correlating the metabolic and/or genetic profile of step "a" to a required dose of pharmaceutical active needed to provide a sufficient amount of such active for maximum therapeutic effectiveness, thereby; [0016] c) selecting the proper amount of individual pharmaceutical active-containing components selected from the group consisting of preformulated beads, pellets, minitablets, powders, granules, suspensions, emulsions, and any combinations thereof, to meet the correlating determination of step "b" when present within a capsule or tablet; and [0017] d) introducing the amount of individual pharmaceutical active-containing components of step "c" into a customized/individualized capsule or tablet.
[0018] Furthermore, this invention encompasses the capsule and/or tablet manufactured by this method. Additionally, this invention encompasses the method of producing a drug delivery system (as defined below) comprised of a plurality of API-containing materials selected from the group consisting of beads, pellets, minitablets, emulsions, suspensions, powders, and any mixtures thereof, wherein said API-containing materials are dispensed into said drug delivery system from a plurality of different bins, wherein each individual bin comprises a uniform dosage and preformulated API-containing materials and each separate bin comprises different dosages and preformulated forms of such API-containing materials, wherein the amount of each dosage and preformulated form of API-containing materials selected for inclusion within said drug delivery system is determined through the correlation of a specific patient's metabolic profile for the API present within said API-containing materials such that the final formulation present within said drug delivery system is customized to the metabolic profile of said specific patient. The final manufactured drug delivery system produced from this method is also encompassed within this invention. For purposes of this invention, the term "preformulation" or "preformulated" is intended to mean any compositions, materials, or the like, manufactured prior to final production of the ultimate drug delivery system.
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