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US 5,945,123 AGranted
Maximizing effectiveness of substances used to improve health and well being
AssigneeK-V Pharmaceutical Company
InventorVictor M. Hermelin
Life of this patent
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Abstract
The present disclosure relates to novel dosage forms, drug delivery regimens, methods and pharmaceutical compositions which optimize the therapeutic effects of active therapeutic substances through the application of the concept of uneven dosing.
Claims65
A drug delivery regimen, which comprises:
- an active therapeutic substance administered during at least one 24 hour period of time to provide effective therapeutic levels of the active therapeutic substance at a site of action in an animal over said period, wherein each individual dose is independently adjusted to be administered to optimize levels of the active therapeutic substance at the site of action for maximum efficacy, and wherein the dose amount at each administration is independently predetermined at commencement of said period by the formula TD(t)=CD(t)+RD(t), where t is the time at which the dose is to be administered, TD is the therapeutically effective dose at time (t), CD is the dose to be administered at time (t), and RD is the amount of active therapeutic substance remaining from the previous dose administration;
- wherein the time at which each dose to be administered is tailored to a convenient schedule for said animal.
A pharmaceutical composition for optimizing therapeutic activity, which comprises:
- a substance consisting essentially of multiple active therapeutic substances, wherein the substance has a water-soluble phase and a non water-soluble phase, and wherein the ratio of water-soluble phase to non water-soluble phase is independently tailored to optimize levels of the respective active therapeutic substances at a site of action in an animal for maximum efficacy, and wherein said ratio is determined according to the time at which said composition is to be administered with a suitable pharmaceutical carrier.
A drug delivery regimen, which comprises:
- an active therapeutic substance administered during at least one 24 hour period of time to provide effective therapeutic levels of the active therapeutic substance at a site of action in an animal over said period, wherein each individual dose is independently adjusted to be administered to optimize levels of the active therapeutic substance at the site of action for maximum efficacy, and wherein the dose amount at each administration is independently predetermined at commencement of said period by the formula TD(t)=CD(t)+RD(t), where t is the time at which the dose is to be administered, TD is the therapeutically effective dose at time (t), CD is the dose to be administered at time (t), and RD is the amount of active therapeutic substance remaining from the previous dose administration;
- wherein the time at which each dose to be administered is tailored to a convenient schedule for said animal;
- and wherein the active therapeutic substance is administered in uneven doses.
A drug delivery regimen, which comprises:
- an active therapeutic substance administered during at least one 24 hour period of time to provide effective therapeutic levels of the active therapeutic substance at a site of action in an animal over said period, wherein each individual dose is independently adjusted to be administered to optimize levels of the active therapeutic substance at the site of action for maximum efficacy, and wherein the dose amount at each administration is independently predetermined at commencement of said period by the formula TD(t)=CD(t)+RD(t), where t is the time at which the dose is to be administered, TD is the therapeutically effective dose at time (t), CD is the dose to be administered at time (t) and RD is the amount of active therapeutic substance remaining from the previous dose administration;
- wherein the time at which each dose to be administered is tailored to a convenient schedule for said animal;
- and wherein the active therapeutic substance is administered in uneven doses and at uneven time intervals over the course of the 24 hour period.
A drug delivery regimen, which comprises:
- multiple doses of an active therapeutic substance administered during at least one 24 hour period of time to provide effective therapeutic levels of the active therapeutic substance at a site of action in an animal over said period, wherein the active therapeutic substance is administered in uneven doses and over varying time intervals, and wherein the uneven doses and the varying time intervals are selected to optimize levels of the active therapeutic substance at the site of action for maximum efficacy.
A drug delivery regimen, which comprises:
- multiple doses of an active therapeutic substance administered during at least one 24 hour period of time to provide effective therapeutic levels of the active therapeutic substance at a site of action in an animal over said period, and wherein each dose is independently calculated according to known pharmacokinetic parameters of the active therapeutic substance with variations to account for physiological anomalies which occur during said period to optimize levels of the active therapeutic substance at the site of action for maximum efficacy.
A drug delivery regimen, which comprises:
- multiple doses of an active therapeutic substance administered during at least one 24 hour period of time to provide effective therapeutic levels of the active therapeutic substance at a site of action in an animal over said period, wherein the time at which each dose is to be administered is tailored to a convenient schedule for the animal, and wherein the dose amount at each administration is independently predetermined at commencement of said period by the formula TD(t)=CD(t)+RD(t), where t is the time at which the dose is to be administered, TD (therapeutic dose) is the therapeutically effective dose at time (t), CD (current dose) is the dose to be administered at time (t), and RD (residual dose) is the amount of active therapeutic substance remaining from the previous dose administration;
- wherein the time at which each dose is to be administered is tailored to a convenient schedule for said animal.
A method of enhancing the therapeutic effect of an active therapeutic substance in an animal, which comprises:
- (a) determining known pharmacokinetic parameters of the active therapeutic substance;
- (b) determining a number of doses to be administered during a 24 hour period of time and determining a time at which each dose will be administered by considering both the animal's schedule and physiological anomalies during the 24 hour period;
- and
- (c) independently calculating the amount of each dose in accordance with the equation
- TD(t)=CD(t)+RD(t)
- where t is the time at which the dose is to be administered, TD (therapeutic dose) is the therapeutically effective dose at time (t), CD (current dose) is the dose to be administered at time (t), RD (residual dose) is the amount of active therapeutic substance remaining from the previous dose administration.
3 more elements
A pharmaceutical composition for optimizing therapeutic activity in an animal, which comprises:
- a substance consisting essentially of an active therapeutic substance in dose amounts calculated according to the formula TD(t)=CD(t)+RD(t), where t is the time at which the dose is to be administered, TD (therapeutic dose) is the therapeutically effective dose at time (t), CD (current dose) is the dose to be administered at time (t), and RD (residual dose) is the amount of active therapeutic substance remaining from the previous dose administration;
- and suitable pharmaceutical carrier.
A drug delivery regimen, which comprises:
- multiple active therapeutic substances administered during at least one 24 hour period of time to provide effective therapeutic levels of the active therapeutic substances at a site of action in an animal over said period, wherein each individual dose is independently tailored to optimize levels of the respective active therapeutic substances at the site of action for maximum efficacy as predetermined at commencement of said period, and wherein the time at which each dose is to be administered is tailored to a convenient schedule for said animal.
A drug delivery regimen, which comprises:
- an active therapeutic substance with a water-soluble phase and a non water-soluble phase administered during at least one 24 hour period of time to provide effective therapeutic levels of the active therapeutic substances at a site of action in an animal over said period, wherein the ratio of water-soluble phase to non water-soluble phase for each dose is independently tailored to optimize levels of the active therapeutic substance at the site of action for maximum efficacy as predetermined at commencement of said period, and wherein the time at which each dose is to be administered is tailored to a convenient schedule for said animal.
Dependencies are inferred from the claim text.