Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Reexamination Certificate
2001-04-12
2004-07-13
Dodson, Shelley A. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Reexamination Certificate
active
06761895
ABSTRACT:
TECHNICAL FIELD
The present invention pertains to a novel means for averting undesirable pharmacokinetic (drug) interaction between a drug and concomitant drug(s) (e.g., between a drug and a food) in vivo in humans, and uses as the means of aversion a drug delivery system with which the in vivo release time and/or the release site of the drug is controlled.
BACKGROUND OF THE INVENTION
Recently, drugs are rarely used singularly as a result of diversification of medicine and changes in patient phase with aging, and in many cases multiple drugs are administered simultaneously or at staggered administration times. In this case, interaction between drugs that are administered concomitantly sometimes occurs. Interaction between the drugs in question is classified as pharmacodynamic drug interaction, whereby there is a change in sensitivity, etc., to the drug at its site of action, and pharmacokinetic drug interaction, where there is a change in the in vivo kinetics of the drug. With respect to the former, interaction by concomitant use can be estimated if the clinical mode of action of the drugs is known, and the fact of the matter is that the actual results of concomitant therapy are improved using this same interaction. However, with respect to the latter, clinically, the in vivo kinetics of a drug is still unknown and even when it is known, unexpected results occur when drugs are combined (“Clinical Pharmacokinetics, Revised Version 2,” Chapter VII: Drug Interaction, page 107, Ryuichi Kato, author, Nankodo Publishing).
Pharmacokinetic drug interaction almost always develops because the drugs themselves compete for one route (enzymes, carriers, etc.) when drugs that use the same routes in terms of drugs absorption, distribution, metabolism or excretion are used concomitantly.
This type of pharmacokinetic drug interaction is undesirable unless it is used for an additive action or synergism. The method has been adopted for averting concomitant use of drugs that interact with one another when a prescription is written by a physician or pharmacist whereby attention is drawn to “Drug Safety Data” presented by the Ministry of Health and Welfare and the column on precautions for concomitant use contained in the attached drug literature.
Moreover, the claim is presented in “Yakuzai Yosokugaku Nyumon,” (Yasufumi Sawada, author; Yakugyo Jiho Publishers) that it is possible to avert interaction with an administration protocol whereby the administration time of concomitant drugs to a patient is staggered. However, the administration time is precisely specified and the protocol calls for administration of as much as 6 to 7 times/day with concomitant use of metal cation-containing antacids (magnesium, aluminum, etc.) and new quinolones (norfloxacin, etc.), which were used as examples in this text, and in view of patient compliance, this protocol cannot realistically be used.
Consequently, even if from a pharmacological standpoint the drugs themselves realize excellent therapeutic results when used concomitantly, concomitant use has been averted in the past because of drug interaction and satisfactory therapeutic results could not be realized.
Moreover, since pharmacokinetic interaction with drugs is induced by some foods, pharmacists give instructions on how to take drugs explaining precautions when drugs are taken. However, this has become a source of reduced patient compliance.
SUMMARY OF THE INVENTION
In certain embodiments, the present invention provides a system for averting undesirable pharmacokinetic drug interaction between a drug and concomitant drug(s), the system comprising controlling the in vivo release time and/or release site of the drug and/or the concomitant drug(s).
In another embodiment, the present invention provides a method or use of a drug delivery system which consists of controlling the in vivo release time and/or release site a drug and/or concomitant drug(s), for averting undesirable pharmacokinetic drug interaction between the drug and the concomitant drug(s).
In another embodiment, the present invention provides a method or use of a drug delivery system which consists of controlling the in vivo release time and/or release site of the drug and/or concomitant drug(s), for averting undesirable drug interaction between the drug and the concomitant drug(s), both of which use the same route in terms of in vivo drug absorption, distribution, metabolism or excretion in humans.
In another embodiment, the present invention provides a method or use of a drug delivery system which consists of timed-release control of a drug or control of the site of release of a drug to the digestive tract, for averting undesirable drug interaction between the said drug and concomitant drug(s), both of which are metabolized by the same molecular species of drug-metabolizing enzyme in humans, or between the said drug and concomitant drug(s) that is metabolized by the molecular species of drug-metabolizing enzymes that is inhibited by the said drug.
In another embodiment, the present invention provides a method or use of a drug delivery system which consists of timed-release control of a drug or control of release of a drug specifically to the lower digestive tract, for averting undesirable drug interaction between the said drug and concomitant drug(s), both of which metabolized by the drug metabolizing enzyme CYP3A4, or between the said drug that inhibit CYP3A4 and concomitant drug(s) that is metabolized by CYP3A4.
In another embodiment, the present invention provides a method of averting undesirable pharmacokinetic drug interaction between a drug and concomitant drug(s), by using a drug delivery system with which the in vivo release time and/or release site of the drug and/or the concomitant drug(s) is controlled.
In another embodiment, the present invention provides a method for averting undesirable drug interaction between a drug and concomitant drug(s), both of which use the same route in terms of in vivo drug absorption, distribution, metabolism or excretion in humans, by using a drug delivery system with which the in vivo release time and/or release site of the drug and/or the concomitant drug(s) is controlled.
In another embodiment, the present invention provides a method for averting undesirable drug interaction between a drug and concomitant drug(s), both of which are metabolized by the same molecular species of drug-metabolizing enzyme in humans or between a drug and concomitant drug(s) that is metabolized by the molecular species of drug metabolizing-enzymes that is inhibited by the said drug, by using a drug delivery system with which there is timed-release control of the said drug or control of the site of release of the said drug to the digestive tract.
In another embodiment, the present invention provides a method for averting undesirable drug interaction between a drug and concomitant drug(s), both of which metabolized by the drug metabolizing enzyme CYP3A4 or between a drug that inhibit CYP3A4 and concomitant drug that is metabolized by CYP3A4, by using a drug delivery system with which there is timed-release control of the said drug or control of release of the said drug specifically to the lower digestive tract.
In still another embodiment, the present invention provides a method or use of a drug preparation which consists of controlling the in vivo release time and/or release site of a drug, for averting undesirable pharmacokinetic drug interaction between the said drug and concomitant drug(s).
In still another embodiment, the present invention provides a method or use of a drug preparation which consists of controlling the in vivo release time and/or release site of a drug, for averting undesirable drug interaction between the said drug and concomitant drug(s), both of which use the same route in terms of in vivo drug absorption, distribution, metabolism or excretion in humans.
In another embodiment, the present invention provides a method or use of a drug preparation which consists of timed-release control of a drug or control of the site of release of a drug to the digest
Sako Kazuhiro
Sawada Toyohiro
Watanabe Shunsuke
Yoshioka Tatsunobu
Dodson Shelley A.
George Konata M.
Townsend and Townsend / and Crew LLP
Yamanouchi Pharmaceutical Co. Ltd.
LandOfFree
Drug delivery system for averting pharmacokinetic drug... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Drug delivery system for averting pharmacokinetic drug..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Drug delivery system for averting pharmacokinetic drug... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3254209