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WO2009036287A1 - Schéma posologique - Google Patents

Schéma posologique Download PDF

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Publication number
WO2009036287A1
WO2009036287A1 PCT/US2008/076189 US2008076189W WO2009036287A1 WO 2009036287 A1 WO2009036287 A1 WO 2009036287A1 US 2008076189 W US2008076189 W US 2008076189W WO 2009036287 A1 WO2009036287 A1 WO 2009036287A1
Authority
WO
WIPO (PCT)
Prior art keywords
active agent
daily dose
patient
dosage form
kit
Prior art date
Application number
PCT/US2008/076189
Other languages
English (en)
Inventor
Gary Liversidge
Scott Jenkins
Original Assignee
Elan Pharma International Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Elan Pharma International Limited filed Critical Elan Pharma International Limited
Priority to EP08830097A priority Critical patent/EP2197448A4/fr
Priority to CA2697189A priority patent/CA2697189A1/fr
Priority to JP2010525030A priority patent/JP2010539184A/ja
Publication of WO2009036287A1 publication Critical patent/WO2009036287A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Definitions

  • the present invention relates generally to methods of drug administration; in particular, to methods and kits enabling twice daily administration of a drug that provides daily patient blood levels of the drug comparable to that achieved by a dosing regimen requiting the same drug to be administered three times a day.
  • Dosing regimens requiting a large number of doses to be taken daily, for example, three times a day, are difficult for many patients to comply with.
  • three times a day dosing may be may be a challenging dosing regimen for pediatric patients, particularly in cases in which schools will not administer drug products to children during the school day.
  • compliance may also be difficult. Compliance rates may be improved by requiring less frequent administration of the drug(s) .
  • certain drugs that are typically dosed three times a day may be difficult to formulate as products to be administered once daily or twice daily, since this may require significant clinical and safety testing, due to, for example, different delivery and/or pharmacokinetic profiles of the formulations .
  • drugs that are administered in combination may have differing delivery and/or pharmacokinetic profiles, leading to periods in which the level of one of the drugs is sub-therapeutic.
  • the present invention relates to a drug dosing regimen requiring fewer doses per day than the conventional dosage regime.
  • Certain aspects of the invention provide combinations of immediate release (IR) and delayed release (DR) drug formulations that achieve blood levels of the active pharmaceutical ingredient that mimic the blood levels of the active agent administered via a dosing regimen requiring a greater number of doses per day.
  • aspects of the invention include using combinations of IR and DR dosage forms in a twice a day dosing regimen which achieves daily patient blood levels comparable to that achieved with three times a day dosing of the same active agent.
  • Certain aspects of the invention relate to a method of presenting a twice a day course of drug treatment to a patient comprising (A) presenting to a patient, on a daily basis, a first daily dose comprising at least one dosage form comprising an active drug agent, wherein said first dose comprises an immediate release component and a delayed release (DR) component and B) presenting to the patient a second dose comprising an immediate release dosage form of the active agent; such that, upon administration to the patient of the first daily dose at Time 0 and the second daily dose at some time subsequent to Time 0, the pharmacokinetic profile of the active agent in the blood of the patient over a 24-hour period mimics that of administration of the active agent to the patient three times a day.
  • kits for presenting a course of drug treatment to a patient may comprise (A) at least one first daily dose of an active agent comprising at an immediate release component and a delayed release component; and (B) at least one second daily dose of an active drug agent comprising an immediate release dosage form.
  • A at least one first daily dose of an active agent comprising at an immediate release component and a delayed release component
  • B at least one second daily dose of an active drug agent comprising an immediate release dosage form.
  • Additional aspects of the invention relate to a twice daily method of administering an active pharmaceutical ingredient to a subject in need thereof comprising the steps of: (A) administering to the subject at Time 0 a first dose comprising at least one dosage form comprising an active agent; the first dose comprises an immediate release component and a delayed release component; and (B) administering to the patient at a time subsequent to Time 0 at least one second dose comprising an immediate release dosage form comprising the active agent, such that the pharmacokinetic profile of the active agent in the blood of the patient over a 24-hour period mimics that of administration of the active agent to the patient three times a day.
  • the invention relates to a method of administering a combination of active ingredients to a subject in need thereof where each drug in the combination presents different pharmacokinetic profiles.
  • the drugs are presented to a subject in need thereof such that the pharmacokinetic profile of one drug complements, acts in concert, overlaps, or competes in some manner with the other drug.
  • a dosing card that presents the combination of drugs may be used to ensure patient compliance such that both drugs provide coverage over the dosing period.
  • FIG. 1 represents a dosage card according to an exemplary embodiment of the present invention.
  • therapeutically effective amount means the dosage that provides the specific pharmacological response for which the active agent is administered in a significant number of subjects in need of the relevant treatment. It is emphasized that a therapeutically effective amount of the active agent that is administered to a particular subject in a particular instance will not always be effective in treating the conditions described herein, even though such dosage is deemed to be a therapeutically effective amount by those of skill in the art.
  • the term “subject” is used to mean an animal, preferably a mammal, including a human.
  • the terms “patient” and “subject” may be used interchangeably.
  • certain embodiments of the invention are directed to appropriate dosage forms useful in the administration of active pharmaceutical ingredients to a subject.
  • active pharmaceutical ingredient or “active agent” includes active drug substances described herein or known in the art, as well as salts, derivatives, conjugates, hydrates, polymorphs, and analogues thereof.
  • the active agent may be present either in the form of one substantially optically pure enantiomer or as a mixture, racemic or otherwise, of enantiomers.
  • IR describes an active ingredient delivered to a subject in need thereof in an immediate release fashion as would be understood by one of ordinary skill in the art.
  • DR describes an active ingredient delivered to a subject in need thereof in a manner other than in an IR fashion as defined herein and includes delayed release of an active pharmaceutical ingredient.
  • a DR delivery manner includes delivery mechanisms as would be known in the art including: CR - controlled release, ER - extended release, MR- modulated release; pulsed release, and zero order release.
  • the invention is directed to a once a day administration of a drug that provides daily patient blood levels of the drug comparable to that achieved by a dosing regimen requiring the same drug to be administered twice a day, three times a day, four times a day, or more.
  • the invention is directed to twice daily administration of a drug that provides daily patient blood levels of the drug comparable to that achieved by a dosing regimen requiring the same drug to be administered three times a day, four times a day, or more .
  • the invention relates to combinations of IR and DR drug formulations that provide blood levels of the active agent that mimic the blood levels of the drug administered via a dosing regimen requiring a greater number of doses per day.
  • twice daily dosing using IR and DR formulations provides blood levels of active agent over a 24-hour period that are comparable to that achieved by a dosing regimen requiring administration three times a day.
  • the dosage form provides a delayed release of the drug.
  • the drug formulated in the IR and DR formulations is the same drug, or a different drug as described in the combination therapy aspect of the present invention .
  • twice daily administration of a drug formulation to mimic thrice daily dosing may be achieved by administering (at Time 0) a first dose comprising a drug formulation that contains an IR component and a DR component comprising the active agent, coupled with administration, at a subsequent time, of a second dose comprising an immediate release component comprising the active agent.
  • the first dose is administered in the morning and the second dose is administered later in the day, preferably close to bedtime.
  • administration of the second daily dose takes place about 12 to about 20, about 14 to about 18, or about 16 hours after the administration of the first dose at Time 0.
  • the first dose may comprise a delayed release component that allows for release of the active agent subsequent to the release of the IR component.
  • the delayed release component allows for release of the active agent approximately eight hours after administration.
  • the IR and DR formulations that comprise the first daily (a.m.) dose administered at Time 0 are combined in the same dosage form.
  • the combination of immediate release and delayed release active agent administered at Time 0 may be achieved by the co- administration of two separate formulations; one in a dosage form providing immediate release of the active agent, and the other in a dosage form providing a delayed release of the active agent.
  • the IR and DR formulations are presented to the patient in a package having an a.m. and a p.m. section for each day of a specified treatment period.
  • the a.m. section of the package comprises a formulation comprising an IR component and a DR component in combination, while the p.m. section of the package comprises an IR dosage form of the drug.
  • the IR formulation and the DR formulation may be each be contained in a separate dosage form that is packaged together in the a.m. section of the packaging for administration of the first dose.
  • the second dose in the p.m. section comprises an IR dosage form.
  • the packaging used to present the IR and DR formulations to the patient may be in the form of dosing cards, pill packs, or any other suitable packaging forms .
  • the packaging is in the form of a dosing card.
  • the dosing card comprises an a.m. section presenting the formulation or formulations to be administered at Time 0, as well as a p.m. section presenting the formulation to be administered at a time subsequent to Time 0 as is illustrated in Fig. 1.
  • the IR formulation and the DR formulation may be each be contained in the same dosage form and presented to the patient in a discrete package form, e.g., a first bottle.
  • a second package or bottle may also be given to the patient.
  • the second bottle contains only the IR formulation.
  • the patient in need of the therapeutic effect of the active ingredient formulated in the IR and DR formulations is instructed to take the IR/DR single dosage form from the first package in the am, and instructed to take the IR dosage form from the second package in the pm.
  • the formulation in combination with the prescribing regime decreases the number of dosage forms that a patient would be required to ingest compared to conventional therapies of the same active ingredient.
  • combinations of active agents may be administered.
  • a combination of drugs differing in pharmacokinetic profiles may be presented to a patient such that the morning dose (Time 0) comprises an IR component comprising a long-acting agent, and an IR component comprising a short-acting agent.
  • the p.m. dose comprises an IR component comprising the short-acting agent.
  • the long-acting agent may have a duration of action of about 24 hours and the short-acting agent may have a duration of action of about 12 hours. This dosing regimen provides for twice daily dosing to maintain efficacy of both active agent 24 hours a day.
  • a dose is administered in the morning (Time 0) comprising an IR component comprising a longer-acting agent and an IR component comprising a shorter-acting agent.
  • the p.m. dose comprises an IR dosage form comprising the shorter-acting drug.
  • the longer-acting agent may have a duration of action of about 18 hours, while the shorter- acting agent may have a duration of about 12 hours. This dosing regimen provides for 24-hour efficacy of the longer- acting agent, while providing that the shorter-acting agent is present only during the day.
  • the invention relates to combination therapies where it is desirable to have complementary, overlapping, or even competing pharmacokinetic profiles of at least two, and possibly three or more, active ingredients.
  • One example of the combination therapy aspect of the invention is the combination of at least two active ingredients such as the combination of SINGULAIR® (montelukast sodium tablets with 24 hour duration manufactured by Merck & Co., Inc., of Whitehouse Station, NJ) in co-treatment, co-administration, or co-formulated with ALLEGRA-D® (fexofenadine HCl extended release tablets with 12 hour duration manufactured by Sanofi-Aventis of Bridgewater, NJ) .
  • SINGULAIR® montelukast sodium tablets with 24 hour duration manufactured by Merck & Co., Inc., of Whitehouse Station, NJ
  • ALLEGRA-D® fexofenadine HCl extended release tablets with 12 hour duration manufactured by Sanofi-Aventis of Bridgewater, NJ
  • the patient requires efficacious levels of both the 24 hour montelukast and 12 hour fexofenadine to treat rhinitis over a total of 24 hours.
  • a product that includes the combination of montelukast and fexofenadine may be formulated into one dosage form or alternatively packaged in a dosing card and prescribed in such a manner as to allow for twice daily dosing to maintain efficacy of each active ingredient over the 24 hour dosing period.
  • two active agents may be used.
  • the first active ingredient is administered to treat a medical condition, but this first agent has undesirable side effects.
  • the second agent is provided within the kit.
  • kits of the instant invention may be designed in such a way to ensure active effect of stimulants during the day time, while the effect of an opiate would last twenty-four hours.
  • the stimulant may be combined within the delayed release component of the first daily dose of the opiate.
  • a combination of an opiate and a laxative is provided. As known in the art, an administration of an opiate may cause constipation, which may be severe.
  • a laxative is provided.
  • a laxative is provided in the IR component such that it exerts its effect only for a relatively short period.
  • Other suitable combinations of agents include a chemotherapeutic agent for cancer treatment, and a second active agent which decreases undesirable side effects of the chemotherapeutic agent.
  • the side effects of chemotherapeutic agents include, without limitations, fatigue, hair loss, nausea and/or vomiting, anemias and infections. It is important to keep in mind, however, that not every person gets every side effect. Accordingly the choice of the suitable second agent depends on the nature of the side effects in a particular patient treated with the chemotherapeutic agent.
  • the second active agent would be present in the IR and DR components of the first dose as well as in the second dose.
  • active ingredients include but are not limited to drug compounds acting on the central nervous system such as psychostimulants and cerebral stimulants, for example methylphenidate; aldosterone inhibitors such as spironolactone, eplerenone and analogs thereof; alkaloids; alpha/beta-blockers such as labetalol, carvedilol and analogs thereof; analgesics such as acetaminophen, naproxen, paverin, and analogues thereof tramadol and opioids such as morphine, codeine, thebaine, heroin, oxycodone, hydrocodone, dihydrocodiene, hydromorphone, oxymorphone, buprenorphine, etorphine, naloxone, nicomorphine, methadone, pethidine, fentanyl, alfentanil, sufentanil, remifentanil, carfentanyl, pentazocine, phenazocine, butorphanol
  • preferred active agents include, but are not limited to, famciclovir, pregabalin, sevelamer, nelfinavir, indinavir, pramipexole, metaxalone, trientine, thioridazine, rifaximin, alprazolam, carbidopa, levodopa, erythromycin ethylsuccinate, phenytoin, acamprosate, praziquantel, molindone, levocamitine, dichlorphenamide, posaconazole, promethazine, delavirdine, and sildenafil.
  • Advantages of the methods and kits described herein include reducing the dosing frequency required while still maintaining the benefits normally derived from the conventional dosing regimen.
  • This reduced dosing frequency is particularly advantageous in the case of children in that it eliminates the need for dosing during the middle of the school day which can be both disruptive and embarrassing for the patient.
  • the reduction in dosage frequency made possible by utilizing embodiments described herein may contribute to reducing health care costs by reducing the amount of time spent by health care workers on the administration of drugs.
  • the active agents employed herein may be formulated into any suitable dosage form(s) providing the required combination of immediate release and delayed release, as well as the required immediate release component.
  • the IR and DR form may be combined in the same dosage form.
  • separate dosage forms may provide the IR and DR components and may, in certain aspects, be combined by packaging for presentation to the patient, providing convenience to the patient and providing for ease of compliance.
  • Immediate release components and dosage forms employed herein may be made by any suitable methods known to the art. Release of certain active agents, including, without limitation, delayed release, may be achieved by any suitable means known to the art. Examples include, without limitation, U.S. Patent No. 6,228,398 to Devane et al . , titled “Multiparticulate Modified Release Composition", hereby incorporated by reference.
  • coating material which modifies the release of the active ingredient in the desired manner may be used.
  • coating materials suitable for use in the practice of the invention include, but are not limited to, polymer coating materials, such as cellulose acetate phthalate, cellulose acetate trimaletate, hydroxy propyl methylcellulose phthalate, polyvinyl acetate phthalate, ammonio methacrylate copolymers such as those sold under the
  • delayed release may be achieved by a release component comprising matrix material.
  • the delayed release component comprises a matrix material
  • any suitable matrix material or suitable combination of matrix materials may be used.
  • Such materials are known to those skilled in the art and include, but are not limited to, hydrophilic polymers, hydrophobic polymers and mixtures thereof which are capable of modifying the release of an active ingredient dispersed therein in vitro or in vivo.
  • More specific matrix materials suitable for the practice of the present invention include, but are not limited to, microcrytalline cellulose, sodium carboxymethylcellulose, hydoxyalkylcelluloses such as hydroxypropylmethylcellulose and hydroxypropylcellulose, polyethylene oxide, alkylcelluloses such as methylcellulose and ethylcellulose, polyethylene glycol, polyvinylpyrrolidone, cellulose acetate, cellulose acetate butyrate, cellulose acetate phthalate, cellulose acetate trimellitate, polyvinylacetate phthalate, polyalkylmethacrylates, polyvinyl acetate and mixture thereof.
  • active agents may be incorporated into a suitable dosage form which facilitates release of the active ingredient in a pulsatile manner.
  • the dosage form may be a blend of the different populations of active ingredient containing particles which make up the immediate release and the delayed release components, the blend being filled into suitable capsules, such as hard or soft gelatin capsules .
  • the different individual populations of active ingredient containing particles may be compressed (optionally with additional excipients) into mini-tablets which may be subsequently filled into capsules in the appropriate proportions.
  • Another suitable dosage form is that of a multilayer tablet. In this instance the first component of the multiparticulate composition may be compressed into one layer, with the second component being subsequently added as a second layer of the multilayer tablet.
  • the populations of active ingredient-containing particles making up the composition may further be included in rapidly dissolving dosage forms such as an effervescent dosage form or a fast- melt dosage form.
  • compositions are employed that comprise at least two populations of active ingredient- containing particles which have different in vitro dissolution profiles.
  • Solid oral dosage forms are employed.
  • Solid dosage forms for oral administration include, but are not limited to, tablets, capsules, sachets, lozenges, powders, pills, or granules, and the solid dosage form can be, for example, a fast melt dosage form, lyophilized dosage form, or a combination thereof.
  • the dosage forms employed will be administered to a subject in need thereof using a level of a drug or an active agent that is sufficient to provide the desired physiological effect.
  • the effective amounts of the active agent of the compositions of the invention can be determined empirically and can be employed in pure form or, where such forms exist, in pharmaceutically acceptable salt, ester, or prodrug form. Actual dosage levels of the active agent in the dosage form may be varied to obtain an amount of the active agent that is effective to obtain a desired therapeutic response for a particular composition and method of administration and the condition to be treated.
  • the selected dosage level therefore depends upon the desired therapeutic effect, the route of administration, the potency of the administered active agent, the desired duration of treatment, and other factors.
  • the level of active agent needed to give the desired physiological result is readily determined by one of ordinary skill in the art by referring to standard texts, such as Goodman and Gillman and the Physician's Desk Reference.
  • Dosage unit compositions may contain such amounts of such submultiples thereof as may be used to make up the daily dose. It will be understood, however, that the specific dose level for any particular subject will depend upon a variety of factors : the type and degree of the cellular or physiological response to be achieved; activity of the specific agent or composition employed; the specific agent (s) or composition employed; the age, body weight, general health, sex, and diet of the patient; the time of administration, route of administration, and rate of excretion of the active agent; the duration of the treatment; active agents used in combination or coincidental with the specific active agent; and like factors well known in the medical arts.
  • the solid oral dosage forms release the active ingredient such that substantially all of the active ingredient contained in the first component is released prior to release of the active ingredient from the second component.
  • the first component comprises an IR and DR combination (either in the same dosage form or separate dosage forms)
  • the IR component releases the active ingredient immediately after ingestion or after placed in the mouth (depending on the dosage form, i.e., fast melt), and the release of the active ingredient in the DR component is delayed until substantially all the active ingredient in the IR component has been released. Release of the active ingredient from the DR component may be delayed as detailed above by the use of release coatings and/or release matrix materials.
  • the present invention also provides methods comprising the administration to a subject in need thereof an effective amount of at least one active agent .
  • a method of administering an active agent to a subject in need thereof comprises the steps of: (A) administering to the subject at Time 0 a first dose comprising at least one dosage form comprising the active agent, wherein the dosage form comprises an IR component and a DR component; and (B) administering to the patient at some time subsequent to Time 0 at least one second dose comprising an immediate release dosage form of the active agent; wherein the pharmacokinetic profile of the active agent in the blood of the patient over a 24-hour period mimics that of administration of the active agent to the patient three times a day.
  • the second dose is administered to the subject about 12 to about 20 hours after Time 0, about 14 to about 18 hours after Time 0, or about 16 hours after Time 0.
  • Certain aspects of the invention may be directed to the administration to a subject of a therapeutically effective amount of a composition comprising an anti-viral agent.
  • famciclovir is an active agent administered according to various aspects of the invention.
  • a twice daily dosing regimen is provided for the treatment of Herpes Zoster, for which the current recommended dosage is 500 mg of famciclovir every 8 hours
  • a dosing card as described herein contains two types of doses: one to be taken after waking in the morning (Time 0), the other before bedtime (Time 12-18h) .
  • a seven day dosing regimen is provided on the card.
  • the morning dose (Time 0) consists of two oral dosage forms (such as tablets or capsules) each containing 500 mg of famciclovir, with 250 mg formulated for immediate release and 250 mg formulated for a delayed release of 8 hours.
  • the bedtime dose (Time 12-18h) is formulated as 500 mg of immediate release famciclovir.
  • Administration using the above twice daily dosing regimen mimics the pharmacokinetics of the conventional (three times daily) dosing regimen.
  • the clinical benefits are expected to be increased patient compliance by simplifying the dosing regimen from three times a day to twice a day.
  • each morning dose (Time 0) comprises two separate oral dosage forms (which may be tablets or capsules) provided together in the a.m. section of the card; the first dosage form contains 500 mg of famciclovir formulated for immediate release and the second contains 500 mg of famciclovir formulated for a delayed release of 8 hours.
  • An example of a long -acting agent that may be paired with a short-acting agent includes montekulast, having a 24- hour duration of action, paired with fexofenadine, which has a 12-hour duration of action.
  • montekulast having a 24- hour duration of action
  • fexofenadine which has a 12-hour duration of action.
  • These agents are formulated and packaged in a dosing card having a breakfast (a.m.) and dinner (p.m.) section each day of a specified treatment period.
  • Administration according to the dosing schedule allows for twice-daily administration to maintain efficacy over a 24-hour period for the treatment of rhinitis. This is achieved by dosing in the morning with a combination of an IR montekulast element and an IR fexofenadine element, and dosing at dinnertime with an IR element of fexofenadine.
  • oxycodone e.g., OXYCONTIN®' Purdue Pharma
  • Coadministration as described herein may provide continual levels of oxycodone to treat pain but allow for modafinil to be present only during the day to overcome somnolence, an adverse side effect of oxycodone.
  • Oxycodone is a short acting drug and it is desirable to have a drug-free period between presentations of the drug to a patient.
  • Such a drug-free period is achieved by dosing, in the a.m., an IR/DR formulation comprising oxycodone in the in a controlled released formulation in combination with the longer-acting modafinil.
  • the p.m. IR component taken by the patient at dinnertime would include only the oxycodone controlled release formulation.
  • the treatment regime maybe presented on a dosing card with a breakfast (a.m.) and dinner (p.m.) section for each day of a specified treatment period.
  • a patient following such a treatment regime that includes the IR/DR and IR compositions benefits from a reduction in the number of times that a dosage form is required to be taken; thereby, statistically, increasing compliance .

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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention a pour objet des procédés et des kits permettant un schéma posologique de deux fois par jour qui atteint des taux sanguins quotidiens chez le patient du principe actif pharmaceutique comparables à un schéma posologique nécessitant que le même principe actif soit administré trois fois par jour.
PCT/US2008/076189 2007-09-12 2008-09-12 Schéma posologique WO2009036287A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP08830097A EP2197448A4 (fr) 2007-09-12 2008-09-12 Schéma posologique
CA2697189A CA2697189A1 (fr) 2007-09-12 2008-09-12 Schema posologique
JP2010525030A JP2010539184A (ja) 2007-09-12 2008-09-12 投薬レジメン

Applications Claiming Priority (2)

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US97188207P 2007-09-12 2007-09-12
US60/971,882 2007-09-12

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WO2009036287A1 true WO2009036287A1 (fr) 2009-03-19

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JP (1) JP2010539184A (fr)
CA (1) CA2697189A1 (fr)
WO (1) WO2009036287A1 (fr)

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US8460331B2 (en) 1998-08-12 2013-06-11 Maquet Cardiovascular, Llc Tissue dissector apparatus and method
WO2014022570A1 (fr) * 2012-07-31 2014-02-06 Zogenix, Inc. Traitement de la douleur chez des patients souffrant de déficience hépatique
US8951555B1 (en) 2000-10-30 2015-02-10 Purdue Pharma L.P. Controlled release hydrocodone formulations
US8975273B2 (en) 1999-10-29 2015-03-10 Purdue Pharma L.P. Controlled release hydrocodone formulations
WO2015065497A1 (fr) * 2013-11-04 2015-05-07 Schultz Jack William Traitement de troubles et problèmes cognitifs, émotionnels et mentaux
US9149472B2 (en) 2004-08-31 2015-10-06 Jack William Schultz Controlled release compositions for treatment of cognitive, emotional and mental ailments and disorders
US9265760B2 (en) 2012-07-31 2016-02-23 Pemix Ireland Pain Limited Treating pain in patients with hepatic impairment
US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
US10299770B2 (en) 2006-06-01 2019-05-28 Maquet Cardiovascular Llc Endoscopic vessel harvesting system components
US10507012B2 (en) 2000-11-17 2019-12-17 Maquet Cardiovascular Llc Vein harvesting system and method

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JP2010539184A (ja) 2010-12-16
CA2697189A1 (fr) 2009-03-19
EP2197448A1 (fr) 2010-06-23

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