DOSING REGIMEN

• US 20090149479A1
• Filed: 09/12/2008
• Published: 06/11/2009
• Est. Priority Date: 11/02/1998
• Status: Abandoned Application

• Current Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Original Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Inventors: Liversidge, Gary, Jenkins, Scott
• Application Number:
  US12/209,728
• Publication Number:
  US 20090149479A1
• Time in Patent Office: Days
• US Class Current: 514/263.400
• CPC Class Codes: A61K 31/522 having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

Methods and kits are provided enabling a twice daily dosing regimen that achieves daily patient blood levels of active pharmaceutical ingredient comparable to a dosing regimen requiring the same active ingredient to be administered three times a day.

Claims

1. A method of presenting a course of drug treatment comprising the steps of:

(A) presenting to a patient at least one first daily dose comprising at least one dosage form comprising an active agent, wherein said first dose comprises an immediate release component and a delayed release component;

(B) presenting to the patient at least one second dose comprising an immediate release dosage form of said active agent;

wherein, upon administration to said patient of the first daily dose at Time 0 and the second daily dose at a time about 12 to about 20 hours after 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.

2. The method of claim 1, wherein in (A), the at least one first daily dose comprises

two dosage forms;

the first dosage form comprising an immediate release component, and the second dosage form comprising a delayed release component.

3. A kit for presenting a course of drug treatment to a patient comprising:

(A) at least one first daily dose of an active agent comprising at least one dosage form comprising an immediate release component and a delayed release component;

(B) at least one second daily dose of an active agent comprising at least one immediate release dosage form;

wherein, upon administration to said patient of the first daily dose at Time 0 and the second daily dose at a time about 12 to about 20 hours after Time 0, the pharmacokinetic profile of said 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.

4. The kit of claim 3 wherein the (A) the at least one first daily dose comprises two dosage forms;

the first dosage form comprising an immediate release component, and the second dosage form comprising a delayed release component.

5. The kit of claim 3 wherein the kit comprises a dosage card.

6. The kit of claim 3 wherein the active agent is selected from the group consisting of famciclovir, pregabalin, sevelamer, nelfinavir, indinavir, pramipexole, metaxalone, trientine, thioridazine, rifaximin, alprazolam, carbidopa, levodopa, erythromycin ethylsuccinate, phenyloin, acamprosate, praziquantel, molindone, levocarnitine, dichlorphenamide, posaconazole, promethazine, delavirdine, sildenafil and mixtures thereof.

7. The kit of claim 6 wherein the active agent is famciclovir.

8. A method of administering an active agent 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 the active agent, wherein the dosage form comprises an immediate release component and a delayed release component;

(B) administering to the patient about 12 to about 20 hours after 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.

9. A kit for presenting a course of drug treatment to a patient comprising:

(A) at least one first daily dose of a first active agent comprising at least one dosage form comprising an immediate release component and a delayed release component;

(B) at least one second daily dose of a first active agent comprising at least one immediate release dosage form;

(C) at least one first daily dose of a second active agent;

wherein, upon administration to said patient of the first daily dose at Time 0 and the second daily dose at a time about 12 to about 20 hours after Time 0, the pharmacokinetic profile of said first active agent in the blood of the patient over a 24-hour period mimics that of administration of the first active agent to the patient three times a day, and wherein the kit.

10. The kit of claim 9, wherein

A) said at least one first daily dose of the first active agent and said at least one first daily dose of a second active agent are presented within a single dose;

or

B) said at least one second daily dose of the first active agent and said at least one first daily dose of a second active agent are presented within a single dose;

or

C) a combination thereof.

11. The kit of claim 10, wherein said at least one first daily dose of the first active agent and said at least one first daily dose of a second active agent are presented within a single dose and wherein further:

A) said at least one first daily dose of a second active agent is presented within the immediate release component;

or

B) said at least one first daily dose of a second active agent is presented within the delayed release component;

or

C) a combination thereof.

12. The kit of claim 9, wherein the first active agent causes a side effect amenable to treatment with the second active agent.

13. The kit of claim 9, wherein the first active agent is an opiate, and the second active agent is a stimulant or a laxative.

14. The kit of claim 13, wherein the laxative is present in

A) the immediate release component of said at least one first daily dose;

or

B) the at least one second daily dose;

or

C) a combination thereof.

15. The kit of claim 13, wherein the stimulant is present in the delayed release component of said at least one first daily dose.