Method of therapy comprising an osmotic caplet

• US 5,869,097 A
• Filed: 11/02/1992
• Issued: 02/09/1999
• Est. Priority Date: 11/02/1992
• Status: Expired due to Term

• Current Assignee: Encinal Pharmaceutical Investments, LLC
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Wong, Patrick S.-L., Ayer, Atul D., Theeuwes, Felix, Guittard, George V.
• Primary Examiner(s): Webman, Edward J.
• Application Number:
  US07/970,519
• Time in Patent Office: 2,290 Days
• Field of Search: 424/451, 424/456, 424/469-470, 424/473
• US Class Current: 424/473
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/1635 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/4808 characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084
• CPC Class Codes: A61K 9/4816 Wall or shell material
• CPC Class Codes: A61K 9/4891 Coated capsules; Multilayered drug free capsule shells with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004

Abstract

An osmotic caplet is disclosed comprising an osmotic caplet exit for delivering a preselected dose of drug to a patient in need of therapy.

Claims

1. A method for administering 300 ng to 1200 mg of an antiviral drug to a patient, which method comprises orally administering 300 ng to 1200 mg of the drug to the patient from an osmotic caplet comprising:

(1) an oblong body;

(2) a semipermeable wall that forms the osmotic oblong body;

(3) a dose of 300 ng to 1200 mg of the drug in the osmotic caplet;

(4) a passageway for maximizing the delivery of the drug from the osmotic caplet, said passageway comprising a convex surface having a radius of curvature at least equal to the radius of the osmotic oblong caplet, the osmotic caplet administering the drug by;

(5) imbibing fluid into the osmotic caplet for hydroactivating the osmotic caplet;

thereby,

(6) administering the drug to the patient from the osmotic caplet over time.

2. The method for administering the drug to the patient according to claim 1, wherein the drug is a member selected from the group consisting of didanosine, zidovudine, zalcitabine, acyclovir, fluxuridine, ribavirin, cytarabine, vidarabine, azidouridine, ganciclovir, deoxynojirmycin, fiacitabine, fialuridine, fluorothymidine, foscarnet, dideoxycitidine, nevirapine, staviudine, dideoxyinosine, and isoprinosine.

3. The method for administering the drug to the patient according to claim 1, wherein the drug is replaced by a member selected from the group consisting of cimetidine, ranitidine, famotidine, omeprazole, nizatidine, bifentidine, erbrotidine, nifentidine, roxatidine and lansoprazole.

4. The method for administering the drug to the patient according to claim 1, wherein the drug is replaced by a member selected from the group consisting of carbidopa, levodopa, methyldopa, and selegiline.

5. The method for administering the drug to the patient according to claim 1, wherein the drug is replaced by a member selected from the group consisting of amrinone, bepridil, diltiazem, felodipine, fendilinc, flunarizine, nicardipine, isradipine, nifedipine, nimodipine, nisoldipine, nilredipine, perhexiline, amlodipine, nilvadipine, prenylamine, verapamil, cinnarizine, gallopamil, belfosdil and fostedil.

6. The method for administering the drug to the patient according to claim 1, wherein the drug is replaced by a member selected from the group consisting of quinapril, indolapril, olindapril, rentiapril, spirapril, cilazaprilat, lisinopril, imidopril, benozeprilat, cilazapril, alacepril, captopril, delapril, fosinopril, libenzapril, pentopril, perindopril, altiopril, quinaprilat, ramipril, spiraprilat, teprotide, zofenopril, enalapril, benazepril, enalaprilat, antipain, and cilastatin.

7. A method for administering 300 ng to 1200 mg of a drug to a patient, which method comprises orally administering 300 ng to 1200 mg of the drug to the patient from an osmotic caplet comprising:

(1) a wall comprising a semipermeable composition that surrounds;

(2) an oblong body;

(3) 300 ng to 1200 ng of drug in the osmotic caplet; and

,

(4) a passageway comprising means for maximizing the delivery of drug from the osmotic caplet, said passageway comprising a convex surface with a radius of curvature at least equal to the radius of the osmotic oblong caplet.

8. A method for administering 300 ng to 1200 mg of a drug to a patient, which method comprises orally administering 300 ng to 1200 mg of the drug to the patient from an osmotic caplet comprising:

(1) a wall comprising a semipermeable composition that surrounds;

(2) an oblong body;

(3) 300 ng to 1200 mg of drug in the osmotic caplet; and

,

(4) a passageway comprising means for maximizing the delivery of drug from the osmotic caplet, which passageway is characterized by an area equal to 0.1 to 0.9 of the cross-section area of the oblong body of the osmotic caplet.