Dosage form having first and second coats

• US 6,210,712 B1
• Filed: 12/04/1998
• Issued: 04/03/2001
• Est. Priority Date: 12/05/1997
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Skluzacek, Robert R., Edgren, David E.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): FUBARA, BLESSING M
• Application Number:
  US09/206,211
• Time in Patent Office: 851 Days
• Field of Search: 424/473, 424/472, 604/892
• US Class Current: 424/473
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

A dosage form comprising a composition comprising a drug surrounded by a first coat and a second coat with an exit for administering the drug to a patient; and a method of using the dosage form are disclosed for an indicated therapy.

Claims

1. An extended release dosage form comprising:

a drug composition that comprises a drug and a pharmaceutically acceptable carrier, a first coat that surrounds the drug composition, wherein the first coat comprising ethyl cellulose and hydroxyalkycellulose;

a second coat that surrounds the first coat, the second coat comprising a composition having at least one of a cellulose acylate, cellulose diacylate or cellulose triacylate wherein the composition is permeable to the passage of fluid and impermeable to the passage of drug; and

an exit passageway in the first and second coats for releasing the drug from the dosage form over an extended time.

2. The extended release dosage form according to claim 1, wherein the first coat comprises 55 to 99 wt % of ethyl cellulose and 1 to 50 wt % of the hydroxylalkylcellulose.

3. The extended release dosage form according to claim 1, wherein the hydroxyalkylcellulose is hydroxypropylcellulose.

4. The extended release dosage form according to claim 1, wherein the pharmaceutically acceptable carrier is a hydrogel.

5. The extended release dosage form according to claim 1, wherein the dosage form comprises an expandable composition comprising a hydrogel.

6. The extended release dosage form according to claim 1, wherein the pharmaceutically acceptable carrier is a hydrogel.

7. The extended release dosage form according to claim 1, wherein the exit passageway is a pore.

8. The extended release dosage form according to claim 1, wherein the drug is oxybutynin.

9. The extended release dosage form according to claim 1, wherein the pharmaceutically acceptable carrier is poly(ethylene oxide) of 50,000 daltons to 750,000 daltons molecular weight.

10. The extended release dosage form according to claim 6, wherein the dosage form comprises an expandable composition comprising a hydrogel that possesses a higher molecular weight than the pharmaceutically acceptable carrier hydrogel.

11. The extended release dosage form according to claim 1, wherein the drug is selected from the group consisting of vancomycin, phentolamine, valoxifene, cyclosporin, lisinopril, ondansetron, fluvoxamine, captopril, enalapril, amisulpride, imipramine, carbamazepine, famciclovir, clomipramine, penciclovir, pergolide, mesalazine, enitabas, talviraline, clozapine, clopidogrel, nevirapine, zidoviudine, ganciclovir alendronic, imiquimod, naratriptan, sparflozacin, lamivudine, omeprazole, acyclovir, valaceclovir, oxcarbazepine, ganciclovir, amfebutamonc, cidofovir, doxazosin, ebastine, formoterol, moexipril, penciclovir, sertraline, spirapril, fenluramine, dexfenfluramine, phentermine, fenphen, oxybutynin, felodipene, metoprolol, saquinavir, ritonavir, indinavir, and neflinavir.

12. The extended release dosage form according to claim 1, wherein the drug is present in the extended release dosage form in an amount of 0.5 mg to 750 mg.

13. A method for providing controlled delivery of a drug to a mammal over an extended time period comprising:

providing an extended release dosage form comprising a drug composition that comprises a drug and a pharmaceutically acceptable carrier, a first coat that surrounds the drug composition, wherein the first coat comprising ethyl cellulose and hydroxyalkycellulose, a second coat that surrounds the first coat, the second coat comprising a composition having at least one of a cellulose acylate, cellulose diacylate or cellulose triacylate wherein the composition is permeable to the passage of fluid and impermeable to the passage of drug, and an exit passageway in the first and second coats for releasing the drug from the dosage form over an extended time; and

administering to the mammal the extended release dosage form.