Triple combination release multi-layered tablet

• US 8,685,451 B2
• Filed: 06/18/2008
• Issued: 04/01/2014
• Est. Priority Date: 12/29/2005
• Status: Active Grant

• Current Assignee: Acella Holdings LLC
• Original Assignee: Osmotica Kereskedelmi Es Szolgaltato Kft (Osmotica Pharmaceuticals Plc)
• Inventors: Toneguzzo, Fernando G., Meyer, Glenn A., Ricci, Marcelo A., Coppari, Marcelo A., Pastini, Ana C., Fischbein, Gustavo A.
• Primary Examiner(s): Heyer, Dennis
• Application Number:
  US12/141,677
• Publication Number:
  US 20080299197A1
• Time in Patent Office: 2,113 Days
• Field of Search: None
• 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 9/209 containing drug in at least two layers or in the core and in at least one outer layer
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system

Abstract

This invention pertains to a multi-layered tablet for a triple combination release of active agents to an environment of use. More particularly, the invention pertains to a multi-layered tablet (1) comprising two external drug-containing layers (2 and 3) in stacked arrangement with respect to and on opposite sides of an oral dosage form (4) that provides a triple combination release of at least one active agent. In one embodiment of the invention the dosage form is an osmotic device. In another embodiment of the invention the dosage form is a gastro-resistant coated core. In yet another embodiment of the invention the dosage form is a matrix tablet. In a different embodiment the dosage form is a hard capsule.

Claims

1. A combination release tablet comprising:

a) a drug-containing rapid release first compressed composition comprising filler, binder, disintegrant, and at least one drug selected from the group consisting of levodopa, carbidopa, ondansetron, quetiapine and ergotamine;

b) a drug-containing extended release second compressed composition comprising filler, inorganic salt, a release rate modifier extended release polymer, and at least one drug selected from the group consisting of levodopa, alprazolam, quetiapine, divalproex and naproxen; and

c) an osmotic device comprising a drug-containing core comprising filler, binder, and at least one drug, the core being surrounded by a membrane comprising cellulose ester and plasticizer and having a preformed passageway through it;

wherein the first compressed composition and second compressed composition oppose one another, are in direct contact with, in stacked arrangement with respect to, and disposed on opposite faces or surfaces of the membrane, whereby the tablet provides three different active agent release profiles, and wherein the membrane is a semipermeable membrane, a microporous membrane, or an impermeable membrane.

2. The tablet of claim 1, wherein

(i) the preformed passageway is not plugged, or

(ii) the preformed passageway is plugged by the first or second compressed composition and initial release of drug from the core is delayed.

3. The tablet of claim 1, wherein the tablet comprises three different drugs.

4. The tablet of claim 3, wherein a drug in the first compressed composition is different than a drug in the second compressed composition.

5. The tablet of claim 4, wherein

(i) a drug in the first compressed composition is different than a drug in the drug-containing core, or

(ii) the drug in the second compressed composition is different than the drug in the drug-containing core.

6. The tablet of claim 3, wherein

(i) the drug in the first compressed composition is the same as the drug in the drug-containing core,

(ii) the first compressed composition comprises two different drugs, the core comprises the third different drug, and the second compressed composition comprises a charge of either one of the three different drugs, or

(iii) the first compressed composition comprises a charge of each of two different drugs, the core comprises a charge of the third different drug, and the second compressed composition comprises an additional charge of either one of the three different drugs.

7. The tablet of claim 3, wherein the drug in the first compressed composition is the same as the drug in the second compressed composition.

8. The tablet of claim 7, wherein

(i) the drug in the first compressed composition is the same as the drug in the drug-containing core, or

(ii) the drug in the second compressed composition is different than the drug in the drug-containing core.

9. The tablet according to claim 1, wherein

(i) the rapid release first compressed composition comprises carbidopa and optionally levodopa;

the extended release second compressed composition comprises levodopa; and

the osmotic device comprises amantadine,

(ii) the rapid release first compressed composition comprises ondansetron;

the extended release second compressed composition comprises alprazolam; and

the osmotic device comprises venlafaxine,

(iii) the rapid release first compressed composition comprises carbidopa and optionally levodopa;

the extended release second compressed composition comprises levodopa; and

the osmotic device comprises ropinirole,

(iv) the rapid release first compressed composition comprises ondansetron;

the extended release second compressed composition comprises quetiapine; and

the osmotic device comprises venlafaxine,

(v) the rapid release first compressed composition comprises quetiapine;

the extended release second compressed composition comprises divalproex sodium; and

the osmotic device comprises lithium, or

(vi) the rapid release first compressed composition comprises ergotamine;

the extended release second compressed composition comprises naproxen; and

the osmotic device comprises domperidone.

10. The tablet of claim 1, wherein the first compressed composition further comprises glidant and lubricant, and the second compressed composition further comprises glidant, lubricant and plasticizer.

11. The tablet of claim 1, wherein the first compressed composition further comprises a second filler, and the second compressed composition further comprises a second filler.

12. The tablet of claim 1, wherein the at least one drug in the core is selected from the group consisting of amantadine, venlafaxine, ropinorole, lithium and domperidone.

13. The tablet of claim 1, wherein the core further comprises osmotic agent, plasticizer, glidant and lubricant.

14. The tablet of claim 1, wherein the core further comprises second filler and second plasticizer.