Fast dissolving pharmaceutical composition

Patent metadata

Field	Value
Publication number	US-10023335-B2
Application number	US-201414571883-A
Country	US
Kind code	B2
Filing date	Dec 16, 2014
Priority date	Mar 29, 2010
Publication date	Jul 17, 2018
Grant date	Jul 17, 2018

Abstract

The subject invention is directed to a pharmaceutical composition comprising an open matrix network carrying a pharmaceutically active ingredient, wherein the open matrix network comprises levan.

First claim

The invention claimed is:

1. A pharmaceutical composition comprising:
(a) at least one matrix-forming agent that is levan to form an open matrix network comprised of water-soluble or water-dispersible matrix-forming levan having interstices dispersed throughout, wherein the levan ranges from 30% to 85% of the entire weight of the composition; and
(b) at least one pharmaceutically active ingredient carried by the open matrix network,
wherein at least 80% of the composition dissolves within 10 seconds upon contact with an aqueous solution or with saliva, and the composition is an orodispersible pharmaceutical dosage form.

2. The pharmaceutical composition according to claim 1 , further comprising one or more secondary matrix-forming agents.

3. The pharmaceutical composition according to claim 2 , wherein the one or more secondary matrix-forming agents is selected from the group consisting of trehalose, raffinose, and mannitol.

4. The pharmaceutical composition according to claim 2 , wherein the one or more secondary matrix-forming agent is mannitol.

5. The pharmaceutical composition according to claim 1 , wherein the at least one pharmaceutically active ingredient is chosen from loratidine, famotidine, montelukast sodium, and ondansetron.

6. The pharmaceutical composition according to claim 1 , wherein the composition has a tensile strength from about 0.05 to about 1.6 N/mm 2 .

7. A pharmaceutical composition prepared by a process comprising at least a step of sublimating a solvent from a liquid preparation that comprises:
(a) at least one matrix-forming agent that is levan to form an open matrix network comprised of water-soluble or water-dispersible matrix-forming levan having interstices dispersed throughout, wherein the levan ranges from 30% to 85% of the entire weight of the composition; and
(b) at least one pharmaceutically active ingredient carried by the open matrix network,
wherein at least 80% of the composition dissolves within 10 seconds upon contact with an aqueous solution or with saliva, and the composition is an orodispersible pharmaceutical dosage form.

8. The pharmaceutical composition according to claim 7 , wherein the liquid preparation further comprises one or more secondary matrix-forming agents.

9. The pharmaceutical composition according to claim 8 , wherein the one or more secondary matrix-forming agent is mannitol.

10. The pharmaceutical composition according to claim 7 , wherein the at least one pharmaceutically active ingredient is chosen from loratidine, famotidine, montelukast sodium, and ondansetron.

11. A blister pack having one or more depressions disposed therein, wherein each of the one or more depressions comprises a pharmaceutical composition, the composition comprising:
(a) at least one matrix-forming agent that is levan to form an open matrix network comprised of water-soluble or water-dispersible matrix-forming levan having interstices dispersed throughout, wherein the levan ranges from 30% to 85% of the entire weight of the composition; and
(b) at least one pharmaceutically active ingredient carried by the open matrix network,
wherein at least 80% of the composition dissolves within 10 seconds upon contact with an aqueous solution or with saliva, and the composition is an orodispersible pharmaceutical dosage form.

12. The blister pack according to claim 11 which is prepared by a process comprising steps of:
(a) introducing a liquid preparation into one or more depressions of a blister pack, the liquid preparation comprising the matrix forming agent and the pharmaceutically active ingredient; and
(b) sublimating the solvent from the liquid preparation in the one or more depressions.

13. The blister pack according to claim 11 , wherein the composition further comprises one or more secondary matrix-forming agents.

14. The blister pack according to claim 13 , wherein the one or more secondary matrix-forming agents is selected from the group consisting of trehalose, raffinose, and mannitol.

15. The blister pack according to claim 13 , wherein the one or more secondary matrix-forming agent is mannitol.

16. The blister pack according to claim 11 , wherein the at least one pharmaceutically active ingredient is chosen from loratidine, famotidine, montelukast sodium, and ondansetron.

17. The pharmaceutical composition according to claim 1 , wherein 100% of the composition dissolves within 10 seconds upon contact with an aqueous solution or with saliva within the mouth.

18. The pharmaceutical composition according to claim 7 , wherein 100% of the composition dissolves within 10 seconds upon contact with an aqueous solution or with saliva within the mouth.

19. The pharmaceutical composition according to claim 11 , wherein 100% of the composition dissolves within 10 seconds upon contact with an aqueous solution or with saliva within the mouth.

Assignees

• Ferring Bv

Inventors

• Gupta Shweta
• Ahuja Varinder
• Gunjikar Tejas
• Wannerberger Kristin

Classifications

• A61P37/08

  Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14) · CPC title

• A61P3/10

  for hyperglycaemia, e.g. antidiabetics · CPC title

• A61P13/00

  Drugs for disorders of the urinary system · CPC title

• A61P11/06

  Antiasthmatics · CPC title

• A61P1/08

  for nausea, cinetosis or vertigo; Antiemetics · CPC title