Dry powder comprising levothyroxine sodium administrated via inhalator

• US 8,333,192 B2
• Filed: 11/18/2004
• Issued: 12/18/2012
• Est. Priority Date: 11/18/2004
• Status: Expired due to Fees

• Current Assignee: Uni-pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
• Original Assignee: Uni-pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
• Inventors: Tseti, Ioulia
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US11/791,100
• Publication Number:
  US 20080178870A1
• Time in Patent Office: 2,952 Days
• Field of Search: 128/203.15, 128/200.14, 128/200.12, 128/200.15, 128/200.17, 12820316-20324, 424/46, 424/489
• US Class Current: 128/203.15
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52

Abstract

A device comprising an inhaler suitable for administration of a stable dry powder blend is described, which contains a blend comprising a thyroid hormone, in particular levothyroxine sodium, and other additives such as lactose particles, sodium starch glycolate, magnesium stearate, and talc silicified.

Claims

1. A device comprising an inhaler suitable for administration of a stable dry powder blend, said device containing a blend comprising

a) levothyroxine sodium hydrate,

b) lactose particles, comprising lactose H₂O, gelatine and starch maize,

c) sodium starch glycolate,

d) magnesium stearate, and

e) talc silicified, comprising talc purified and colloidal silicon dioxide;

and wherein the dry powder comprises levothyroxine sodium in an amount 4 to 0.02 mg per 100 mg of the dry powder.

2. The device according to claim 1 wherein the dry powder comprises lactose in an amount higher than 90 mg per 100 mg of the dry powder preparation.

3. The device according to claim 1 wherein the dry powder comprises lactose particles consisting of lactose H₂O, gelatine and starch maize, wherein the ratio by weight-mg of:

“

lactose H₂O”

;

“

gelatine”

;

“

starch maize”

is 55-75;

0.20-0.80;

20-40.

4. The device according to claim 1 wherein the dry powder comprises sodium starch glycolate in an amount of 4-8 mg per 100 mg of dry powder.

5. The device according to claim 1 wherein the dry powder comprises magnesium stearatein an amount of 0.5-2 mg per 100 mg of dry powder.

6. The device according to claim 1 wherein the dry powder comprises talc silicified, in an amount of 2 mg per 100 mg of dry powder, wherein said talc silicified comprises talc purified and colloidal silicon dioxide in an amount of 0.667 mg of talc purified and 1.333 mg of colloidal silicon dioxide for 2 mg of talc silicified.

7. The device according to claim 1, wherein the blend further comprises a lake.

8. The device according to claim 1 wherein the dry powder comprises sodium starch glycolate in an amount of 5-6 mg per 100 mg of dry powder.

9. The device according to claim 1 wherein the dry powder comprises magnesium stearate in an amount of 1 mg per 100 mg of dry powder.