IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
US-0688436
(2007-03-20)
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등록번호 |
US-7465756
(2008-12-16)
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발명자
/ 주소 |
- Chaudry,Imtiaz A.
- Pham,Stephen
- Banerjee,Partha S.
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출원인 / 주소 |
- JPMorgan Chase Bank, N.A.
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대리인 / 주소 |
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인용정보 |
피인용 횟수 :
3 인용 특허 :
51 |
초록
▼
Bronchodilating compositions and methods are provided. The compositions are intended for administration as a nebulized aerosol. In certain embodiments, the compositions contain formoterol, or a derivative thereof. Methods for treatment, prevention, or amelioration of one or more symptoms of broncho
Bronchodilating compositions and methods are provided. The compositions are intended for administration as a nebulized aerosol. In certain embodiments, the compositions contain formoterol, or a derivative thereof. Methods for treatment, prevention, or amelioration of one or more symptoms of bronchoconstrictive disorders using the compositions provided herein are also provided.
대표청구항
▼
What is claimed is: 1. A sterile unit dose, comprising: (a) between about 0.1 to about 3.0 mL of a pharmaceutical composition comprising (R) formoterol or a salt thereof at a concentration of from about 0.08 μg/mL to about 43 μg/mL based on formoterol free base, in a pharmacologically sui
What is claimed is: 1. A sterile unit dose, comprising: (a) between about 0.1 to about 3.0 mL of a pharmaceutical composition comprising (R) formoterol or a salt thereof at a concentration of from about 0.08 μg/mL to about 43 μg/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a buffer having a concentration of from about 1 mM to about 50 mM, said composition having a pH of about 4.0 to about 6.0, and having an estimated shelf life of greater than about 94% after 3 months storage at 25�� C. and greater than about 96% after 3 months storage at 5�� C.; (b) packaged in a pharmaceutical packaging material. 2. A sterile unit dose, comprising: (a) between about 0.1 to about 3.0 mL of a pharmaceutical composition comprising (R) formoterol or a salt thereof at a concentration of from about 0.08 μg/mL to about 43 μg/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a buffer having a concentration of from about 1 mM to about 50 mM, said composition having a pH of about 4.0 to about 6.0, and having an estimated shelf life of greater than 90% after 3 months storage at 25�� C. and after 3 years storage at 5�� C.; (b) packaged in a pharmaceutical packaging material. 3. The sterile unit dose as in any one of claims 1 and 2 wherein said buffer is selected from the group consisting of a citric acid/phosphate buffer, acetate buffer, citrate buffer or phosphate buffer. 4. The sterile unit dose of claim 3 wherein said buffer is present at a concentration of between about 1 mM and about 20 mM. 5. The sterile unit dose as in any one of claims 1 and 2 wherein said pharmaceutical packaging material is selected from the group consisting of blister packs, bottles, tubes, inhalers, pumps, bags, vials, containers and syringes 6. The sterile unit dose of claim 5 wherein said pharmaceutical packaging material is a vial over wrapped with a laminate. 7. The sterile unit dose as in any one of claims 1 and 2, wherein said buffer has a concentration of from about 1 mM to about 20 mM. 8. The sterile unit dose as in any one of claims 1 and 2, wherein said composition has a pH of about 5. 9. The sterile unit dose of claim 7, wherein said buffer has a pH of about 5. 10. The sterile unit dose as in any one of claims 1 and 2, wherein said (R) formoterol or a salt thereof is (R) formoterol tartrate. 11. The sterile unit dose of claim 7, wherein said (R) formoterol or a salt thereof is (R) formoterol tartrate. 12. A sterile unit dose, comprising: (a) about 0.1 to about 3 mL of a pharmaceutical composition comprising (R) formoterol or a salt thereof at a concentration of from about 0.08 μg/mL to about 43 μg/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a buffer selected from the group consisting of citric acid/phosphate buffer, acetate buffer, citrate buffer or phosphate buffer at a concentration of from about 1 mM to about 50 mM, said composition having a pH of about 4.5 to about 5.5; (b) packaged in a pharmaceutical packaging material. 13. The sterile unit dose of claim 12, wherein said pharmaceutical packaging material is a vial over wrapped with a laminate. 14. The sterile unit dose of claim 12, wherein said buffer has a concentration of from about 1 mM to about 20 mM. 15. The sterile unit dose of claim 12, wherein said composition has a pH of about 5. 16. The sterile unit dose of claim 14, wherein said buffer has a pH of about 5. 17. The sterile unit dose of claim 12, wherein said (R) formoterol or a salt thereof is (R) formoterol tartrate. 18. The sterile unit dose of claim 14, wherein said (R) formoterol or a salt thereof is (R) formoterol tartate. 19. The sterile unit dose of claim 16, wherein said (R) formoterol or a salt thereof is (R) formoterol tartrate.
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