СМАТНИ Чад С. (US),АДАМО Бенуа (US),ПОЛИДОРО Джон М. (US),КИНСИ П. Спенсер (US),ОВЕРФИЛД Деннис (US),САХИ Карл (US),БИЛЛИНГС Кристин (US),МАРИНО Марк Т. (US)
申请号：
RU2014133362/14
公开号：
RU2014133362A
申请日:
2011.06.21
申请国别(地区):
RU
年份:
2015
代理人:
摘要：
A method of delivering a dry powder using a dry powder inhaler with a high resistance, comprising: providing a dry powder inhaler containing a dose of dry powder, applying sufficient force to achieve a maximum inspiratory pressure of at least 2 kPa for 2 seconds and creating an area under the curve for the first second (AUC) for the inspiratory pressure versus time curve of at least about 1.0, 1.1 or 1.2 kPa · s, while issuing or releasing a dose of dry powder from inhaler in the form of powder particles. The method of claim 1, wherein the dry powder is a pulmonary delivery preparation and contains an amount of about 1 mg to about 30 mg dry powder. The method of claim 2, wherein the dry powder comprises diketopiperazine or a pharmaceutically acceptable salt of diketopiperazine. The method of claim 3, in which diketopiperazine has the formula 3,6-bis (NX-4-aminobutyl) -2,5-diketopiperazine, wherein X is selected from the group consisting of fumaryl, succinyl, maleim and glutaryl. The process of claim 3, wherein the diketopiperazine is 3,6-bis (N-fumaryl-4-aminobutyl) -2,5-diketo-diketopiperazine. The method of claim 1, wherein the dry powder preparation comprises a drug or active agent selected from the group consisting of a small organic molecule, a peptide, a polypeptide, a protein or a nucleic acid molecule. The method of claim 6, wherein the small organic molecule is a vasoactive agent, a neurotransmitter agonist, a neurotransmitter antagonist, or a steroid molecule. The method of claim 5, wherein the dry powder preparation contains microparticles of fumaryl diketopiperazine which, when released from a dry inhaler 6-bis (NX-4-aminobutyl) -2,5-diketopiperazine, wherein X is selected from the group consisting of fumaryl, succinyl, maleyl and glutaryl. The process of claim 3, wherein the diketopiperazine is 3,6-bis (N-fumaryl-4-aminobutyl) -2,5-diketo-diketopiperazine. The method of claim 1, wherein the dry powder preparation comprises a drug or active agent selecte
