公开(公告)号：US20080053437A1

公开(公告)日：2008-03-06

申请号：US11934643

申请日：2007-11-02

申请人： Solomon Steiner ,  Robert Feldstein ,  Per Fog ,  Trent Poole

发明人： Solomon Steiner ,  Robert Feldstein ,  Per Fog ,  Trent Poole

IPC分类号： A61M15/00

CPC分类号： A61M15/003 ,  A61M13/00 ,  A61M15/002 ,  A61M15/0021 ,  A61M15/0023 ,  A61M15/0025 ,  A61M15/0028 ,  A61M15/0043 ,  A61M16/0495 ,  A61M16/0825 ,  A61M2202/064 ,  A61M2205/43 ,  F16L37/252

摘要： Described is a dry powder inhaler comprising an intake section; a mixing section, and a mouthpiece. The mouthpiece is connected by a swivel joint to the mixing section, and may swivel back onto the intake section and be enclosed by a cover. The intake chamber comprises a special piston with a tapered piston rod and spring, and one or more bleed-through orifices to modulate the flow of air through the device. The intake chamber further optionally comprises a feedback module to generate a tone indicating to the user when the proper rate of airflow has been achieved. The mixing section holds a capsule with holes containing a dry powder medicament, and the cover only can open when the mouthpiece is at a certain angle to the intake section. The mixing section further opens and closes the capsule when the intake section is at a certain angle to the mouthpiece. The mixing section is a Venturi chamber configured by protrusions or spirals to impart a cyclonic flow to air passing through the mixing chamber. The mouthpiece includes a tongue depressor, and a protrusion to contact the lips of the user to tell the user that the DPI is in the correct position. An optional storage section, with a cover, holds additional capsules. The cover for the mouthpiece, and the cover for the storage section may both be transparent, magnifying lenses. The capsules may be two-part capsules where each portion has apertures which correspond to apertures in the other half when each half is partially fitted to the other half, and fully fitted to the other half. All the apertures may be closed when the two halves are rotated around their longitudinal axes with respect to each other. Each capsule may have a unique key on each half that only fits with a particular inhaler.

摘要翻译： 描述了一种干粉吸入器，其包括进气段; 混合部分和喉舌。 接口通过旋转接头连接到混合部分，并且可以旋转回到进气部分并被盖封闭。 进气室包括具有锥形活塞杆和弹簧的特殊活塞，以及一个或多个渗流孔口，用于调节通过该装置的空气流。 进气室还可选地包括反馈模块，以产生当达到适当的气流速率时向用户指示的音调。 混合部分容纳具有含有干粉药物的孔的胶囊，并且仅当吸嘴与进气部分成一定角度时，盖子才能打开。 当进气部分与嘴件成一定角度时，混合部分进一步打开和关闭胶囊。 混合部分是由突起或螺旋构成的文丘里室，以使气流通过混合室。 接口管包括舌形按压器和用于接触用户嘴唇的突起，以告诉用户DPI处于正确的位置。 带有盖子的可选存储部分可容纳另外的胶囊。 用于接口管的盖和用于存储部的盖可以都是透明的放大镜。 胶囊可以是两部分胶囊，其中每个部分具有对应于另一半中的孔的孔，当每个半部分部分地配合到另一半时，并且完全配合到另一半。 当两个半部相对于彼此的纵向轴线旋转时，所有的孔可以被关闭。 每个胶囊可以在每一半上具有仅与特定吸入器配合的唯一键。

公开(公告)号：US20080041372A1

公开(公告)日：2008-02-21

申请号：US11539082

申请日：2006-10-05

申请人： Trent Poole ,  Solomon Steiner

发明人： Trent Poole ,  Solomon Steiner

IPC分类号： A61M15/00

CPC分类号： A61M15/0093 ,  A61K9/14 ,  A61M15/0021 ,  A61M15/0025 ,  A61M15/0028 ,  A61M15/06 ,  A61M2202/064 ,  A61M2205/12 ,  A61M2206/16

摘要： An inhaler is instantly activated upon its removal from a cover or cover unit, and by rotating a cartridge component of the inhaler with respect to a mouthpiece portion, so as to create a flow pathway for ambient air and particles. The cartridge component includes a chamber, whose contents typically include dry powders or the like. Upon creation of the flow pathway, the contents of the chamber are instantly accessible for immediate inhalation by a user through the mouthpiece portion.

摘要翻译： 吸入器在从盖或盖单元移除时立即被激活，并且通过相对于接口部旋转吸入器的盒部件，以便为环境空气和颗粒产生流动通道。 墨盒组件包括一个室，其内容物通常包括干粉或类似物。 在产生流动路径时，腔室的内容物立即可以通过使用者通过接口部分立即吸入。

公开(公告)号：US20050188988A1

公开(公告)日：2005-09-01

申请号：US11118853

申请日：2005-04-29

申请人： Trent Poole ,  Solomon Steiner

发明人： Trent Poole ,  Solomon Steiner

IPC分类号： A61M15/00 ,  A61M15/06 ,  B67D7/78 ,  B05D7/14 ,  A61M16/00

CPC分类号： A61M15/0093 ,  A61K9/14 ,  A61M15/0021 ,  A61M15/0025 ,  A61M15/0028 ,  A61M15/06 ,  A61M2202/064 ,  A61M2205/12 ,  A61M2206/16

摘要： An inhaler is instantly activated upon its removal from a cover or cover unit, and by rotating a cartridge component of the inhaler with respect to a mouthpiece portion, so as to create a flow pathway for ambient air and particles. The cartridge component includes a chamber, whose contents typically include dry powders or the like. Upon creation of the flow pathway, the contents of the chamber are instantly accessible for immediate inhalation by a user through the mouthpiece portion.

摘要翻译： 吸入器在从盖或盖单元移除时立即被激活，并且通过相对于接口部旋转吸入器的盒部件，以便为环境空气和颗粒产生流动通道。 墨盒组件包括一个室，其内容物通常包括干粉或类似物。 在产生流动路径时，腔室的内容物立即可以通过使用者通过接口部分立即吸入。

公开(公告)号：US20080047550A2

公开(公告)日：2008-02-28

申请号：US11037737

申请日：2005-01-18

申请人： Solomon Steiner ,  Craig Brown ,  Roderike Pohl ,  Trent Poole ,  Erik Steiner

发明人： Solomon Steiner ,  Craig Brown ,  Roderike Pohl ,  Trent Poole ,  Erik Steiner

IPC分类号： A61L9/04 ,  A61K9/14

CPC分类号： A61M11/00 ,  A61M15/0028 ,  A61M15/0048 ,  A61M15/0051 ,  A61M2202/064 ,  A61M2205/073 ,  A61M2205/8225

摘要： A drug delivery device that aerosolizes a dry powder formulation so that it forms a fine coating in the oral cavity and, more specifically in the sublingual region of the oral cavity is described herein. In the preferred embodiment, the device contains five main parts: (i) a compressed gas canister, (ii) a dispenser body (also referred to herein as the main housing ), (iii) a means for storing one or more doses of a drug formulation, (iv) a means for releasing a dose of the drug formulation such as a gas canister or spring piston and (v) a mouthpiece. Preferred configurations include circular, tubular, and rectangular. The means for storing the drug formulation may be configured to separately store one or more materials. In one embodiment, the means for storing the active agent is in the form of one or more drug discs, where the drug discs contain a plurality of blister packs, each storing one dose of the drug formulation. In another embodiment, the means for storing the active agent is a dosage cartridge containing a single dose of the drug formulation. In yet another embodiment, the drug formulation is stored on a ribbon containing a plurality of blister packs, each storing one dose of the drug formulation.

摘要翻译： 本文描述了使干燥粉末制剂雾化以使其在口腔中形成细小涂层并且更具体地在口腔的舌下区域中的药物递送装置。 在优选实施例中，该装置包含五个主要部分：（i）压缩气体罐，（ii）分配器主体（在本文中也称为主壳体），（iii）用于存储一个或多个剂量的 药物制剂，（iv）用于释放剂量的药物制剂如气体罐或弹簧活塞的装置，（v）口器。 优选的构造包括圆形，管状和矩形。 用于储存药物制剂的方法可以被配置成分开存储一种或多种材料。 在一个实施方案中，用于储存活性剂的装置是一种或多种药物盘的形式，其中药物盘包含多个泡罩包装，每个存储一剂药物制剂。 在另一个实施方案中，用于储存活性剂的装置是含有单剂量药物制剂的剂量筒。 在另一个实施方案中，药物制剂储存在含有多个泡罩包装的条带上，每个存在一剂药物制剂。

公开(公告)号：US20050155601A1

公开(公告)日：2005-07-21

申请号：US11037737

申请日：2005-01-18

申请人： Solomon Steiner ,  Craig Brown ,  Roderike Pohl ,  Trent Poole ,  Erik Steiner

发明人： Solomon Steiner ,  Craig Brown ,  Roderike Pohl ,  Trent Poole ,  Erik Steiner

IPC分类号： A61K9/14 ,  A61L9/04 ,  A61M11/00 ,  A61M15/00

CPC分类号： A61M11/00 ,  A61M15/0028 ,  A61M15/0048 ,  A61M15/0051 ,  A61M2202/064 ,  A61M2205/073 ,  A61M2205/8225

摘要： A drug delivery device that aerosolizes a dry powder formulation so that it forms a fine coating in the oral cavity and, more specifically, in the sublingual region of the oral cavity is described herein. In the preferred embodiment, the device contains five main parts: (i) a compressed gas canister, (ii) a dispenser body (also referred to herein as the main housing), (iii) a means for storing one or more doses of a drug formulation, (iv) a means for releasing a dose of the drug formulation such as a gas canister or spring piston and (v) a mouthpiece. Preferred configurations include circular, tubular, and rectangular. The means for storing the drug formulation may be configured to separately store one or more materials. In one embodiment, the means for storing the active agent is in the form of one or more drug discs, where the drug discs contain a plurality of blister packs, each storing one dose of the drug formulation. In another embodiment, the means for storing the active agent is a dosage cartridge containing a single dose of the drug formulation. In yet another embodiment, the drug formulation is stored on a ribbon containing a plurality of blister packs, each storing one dose of the drug formulation.

摘要翻译： 本文描述了使干燥粉末制剂气雾化以使其在口腔中，更具体地在口腔舌下区域中形成细小涂层的药物递送装置。 在优选实施例中，该装置包含五个主要部分：（i）压缩气体罐，（ii）分配器主体（在本文中也称为主壳体），（iii）用于存储一个或多个剂量的 药物制剂，（iv）用于释放剂量的药物制剂如气体罐或弹簧活塞的装置，（v）口器。 优选的构造包括圆形，管状和矩形。 用于储存药物制剂的方法可以被配置成分开存储一种或多种材料。 在一个实施方案中，用于储存活性剂的装置是一种或多种药物盘的形式，其中药物盘包含多个泡罩包装，每个存储一剂药物制剂。 在另一个实施方案中，用于储存活性剂的装置是含有单剂量药物制剂的剂量筒。 在另一个实施方案中，药物制剂储存在含有多个泡罩包装的条带上，每个存在一剂药物制剂。

公开(公告)号：US20070191757A1

公开(公告)日：2007-08-16

申请号：US11675430

申请日：2007-02-15

申请人： Solomon Steiner ,  Robert Feldstein ,  Roderike Pohl ,  David Rhodes ,  Erik Steiner

发明人： Solomon Steiner ,  Robert Feldstein ,  Roderike Pohl ,  David Rhodes ,  Erik Steiner

IPC分类号： A61N1/30

CPC分类号： A61N1/306 ,  A61M2210/0625 ,  A61M2210/0643

摘要： Methods, devices and kits for sublingual drug delivery using iontophoresis are described herein. An active agent can be administered sublingually by placing a solid oral dosage form containing the active agent in the sublingual region of a patient and applying iontophoresis for a suitable period of time. Preferably up to 4 mA of current are applied to the sublingual region. Different time ranges can be used to administer iontophoresis; preferably iontophoresis is administered for up to 2 minutes at a time. Any suitable device for administering iontophoresis to the sublingual region may be used. The preferred device is a hand-held device that contains a handle, two electrodes, one of which is located on the handle and the other of which is attached to the end of the handle, and a connection to a power source. Optionally, the device contains a timer, which can be used turn off the current at a preset time. The device can be used to administer an active agent by iontophoresis to the sublingual region of a patient, by attaching the second electrode of the device to a solid oral dosage form containing the active agent to be administered. A kit contains the device for administering iontophoresis and one or more solid oral dosage forms, preferably in the form of one or more tabs or wafers. The tabs or wafers may be completely dissolvable or edible, or may contain a non-edible and non-dissolvable component. In a preferred embodiment, the solid oral dosage form contains insulin or an analog thereof and one or more excipients, preferably EDTA and citric acid.

摘要翻译： 本文描述了使用离子电渗法进行舌下药物递送的方法，装置和试剂盒。 可以通过将含有活性剂的固体口服剂型置于患者的舌下区域中并施用离子电渗疗法适当的时间段来向舌下施用活性剂。 优选地，最多将4mA的电流施加到舌下区域。 不同的时间范围可用于管理离子电渗疗法; 优选每次一次给予离子电渗疗法达2分钟。 可以使用用于向舌下区域施用离子电渗疗法的任何合适的装置。 优选的装置是手持装置，其包括手柄，两个电极，其中一个电极位于手柄上，另一个电极连接到手柄的端部，并且连接到电源。 可选地，设备包含定时器，其可以在预设时间关闭电流。 该装置可用于通过将装置的第二电极连接到含有待施用的活性剂的固体口服剂型，通过离子电渗法向患者的舌下区域施用活性剂。 试剂盒包含用于施用离子电渗疗法的装置和一种或多种固体口服剂型，优选以一个或多个片或晶片的形式。 标签或晶片可以是完全可溶的或可食用的，或者可以包含不可食用和不可溶的组分。 在优选的实施方案中，固体口服剂型含有胰岛素或其类似物和一种或多种赋形剂，优选EDTA和柠檬酸。

公开(公告)号：US20060191375A1

公开(公告)日：2006-08-31

申请号：US11385513

申请日：2006-03-21

申请人： Robert Feldstein ,  Solomon Steiner

发明人： Robert Feldstein ,  Solomon Steiner

IPC分类号： B22F9/08

CPC分类号： A61K9/0073 ,  A61K9/1652 ,  A61K9/1658 ,  A61K9/1688 ,  A61K9/1694 ,  F26B5/065

摘要： Improved methods for forming fine particles of a material have been developed, wherein the method steps include dissolving the material in a solvent to form a dilute solution, immobilizing the dilution solution, and then removing the solvent to yield particles of the material. Methods of immobilizing the dilute solution include freezing, gelation, and chelation. In a preferred embodiment, the immobilized solvent is removed by lyophilization, i.e. reducing the ambient pressure while avoiding application of sufficient heat to power a phase transition. Essentially any material and solvent for the material can be used in the methods described herein. Proteins and peptides in an aqueous solvent are the preferred systems.

公开(公告)号：US4925673A

公开(公告)日：1990-05-15

申请号：US98027

申请日：1987-09-08

申请人： Solomon Steiner ,  Robert Rosen

发明人： Solomon Steiner ,  Robert Rosen

IPC分类号： A61K9/50 ,  A61K9/16 ,  A61K9/64 ,  A61K31/40 ,  A61K31/715 ,  A61K38/28 ,  A61K47/42

CPC分类号： A61K9/1641 ,  A61K47/48161

摘要： Methods are described for targeting the release of an active pharmacological agent in an animal by administering that agent encapsulated in proteinoid microspheres which are stable to the environment encountered from the point of introduction until they migrate to the targeted body organs, fluids or cells and are there unstable. Orally administered delivery systems for insulin, heparin and physostigmine utilize encapsulating microspheres which are predominantly of less than about 10 microns in diameter and pass readily through the gastrointestinal mucosa and which are made of an acidic proteinoid that is stable and unaffected by stomach enzymes and acid, but which releases the microencapsulated agent in pharmacologically active form in the near neutral blood stream. Basic proteinoid microspheres encapsulating a dopamine redox carrier system are administered in the weakly basic, where they are stable, and then enter the blood stream, where the encapsulated agent is similarly released.

摘要翻译： PCT No.PCT / US87 / 02025 Sec。 371日期1987年9月8日 102（e）1987年9月8日PCT PCT 1987年8月14日PCT公布。 出版物WO88 / 01213 日期为1988年2月25日。描述了用于通过施用封装在从引入点遇到的环境稳定的蛋白质微球中直至其迁移至目标身体器官的药剂来靶向动物中的活性药理学试剂的方法 ，流体或细胞，并且存在不稳定。 胰岛素，肝素和毒扁豆碱的口服给药系统使用包封微球，其主要直径小于约10微米，并且容易通过胃肠粘膜，并且其由稳定且不受胃酶和酸影响的酸性蛋白酶制成， 但是在近中性血液中释放具有药理活性形式的微胶囊化剂。 包埋多巴胺氧化还原载体体系的基本蛋白质微球体以弱碱性施用，其中它们是稳定的，然后进入血流，其中胶囊剂类似地释放。

公开(公告)号：US20080085298A1

公开(公告)日：2008-04-10

申请号：US11869724

申请日：2007-10-09

申请人： Roderike Pohl ,  Solomon Steiner

发明人： Roderike Pohl ,  Solomon Steiner

IPC分类号： A61K38/28 ,  A61K9/70 ,  A61P3/00

CPC分类号： A61K9/0056 ,  A61K9/006 ,  A61K9/06 ,  A61K9/107 ,  A61K38/28 ,  A61K47/12 ,  A61K47/183 ,  A61K2300/00

摘要： Gel, powder, suspension, emulsions or film formulations for systemic delivery of insulin with improved stability and rapid onset of action are described herein. The formulations are preferably absorbed to a mucosal surface, most preferably via buccal or sublingual administration, although rectal, vaginal, nasal or ocular administration is possible. The formulations contain insulin in combination with a chelator and dissolution agent, and optionally additional excipients. In the preferred embodiment, the formulation contains human insulin, a zinc chelator such as EDTA and a dissolution agent such as citric acid. Following administration, these formulations are rapidly absorbed into the blood stream. The formulation is preferably a polymeric gel, powder or film which adheres to the mucosal surface, thereby enhancing uptake of the incorporated drug. In the preferred embodiment, this formulation is administered sublingually, most preferably before a meal or after a meal.

摘要翻译： 本文描述了具有改善的稳定性和快速起效的胰岛素全身递送的凝胶，粉末，悬浮液，乳剂或膜制剂。 制剂优选被吸收到粘膜表面，最优选通过颊或舌下施用，尽管可以进行直肠，阴道，鼻或眼睛给药。 制剂含有与螯合剂和溶解剂以及任选的其它赋形剂组合的胰岛素。 在优选的实施方案中，制剂含有人胰岛素，锌螯合剂如EDTA和溶解剂如柠檬酸。 给药后，这些制剂被快速吸收到血液中。 制剂优选是粘附到粘膜表面的聚合物凝胶，粉末或膜，从而增强所掺入的药物的摄取。 在优选的实施方案中，该制剂是舌下给药，最优选在饭前或​​饭后服用的。

公开(公告)号：US20080038358A1

公开(公告)日：2008-02-14

申请号：US11842863

申请日：2007-08-21

申请人： Solomon Steiner ,  Bryan Wilson

发明人： Solomon Steiner ,  Bryan Wilson

IPC分类号： A61K9/14 ,  A61K31/55 ,  A61M31/00 ,  A61P27/00

CPC分类号： A61K31/4402 ,  A61K9/0043 ,  A61K9/145 ,  A61K9/146 ,  A61K9/1617 ,  A61K9/1629 ,  A61K9/19 ,  A61K31/55

摘要： Dry powder formulations of drugs such as antihistamine for nasal administration are provided where the drug is retained in the nasal cavity, and systemic side effects minimized or eliminated, through the selection of a narrow particle size range, between approximately 10 and 20 microns in diameter. In a preferred embodiment wherein the drug is an antihistamine, retention of the antihistamine at the nasal mucosa is improved and the bitter aftertaste associated with liquid antihistamine formulations significantly reduced. By making a dry powder formulation of an antihistamine (e.g., azelastine) having an average particle size of between 10 and 20 microns, the antihistamine is restricted primarily to the desired target organ, the nasal mucosa. Because the active ingredient stays in the nasal region, a lower dose can be used to achieve the same desired effect. As demonstrated by the examples, this lower dose reduces the incidence of somnolence, and because the active ingredient remains at the target organ and does not accumulate in the back of the throat and mouth, this formulation does not impart a bitter taste.

摘要翻译： 提供药物的干粉制剂，例如用于鼻内给药的抗组胺药物，其中药物保留在鼻腔中，通过选择直径约10至20微米之间的窄粒度范围，将全身副作用最小化或消除。 在其中药物是抗组胺剂的优选实施方案中，抗组胺剂在鼻粘膜处的保留性得到改善，并且与液体抗组胺药配方相关的苦味回味显着降低。 通过制备平均粒度为10至20微米的抗组胺药（例如氮卓斯汀）的干粉制剂，抗组织胺主要限于所需的靶器官鼻粘膜。 因为活性成分停留在鼻区域，所以可以使用较低的剂量来达到相同的期望效果。 如实施例所示，该较低剂量降低嗜睡的发生率，并且由于活性成分保留在目标器官处并且不积聚在喉部和口腔的后部，所以该制剂不赋予苦味。