RU98116485A - DEVICE FOR ADMINISTRATION OF ACTIVE SUBSTANCES IN liquid medium and stored therein (VARIANTS) ADMINISTRATION OF ACTIVE SUBSTANCES IN liquid medium and stored therein within the set reception period ACTIVE SUBSTANCES outlet member obstructing reverse diffusion, the semipermeable plug and methods of treating patients suffering from cancer Of the prostate, by implantation, at least one of the above devices - Google Patents

DEVICE FOR ADMINISTRATION OF ACTIVE SUBSTANCES IN liquid medium and stored therein (VARIANTS) ADMINISTRATION OF ACTIVE SUBSTANCES IN liquid medium and stored therein within the set reception period ACTIVE SUBSTANCES outlet member obstructing reverse diffusion, the semipermeable plug and methods of treating patients suffering from cancer Of the prostate, by implantation, at least one of the above devices

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Publication number
RU98116485A
RU98116485A RU98116485/14A RU98116485A RU98116485A RU 98116485 A RU98116485 A RU 98116485A RU 98116485/14 A RU98116485/14 A RU 98116485/14A RU 98116485 A RU98116485 A RU 98116485A RU 98116485 A RU98116485 A RU 98116485A
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Russia
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active substance
chamber
liquid medium
introducing
leuprolide
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RU98116485/14A
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Russian (ru)
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RU2189221C2 (en
Inventor
Кейт Э. Дайон
Скот Д. Лотенбэч
Феликс Э. Лэндрау
Джуди Э. Мэгрудэ
Джон Р. Пири
Джерими К. Райт
Джеймс Б. Эккенхоф
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Элзэ Копэрейшн
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Publication of RU98116485A publication Critical patent/RU98116485A/en
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Publication of RU2189221C2 publication Critical patent/RU2189221C2/en

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1. Устройство для введения активного вещества в жидкую среду и сохранения в ней, отличающееся тем, что оно содержит полупроницаемый материал, установленный в одной торцевой части непроницаемого резервуара суплотнением относительно внутренней поверхности резервуара, с возможностью изменения своих размеров за счет набухания в воде и вытеснения активного вещества за счет изменения названных размеров.1. Device for introducing an active substance into a liquid medium and storing in it, characterized in that it contains a semi-permeable material installed in one end part of the impermeable reservoir by sealing relative to the inner surface of the reservoir, with the possibility of changing its size due to swelling in water and displacement of the active substances by changing the named sizes. 2. Устройство по п. 1, отличающееся тем, что отношение длины заглушки к ее диаметру составляет от 1:10 до 10:1. 2. The device according to p. 1, characterized in that the ratio of the length of the stub to its diameter is from 1:10 to 10: 1. 3. Устройство по п. 1, отличающееся тем, что полупроницаемый материал установлен в открытом торце устройства. 3. The device according to claim 1, characterized in that the semipermeable material is installed in the open end of the device. 4. Устройство по п. 1, отличающееся тем, что полупроницаемый материал установлен в полости резервуара. 4. The device according to p. 1, characterized in that the semi-permeable material is installed in the cavity of the tank. 5. Устройство по п. 4, отличающееся тем, что полость выполнена цилиндрической, ступенчатой, винтовой, а также с выступом посредине. 5. The device according to p. 4, characterized in that the cavity is cylindrical, stepped, screw, and also with a protrusion in the middle. 6. Устройство для введения активного вещества в жидкую среду и сохранения в ней, в частности устройство для имплантации, отличающееся тем, что оно содержит резервуар и установленный в соприкосновении с ним выпускной элемент препятствования обратной диффузии, канал для потока активного вещества образован сопряженными поверхностями резервуара и выпускного элемента препятствования обратной диффузии. 6. A device for introducing an active substance into a liquid medium and storing in it, in particular an implantation device, characterized in that it contains a reservoir and an outlet element for preventing back diffusion installed in contact with it, the channel for the flow of the active substance is formed by the mating surfaces of the reservoir and exhaust element to prevent back diffusion. 7. Устройство по п. 6, отличающееся тем, что расход активного вещества составляет 0,02-50 мкл/сутки. 7. The device according to p. 6, characterized in that the flow rate of the active substance is 0.02-50 μl / day. 8. Устройство для введения активного вещества в жидкую среду и сохранения в ней в течение назначенного периода приема активного вещества отличающееся тем, что оно содержит резервуар с активным веществом, выполненный, по меньшей мере частично, из металла, при этом находящаяся в контакте с активным веществом часть резервуара выполнена из химически инертного по отношению к активному веществу материала, а металлом, находящимся в контакте с активным веществом, является материал из группы, к которой относятся титан и его сплавы. 8. A device for introducing an active substance into a liquid medium and storing therein for a prescribed period of administration of the active substance, characterized in that it contains a reservoir with the active substance, made at least partially of metal, while in contact with the active substance part of the tank is made of a material chemically inert with respect to the active substance, and the metal in contact with the active substance is material from the group to which titanium and its alloys belong. 9. Устройство по п. 8, отличающееся тем, что титановый сплав содержит, по меньшей мере, 60% титана. 9. The device according to p. 8, characterized in that the titanium alloy contains at least 60% titanium. 10. Устройство для введения активного вещества в жидкую среду и сохранения в ней, в частности устройство для имплантации, отличающееся тем, что оно содержит непроницаемый резервуар, поршень, который расположен разделяющим резервуар на камеру, содержащую активное вещество, и камеру, содержащую набухающее в воде вещество, при этом камера, содержащая активное вещество, снабжена выпускным элементом, препятствования обратной диффузии, а камера, содержащая набухающее в воде вещество, снабжена полупроницаемой заглушкой, при этом заглушка установлена с возможностью выдавливания из резервуара при определенном внутреннем давлении, меньшем максимального осмотического давления, создаваемого набухающим в воде веществом. 10. A device for introducing an active substance into a liquid medium and storing therein, in particular an implantation device, characterized in that it contains an impermeable reservoir, a piston that separates the reservoir into a chamber containing the active substance, and a chamber containing swelling in water substance, while the chamber containing the active substance is equipped with an outlet element, preventing back diffusion, and the chamber containing the substance swelling in water is equipped with a semipermeable plug, while the plug is installed It is possible to extrude from the reservoir at a certain internal pressure less than the maximum osmotic pressure created by a substance swelling in water. 11. Устройство для введения активного вещества в жидкую среду и сохранения в ней, в частности, устройство для имплантации, отличающееся тем, что оно содержит непроницаемый резервуар, поршень, который делит резервуар на камеру, содержащую активное вещество, и камеру, содержащую набухающее в воде вещество, при этом камера, содержащая активное вещество, снабжена выпускным элементом препятствования обратной диффузии, а камера, содержащая набухающее в воде вещество, снабжена полупроницаемой заглушкой, при этом выпускной элемент установлен с возможностью выдавливания из резервуара при определенном внутреннем давлении, меньшем максимального осмотического давления, создаваемого набухающим в воде веществом. 11. A device for introducing an active substance into a liquid medium and storing in it, in particular, an implantation device, characterized in that it contains an impermeable reservoir, a piston that divides the reservoir into a chamber containing the active substance, and a chamber containing swelling in water substance, wherein the chamber containing the active substance is provided with an outlet element for preventing back diffusion, and the chamber containing the substance swelling in water is equipped with a semipermeable plug, while the outlet element is installed with the ability to extrude from the tank at a certain internal pressure less than the maximum osmotic pressure created by a substance swelling in water. 12. Устройство для введения активного вещества в жидкую среду и сохранения в ней в течение назначенного периода приема активного вещества, в частности устройство для имплантации, отличающееся тем, что период вступления устройства в действие составляет менее 10% от назначенного периода приема активного вещества. 12. A device for introducing an active substance into a liquid medium and storing in it for a designated period of administration of an active substance, in particular an implantation device, characterized in that the period of entry into operation of the device is less than 10% of the prescribed period of administration of the active substance. 13. Способ введения активного вещества в жидкую среду и сохранения в ней в течение назначенного периода приема активного вещества, отличающийся тем, что впрыскивают под давлением расплавленный материал полупроницаемой заглушки в торцевую часть непроницаемого резервуара, предохранитель полупроницаемой заглушки от повреждений. 13. A method of introducing an active substance into a liquid medium and preserving it for a prescribed period of administration of the active substance, characterized in that molten material of a semipermeable plug is injected under pressure into the end part of the impermeable reservoir, and the fuse of the semipermeable plug from damage. 14. Устройство для введения активного вещества в жидкую среду и сохранения в ней, в частности устройство для имплантации, отличающееся тем, что оно разделено на первую и вторую камеры, которые как первая, так и вторая камеры имеют открытые торцы, состав, содержащий набухающее в воде вещество, размещенное в первой камере, состав, содержащий активное вещество, размещенный во второй камере, полупроницаемую заглушку, расположенную в открытом торце первой камеры, выпускной элемент, препятствующий обратной диффузии, расположенный в открытом торце второй камеры, при этом устройство выполнено с возможностью обеспечения герметичности камеры для активного вещества и ее изоляции от окружающей среды применения. 14. A device for introducing an active substance into a liquid medium and storing in it, in particular an implantation device, characterized in that it is divided into first and second chambers, which both the first and second chambers have open ends, the composition containing swellable water, a substance placed in the first chamber, a composition containing the active substance located in the second chamber, a semipermeable plug located in the open end of the first chamber, an outlet element preventing the back diffusion located in the open end the second chamber, wherein the device is adapted to ensure sealing chamber for the active substance and its isolation from the surrounding environment of use. 15. Выпускной элемент препятствования обратной диффузии для применения в устройстве введения активного вещества в жидкую среду, отличающийся тем, что он образован каналом, имеющим длину, форму и площадь поперечного сечения, при которых средняя линейная скорость выходящего из устройства активного вещества превышает линейный поток жидкости из окружающей среды применения, стремящейся проникнуть внутрь устройства. 15. An outlet element for preventing back diffusion for use in a device for introducing an active substance into a liquid medium, characterized in that it is formed by a channel having a length, shape and cross-sectional area at which the average linear velocity of the active substance exiting the device exceeds the linear liquid flow from application environment tending to penetrate the device. 16. Выпускной элемент по п. 15, отличающийся тем, что канал выполнен винтовым. 16. The exhaust element according to p. 15, characterized in that the channel is made screw. 17. Полупроницаемая заглушка для применения в устройстве введения активного вещества в жидкую среду, отличающаяся тем, что заглушка способна к набуханию в воде и при впитывании воды к линейному расширению в упомянутом устройстве с возможностью инициирования процесса вытеснения активного вещества после помещения устройства в жидкую окружающую среду. 17. A semi-permeable plug for use in a device for introducing an active substance into a liquid medium, characterized in that the plug is capable of swelling in water and, upon absorption of water, expands linearly in said device with the possibility of initiating the process of displacing the active substance after placing the device in a liquid environment. 18. Устройство по пп. 1 - 13, отличающееся тем, что полупроницаемый материал, выбирают из группы, в которую входят материалы из пластифицированной целлюлозы, полиуретаны и полиамиды. 18. The device according to paragraphs. 1 to 13, characterized in that the semi-permeable material is selected from the group consisting of plasticized cellulose materials, polyurethanes and polyamides. 19. Устройство по пп. 1, 6, 8 или 14, отличающееся тем, что активное вещество относится к группе, в которую входят белки, пептиды, или вещества для генной терапии. 19. The device according to paragraphs. 1, 6, 8 or 14, characterized in that the active substance belongs to the group which includes proteins, peptides, or substances for gene therapy. 20. Устройство по п. 19, отличающееся тем, что активным веществом является агонист или антагонист лютеинизирующего гормона высвобождающего гормона. 20. The device according to p. 19, characterized in that the active substance is an agonist or antagonist of the luteinizing hormone releasing hormone. 21. Устройство по п. 19, отличающееся тем, что активным веществом является лейпролид. 21. The device according to p. 19, characterized in that the active substance is leuprolide. 22. Устройство по п. 19, отличающееся тем, что активное вещество выбирают из группы, в которую входят фактор VIII и фактор IХ. 22. The device according to p. 19, characterized in that the active substance is selected from the group consisting of factor VIII and factor IX. 23. Устройство по п. 1, 6 или 8, отличающееся тем, что активное вещество вводится в область, расположенную на удалении от устройства. 23. The device according to p. 1, 6 or 8, characterized in that the active substance is introduced into the area located at a distance from the device. 24. Устройство для введения активного вещества в жидкую среду и сохранения в ней, в частности устройство для введения лейпролида посредством инструмента для имплантации, отличающееся тем, что оно содержит непроницаемый резервуар, поршень, разделяющий устройство на первую и вторую камеры, причем как первая, так и вторая камеры имеют открытые торцы, состав, содержащий набухающее в воде вещество, размещенный в первой камере, состав, содержащий лейпролид, размещенный во второй камере, полупроницаемую заглушку, установленную в открытом торце первой камеры, выпускной элемент, препятствования обратной диффузии, установленный в открытом торце второй камеры, при этом вторая камера выполнена герметичной, а состав содержащий лейпролид расположен изолированным от окружающей среды применения. 24. A device for introducing an active substance into a liquid medium and storing therein, in particular a device for introducing leuprolide by means of an implantation tool, characterized in that it contains an impermeable reservoir, a piston separating the device into the first and second chambers, both the first and the second and the second chamber have open ends, a composition containing water swellable substance placed in the first chamber, a composition containing leuprolide placed in the second chamber, a semi-permeable plug installed in the open end p rvoy chamber outlet member, preventing back diffusion mounted in the open end of the second chamber, the second chamber is sealed, and the composition containing the leuprolide is isolated from the environment of application. 25. Устройство по п. 24, отличающееся тем, что резервуар выполнен из титана или титанового сплава. 25. The device according to p. 24, characterized in that the reservoir is made of titanium or titanium alloy. 26. Устройство по п. 24, отличающееся тем, что поршень выполнен из эластомера с фирменным наименованием C-Flex® ТРЕ.26. The device according to p. 24, characterized in that the piston is made of elastomer with the trade name C-Flex ® TPE. 27. Устройство по п. 24, отличающееся тем, что в состав, содержащий набухающее в воде вещество, входит, по меньшей мере, около 64 мг хлористого натрия. 27. The device according to p. 24, characterized in that the composition containing water-swellable substance includes at least about 64 mg of sodium chloride. 28. Устройство по п. 24, отличающееся тем, что состав набухающего в воде вещества содержит хлористый натрий, гелеобразующий осмополимер и добавки, способствующие гранулированию и обработке. 28. The device according to p. 24, characterized in that the composition of the swelling substance in water contains sodium chloride, a gelling osmopolymer and additives that contribute to granulation and processing. 29. Устройство по п. 24, отличающееся тем, что в первой камере дополнительно содержится добавка. 29. The device according to p. 24, characterized in that the first chamber additionally contains an additive. 30. Устройство по п. 29, отличающееся тем, что добавкой является полиэтиленгликоль 400. 30. The device according to p. 29, characterized in that the additive is polyethylene glycol 400. 31. Устройство по п. 24, отличающееся тем, что составом, содержащим лейпролид, является ацетат лейпролида, растворенный в диметилсульфоксиде в такой пропорции, чтобы содержание лейпролида составляло 37%. 31. The device according to p. 24, characterized in that the composition containing leuprolide is leuprolide acetate dissolved in dimethyl sulfoxide in such a proportion that the leuprolide content is 37%. 32. Устройство по п. 24, отличающееся тем, что оно содержит 65 мг лейпролида. 32. The device according to p. 24, characterized in that it contains 65 mg of leuprolide. 33. Устройство по п. 24, отличающееся тем, что полупроницаемая заглушка выполнена из полиуретана с водопоглощением 20%. 33. The device according to p. 24, characterized in that the semipermeable plug is made of polyurethane with a water absorption of 20%. 34. Устройство по п. 24, отличающееся тем, что выпускной элемент, препятствующий обратной диффузии, выполнен из полиэтилена и имеет винтовой канал диаметром 0,076-0,51 мм и длиной 2-7 см. 34. The device according to p. 24, characterized in that the exhaust element that prevents reverse diffusion is made of polyethylene and has a helical channel with a diameter of 0.076-0.51 mm and a length of 2-7 cm. 35. Устройство по п. 24, отличающееся тем, что оно выполнено с возможностью введения 0,35 мкл состава, содержащего лейпролид, в сутки. 35. The device according to p. 24, characterized in that it is made with the possibility of introducing 0.35 μl of the composition containing leuprolide per day. 36. Устройство по п. 35, отличающееся тем, что оно выполнено с возможностью непрерывного введения состава, содержащего лейпролид, в течение около одного года. 36. The device according to p. 35, characterized in that it is made with the possibility of continuous administration of a composition containing leuprolide for about one year. 37. Устройство по п. 24, отличающееся тем, что оно выполнено с возможностью достижения на 14-е сутки после имплантации расхода содержащего активное вещество состава уровня как минимум 70% от установившегося расхода. 37. The device according to p. 24, characterized in that it is made with the possibility of reaching on the 14th day after implantation the flow rate containing the active substance at least 70% of the steady-state flow rate. 38. Устройство по п. 24, отличающееся тем, что оно обеспечивает введение 150 мкг лейпролида в сутки. 38. The device according to p. 24, characterized in that it provides the introduction of 150 μg of leuprolide per day. 39. Способ лечения пациента, страдающего раком предстательной железы, путем имплантации, по меньшей мере, одного устройства по п. 24. 39. A method of treating a patient suffering from prostate cancer by implanting at least one device according to claim 24. 40. Устройство для введения активного вещества в жидкую среду и сохранения в ней, в частности устройство для введения уксуснокислого лейпролида посредством инструмента для имплантации, отличающееся тем, что оно содержит резервуар из титанового сплава, поршень, выполненный из эластомера с фирменным наименованием C-Flex® ТРЕ и расположенный разделяющим резервуар на первую и вторую камеры, которые как первая, так и вторая камеры имеют открытые торцы, уплотненный осмотический вытеснитель на основе хлористого натрия с полиэтиленгликолевой добавкой, помещенный в первую камеру, 65 мг лейпролида в виде раствора ацетата лейпролида в диметилсульфоксиде, помещенного во вторую камеру, полупроницаемую заглушку из полиуретана с водопоглощением 20%, установленную в открытом торце первой камеры, выпускной полиэтиленовый элемент препятствования обратной диффузии, имеющий винтовой канал и установленный в открытом торце второй камеры, при этом устройство выполнено с возможностью обеспечения непрерывного введения 150 мкг ацетата лейпролида в сутки на протяжении примерно одного года после подкожной имплантации.40. A device for introducing an active substance into a liquid medium and storing therein, in particular a device for introducing leuprolide acetic acid through an implantation tool, characterized in that it contains a titanium alloy reservoir, a piston made of an elastomer with the trade name C-Flex ® TPE and located dividing the tank into the first and second chambers, which both the first and second chambers have open ends, a sealed osmotic displacer based on sodium chloride with polyethylene glycol add avka placed in the first chamber, 65 mg of leuprolide in the form of a solution of leuprolide acetate in dimethyl sulfoxide, placed in the second chamber, a semipermeable plug made of polyurethane with water absorption of 20%, installed in the open end of the first chamber, an outlet polyethylene back diffusion preventing element having a helical channel and installed in the open end of the second chamber, the device is configured to provide continuous administration of 150 μg of leuprolide acetate per day for about one year after odkozhnoy implantation.
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