RU97106511A - PHARMACEUTICAL AEROSOL COMPOSITION, METHOD FOR PRODUCING SUCH COMPOSITION, METHOD FOR TREATING RESPIRATORY DISEASES, SURFACE ACTIVE SUBSTANCE FOR SUCH COMPOSITIONS AND METHOD FOR ITS - Google Patents

PHARMACEUTICAL AEROSOL COMPOSITION, METHOD FOR PRODUCING SUCH COMPOSITION, METHOD FOR TREATING RESPIRATORY DISEASES, SURFACE ACTIVE SUBSTANCE FOR SUCH COMPOSITIONS AND METHOD FOR ITS

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RU97106511A
RU97106511A RU97106511/14A RU97106511A RU97106511A RU 97106511 A RU97106511 A RU 97106511A RU 97106511/14 A RU97106511/14 A RU 97106511/14A RU 97106511 A RU97106511 A RU 97106511A RU 97106511 A RU97106511 A RU 97106511A
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composition according
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hydrogen
integer
composition
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RU2157188C2 (en
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Ли Ли-Бове
Кейт Артур Джонсон
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Глаксо Вэллкам Инк.
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1. Фармацевтическая аэрозольная композиция, содержащая порошкообразный медикамент, фторуглеродный или водородсодержащий хлорфторуглеродный пропеллент и поверхностно-активное вещество (ПАВ) общей формулы (Ia) или (Ib)
Figure 00000001

или
Figure 00000002

в которых R1 обозначает: RF-(CH2)a-(CH=CH)b-(CH2)c-(CH=CH)d-(CH2)e-A-;
RF-(CH2)f-OCH2CH(CH2OH)CH2-A-; RF-(CH2)g-OCH2CH(CH2OH)-A-; в которых -A: -O-, -C(O)O-, -R6(R7)N+-, (где каждый из R6 и R7 - C1-C4 алкил, или гидроксиэтил), -(CH2)t-(где t=0 или 1), или -C(O)N(R9)-(CH2)q-B (где q - целое число от 0 до 12, B - -O-, или -C(O)-, и R9 - водород, или R6), и где сумма a+c+e=0-17, сумма b+d=0-12, а каждый из f и g равен 1-12; RF-(CH2-CH2-O)h-; RF-(CH(CH3)CH2O)h-; RF-(-CH2-CH2-S)h-; где h равно 1-12 и где RF - фторсодержащая часть одной из следующих структур:
(a) F(CF2)i-, где i равно 1-18,
(b) (CF3)2CF(CF2)j-, где j равно 0-8,
(с) RF1(CF2CF(CF3))k-, где k равно 1-4, а RF1 - CF3-, C2F5-, или (CF3)2CF-,
(d) RF2(RF3)CFO(CF2CF2)I, где I равно 1-6 и где каждый из RF2 и RF3 либо независимо CF3-, C2F5-, н-C3F7- или CF3CF2CF(CF3)-, либо вместе взятые RF2 и RF3 обозначают -(CF2)4- или (CF2)5-, или
(е) одну из структур от (а) до (d), в которой один или несколько атомов фтора заменены одним или несколькими атомами водорода или брома и/или по меньшей мере двумя атомами хлора при условиях, что по меньшей мере 50% атомов связанных с углеродным скелетом RF представляют собой атомы фтора и что RF содержит по меньшей мере 4 атома фтора,
r=0, или 1;
R2 обозначает R1, водород или группу OR, где R - насыщенный или ненасыщенный C1-C20алкил, или C3-C20ацил, причем при r=1 R1 и R2 могут менять свои позиции; и каждый из X или Y независимо обозначают: гидроксил; -OCH2CH(OH)CH2OH; -O(CH2CH2O)tR3, где t - целое число от 1 до 5, а R3 - атом водорода, или C1-C4алкил; -NR4R5, или N+R4R5R8, где каждое из R4, R5 и R8 либо независимо обозначают атом водорода, C1-C4алкил или -CH2CH2O(CH2CH2O)sR3, где s - число от 1 до 5, либо вместе взятые R4 и R5 обозначают -(CH2)q, где q - целое число от 2 до 5, либо R4 и R5 образуют с атомом азота морфолиновую группу; -O(CH2)pZ, где Z - группа 2-аминоуксусной кислоты, -NR4R5, или -N+R4R5R8, где R8 определено выше для R4 и R5, а p - целое число от 1 до 5; при условии, что X и Y оба не являются гидроксилом или ионизированной формой производного гидроксила.1. A pharmaceutical aerosol composition containing a powdered medicament, a fluorocarbon or hydrogen-containing chlorofluorocarbon propellant, and a surfactant of the general formula (Ia) or (Ib)
Figure 00000001

or
Figure 00000002

in which R 1 means: R F - (CH 2 ) a - (CH = CH) b - (CH 2 ) c - (CH = CH) d - (CH 2 ) e -A-;
R F - (CH 2 ) f -OCH 2 CH (CH 2 OH) CH 2 -A-; R F - (CH 2 ) g -OCH 2 CH (CH 2 OH) -A-; in which -A: -O-, -C (O) O-, -R 6 (R 7 ) N + -, (where each of R 6 and R 7 is C 1 -C 4 alkyl, or hydroxyethyl), - (CH 2 ) t - (where t = 0 or 1), or -C (O) N (R 9 ) - (CH 2 ) q -B (where q is an integer from 0 to 12, B is -O- , or -C (O) -, and R 9 is hydrogen, or R 6 ), and where the sum a + c + e = 0-17, the sum b + d = 0-12, and each of f and g is 1 -12; R F - (CH 2 —CH 2 —O) h -; R F - (CH (CH 3 ) CH 2 O) h -; R F - (- CH 2 -CH 2 -S) h -; where h is 1-12 and where R F is a fluorine-containing part of one of the following structures:
(a) F (CF 2 ) i -, where i is 1-18,
(b) (CF 3 ) 2 CF (CF 2 ) j -, where j is 0-8,
(c) R F 1 (CF 2 CF (CF 3 )) k -, where k is 1-4 and R F 1 - CF 3 -, C 2 F 5 -, or (CF 3 ) 2 CF-,
(d) R F 2 (R F 3) CFO (CF 2 CF 2 ) I , where I is 1-6 and where each of R F 2 and R F 3 is either independently CF 3 -, C 2 F 5 -, n —C 3 F 7 - or CF 3 CF 2 CF (CF 3 ) -, or, taken together, R F 2 and R F 3 are - (CF 2 ) 4 - or (CF 2 ) 5 -, or
(e) one of the structures (a) to (d), in which one or more fluorine atoms are replaced by one or more hydrogen or bromine atoms and / or at least two chlorine atoms under the conditions that at least 50% of the atoms are bound with a carbon skeleton, R F are fluorine atoms and that R F contains at least 4 fluorine atoms,
r is 0 or 1;
R 2 is R 1 , hydrogen or an OR group, where R is saturated or unsaturated C 1 -C 20 alkyl, or C 3 -C 20 acyl, with r = 1 R 1 and R 2 can change their positions; and each of X or Y is independently: hydroxyl; -OCH 2 CH (OH) CH 2 OH; —O (CH 2 CH 2 O) t R 3 , where t is an integer from 1 to 5, and R 3 is a hydrogen atom, or C 1 -C 4 alkyl; —NR 4 R 5 , or N + R 4 R 5 R 8 , where each of R 4 , R 5, and R 8 either independently represent a hydrogen atom, C 1 -C 4 alkyl, or —CH 2 CH 2 O (CH 2 CH 2 O) s R 3 , where s is a number from 1 to 5, or together R 4 and R 5 denote - (CH 2 ) q , where q is an integer from 2 to 5, or R 4 and R 5 form with nitrogen atom morpholine group; —O (CH 2 ) p Z, where Z is a 2-aminoacetic acid group, —NR 4 R 5 , or —N + R 4 R 5 R 8 , where R 8 is as defined above for R 4 and R 5 , and p is an integer from 1 to 5; with the proviso that X and Y are both not hydroxyl or an ionized form of a hydroxyl derivative. 2. Фармацевтическая аэрозольная композиция, содержащая порошкообразный медикамент, фторуглеродный или водородсодержащий хлорфторуглеродный пропеллент и ПАВ общей формулы I
Figure 00000003

в которой n - целое число от 1 до 18;
m - целое число от 0 до 17;
R1, R2 и R3 каждый независимо - водород или С1-4алкил.2. A pharmaceutical aerosol composition containing a powdered medicament, a fluorocarbon or hydrogen-containing chlorofluorocarbon propellant and a surfactant of the general formula I
Figure 00000003

in which n is an integer from 1 to 18;
m is an integer from 0 to 17;
R 1 , R 2 and R 3 are each independently hydrogen or C 1-4 alkyl. 3. Композиция по п. 2, отличающаяся тем, что каждый R1, R2, R3 - метил.3. The composition according to p. 2, characterized in that each R 1 , R 2 , R 3 is methyl. 4. Композиция по п. 2 или 3, отличающаяся тем, что n - целое число от 4 до 8. 4. The composition according to p. 2 or 3, characterized in that n is an integer from 4 to 8. 5. Композиция по п. 4, отличающаяся тем, что n равно 4 или 6. 5. The composition according to p. 4, characterized in that n is 4 or 6. 6. Композиция по пп. 2-5, отличающаяся тем, что m - целое число от 4 до 10. 6. The composition according to paragraphs. 2-5, characterized in that m is an integer from 4 to 10. 7. Композиция по п. 6, отличающаяся тем, что m равно 4, 6, или 10. 7. The composition according to p. 6, characterized in that m is 4, 6, or 10. 8. Композиция по любому из пп. 1-7, отличающаяся тем, что ПАВ присутствует в количестве от 0,05 до 15% от массы медикамента. 8. The composition according to any one of paragraphs. 1-7, characterized in that the surfactant is present in an amount of from 0.05 to 15% by weight of the drug. 9. Композиция по п. 8, отличающаяся тем, что ПАВ присутствует в количестве от 0,5 до 10% от массы медикамента. 9. The composition according to p. 8, characterized in that the surfactant is present in an amount of from 0.5 to 10% by weight of the drug. 10. Композиция по любому из пп. 1-9, отличающаяся тем, что частицы медикамента имеют размеры в интервале 1-10 мкм. 10. The composition according to any one of paragraphs. 1-9, characterized in that the particles of the drug have sizes in the range of 1-10 microns. 11. Композиция по любому из пп. 1-10, отличающаяся тем, что медикамент присутствует в количестве от 0,01 до 1% от ее общей массы. 11. The composition according to any one of paragraphs. 1-10, characterized in that the medication is present in an amount of from 0.01 to 1% of its total mass. 12. Композиция по любому из пп. 1-11, отличающаяся тем, что порошкообразный медикамент выбран из группы, состоящей из хромогликата, салбутамола, салметерола, тербуталина, репротерола, эфира беклометазона, эфира флутиказона и (-)-4-амино-3,5-дихлоро-α-[[[6-[2-(2-пиридинил)этокси]гексил]амино]метил]бензолометанола. 12. The composition according to any one of paragraphs. 1-11, characterized in that the powder medication is selected from the group consisting of chromoglycate, salbutamol, salmeterol, terbutaline, reproterol, beclomethasone ether, fluticasone ether and (-) - 4-amino-3,5-dichloro-α - [[ [6- [2- (2-pyridinyl) ethoxy] hexyl] amino] methyl] benzene methanol. 13. Композиция по п. 12, отличающаяся тем, что порошкообразный медикамент выбран из группы, состоящей из ксинафоата салметерола, салбутамола, пропионата флутиказона, дипропионата беклометазона и их физиологически приемлемых солей и сольватов. 13. The composition according to p. 12, characterized in that the powdered medication is selected from the group consisting of salmeterol xinafoate, salbutamol, fluticasone propionate, beclomethasone dipropionate and their physiologically acceptable salts and solvates. 14. Композиция по любому из пп. 2-13, отличающаяся тем, что она содержит: (а) эффективное количество порошкообразного бронхорасширяющего медикамента, (б) эффективное количество порошкообразного противовоспалительного средства, (в) фторуглеродный или водородсодержащий хлорфторуглеродный пропеллент и (в) ПАВ общей формулы (1). 14. The composition according to any one of paragraphs. 2-13, characterized in that it contains: (a) an effective amount of a powdered bronchodilator medication, (b) an effective amount of a powdered anti-inflammatory agent, (c) a fluorocarbon or hydrogen-containing chlorofluorocarbon propellant, and (c) a surfactant of the general formula (1). 15. Композиция по любому из пп. 1-14, отличающаяся тем, что указанный пропеллент содержит С1-4водородсодержащий фторуглерод.15. The composition according to any one of paragraphs. 1-14, characterized in that said propellant contains C 1-4 hydrogen-containing fluorocarbon. 16. Композиция по п. 15, отличающаяся тем, что указанный пропеллент выбран из 1,1,1,2-тетрафторэтана(CF3CH2F) и 1,1,1,2,3,3,3-гептафтор-н-пропана(СF3СНFСF3).16. The composition of claim 15, wherein said propellant is selected from 1,1,1,2-tetrafluoroethane (CF 3 CH 2 F) and 1,1,1,2,3,3,3-heptafluoro-n -propane (CF 3 CHFCF 3 ). 17. Композиция по любому из пп. 2-16, отличающаяся тем, что она состоит по существу из одного или более порошкообразных медикаментов, одного или более фторуглеродных или водородсодержащих хлорфторуглеродных пропеллентов и ПАВ. 17. The composition according to any one of paragraphs. 2-16, characterized in that it consists essentially of one or more powdered medicines, one or more fluorocarbon or hydrogen-containing chlorofluorocarbon propellants and surfactants. 18. Способ лечения респираторных заболеваний, включающий ингаляционное введение эффективного количества композиции по любому из пп. 1-17. 18. A method of treating respiratory diseases, including inhalation of an effective amount of a composition according to any one of paragraphs. 1-17. 19. Способ изготовления композиции по любому из пп. 1-17, включающий диспергирование указанного медикамента и ПАВ в указанном пропелленте. 19. A method of manufacturing a composition according to any one of paragraphs. 1-17, including the dispersion of the specified medication and surfactant in the specified propellant.
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