RU97116843A - PHARMACEUTICAL MEDICINAL FORMS FOR ORAL ADMINISTRATION CONTAINING A PROTON PUMP INHIBITOR AND A NON-STEROID ANTI-INFLAMMATORY THERAPY - Google Patents

PHARMACEUTICAL MEDICINAL FORMS FOR ORAL ADMINISTRATION CONTAINING A PROTON PUMP INHIBITOR AND A NON-STEROID ANTI-INFLAMMATORY THERAPY

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Publication number
RU97116843A
RU97116843A RU97116843/14A RU97116843A RU97116843A RU 97116843 A RU97116843 A RU 97116843A RU 97116843/14 A RU97116843/14 A RU 97116843/14A RU 97116843 A RU97116843 A RU 97116843A RU 97116843 A RU97116843 A RU 97116843A
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Russia
Prior art keywords
tablet
dosage form
proton pump
pump inhibitor
granules
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RU97116843/14A
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Russian (ru)
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RU2158138C2 (en
Inventor
Депюи Элен
Йохан Лундберг Пер
Original Assignee
Астра Актиеболаг
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Priority claimed from SE9600070A external-priority patent/SE9600070D0/en
Application filed by Астра Актиеболаг filed Critical Астра Актиеболаг
Publication of RU97116843A publication Critical patent/RU97116843A/en
Application granted granted Critical
Publication of RU2158138C2 publication Critical patent/RU2158138C2/en

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Claims (29)

1. Фармацевтическая лекарственная форма для перорального приема, содержащая кислоточувствительный ингибитор протонного насоса, по меньшей мере, одно средство нестероидной противовоспалительной терапии (СНПТ) и, необязательно, фармацевтически приемлемые эксципиенты, отличающаяся тем, что она является дозированной лекарственной формой, которая содержит, по меньшей мере, два фармацевтически активных вещества и в которой, по меньшей мере, ингибитор протонного насоса защищен энтеросолюбильным покрытием.1. A pharmaceutical dosage form for oral administration comprising an acid-sensitive proton pump inhibitor, at least one non-steroidal anti-inflammatory therapy (NSAID) agent and, optionally, pharmaceutically acceptable excipients, characterized in that it is a dosage form that contains at least at least two pharmaceutically active substances and in which at least the proton pump inhibitor is protected by an enteric coating. 2. Лекарственная форма по п. 1, отличающаяся тем, что является таблеткой. 2. A dosage form according to claim 1, characterized in that it is a tablet. 3. Лекарственная форма по п. 1, отличающаяся тем, что является капсулой. 3. The dosage form according to claim 1, characterized in that it is a capsule. 4. Лекарственная форма по п. 1, отличающаяся тем, что ингибитор протонного насоса защищен двумя слоями: энтеросолюбильным покрытием и слоем, отделяющим энтеросолюбильное покрытие от ингибитора протонного насоса. 4. The dosage form according to claim 1, characterized in that the proton pump inhibitor is protected by two layers: an enteric coating and a layer separating the enteric coating from the proton pump inhibitor. 5. Лекарственная форма по п. 1, отличающаяся тем, что содержит ингибитор протонного насоса и одно средство нестероидной противовоспалительной терапии (СНПТ). 5. The dosage form according to claim 1, characterized in that it contains a proton pump inhibitor and one means of non-steroidal anti-inflammatory therapy (NSAIDs). 6. Лекарственная форма по п. 1, отличающаяся тем, что ингибитор протонного насоса является омепразолом, его солью щелочного металла, S-омепразолом или его солью щелочного металла. 6. The dosage form according to claim 1, characterized in that the proton pump inhibitor is omeprazole, its alkali metal salt, S-omeprazole or its alkali metal salt. 7. Лекарственная форма по п. 1, отличающаяся тем, что ингибитор протонного насоса является ланзопразолом, одним из его отдельных энантиомеров или его фармацевтически приемлемой солью. 7. The dosage form according to claim 1, characterized in that the proton pump inhibitor is lansoprazole, one of its individual enantiomers or its pharmaceutically acceptable salt. 8. Лекарственная форма по п. 1, отличающаяся тем, что ингибитор протонного насоса является пантопразолом или одним из его отдельных энантиомеров или его фармацевтически приемлемой солью. 8. The dosage form according to claim 1, characterized in that the proton pump inhibitor is pantoprazole or one of its individual enantiomers or its pharmaceutically acceptable salt. 9. Лекарственная форма по любому из пп. 6-8, отличающаяся тем, что средство нестероидной противовоспалительной терапии является ибупрофеном, диклофенаком, пироксикамом или напроксеном или их фармацевтически приемлемой солью. 9. The dosage form according to any one of paragraphs. 6-8, characterized in that the non-steroidal anti-inflammatory drug is ibuprofen, diclofenac, piroxicam or naproxen or a pharmaceutically acceptable salt thereof. 10. Лекарственная форма по п. 1, отличающаяся тем, что количество ингибитора протонного насоса составляет 10-80 мг и количество СНПТ составляет 10-800 мг. 10. The dosage form according to claim 1, characterized in that the amount of the proton pump inhibitor is 10-80 mg and the amount of SNPT is 10-800 mg. 11. Лекарственная форма по п. 1, отличающаяся тем, что количество ингибитора протонного насоса составляет 10-40 мг и количество СНПТ составляет 10-500 мг. 11. The dosage form according to claim 1, characterized in that the amount of the proton pump inhibitor is 10-40 mg and the amount of SNPT is 10-500 mg. 12. Таблетированная лекарственная форма по п.2, отличающаяся тем, что таблетка состоит из двух отдельных слоев, из которых один слой содержит ингибитор протонного насоса, а другой слой содержит одно или несколько СНПТ. 12. The tablet dosage form according to claim 2, characterized in that the tablet consists of two separate layers, of which one layer contains a proton pump inhibitor, and the other layer contains one or more SNPTs. 13. Таблетированная лекарственная форма по п. 2, отличающаяся тем, что является таблетированной лекарственной формой со сложной структурой, содержащей ингибитор протонного насоса в виде отдельных гранул с энтеросолюбильным покрытием, спрессованных вместе с гранулами, содержащими СНПТ, в таблетку, причем энтеросолюбильное покрытие, нанесенное на отдельные гранулы, обладает такими механическими свойствами, что таблетирование указанных гранул вместе с гранулами, содержащими СНПТ, и, необязательно, фармацевтически приемлемыми эксципиентами не оказывает существенного влияния на кислотостойкость отдельных гранул с энтеросолюбильным покрытием. 13. The tablet dosage form according to claim 2, characterized in that it is a tablet dosage form with a complex structure containing a proton pump inhibitor in the form of separate enteric-coated granules, compressed together with granules containing SNPT, into a tablet, the enteric coating being applied into individual granules, has such mechanical properties that tabletting said granules together with granules containing SNPTs and, optionally, pharmaceutically acceptable excipients and it does not significantly affect the acid resistance of the individual enteric coated beads. 14. Таблетированная лекарственная форма по п. 13, отличающаяся тем, что кислотостойкость гранул с энтеросолюбильным покрытием соответствует требованиям, предъявляемым фармакопеей США к изделиям с энтеросолюбильным покрытием. 14. The tablet dosage form according to claim 13, characterized in that the acid resistance of the enteric coated granules meets the requirements of the United States Pharmacopeia for enteric coated products. 15. Таблетированная лекарственная форма по п. 13, отличающаяся тем, что кислотостойкость гранул с энтеросолюбильным покрытием не снижается более чем на 10% во время прессования указанных гранул в таблетированную лекарственную форму со сложной структурой. 15. The tablet dosage form according to claim 13, characterized in that the acid resistance of the enteric coated granules does not decrease by more than 10% during pressing of said granules into a tablet dosage form with a complex structure. 16. Таблетированная лекарственная форма по п. 13, отличающаяся тем, что энтеросолюбильное покрытие отдельных гранул состоит из пластифицированного вещества энтеросолюбильного покрытия. 16. A tablet dosage form according to claim 13, characterized in that the enteric coating of the individual granules consists of a plasticized substance of the enteric coating. 17. Таблетированная лекарственная форма по п. 13, отличающаяся тем, что на гранулы с энтеросолюбильным покрытием дополнительно наносят защитное покрытие, содержащее фармацевтически приемлемые эксципиенты. 17. The tablet dosage form according to claim 13, characterized in that the enteric coated granules are additionally coated with a protective coating containing pharmaceutically acceptable excipients. 18. Таблетированная лекарственная форма по п. 13, отличающаяся тем, что является таблеткой, диспергируемой с получением водной суспензии, содержащей СНПТ и гранулы ингибитора протонного насоса с энтеросолюбильным покрытием. 18. A tablet dosage form according to claim 13, characterized in that it is a tablet dispersible to obtain an aqueous suspension containing NSAIDs and enteric coated proton pump inhibitor granules. 19. Таблетированная лекарственная форма по п. 2, отличающаяся тем, что является таблеткой, состоящей из двух отдельных слоев, из которых один слой содержит ингибитор протонного насоса в виде гранул с энтеросолюбильным покрытием, спрессованных в слой вместе с эксципиентами для таблетки, а другой слой содержит одно или несколько СНПТ с пролонгированным действием. 19. The tablet dosage form according to claim 2, characterized in that it is a tablet consisting of two separate layers, of which one layer contains a proton pump inhibitor in the form of enteric coated granules, compressed into a layer together with tablet excipients, and the other layer contains one or more NSAIDs with prolonged action. 20. Таблетированная лекарственная форма по п. 19, отличающаяся тем, что слой, содержащий одно или несколько СНПТ представляет собой гелеобразующую матрицу с пролонгированным действием. 20. The tablet dosage form according to claim 19, characterized in that the layer containing one or more SNPTs is a gel-forming matrix with a prolonged action. 21. Таблетированная лекарственная форма по п. 2, отличающаяся тем, что является таблеткой с энтеросолюбильным покрытием, состоящей из смеси ингибитора протонного насоса и гранул, содержащих СНПТ, и, необязательно, имеющей водорастворимый или быстро распадающийся в воде разделительный слой между сердцевиной таблетки и энтеросолюбильным покрытием. 21. The tablet dosage form according to claim 2, characterized in that it is an enteric-coated tablet consisting of a mixture of a proton pump inhibitor and granules containing SNPT, and optionally having a water-soluble or water-soluble separation layer between the tablet core and the enteric coated. 22. Таблетированная лекарственная форма по п. 2, отличающаяся тем, что является таблеткой, содержащей гранулы ингибитора протонного насоса с энтеросолюбильным покрытием, спрессованные в таблетку, на которую нанесен разделительный слой, содержащий одно или несколько СНПТ, и, необязательно, пигментированным пленочным покрытием. 22. The tablet dosage form according to claim 2, characterized in that it is a tablet containing granules of a proton pump inhibitor with an enteric coating, compressed into a tablet coated with a release layer containing one or more SNPTs, and optionally a pigmented film coating. 23. Таблетированная лекарственная форма по п. 2, отличающаяся тем, что таблетка состоит из двух типов гранул с энтеросолюбильным покрытием: гранулы одного типа содержат ингибитор протонного насоса, а гранулы другого типа содержат СНПТ, которые спрессованы в таблетку вместе с эксципиентами для таблетки. 23. A tablet dosage form according to claim 2, characterized in that the tablet consists of two types of enteric-coated granules: one type of granule contains a proton pump inhibitor, and another type of granule contains SNPT, which are compressed into a tablet together with tablet excipients. 24. Таблетированная лекарственная форма по п. 2, отличающаяся тем, что таблетка состоит из гранул с энтеросолюбильным покрытием, содержащих ингибитор протонного насоса, содержащих СНПТ, покрытых пленкой с пролонгированным действием, которые спрессованы в таблетку вместе с эксципиентами для таблетки. 24. A tablet dosage form according to claim 2, characterized in that the tablet consists of enteric-coated granules containing a proton pump inhibitor, containing an NSAID coated with a film with a prolonged action, which are compressed into a tablet together with tablet excipients. 25. Способ получения дозированной лекарственной формы, содержащей ингибитор протонного насоса и одно или несколько СНПТ в капсуле, отличающийся тем, что ингибитор протонного насоса получают в виде гранул с энтеросолюбильным покрытием, этими гранулами наполняют капсулу вместе с полученными гранулами СНПТ или гранулами СНПТ с энтеросолюбильным покрытием или гранулами СНПТ с пленочным покрытием с пролонгированным действием, необязательно, смесь упомянутых гранул смешивают с фармацевтически приемлемыми эксципиентами и вводят в капсулу. 25. A method of obtaining a dosage form containing a proton pump inhibitor and one or more SNPTs in a capsule, characterized in that the proton pump inhibitor is obtained in the form of enteric-coated granules, fill the capsule with the obtained SNPT granules or enteric-coated SNPT granules or sustained release film-coated SNPT granules, optionally, a mixture of said granules is mixed with pharmaceutically acceptable excipients and introduced into a capsule. 26. Способ получения дозированной лекарственной формы, содержащей ингибитор протонного насоса и одно или несколько СНПТ в таблетированной лекарственной форме со сложной структурой, отличающийся тем, что ингибитор протонного насоса получают в виде гранул с энтеросолюбильным покрытием и смешивают с полученными гранулами СНПТ и, необязательно, с фармацевтически приемлемыми эксципиентами для таблетки, после чего сухую смесь прессуют в таблетку со сложной структурой без существенного изменения кислотостойкости энтеросолюбильного покрытия. 26. A method of obtaining a dosage form containing a proton pump inhibitor and one or more SNPTs in a tablet dosage form with a complex structure, characterized in that the proton pump inhibitor is obtained in the form of enteric coated granules and mixed with the obtained SNPT granules and, optionally, with pharmaceutically acceptable excipients for the tablet, after which the dry mixture is pressed into a tablet with a complex structure without significantly changing the acid resistance of the enteric coating i. 27. Способ получения дозированной лекарственной формы, содержащей ингибитор протонного насоса и одно или несколько СНПТ в таблетированной лекарственной форме со сложной структурой, отличающийся тем, что ингибитор протонного насоса получают в виде гранул с энтеросолюбильным покрытием, СНПТ получают в виде гранул с покрытием, которое является покрытием с пролонгированным действием или энтеросолюбильным покрытием, полученные гранулы смешивают с эксципиентами и прессуют в таблетку. 27. A method of obtaining a dosage form containing a proton pump inhibitor and one or more SNPTs in a tablet dosage form with a complex structure, characterized in that the proton pump inhibitor is obtained in the form of enteric coated granules, the SNPT is obtained in the form of coated granules, which is coated with a prolonged action or enteric coating, the obtained granules are mixed with excipients and pressed into a tablet. 28. Способ получения дозированной лекарственной формы, содержащей ингибитор протонного насоса и одно или несколько СНПТ в таблетке с энтеросолюбильным покрытием, отличающийся тем, что ингибитор протонного насоса смешивают с СНПТ и фармацевтически приемлемыми эксципиентами, после чего смесь прессуют в таблетку, на которую наносят энтеросолюбильное покрытие и, необязательно, покрывают разделительным слоем до нанесения энтеросолюбильного покрытия. 28. A method of obtaining a dosage form containing a proton pump inhibitor and one or more NSAIDs in an enteric coated tablet, characterized in that the proton pump inhibitor is mixed with NSAIDs and pharmaceutically acceptable excipients, after which the mixture is pressed into a tablet on which an enteric coating is applied and, optionally, coated with a release layer prior to application of the enteric coating. 29. Способ лечения побочных эффектов, возникающих в желудочно-кишечном тракте вследствие лечения средствами нестероидной противовоспалительной терапии у млекопитающих и человека, и, в частности, в верхнем отделе желудочно-кишечного тракта вследствие лечения СНПТ посредством введения нуждающемуся субъекту терапевтически эффективной дозы таблетированной лекарственной формы со сложной структурой по любому из пп. 1-28. 29. A method of treating side effects that occur in the gastrointestinal tract as a result of treatment with non-steroidal anti-inflammatory drugs in mammals and humans, and in particular in the upper gastrointestinal tract as a result of treatment of DST by administering to a needy subject a therapeutically effective dose of a tablet dosage form with complex structure according to any one of paragraphs. 1-28.
RU97116843/14A 1996-01-08 1996-12-20 Pharmaceutical medicinal forms for oral intake containing inhibitor of proton pump and agent for nonsteroid anti-inflammatory therapy RU2158138C2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE9600070-8 1996-01-08
SE9600070A SE9600070D0 (en) 1996-01-08 1996-01-08 New oral pharmaceutical dosage forms

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RU97116843A true RU97116843A (en) 1999-08-10
RU2158138C2 RU2158138C2 (en) 2000-10-27

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