RU2014144001A - Мягкие жевательные фармацевтические продукты - Google Patents
Мягкие жевательные фармацевтические продукты Download PDFInfo
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Abstract
1. Мягкий жевательный ветеринарный фармацевтический продукт, содержащий в качестве ингредиентов:- памовую кислоту или ее фармацевтически приемлемую соль, при условии, что памовая кислота или ее фармацевтически приемлемая соль не является активным фармацевтическим ингредиентом,- один или несколько активных фармацевтических ингредиентов,- жидкий компонент,- формообразующий агент, и- необязательно, один или несколько эксципиентов.2. Продукт по п. 1, где продукт содержит памоат натрия.3. Продукт по п. 1 или 2, в котором количество памовой кислоты или ее фармацевтически приемлемой соли составляет от 1,5 до 30% (масс./масс.).4. Мягкий жевательный ветеринарный фармацевтический продукт, содержащий в качестве ингредиентов:- памоатную соль активного фармацевтического ингредиента, при условии, что такой активный фармацевтический ингредиент не является памоатом пирантела или памоатом оксантела,- необязательно, один или несколько других активных фармацевтических ингредиентов,- жидкий компонент,- формообразующий агент,- необязательно, памовую кислоту или ее фармацевтически приемлемую соль, и- необязательно, один или несколько эксципиентов.5. Продукт по любому из пп. 1, 2 или 4, дополнительно содержащий один или несколько следующих эксципиентов:- наполнитель,- стабилизирующий компонент,- ароматизирующий компонент, и/или- сахарный компонент.6. Продукт по п. 1, в котором активный фармацевтический ингредиент представляет собой изоксазолиновое соединение формулы (I):где R= галоген, CF, OCF, CN,n = целое число от 0 до 3, предпочтительно 1, 2 или 3,R= C-С-галогеналкил, предпочтительно CFили CFCl,Т = 5- или 6-членное кольцо, которое необязательно замещено одним или несколькими радикалами Y,Y = метил, галогенметил, гал
Claims (20)
1. Мягкий жевательный ветеринарный фармацевтический продукт, содержащий в качестве ингредиентов:
- памовую кислоту или ее фармацевтически приемлемую соль, при условии, что памовая кислота или ее фармацевтически приемлемая соль не является активным фармацевтическим ингредиентом,
- один или несколько активных фармацевтических ингредиентов,
- жидкий компонент,
- формообразующий агент, и
- необязательно, один или несколько эксципиентов.
2. Продукт по п. 1, где продукт содержит памоат натрия.
3. Продукт по п. 1 или 2, в котором количество памовой кислоты или ее фармацевтически приемлемой соли составляет от 1,5 до 30% (масс./масс.).
4. Мягкий жевательный ветеринарный фармацевтический продукт, содержащий в качестве ингредиентов:
- памоатную соль активного фармацевтического ингредиента, при условии, что такой активный фармацевтический ингредиент не является памоатом пирантела или памоатом оксантела,
- необязательно, один или несколько других активных фармацевтических ингредиентов,
- жидкий компонент,
- формообразующий агент,
- необязательно, памовую кислоту или ее фармацевтически приемлемую соль, и
- необязательно, один или несколько эксципиентов.
5. Продукт по любому из пп. 1, 2 или 4, дополнительно содержащий один или несколько следующих эксципиентов:
- наполнитель,
- стабилизирующий компонент,
- ароматизирующий компонент, и/или
- сахарный компонент.
6. Продукт по п. 1, в котором активный фармацевтический ингредиент представляет собой изоксазолиновое соединение формулы (I):
где R1 = галоген, CF3, OCF3, CN,
n = целое число от 0 до 3, предпочтительно 1, 2 или 3,
R2 = C1-С3-галогеналкил, предпочтительно CF3 или CF2Cl,
Т = 5- или 6-членное кольцо, которое необязательно замещено одним или несколькими радикалами Y,
Y = метил, галогенметил, галоген, CN, NO2, NH2C=S, или два соседних радикала Y вместе образуют цепь, преимущественно 3- или 4-членную цепь;
Q = X-NR3R4 или 5-членное N-гетероарильное кольцо, которое необязательно замещено одним или несколькими радикалами;
X = СН2, СН(СН3), CH(CN), СО, CS,
R3 = водород, метил, галогенэтил, галогенпропил, галогенбутил, метоксиметил, метоксиэтил, галогенметоксиметил, этоксиметил, галогенэтоксиметил, пропоксиметил, этиламинокарбонилметил, этиламинокарбонилэтил, диметоксиэтил, пропиниламинокарбонилметил, N-фенил-N-метиламино, галогенэтиламинокарбонилметил, галогенэтиламинокарбонилэтил, тетрагидрофурил, метиламинокарбонилметил, (N,N-диметиламино)карбонилметил, пропиламинокарбонилметил, циклопропиламинокарбонилметил, пропениламинокарбонилметил, галогенэтиламинокарбонилциклопропил,
где ZA = водород, галоген, циано, галогенметил (CF3);
R4 = водород, этил, метоксиметил, галогенметоксиметил, этоксиметил, галогенэтоксиметил, пропоксиметил, метилкарбонил, этилкарбонил, пропилкарбонил, циклопропилкарбонил, метоксикарбонил, метоксиметилкарбонил, аминокарбонил, этиламинокарбонилметил, этиламинокарбонилэтил, диметоксиэтил, пропиниламинокарбонилметил, галогенэтиламинокарбонилметил, цианометиламинокарбонилметил или галогенэтиламинокарбонилэтил;
или R3 и R4 вместе образуют заместитель, выбранный из группы, состоящей из:
или его соль или сольват.
7. Продукт по п. 6, в котором активный фармацевтический ингредиент представляет собой 4-[5-(3,5-дихлорфенил)-5-трифторметил-4,5-дигидроизоксазол-3-ил]-2-метил-N-[(2,2,2-трифторэтилкарбомоил)метил]бензамид.
8. Продукт по п. 6, в котором активный фармацевтический ингредиент представляет собой 4-[5-[3-хлор-5-(трифторметил)фенил]-4,5-дигидро-5-(трифторметил)-3-изоксазолил]-N-[2-оксо-2-[(2,2,2-трифторэтил)амино]этил]-1-нафталинкарбоксамид.
9. Продукт по п. 6, в котором активный фармацевтический ингредиент представляет собой 4-[5-(3,5-дихлорфенил)-5(трифторметил)-4Н-изоксазол-3-ил]-2-метил-N-(триэтан-3-ил)бензамид.
10. Продукт по п. 6, в котором активный фармацевтический ингредиент представляет собой 5-[5-(3,5-дихлорфенил)-4,5-дигидро-5-(трифторметил)-3-изоксазолил]-3-метил-N-[2-оксо-2-[(2,2,2-трифторэтил)амино]этил]-2-тиофенкарбоксамид.
11. Продукт по п. 1, который содержит более чем один активный фармацевтический ингредиент.
12. Способ получения продукта по любому из пп. 1-11 в формующей машине, где способ включает стадии:
(a) смешивания ингредиентов в тестообразную массу,
(b) заполнения формы тестообразной массой, и
(c) удаления тестообразной массы из формы,
где на стадии смешивания а) памовую кислоту или ее фармацевтически приемлемую соль смешивают с другими ингредиентами.
13. Применение памовой кислоты или ее фармацевтически приемлемой соли в способе по п. 12 для увеличения смазывающей способности продукта по пп. 1-11 при заполнении пресс-формы тестообразной массой или при удалении тестообразной массы из пресс-формы формы, или в обоих случаях.
14. Применение мягкого жевательного ветеринарного фармацевтического продукта по любому из пп. 1-11 в производстве лекарственного средства для борьбы с заражением животного паразитарными насекомыми, акаридами или нематодами.
15. Мягкая жевательная ветеринарная фармацевтическая композиция, содержащая изоксазолиновое соединение формулы (I), как определено в пп. 6, 7, 8, 9 или 10, для применения в способе борьбы с заражением животного паразитарными насекомыми, акаридами или нематодами.
16. Композиция по п. 15, в котором жидкий компонент содержит одно или более масло, один или более неводный растворитель и один или более увлажнитель.
17. Композиция по п. 15, в котором жидкий компонент содержит одно или более масло, один или более неводный растворитель и глицерин.
18. Композиция по п. 15, в котором жидкий компонент содержит соевое масло, один или более неводный растворитель и увлажнитель.
19. Композиция по п. 15, в котором формообразующий агент содержит полиэтиленгликоль.
20. Продукт по п. 1, содержащий соевое масло, глицерин и полиэтиленгликоль 3350.
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| PCT/EP2013/056987 WO2013150052A1 (en) | 2012-04-04 | 2013-04-03 | Soft chewable pharmaceutical products |
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| RU2014144360A RU2646483C2 (ru) | 2012-04-04 | 2013-04-03 | Твердые фармацевтические композиции для перорального введения на основе изоксазолиновых соединений |
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