RU95118099A - SOLID PHARMACEUTICAL COMPOSITION AND METHOD FOR PRODUCING IT - Google Patents

SOLID PHARMACEUTICAL COMPOSITION AND METHOD FOR PRODUCING IT

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Publication number
RU95118099A
RU95118099A RU95118099/14A RU95118099A RU95118099A RU 95118099 A RU95118099 A RU 95118099A RU 95118099/14 A RU95118099/14 A RU 95118099/14A RU 95118099 A RU95118099 A RU 95118099A RU 95118099 A RU95118099 A RU 95118099A
Authority
RU
Russia
Prior art keywords
water
composition according
paragraphs
crosslinked polymer
active ingredient
Prior art date
Application number
RU95118099/14A
Other languages
Russian (ru)
Other versions
RU2152802C2 (en
Inventor
Де Хан Питер
Герардина Мария Пульс-Янссен Хендрика
Original Assignee
Акцо Нобель Н.В.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Акцо Нобель Н.В. filed Critical Акцо Нобель Н.В.
Publication of RU95118099A publication Critical patent/RU95118099A/en
Application granted granted Critical
Publication of RU2152802C2 publication Critical patent/RU2152802C2/en

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Claims (10)

1. Твердая фармацевтическая композиция, содержащая менее 7 мас.% масла или маслянистого вещества, небольшую дозу активного ингредиента и не растворимый в воде несшитый полимерный наполнитель, способный связывать воду и имеющий средний размер частиц более 150 мкм.1. A solid pharmaceutical composition containing less than 7 wt.% Oil or an oily substance, a small dose of the active ingredient and a water-insoluble non-crosslinked polymer excipient capable of binding water and having an average particle size of more than 150 microns. 2. Композиция по п. 1, содержащая менее 4 мас.% масла или маслянистого вещества. 2. The composition according to p. 1, containing less than 4 wt.% Oil or oily substances. 3. Композиция по п. 1 или 2, отличающаяся тем, что масло или маслянистое вещество имеет температуру плавления ниже приблизительно 40°С. 3. The composition according to p. 1 or 2, characterized in that the oil or oily substance has a melting point below about 40 ° C. 4. Композиция по пп. 1 - 3, отличающаяся тем, что доза активного ингредиента составляет от 0,005 до 5 мас.%. 4. The composition according to paragraphs. 1 to 3, characterized in that the dose of the active ingredient is from 0.005 to 5 wt.%. 5. Композиция по любому из пп. 1 - 4, отличающаяся тем, что активный ингредиент представляет собой стероид. 5. The composition according to any one of paragraphs. 1 to 4, characterized in that the active ingredient is a steroid. 6. Композиция по любому из пп. 1 - 5, отличающаяся тем, что не растворимый в воде несшитый полимерный наполнитель, способный связывать воду, имеет средний размер частиц по меньшей мере 180 мкм. 6. The composition according to any one of paragraphs. 1 to 5, characterized in that the water-insoluble non-crosslinked polymer filler capable of binding water, has an average particle size of at least 180 microns. 7. Композиция по любому из пп. 1 - 6, отличающаяся тем, что не растворимый в воде несшитый полимерный наполнитель, способный связывать воду, представляет собой целлюлозу или крахмал. 7. The composition according to any one of paragraphs. 1 to 6, characterized in that the water-insoluble, non-crosslinked polymer filler capable of binding water is cellulose or starch. 8. Композиция по любому из пп. 1 - 7, отличающаяся тем, что активный ингредиент представляет собой дезогестрел, этинилэстрадиол или их смесь. 8. The composition according to any one of paragraphs. 1 to 7, characterized in that the active ingredient is desogestrel, ethinyl estradiol or a mixture thereof. 9. Способ получения твердой фармацевтической композиции по любому из пп. 1 - 8, отличающийся тем, что небольшую дозу активного ингредиента растворяют или диспергируют в масле или маслянистом веществе, в его водной дисперсии или в воде, после чего смешивают с не растворимым в воде несшитым полимерным наполнителем, способным связывать воду и имеющим средний размер частиц более 150 мкм, после чего твердая композиция может быть необязательно смешана с дополнительным количеством не растворимого в воде несшитого полимерного наполнителя, способного связывать воду или необязательно с другими фармацевтически приемлемыми добавками, после чего полученная твердая композиция может быть необязательно спрессована в таблетки или введена в капсулы. 9. A method of obtaining a solid pharmaceutical composition according to any one of paragraphs. 1 to 8, characterized in that a small dose of the active ingredient is dissolved or dispersed in oil or an oily substance, in its aqueous dispersion or in water, and then mixed with a water-insoluble non-crosslinked polymer filler capable of binding water and having an average particle size of more 150 μm, after which the solid composition may optionally be mixed with additional water-insoluble, non-crosslinked polymer excipient capable of binding water or optionally with other pharmaceutically acceptable mixtures, after which the resulting solid composition may optionally be compressed into tablets or introduced into capsules. 10. Способ по п. 9, отличающийся тем, что отношение не растворимого в воде несшитого полимерного наполнителя, способного связывать воду и воды, которая присутствует при осуществлении способа, составляет более 5 : 1 и предпочтительно более 10 : 1. 10. The method according to p. 9, characterized in that the ratio of water-insoluble non-crosslinked polymer filler capable of binding water and water, which is present during the implementation of the method, is more than 5: 1 and preferably more than 10: 1.
RU95118099/14A 1994-10-17 1995-10-16 Solid pharmaceutical composition and method of its preparing RU2152802C2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP94203017 1994-10-17
EP94203017.2 1994-10-17

Publications (2)

Publication Number Publication Date
RU95118099A true RU95118099A (en) 1998-01-10
RU2152802C2 RU2152802C2 (en) 2000-07-20

Family

ID=8217284

Family Applications (1)

Application Number Title Priority Date Filing Date
RU95118099/14A RU2152802C2 (en) 1994-10-17 1995-10-16 Solid pharmaceutical composition and method of its preparing

Country Status (20)

Country Link
US (1) US6187339B1 (en)
EP (1) EP0707848B1 (en)
JP (1) JPH08268914A (en)
KR (1) KR100388932B1 (en)
CN (1) CN1112185C (en)
AT (1) ATE211647T1 (en)
AU (1) AU688581B2 (en)
BR (1) BR9504400A (en)
CA (1) CA2159419C (en)
DE (1) DE69524917T2 (en)
DK (1) DK0707848T3 (en)
ES (1) ES2171498T3 (en)
FI (1) FI117121B (en)
HK (1) HK1001886A1 (en)
HU (1) HU221427B (en)
IL (1) IL115445A (en)
MX (1) MX9504252A (en)
PT (1) PT707848E (en)
RU (1) RU2152802C2 (en)
TR (1) TR199501246A2 (en)

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