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RU98114678A - COMPOSITIONS SIMETICON / ANALYZED PHOSPHATE CALCIUM - Google Patents

COMPOSITIONS SIMETICON / ANALYZED PHOSPHATE CALCIUM

Info

Publication number
RU98114678A
RU98114678A RU98114678/14A RU98114678A RU98114678A RU 98114678 A RU98114678 A RU 98114678A RU 98114678/14 A RU98114678/14 A RU 98114678/14A RU 98114678 A RU98114678 A RU 98114678A RU 98114678 A RU98114678 A RU 98114678A
Authority
RU
Russia
Prior art keywords
calcium phosphate
dosage form
simethicone
granular
mixture
Prior art date
Application number
RU98114678/14A
Other languages
Russian (ru)
Other versions
RU2216317C2 (en
Inventor
Р.Лубер Джозеф
Мэдисон Гленн
МакНэлли Джерард
Original Assignee
МакНЕЙЛ-ППС, ИНК.
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
Priority claimed from US08/896,189 external-priority patent/US6103260A/en
Application filed by МакНЕЙЛ-ППС, ИНК. filed Critical МакНЕЙЛ-ППС, ИНК.
Publication of RU98114678A publication Critical patent/RU98114678A/en
Application granted granted Critical
Publication of RU2216317C2 publication Critical patent/RU2216317C2/en

Links

Claims (12)

1. Противовспенивающий симетиконовый препарат в виде пероральной твердой лекарственной формы, полученной из свободно текущей гранулированной композиции, включающей смесь из симетикона и гранулированного трехосновного или двухосновного фосфата кальция или их смеси; при этом смесь симетикон/фосфат кальция представляет однородную гранулированную композицию с размером частиц не более, чем 1000 микрон.1. Anti-foaming simethicone preparation in the form of an oral solid dosage form obtained from a freely flowing granular composition comprising a mixture of simethicone and granular tribasic or dibasic calcium phosphate or a mixture thereof; wherein the simethicone / calcium phosphate mixture is a uniform granular composition with a particle size of not more than 1000 microns. 2. Пероральная твердая лекарственная форма по п.1, отличающаяся тем, что указанная лекарственная форма находится в форме единичной дозы прессованной глотаемой или разжевываемой таблетки, или колпачка, гелькрышки, капсулы, лепешки или быстро растворимой облатки. 2. The oral solid dosage form according to claim 1, characterized in that said dosage form is in the form of a unit dose of a pressed swallowed or chewed tablet, or cap, gel cap, capsule, lozenge, or rapidly soluble cachet. 3. Пероральная твердая лекарственная форма по п.1, отличающаяся тем, что дополнительно содержит один или несколько разбавителей в дополнение к указанной свободно текущей гранулированной композиции. 3. The oral solid dosage form according to claim 1, characterized in that it further comprises one or more diluents in addition to the free flowing granular composition. 4. Пероральная твердая лекарственная форма по п.3, отличающаяся тем, что указанные разбавители выбирают из одного или нескольких наполнителей, связующих, подсластителей, искусственных подсластителей, смазок, глидантов, дезинтеграторов, красителей, адсорбентов, подкисляющих средств и ароматизирующих средств. 4. The oral solid dosage form according to claim 3, characterized in that said diluents are selected from one or more excipients, binders, sweeteners, artificial sweeteners, lubricants, glidants, disintegrants, dyes, adsorbents, acidifying agents and flavoring agents. 5. Пероральная твердая лекарственная форма по п.1, отличающаяся тем, что содержание симетикона в лекарственной форме составляет 8 - 20 мас.%. 5. The oral solid dosage form according to claim 1, characterized in that the content of simethicone in the dosage form is 8 to 20 wt.%. 6. Пероральная твердая лекарственная форма по п.5, отличающаяся тем, что дополнительно содержит кристаллический сорбит, микрокристаллическую целлюлозу и безводный трехосновной или двухосновной фосфат кальция в качестве наполнителей помимо свободно текущей гранулированной композиции симетикона и гранулированного безводного трехосновного или двухосновного фосфата кальция. 6. The oral solid dosage form according to claim 5, characterized in that it further comprises crystalline sorbitol, microcrystalline cellulose and anhydrous tribasic or dibasic calcium phosphate as fillers in addition to the freely flowing granular composition of simethicone and granular anhydrous tribasic or dibasic calcium phosphate. 7. Пероральная твердая лекарственная форма по п.1, отличающаяся тем, что дополнительно включает один или несколько дополнительных ингредиентов, пригодных для лечения желудочно-кишечных расстройств. 7. The oral solid dosage form according to claim 1, characterized in that it further includes one or more additional ingredients suitable for the treatment of gastrointestinal disorders. 8. Пероральная твердая лекарственная форма по п.7, отличающаяся тем, что дополнительный активный ингредиент выбирают из одного или нескольких из следующей группы: антагонистов Н2 рецептора, ингибиторов протонового насоса, средств против диареи, средств желудочно-кишечной мобильности и антацидов. 8. The oral solid dosage form according to claim 7, characterized in that the additional active ingredient is selected from one or more of the following group: H2 receptor antagonists, proton pump inhibitors, anti-diarrhea agents, gastrointestinal mobility agents, and antacids. 9. Свободно текущая гранулированная композиция, включающая смесь симетикона и гранулированного безводного трехосновного или двухосновного фосфата кальция или их смеси; при этом смесь симетикон/фосфат кальция представляет однородную гранулированную композицию с размером частиц не более, чем 1000 мкм. 9. Free flowing granular composition comprising a mixture of simethicone and granular anhydrous tribasic or dibasic calcium phosphate or a mixture thereof; wherein the simethicone / calcium phosphate mixture is a homogeneous granular composition with a particle size of not more than 1000 microns. 10. Свободно текущая гранулированная композиция по п.9, отличающаяся тем, что пропорциональные количества ингредиентов композиции гранулированной смеси составляют приблизительно 10-70 мас.%/мас симетикона и приблизительно 30-90 мас.%/мас. гранулированного безводного трехосновного или двухосновного фосфата кальция. 10. The free-flowing granular composition according to claim 9, characterized in that the proportional amounts of the ingredients of the composition of the granular mixture are approximately 10-70 wt.% / Wt. Simethicone and approximately 30-90 wt.% / Wt. granular anhydrous tribasic or dibasic calcium phosphate. 11. Свободно текущая гранулированная композиция по п.9, отличающаяся тем, что дополнительно содержит либо двуокись кремния в количестве приблизительно 0,5-4 мас.%/мас. или порошка безводного фосфата кальция в количестве приблизительно 1-30 мас.%/мас. гранулированной композиции. 11. Free flowing granular composition according to claim 9, characterized in that it further comprises either silicon dioxide in an amount of about 0.5-4 wt.% / Wt. or anhydrous calcium phosphate powder in an amount of about 1-30 wt.% / wt. granular composition. 12. Способ получения свободно текущей гранулированной композиции семитиконового противовспенивающегося средства для прессования в твердую пероральную лекарственную форму, включающий формирование смеси гранулированного безводного трехосновного и/или двухосновного фосфата кальция, симетиконового противовспенивающего средства и необязательно поглотителя, такого как двуокись кремния или порошок безводного фосфата кальция путем добавления симетикона к гранулированному безводному трехосновному или двухосновному фосфату кальция и необязательно двуокиси кремния или порошку безводного фосфата кальция, сухое смешение до равномерного распределения и сдвиговую деформацию, чтобы гарантировать однородную свободно текущую гранулированную композицию. 12. A method of preparing a free-flowing granular composition of a seven-tonic anti-foaming agent for compression into a solid oral dosage form, comprising forming a mixture of a granular anhydrous tribasic and / or dibasic calcium phosphate, a simethicone anti-foaming agent and optionally an absorbent, such as silicon dioxide or anhydrous calcium phosphate powder simethicone to granular anhydrous tribasic or dibasic calcium phosphate and n Mandatory silicon dioxide or anhydrous calcium phosphate powder, dry blending until uniform distribution and shear deformation to ensure a uniform free flowing granular composition.
RU98114678/14A 1997-07-17 1998-07-16 Composition simethicone/anhydrous calcium phosphate RU2216317C2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/896,189 US6103260A (en) 1997-07-17 1997-07-17 Simethicone/anhydrous calcium phosphate compositions
US08/896,189 1997-07-17

Publications (2)

Publication Number Publication Date
RU98114678A true RU98114678A (en) 2000-05-20
RU2216317C2 RU2216317C2 (en) 2003-11-20

Family

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Country Status (19)

Country Link
US (1) US6103260A (en)
EP (1) EP0891776B1 (en)
JP (1) JPH1192387A (en)
KR (1) KR100549355B1 (en)
CN (1) CN1267106C (en)
AR (1) AR013227A1 (en)
AT (1) ATE259236T1 (en)
AU (1) AU727271B2 (en)
BR (1) BR9802487B1 (en)
CZ (1) CZ294084B6 (en)
DE (1) DE69821553T2 (en)
DK (1) DK0891776T3 (en)
ES (1) ES2216244T3 (en)
HU (1) HUP9801615A3 (en)
NZ (1) NZ330915A (en)
PL (1) PL189988B1 (en)
PT (1) PT891776E (en)
RU (1) RU2216317C2 (en)
ZA (1) ZA986338B (en)

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