RU2001109431A - Sustained-release ranolazine preparations - Google Patents

Sustained-release ranolazine preparations

Info

Publication number
RU2001109431A
RU2001109431A RU2001109431/14A RU2001109431A RU2001109431A RU 2001109431 A RU2001109431 A RU 2001109431A RU 2001109431/14 A RU2001109431/14 A RU 2001109431/14A RU 2001109431 A RU2001109431 A RU 2001109431A RU 2001109431 A RU2001109431 A RU 2001109431A
Authority
RU
Russia
Prior art keywords
dosage form
pharmaceutical dosage
ranolazine
form according
methacrylic acid
Prior art date
Application number
RU2001109431/14A
Other languages
Russian (ru)
Other versions
RU2214233C2 (en
Inventor
Эндрю А. ВОЛЬФФ
Фиона БЭЙКЕР
Джон ЛЭНГРИДЖ
Original Assignee
Си Ви Терапьютикс, Инк.
Синтекс (Ю.Эс.Эй), Ллс.
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 US09/321,522 external-priority patent/US6303607B1/en
Application filed by Си Ви Терапьютикс, Инк., Синтекс (Ю.Эс.Эй), Ллс. filed Critical Си Ви Терапьютикс, Инк.
Publication of RU2001109431A publication Critical patent/RU2001109431A/en
Application granted granted Critical
Publication of RU2214233C2 publication Critical patent/RU2214233C2/en

Links

Claims (20)

1. Фармацевтическая лекарственная форма, содержащая, по меньшей мере, приблизительно 50 вес.% ранолазина и, по меньшей мере, одно рН-зависимое связующее вещество, которое ингибирует высвобождение ранолазина из лекарственной формы с пролонгированным действием, когда лекарственная форма с пролонгированным действием подвергается воздействию водной среды, имеющей значение рН желудка, и способствует высвобождению терапевтического количества ранолазина в водном растворе, имеющем значение рН выше приблизительно 4,5.1. A pharmaceutical dosage form containing at least about 50 wt.% Ranolazine and at least one pH dependent binder that inhibits the release of ranolazine from a sustained release dosage form when the sustained release dosage form is exposed an aqueous medium having a pH of the stomach, and promotes the release of a therapeutic amount of ranolazine in an aqueous solution having a pH above about 4.5. 2. Фармацевтическая лекарственная форма по п.1, отличающаяся тем, что включает не более, чем две таблетки на дозу.2. The pharmaceutical dosage form according to claim 1, characterized in that it includes no more than two tablets per dose. 3. Фармацевтическая лекарственная форма по п.2, отличающаяся тем, что фармацевтическая лекарственная форма содержит приблизительно от 50 до 95 вес.% ранолазина.3. The pharmaceutical dosage form according to claim 2, characterized in that the pharmaceutical dosage form contains from about 50 to 95 wt.% Ranolazine. 4. Фармацевтическая лекарственная форма по п.2, отличающаяся тем, что фармацевтическая лекарственная форма содержит приблизительно от 70 до 80 вес.% ранолазина.4. The pharmaceutical dosage form according to claim 2, characterized in that the pharmaceutical dosage form contains from about 70 to 80 wt.% Ranolazine. 5. Фармацевтическая лекарственная форма по п.1, отличающаяся тем, что рН-зависимое связующее вещество выбирают из сополимеров метакриловой кислоты, фталата гидроксипропилцеллюлозы, фталата гидроксипропилметилцеллюлозы, фталата ацетата целлюлозы, фталата поливинилацетата, фталата поливинилпирролидина, а также их смесей.5. The pharmaceutical dosage form according to claim 1, characterized in that the pH-dependent binder is selected from copolymers of methacrylic acid, hydroxypropyl cellulose phthalate, hydroxypropyl methyl cellulose phthalate, cellulose acetate phthalate, polyvinyl acetate phthalate, polyvinyl pyrrolidine phthalate, as well as mixtures thereof. 6. Фармацевтическая лекарственная форма по п.1, отличающаяся тем, что рН-зависимое связующее вещество представляет сополимер метакриловой кислоты.6. The pharmaceutical dosage form according to claim 1, characterized in that the pH-dependent binder is a methacrylic acid copolymer. 7. Фармацевтическая лекарственная форма по п.6, отличающаяся тем, что сополимер метакриловой кислоты представляет сополимер метакриловой кислоты Типа С (Фармакопея США).7. The pharmaceutical dosage form according to claim 6, characterized in that the methacrylic acid copolymer is a Type C methacrylic acid copolymer (USP). 8. Фармацевтическая лекарственная форма по п.6, отличающаяся тем, что фармацевтическая лекарственная форма включает приблизительно от 5 до 12 вес.% сополимера метакриловой кислоты Типа С (Фармакопея США).8. The pharmaceutical dosage form according to claim 6, characterized in that the pharmaceutical dosage form comprises from about 5 to 12% by weight of a Type C methacrylic acid copolymer (United States Pharmacopeia). 9. Фармацевтическая лекарственная форма по п.6, отличающаяся тем, что фармацевтическая лекарственная форма включает приблизительно 10 вес.% сополимера метакриловой кислоты.9. The pharmaceutical dosage form according to claim 6, characterized in that the pharmaceutical dosage form comprises about 10 wt.% Copolymer of methacrylic acid. 10. Фармацевтическая лекарственная форма по п.1, отличающаяся тем, что фармацевтическая лекарственная форма содержит рН-независимое связующее вещество.10. The pharmaceutical dosage form according to claim 1, characterized in that the pharmaceutical dosage form contains a pH independent binder. 11. Фармацевтическая лекарственная форма по п.10, отличающаяся тем, что рН-независимое связующее вещество выбирают из гидроксипропилметилцеллюлозы, гидроксипропилцеллюлозы, поли(мет)акрилатных эфиров, поливинилпирролидона и их смесей.11. The pharmaceutical dosage form of claim 10, wherein the pH independent binder is selected from hydroxypropyl methylcellulose, hydroxypropyl cellulose, poly (meth) acrylate esters, polyvinylpyrrolidone and mixtures thereof. 12. Фармацевтическая лекарственная форма по п.10, отличающаяся тем, что рН-независимое связующее вещество представляет гидроксипропилметилцеллюлозу.12. The pharmaceutical dosage form of claim 10, wherein the pH independent binder is hydroxypropyl methylcellulose. 13. Фармацевтическая лекарственная форма по п.12, отличающаяся тем, что фармацевтическая лекарственная форма содержит приблизительно от 1 до 3 вес.% гидроксипропилметилцеллюлозы.13. The pharmaceutical dosage form according to claim 12, characterized in that the pharmaceutical dosage form contains from about 1 to 3 wt.% Hydroxypropylmethyl cellulose. 14. Фармацевтическая лекарственная форма по п.12, отличающаяся тем, что фармацевтическая лекарственная форма содержит приблизительно 2 вес.% гидроксипропилметилцеллюлозы.14. The pharmaceutical dosage form according to claim 12, characterized in that the pharmaceutical dosage form contains about 2 wt.% Hydroxypropyl methylcellulose. 15. Фармацевтическая лекарственная форма по п.1, отличающаяся тем, что лекарственная форма содержит приблизительно от 650 до 850 мг ранолазина.15. The pharmaceutical dosage form according to claim 1, characterized in that the dosage form contains from about 650 to 850 mg of ranolazine. 16. Фармацевтическая лекарственная форма по п.1, отличающаяся тем, что лекарственная форма содержит приблизительно от 900 до 1100 мг ранолазина.16. The pharmaceutical dosage form according to claim 1, characterized in that the dosage form contains from about 900 to 1100 mg of ranolazine. 17. Фармацевтическая лекарственная форма по п.1, отличающаяся тем, что лекарственная форма содержит приблизительно от 400 до 600 мг ранолазина.17. The pharmaceutical dosage form according to claim 1, characterized in that the dosage form contains from about 400 to 600 mg of ranolazine. 18. Фармацевтическая лекарственная форма по п.1, отличающаяся тем, что лекарственная форма содержит приблизительно от 300 до 1000 мг ранолазина.18. The pharmaceutical dosage form according to claim 1, characterized in that the dosage form contains from about 300 to 1000 mg of ranolazine. 19. Фармацевтическая лекарственная форма по п.2, отличающаяся тем, что фармацевтическая лекарственная форма представляет прессованную таблетку.19. The pharmaceutical dosage form according to claim 2, characterized in that the pharmaceutical dosage form is a compressed tablet. 20. Прессованная таблетка, содержащая приблизительно от 70 до 80 вес.% ранолазина, по меньшей мере одно рН-зависимое связующее вещество, выбранное из сополимеров метакриловой кислоты, фталата гидроксипропилцеллюлозы, фталата гидроксипропилметилцеллюлозы, фталата ацетата целлюлозы, фталата поливинилацетата, фталата поливинилпирролидина и их смесей, и, по меньшей мере, одно рН-независимое связующее вещество, при этом прессованная таблетка содержит приблизительно от 350 до 800 мг ранолазина.20. A compressed tablet containing from about 70 to 80% by weight of ranolazine, at least one pH dependent binder selected from copolymers of methacrylic acid, hydroxypropyl cellulose phthalate, hydroxypropyl methyl cellulose phthalate, cellulose acetate phthalate, polyvinyl acetate phthalate and polyphthylate polyvinyl acetate and at least one pH independent binder, wherein the compressed tablet contains about 350 to 800 mg of ranolazine.
RU2001109431/14A 1998-09-10 1999-09-09 Ranolazine preparations with prolonged effect RU2214233C2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US9980498P 1998-09-10 1998-09-10
US60/099,804 1998-09-10
US09/321,522 US6303607B1 (en) 1998-09-10 1999-05-27 Method for administering a sustained release ranolanolazine formulation
US09/321,522 1999-05-27

Publications (2)

Publication Number Publication Date
RU2001109431A true RU2001109431A (en) 2003-05-20
RU2214233C2 RU2214233C2 (en) 2003-10-20

Family

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RU2001109432/14A RU2207856C2 (en) 1998-09-10 1999-09-09 Method of treatment of cardiovascular diseases
RU2001109431/14A RU2214233C2 (en) 1998-09-10 1999-09-09 Ranolazine preparations with prolonged effect

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RU2001109432/14A RU2207856C2 (en) 1998-09-10 1999-09-09 Method of treatment of cardiovascular diseases

Country Status (33)

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US (14) US6303607B1 (en)
EP (3) EP1096937B9 (en)
JP (2) JP3745621B2 (en)
KR (1) KR100475759B1 (en)
CN (2) CN1211086C (en)
AR (3) AR022085A1 (en)
AT (2) ATE217794T1 (en)
AU (4) AU760435B2 (en)
BR (2) BR9913626A (en)
CA (2) CA2342390C (en)
CY (1) CY2008020I2 (en)
CZ (2) CZ301341B6 (en)
DE (3) DE122008000065I1 (en)
DK (2) DK1109558T3 (en)
ES (2) ES2234302T3 (en)
FR (1) FR09C0001I2 (en)
GE (1) GEP20053420B (en)
HK (2) HK1040060A1 (en)
HU (2) HU224215B1 (en)
IL (6) IL141893A0 (en)
LU (1) LU91504I2 (en)
MX (2) MXPA01002598A (en)
NL (1) NL300371I2 (en)
NO (4) NO319434B1 (en)
NZ (2) NZ510386A (en)
PL (3) PL196263B1 (en)
PT (2) PT1096937E (en)
RU (2) RU2207856C2 (en)
SI (2) SI1109558T1 (en)
TR (2) TR200101262T2 (en)
TW (1) TWI241911B (en)
UA (2) UA67793C2 (en)
WO (2) WO2000013687A2 (en)

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