BR9815350A - Composição de pré-concentrado de microemulsão contendo ciclosporina e formulação farmacêutica incluindo uma composição de pré-concentrado de microemulsão contendo ciclosporina - Google Patents
Composição de pré-concentrado de microemulsão contendo ciclosporina e formulação farmacêutica incluindo uma composição de pré-concentrado de microemulsão contendo ciclosporinaInfo
- Publication number
- BR9815350A BR9815350A BR9815350-1A BR9815350A BR9815350A BR 9815350 A BR9815350 A BR 9815350A BR 9815350 A BR9815350 A BR 9815350A BR 9815350 A BR9815350 A BR 9815350A
- Authority
- BR
- Brazil
- Prior art keywords
- present
- microemulsion
- hydrophilic solvent
- composition
- composition containing
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 9
- 239000004530 micro-emulsion Substances 0.000 title abstract 6
- PMATZTZNYRCHOR-CGLBZJNRSA-N Cyclosporin A Chemical compound CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O PMATZTZNYRCHOR-CGLBZJNRSA-N 0.000 title abstract 5
- 108010036949 Cyclosporine Proteins 0.000 title abstract 5
- 229960001265 ciclosporin Drugs 0.000 title abstract 5
- 229930182912 cyclosporin Natural products 0.000 title abstract 5
- 239000012141 concentrate Substances 0.000 title abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- 239000002904 solvent Substances 0.000 abstract 5
- 239000007901 soft capsule Substances 0.000 abstract 3
- 229930105110 Cyclosporin A Natural products 0.000 abstract 2
- 108010010803 Gelatin Proteins 0.000 abstract 2
- 239000012530 fluid Substances 0.000 abstract 2
- 229920000159 gelatin Polymers 0.000 abstract 2
- 239000008273 gelatin Substances 0.000 abstract 2
- 235000019322 gelatine Nutrition 0.000 abstract 2
- 235000011852 gelatine desserts Nutrition 0.000 abstract 2
- 239000002253 acid Substances 0.000 abstract 1
- 125000005907 alkyl ester group Chemical group 0.000 abstract 1
- 239000002775 capsule Substances 0.000 abstract 1
- 125000003262 carboxylic acid ester group Chemical class [H]C([H])([*:2])OC(=O)C([H])([H])[*:1] 0.000 abstract 1
- 239000002552 dosage form Substances 0.000 abstract 1
- 230000002496 gastric effect Effects 0.000 abstract 1
- 239000007902 hard capsule Substances 0.000 abstract 1
- 230000000968 intestinal effect Effects 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 229920005862 polyol Polymers 0.000 abstract 1
- 150000003077 polyols Chemical class 0.000 abstract 1
- 230000009257 reactivity Effects 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
- A61K38/13—Cyclosporins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
- A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Dispersion Chemistry (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Transplantation (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
"COMPOSIçãO DE PRé-CONCENTRADO DE MICROEMULSãO CONTENDO CICLOSPORINA E FORMULAçãO FARMACêUTICA INCLUINDO UMA COMPOSIçãO DE PRé-CONCENTRADO DE MICROEMULSãO CONTENDO CICLOSPORINA". Sendo que a presente invenção relaciona-se a uma composição de pré-concentrado de microemulsão que inclui (1) ciclosporina como componente ativo; (2) alquil éster de ácido policarboxílico e/ou éster de ácido carboxílico de polióis como solvente lipofílico; (3) óleo; e (4) tensoativo. A composição de acordo com a presente invenção é caracterizada pelo fato que dissolve-se numa fase externa como água, fluido gástrico artificial e fluido intestinal artificial controlando a relação de mistura dos componentes da mesma para obter a forma de microemulsão da fase interna com diâmetro de 10nm ou inferior. A composição de acordo com a presente invenção pode ser formulada na forma de dosagem de uma cápsula mole, uma cápsula dura selada com tira de gelatina na parte conjugada, ou uma preparação de líquido para administração oral. Especialmente, no caso em que a composição conforme a presente invenção for formulada numa cápsula mole, a cápsula resultante não apresenta desvantagens das técnicas anteriores como a reatividade do solvente hidrofílico com envelope de gelatina da cápsula mole e a volatilidade do solvente hidrofílico. Ao contrário das patentes existentes que usam um solvente hidrofílico como componente essencial de suas composições, a presente invenção não usa qualquer solvente hidrofílico.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR19970066454 | 1997-12-05 | ||
| KR19980010046 | 1998-03-24 | ||
| KR1019980015309A KR19990076462A (ko) | 1997-12-05 | 1998-04-29 | 사이클로스포린-함유 마이크로에멀젼 예비농축액 조성물 |
| KR1019980024207A KR19990066706A (ko) | 1997-03-24 | 1998-06-25 | 사이클로스포린-함유 마이크로에멀젼 예비농축액 조성물 |
| PCT/KR1998/000315 WO1999000002A2 (en) | 1997-12-05 | 1998-10-16 | Cyclosporin-containing microemulsion preconcentrate composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR9815350A true BR9815350A (pt) | 2001-10-16 |
Family
ID=27483248
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR9815350-1A BR9815350A (pt) | 1997-12-05 | 1998-10-16 | Composição de pré-concentrado de microemulsão contendo ciclosporina e formulação farmacêutica incluindo uma composição de pré-concentrado de microemulsão contendo ciclosporina |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US6063762A (pt) |
| EP (1) | EP1035862B1 (pt) |
| JP (1) | JP2001517602A (pt) |
| CN (1) | CN1280502A (pt) |
| AR (1) | AR017801A1 (pt) |
| AT (1) | ATE244573T1 (pt) |
| AU (1) | AU9465898A (pt) |
| BR (1) | BR9815350A (pt) |
| CA (1) | CA2313015A1 (pt) |
| DE (1) | DE69816335T2 (pt) |
| HU (1) | HUP0004379A2 (pt) |
| IL (1) | IL136444A0 (pt) |
| NO (1) | NO20002800L (pt) |
| NZ (1) | NZ504844A (pt) |
| WO (1) | WO1999000002A2 (pt) |
Families Citing this family (40)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB9325445D0 (en) | 1993-12-13 | 1994-02-16 | Cortecs Ltd | Pharmaceutical formulations |
| US5858401A (en) * | 1996-01-22 | 1999-01-12 | Sidmak Laboratories, Inc. | Pharmaceutical composition for cyclosporines |
| US6465016B2 (en) * | 1996-08-22 | 2002-10-15 | Research Triangle Pharmaceuticals | Cyclosporiine particles |
| WO1998047486A1 (en) * | 1997-04-18 | 1998-10-29 | Taisho Pharmaceutical Co., Ltd. | Microemulsion |
| KR100587551B1 (ko) * | 1997-12-10 | 2006-06-08 | 싸이클로스포린 테라퓨틱스 리미티드 | 오메가-3 지방산 오일을 함유하는 약학 조성물 |
| ID25908A (id) * | 1998-03-06 | 2000-11-09 | Novartis Ag | Prakonsentrat-prakonsentrat emulsi yang mengandung siklosporin atau makrolida |
| GB2380673B (en) * | 1998-03-06 | 2003-05-28 | Novartis Ag | Emulsion preconcentrates containing cyclosporin or a macrolide |
| US6979456B1 (en) | 1998-04-01 | 2005-12-27 | Jagotec Ag | Anticancer compositions |
| KR100635456B1 (ko) | 1998-05-29 | 2006-10-18 | 스키에파마 캐나다 인코포레이티드 | 열보호화 마이크로입자 조성물 및 그의 말단의 스팀멸균방법 |
| EP1105096B1 (en) | 1998-08-19 | 2003-10-29 | Skyepharma Canada Inc. | Injectable aqueous dispersions of propofol |
| KR20010073232A (ko) | 1998-11-20 | 2001-07-31 | 추후제출 | 분산성 인지질로 안정화된 마이크로입자 |
| SE9804192D0 (sv) * | 1998-12-03 | 1998-12-03 | Scotia Lipidteknik Ab | New formulation |
| DK1154759T3 (da) | 1998-12-30 | 2008-12-08 | Dexcel Ltd | Dispergerbart koncentrat til indgift af cyclosporin |
| US6267985B1 (en) * | 1999-06-30 | 2001-07-31 | Lipocine Inc. | Clear oil-containing pharmaceutical compositions |
| GB9912476D0 (en) * | 1999-05-28 | 1999-07-28 | Novartis Ag | Organic compounds |
| AU763945B2 (en) * | 1999-06-04 | 2003-08-07 | Skyepharma Inc. | Oil-core compositions for the sustained release of hydrophobic drugs |
| GB2355656B (en) * | 1999-08-17 | 2004-04-07 | Galena As | Pharmaceutical compositions for oral and topical administration |
| AU2003254754B2 (en) * | 1999-08-17 | 2006-01-12 | Ivax Pharmaceuticals, S.R.O. | Pharmaceutical compositions for oral and topical administration |
| JP2003509453A (ja) * | 1999-09-21 | 2003-03-11 | アールティーピー・ファーマ・インコーポレーテッド | 生物学的に活性な物質の、表面改質された粒状組成物 |
| WO2001028518A1 (de) * | 1999-10-20 | 2001-04-26 | Vesifact Ag | Cyclosporine enthaltende mikroemulsion-prekonzentrate und mikroemulsionen |
| US7732404B2 (en) * | 1999-12-30 | 2010-06-08 | Dexcel Ltd | Pro-nanodispersion for the delivery of cyclosporin |
| US6623765B1 (en) * | 2000-08-01 | 2003-09-23 | University Of Florida, Research Foundation, Incorporated | Microemulsion and micelle systems for solubilizing drugs |
| JP4391673B2 (ja) * | 2000-08-08 | 2009-12-24 | 花王株式会社 | 油脂組成物 |
| JP2005500314A (ja) | 2001-06-21 | 2005-01-06 | ファイザー・プロダクツ・インク | コレステロールエステル転送蛋白インヒビターの自己乳化性製剤 |
| US6960563B2 (en) * | 2001-08-31 | 2005-11-01 | Morton Grove Pharmaceuticals, Inc. | Spontaneous emulsions containing cyclosporine |
| US6479060B1 (en) | 2001-09-04 | 2002-11-12 | Healthpoint, Ltd. | Elegant hydrogenated castor oil ointments |
| ATE437629T1 (de) * | 2001-10-19 | 2009-08-15 | Isotechnika Inc | Neue cyclosporin-analoge mikroemulsionsvorkonzentrate |
| ITBS20010111A1 (it) * | 2001-12-20 | 2003-06-20 | Paoli Ambrosi Gianfranco De | Composizione per uso topico a base dell'estere etilico dell'acido linoleico e e del trietil estere dell'acido citrico associati con opportun |
| KR100441167B1 (ko) * | 2001-12-27 | 2004-07-21 | 씨제이 주식회사 | 마이크로에멀젼 예비 농축액 조성물 |
| US7182950B2 (en) * | 2002-06-12 | 2007-02-27 | Nutralease Ltd. | Nano-sized self-assembled liquid dilutable vehicles |
| DE10226990A1 (de) * | 2002-06-18 | 2004-03-18 | Sanguibiotech Ag | Topisch applizierbare Mikro-Emulsionen mit binärer Phasen- und Wirkstoffdifferenzierbarkeit, deren Herstellung und deren Verwendung, insbesondere zur Versorgung der Haut mit bioverfügbarem Sauerstoff |
| CN101141953A (zh) * | 2005-03-21 | 2008-03-12 | 伊瓦克斯制药有限公司 | 结晶抑制剂及其在明胶胶囊中的用途 |
| CN100478025C (zh) * | 2005-03-25 | 2009-04-15 | 中国科学院上海药物研究所 | 一种环孢菌素a眼用微乳制剂及其制备方法 |
| JP4842553B2 (ja) * | 2005-03-30 | 2011-12-21 | 株式会社ナリス化粧品 | ヒドロキシカルボン酸エステルを用いてナノ乳化粒子を安定化させる方法及びナノ乳化粒子を含有する皮膚外用剤 |
| BRPI0520704A2 (pt) * | 2005-11-30 | 2009-05-19 | Generex Pharm Inc | formulação farmacêutica absorvida oralmente e método de administração |
| US10137083B2 (en) * | 2006-03-07 | 2018-11-27 | SGN Nanopharma Inc | Ophthalmic preparations |
| CA2645080A1 (en) * | 2006-03-07 | 2007-09-13 | Novavax,Inc. | Nanoemulsions of poorly soluble pharmaceutical active ingredients and methods of making the same |
| US11311477B2 (en) | 2006-03-07 | 2022-04-26 | Sgn Nanopharma Inc. | Ophthalmic preparations |
| WO2008058366A1 (en) * | 2006-09-28 | 2008-05-22 | Université de Montréal | Oil-in-water emulsions, methods of use thereof, methods of preparation thereof and kits thereof |
| WO2009042114A2 (en) | 2007-09-21 | 2009-04-02 | The Johns Hopkins University | Phenazine derivatives and uses thereof |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FI65914C (fi) * | 1978-03-07 | 1984-08-10 | Sandoz Ag | Foerfarande foer framstaellning av farmaceutiska kompositionerinnehaollande cyklosporin a |
| US5639724A (en) * | 1984-07-24 | 1997-06-17 | Sandoz Ltd. | Cyclosporin galenic forms |
| GB2222770B (en) * | 1988-09-16 | 1992-07-29 | Sandoz Ltd | Pharmaceutical compositions containing cyclosporins |
| US5342625A (en) * | 1988-09-16 | 1994-08-30 | Sandoz Ltd. | Pharmaceutical compositions comprising cyclosporins |
| IT1256386B (it) * | 1992-11-13 | 1995-12-04 | Luigi Boltri | Composizioni farmaceutiche comprendenti un farmaco,una sostanza polimerica reticolata,un olio ed un agente tensioattivo |
| US5639474A (en) * | 1993-07-01 | 1997-06-17 | Hanmi Pharm. Ind., Ltd. | Cyclosporin soft capsule composition |
| GB9405304D0 (en) * | 1994-03-16 | 1994-04-27 | Scherer Ltd R P | Delivery systems for hydrophobic drugs |
| HU215966B (hu) * | 1994-11-21 | 1999-07-28 | BIOGAL Gyógyszergyár Rt. | Orálisan alkalmazható, ciklosporint tartalmazó, összetett emulzió-előkoncentrátum |
| EP0760237A1 (en) * | 1995-08-30 | 1997-03-05 | Cipla Limited | Oil-in-water microemulsions |
-
1998
- 1998-09-03 US US09/146,584 patent/US6063762A/en not_active Expired - Fee Related
- 1998-10-16 IL IL13644498A patent/IL136444A0/xx unknown
- 1998-10-16 CA CA002313015A patent/CA2313015A1/en not_active Abandoned
- 1998-10-16 WO PCT/KR1998/000315 patent/WO1999000002A2/en not_active Ceased
- 1998-10-16 HU HU0004379A patent/HUP0004379A2/hu unknown
- 1998-10-16 JP JP2000500001A patent/JP2001517602A/ja active Pending
- 1998-10-16 EP EP98947987A patent/EP1035862B1/en not_active Expired - Lifetime
- 1998-10-16 AT AT98947987T patent/ATE244573T1/de not_active IP Right Cessation
- 1998-10-16 CN CN98811777A patent/CN1280502A/zh active Pending
- 1998-10-16 AU AU94658/98A patent/AU9465898A/en not_active Abandoned
- 1998-10-16 BR BR9815350-1A patent/BR9815350A/pt not_active IP Right Cessation
- 1998-10-16 NZ NZ504844A patent/NZ504844A/en unknown
- 1998-10-16 DE DE69816335T patent/DE69816335T2/de not_active Expired - Fee Related
- 1998-12-04 AR ARP980106160A patent/AR017801A1/es not_active Application Discontinuation
-
2000
- 2000-05-31 NO NO20002800A patent/NO20002800L/no not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| HUP0004379A2 (hu) | 2001-08-28 |
| JP2001517602A (ja) | 2001-10-09 |
| DE69816335T2 (de) | 2004-04-15 |
| AU9465898A (en) | 1999-01-19 |
| CN1280502A (zh) | 2001-01-17 |
| EP1035862B1 (en) | 2003-07-09 |
| DE69816335D1 (de) | 2003-08-14 |
| NO20002800L (no) | 2000-08-03 |
| AR017801A1 (es) | 2001-10-24 |
| NZ504844A (en) | 2001-11-30 |
| CA2313015A1 (en) | 1999-01-07 |
| NO20002800D0 (no) | 2000-05-31 |
| IL136444A0 (en) | 2001-06-14 |
| WO1999000002A2 (en) | 1999-01-07 |
| US6063762A (en) | 2000-05-16 |
| EP1035862A2 (en) | 2000-09-20 |
| ATE244573T1 (de) | 2003-07-15 |
| WO1999000002A3 (en) | 1999-03-25 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B25D | Requested change of name of applicant approved |
Owner name: CHONG KUN DANG PHARMACEUTICAL CORP. (KR) Free format text: ALTERADO DE: CHONG KUN DANG CORP. |
|
| B25G | Requested change of headquarter approved |
Owner name: CHONG KUN DANG PHARMACEUTICAL CORP. (KR) Free format text: SEDE ALTERADA CONFORME SOLICITADO NA PETICAO NO 037554/SP DE 29/11/2000. |
|
| B08F | Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette] |
Free format text: REFERENTE A 6A,7A E 8A ANUIDADES. |
|
| B08K | Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette] |
Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 1890 DE 27/03/2007. |