PE20061126A1 - SOLID ORAL DOSAGE FORMS CONTAINING A LOW DOSE OF ESTRADIOL - Google Patents
SOLID ORAL DOSAGE FORMS CONTAINING A LOW DOSE OF ESTRADIOLInfo
- Publication number
- PE20061126A1 PE20061126A1 PE2005001279A PE2005001279A PE20061126A1 PE 20061126 A1 PE20061126 A1 PE 20061126A1 PE 2005001279 A PE2005001279 A PE 2005001279A PE 2005001279 A PE2005001279 A PE 2005001279A PE 20061126 A1 PE20061126 A1 PE 20061126A1
- Authority
- PE
- Peru
- Prior art keywords
- estradiol
- oral dosage
- dosage form
- solid oral
- dosage forms
- Prior art date
Links
Classifications
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/06—Antimigraine agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/30—Oestrogens
Abstract
SE REFIERE A UNA FORMA DE DOSIFICACION ORAL SOLIDA QUE COMPRENDE ESTRADIOL, UN HIDRATO, UNA SAL O UN DERIVADO DEL MISMO EN UNA CANTIDAD EQUIVALENTE ENTRE 0,01mg Y 0,5mg DE HEMIHIDRATO DE ESTRADIOL Y AL MENOS UN EXCIPIENTE FARMACEUTICAMENTE ACEPTABLE TENIENDO EN CUENTA QUE CUANDO HAY POLIVINILPIRROLIDONA LA RELACION DE PESO ENTRE LA POLIVILPIRROLIDONA Y EL ESTRADIOL ES MENOR QUE 10:1. EL DERIVADO DE ESTRADIOL ES SELECCIONADO DE VALERATO DE ESTRADIOL, ACETATO DE ESTRADIOL, PROPIONATO DE ESTRADIOL, BENZOATO DE ESTRADIOL, ENTRE OTROS. SE REFIERE TAMBIEN A LA FORMA DE DOSIFICACION CARACTERIZADA PORQUE MAS DE 70%, 80% o 90% DE ESTRADIOL SE DISUELVE EN 30 MINUTOS DONDE LA DETERMINACION SE REALIZA MEDIANTE EL SISTEMA DE PALETAS USANDO 900 ml DE AGUA A 37°C COMO MEDIO DE DISOLUCION Y 50 rpm COMO VELOCIDAD DE ROTACION. LA FORMA DE DOSIFICACION ORAL COMPRENDE UNA CANTIDAD DE HEMIHIDRATO DE ESTRADIOL ENTRE 0,05mg Y 0,4mg SIENDO UTIL EN EL TRATAMIENTO DE UNA CONDICION FISICA PROVOCADA POR LOS NIVELES ENDOGENOS INSUFICIENTES DE ESTRADIOLREFERS TO A SOLID ORAL DOSAGE FORM THAT INCLUDES ESTRADIOL, A HYDRATE, A SALT OR A DERIVATIVE OF THE SAME IN AN EQUIVALENT QUANTITY BETWEEN 0.01mg AND 0.5mg OF ESTRADIOL HEMIHYDRATE AND AT LEAST ONE EXCIPIENT STRADIOLLY ACCEPTED BY PHARMACEUTICALLY ACCEPTABLE WHEN THERE IS POLYVINYLPYRROLIDONE, THE WEIGHT RATIO BETWEEN POLYVYLPYRROLIDONE AND ESTRADIOL IS LESS THAN 10: 1. THE ESTRADIOL DERIVATIVE IS SELECTED FROM ESTRADIOL VALERATE, ESTRADIOL ACETATE, ESTRADIOL PROPIONATE, ESTRADIOL BENZOATE, AMONG OTHERS. IT ALSO REFERS TO THE CHARACTERIZED DOSAGE FORM BECAUSE MORE THAN 70%, 80% or 90% OF ESTRADIOL IS DISSOLVED IN 30 MINUTES WHERE THE DETERMINATION IS PERFORMED BY THE PADDLE SYSTEM USING 900 ml OF WATER AT 37 ° C AS A DISSOLUTION MEANS AND 50 rpm AS ROTATION SPEED. THE ORAL DOSAGE FORM INCLUDES AN AMOUNT OF ESTRADIOL HEMIHYDRATE BETWEEN 0.05mg AND 0.4mg BEING USEFUL IN THE TREATMENT OF A PHYSICAL CONDITION CAUSED BY INSUFFICIENT ENDOGENE LEVELS OF ESTRADIOL
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP04078014 | 2004-11-02 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20061126A1 true PE20061126A1 (en) | 2006-11-11 |
Family
ID=34928627
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2005001279A PE20061126A1 (en) | 2004-11-02 | 2005-11-02 | SOLID ORAL DOSAGE FORMS CONTAINING A LOW DOSE OF ESTRADIOL |
Country Status (21)
| Country | Link |
|---|---|
| EP (1) | EP1814526A2 (en) |
| JP (1) | JP2008518895A (en) |
| KR (1) | KR20070085558A (en) |
| CN (1) | CN101094656A (en) |
| AR (1) | AR053650A1 (en) |
| AU (1) | AU2005300658A1 (en) |
| BR (1) | BRPI0517940A (en) |
| CA (1) | CA2585095A1 (en) |
| CR (1) | CR9112A (en) |
| CU (1) | CU20070094A7 (en) |
| EA (1) | EA013262B1 (en) |
| GT (1) | GT200500315A (en) |
| IL (1) | IL182635A0 (en) |
| MX (1) | MX2007005281A (en) |
| NO (1) | NO20072704L (en) |
| PA (1) | PA8651401A1 (en) |
| PE (1) | PE20061126A1 (en) |
| TW (1) | TW200621312A (en) |
| UY (1) | UY29185A1 (en) |
| WO (1) | WO2006048261A2 (en) |
| ZA (1) | ZA200705012B (en) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8022053B2 (en) | 2004-11-02 | 2011-09-20 | Bayer Schering Pharma Aktiengesellschaft | Oral solid dosage forms containing a low dose of estradiol |
| KR20080047957A (en) * | 2006-11-27 | 2008-05-30 | 주식회사 엠디바이오알파 | Pharmaceutical composition for treatment and prevention of hypertension |
| DE102009007771B4 (en) | 2009-02-05 | 2012-02-16 | Bayer Schering Pharma Aktiengesellschaft | Buccal administration system containing 17α-estradiol |
| WO2011128336A1 (en) | 2010-04-15 | 2011-10-20 | Bayer Pharma Aktiengesellschaft | Very low-dosed solid oral dosage forms for hrt |
| WO2011128337A2 (en) | 2010-04-15 | 2011-10-20 | Bayer Pharma Aktiengesellschaft | Low-dosed solid oral dosage forms for hrt |
| CN112516149B (en) * | 2020-07-21 | 2023-07-18 | 南方医科大学 | Application of estradiol benzoate or pharmaceutically acceptable salt thereof in preparation of anti-coronavirus drugs |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NL125071C (en) * | 1963-12-24 | |||
| US4755386A (en) * | 1986-01-22 | 1988-07-05 | Schering Corporation | Buccal formulation |
| US5073374A (en) * | 1988-11-30 | 1991-12-17 | Schering Corporation | Fast dissolving buccal tablet |
| FR2739558B1 (en) * | 1995-10-05 | 1997-11-28 | Innothera Lab Sa | UNITAL GALENIC FORM FOR LOCAL HORMONOTHERAPY OF VAGINAL DROUGHT |
| FR2754179B1 (en) * | 1996-10-08 | 1998-12-24 | Theramex | NOVEL HORMONONAL COMPOSITION AND ITS USE |
| US6326366B1 (en) * | 2000-08-22 | 2001-12-04 | Protein Technologies International | Hormone replacement therapy |
| WO2002036144A1 (en) * | 2000-10-30 | 2002-05-10 | University Of Zurich | Gnrh analogues for treatment of urinary incontinence |
| EP3747443A3 (en) * | 2000-12-15 | 2021-03-03 | Novo Nordisk Health Care AG | Use of an oestrogen in the manufacture of a composition containing oestrogen for the treatment of atrophic vaginitis |
| FR2823976A1 (en) * | 2001-04-25 | 2002-10-31 | Theramex | NOVEL HORMONAL COMPOSITION AND ITS USE |
| US20030018018A1 (en) * | 2001-07-10 | 2003-01-23 | Medical College Of Hampton Roads | Ultra low dose oral contraceptives with sustained efficacy and induced amenorrhea |
| US6962908B2 (en) * | 2001-12-21 | 2005-11-08 | Warner Chilcott Company Inc. | Oral pharmaceutical products containing 17 β-estradiol-3-lower alkanoate, method of administering the same and process of preparation |
| JP2004155779A (en) * | 2002-10-16 | 2004-06-03 | Taisho Pharmaceut Co Ltd | Peroral composition for preventing and treating climacteric symptom |
-
2005
- 2005-10-31 GT GT200500315A patent/GT200500315A/en unknown
- 2005-10-31 UY UY29185A patent/UY29185A1/en not_active Application Discontinuation
- 2005-11-01 CA CA002585095A patent/CA2585095A1/en not_active Abandoned
- 2005-11-01 MX MX2007005281A patent/MX2007005281A/en not_active Application Discontinuation
- 2005-11-01 JP JP2007538360A patent/JP2008518895A/en active Pending
- 2005-11-01 EP EP05800512A patent/EP1814526A2/en not_active Withdrawn
- 2005-11-01 CN CNA200580045694XA patent/CN101094656A/en active Pending
- 2005-11-01 BR BRPI0517940-8A patent/BRPI0517940A/en not_active IP Right Cessation
- 2005-11-01 TW TW094138264A patent/TW200621312A/en unknown
- 2005-11-01 AU AU2005300658A patent/AU2005300658A1/en not_active Abandoned
- 2005-11-01 KR KR1020077012174A patent/KR20070085558A/en not_active Application Discontinuation
- 2005-11-01 EA EA200700979A patent/EA013262B1/en not_active IP Right Cessation
- 2005-11-01 WO PCT/EP2005/011726 patent/WO2006048261A2/en active Application Filing
- 2005-11-02 AR ARP050104580A patent/AR053650A1/en unknown
- 2005-11-02 PE PE2005001279A patent/PE20061126A1/en not_active Application Discontinuation
- 2005-11-02 PA PA20058651401A patent/PA8651401A1/en unknown
-
2007
- 2007-04-18 IL IL182635A patent/IL182635A0/en unknown
- 2007-04-30 CU CU20070094A patent/CU20070094A7/en unknown
- 2007-05-09 CR CR9112A patent/CR9112A/en not_active Application Discontinuation
- 2007-05-29 NO NO20072704A patent/NO20072704L/en not_active Application Discontinuation
- 2007-06-01 ZA ZA200705012A patent/ZA200705012B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CA2585095A1 (en) | 2006-05-11 |
| WO2006048261A2 (en) | 2006-05-11 |
| GT200500315A (en) | 2006-06-06 |
| UY29185A1 (en) | 2006-05-31 |
| MX2007005281A (en) | 2008-03-11 |
| EP1814526A2 (en) | 2007-08-08 |
| WO2006048261A3 (en) | 2006-09-21 |
| IL182635A0 (en) | 2007-07-24 |
| ZA200705012B (en) | 2008-10-29 |
| PA8651401A1 (en) | 2006-12-07 |
| TW200621312A (en) | 2006-07-01 |
| BRPI0517940A (en) | 2008-10-21 |
| AU2005300658A1 (en) | 2006-05-11 |
| CU20070094A7 (en) | 2009-09-08 |
| NO20072704L (en) | 2007-05-29 |
| CR9112A (en) | 2007-11-23 |
| JP2008518895A (en) | 2008-06-05 |
| KR20070085558A (en) | 2007-08-27 |
| CN101094656A (en) | 2007-12-26 |
| EA200700979A1 (en) | 2007-10-26 |
| AR053650A1 (en) | 2007-05-16 |
| EA013262B1 (en) | 2010-04-30 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FC | Refusal |