TWI332400B - Preformulation for the tableting of natural mixtures of conjugated estrogens - Google Patents
Preformulation for the tableting of natural mixtures of conjugated estrogens Download PDFInfo
- Publication number
- TWI332400B TWI332400B TW091134752A TW91134752A TWI332400B TW I332400 B TWI332400 B TW I332400B TW 091134752 A TW091134752 A TW 091134752A TW 91134752 A TW91134752 A TW 91134752A TW I332400 B TWI332400 B TW I332400B
- Authority
- TW
- Taiwan
- Prior art keywords
- prescription drug
- pharmaceutical
- content
- estrogen
- weight
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims description 79
- 229940035811 conjugated estrogen Drugs 0.000 title claims description 41
- 239000000284 extract Substances 0.000 claims description 93
- 239000000955 prescription drug Substances 0.000 claims description 78
- 238000000034 method Methods 0.000 claims description 76
- 229940088597 hormone Drugs 0.000 claims description 71
- 239000005556 hormone Substances 0.000 claims description 71
- 229940011871 estrogen Drugs 0.000 claims description 64
- 239000000262 estrogen Substances 0.000 claims description 64
- 239000002245 particle Substances 0.000 claims description 61
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- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 48
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 48
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 48
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 48
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- DNXHEGUUPJUMQT-UHFFFAOYSA-N (+)-estrone Natural products OC1=CC=C2C3CCC(C)(C(CC4)=O)C4C3CCC2=C1 DNXHEGUUPJUMQT-UHFFFAOYSA-N 0.000 claims description 37
- DNXHEGUUPJUMQT-CBZIJGRNSA-N Estrone Chemical compound OC1=CC=C2[C@H]3CC[C@](C)(C(CC4)=O)[C@@H]4[C@@H]3CCC2=C1 DNXHEGUUPJUMQT-CBZIJGRNSA-N 0.000 claims description 37
- 229960003399 estrone Drugs 0.000 claims description 37
- 239000000463 material Substances 0.000 claims description 37
- 239000003937 drug carrier Substances 0.000 claims description 36
- 239000012876 carrier material Substances 0.000 claims description 32
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 31
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- VOXZDWNPVJITMN-ZBRFXRBCSA-N 17β-estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 VOXZDWNPVJITMN-ZBRFXRBCSA-N 0.000 claims description 10
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- FJJCIZWZNKZHII-UHFFFAOYSA-N [4,6-bis(cyanoamino)-1,3,5-triazin-2-yl]cyanamide Chemical compound N#CNC1=NC(NC#N)=NC(NC#N)=N1 FJJCIZWZNKZHII-UHFFFAOYSA-N 0.000 claims 1
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- 238000012360 testing method Methods 0.000 description 50
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- 229920003084 Avicel® PH-102 Polymers 0.000 description 7
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 description 7
- 238000012545 processing Methods 0.000 description 7
- VOXZDWNPVJITMN-SFFUCWETSA-N 17α-estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 VOXZDWNPVJITMN-SFFUCWETSA-N 0.000 description 6
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- 239000007788 liquid Substances 0.000 description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 5
- 235000019888 Vivapur Nutrition 0.000 description 5
- 239000003098 androgen Substances 0.000 description 5
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- 239000007858 starting material Substances 0.000 description 5
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 4
- 238000009472 formulation Methods 0.000 description 4
- 150000002576 ketones Chemical class 0.000 description 4
- 239000011159 matrix material Substances 0.000 description 4
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- 229930182834 17alpha-Estradiol Natural products 0.000 description 3
- 241000283086 Equidae Species 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 241000282320 Panthera leo Species 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 description 3
- 239000004202 carbamide Substances 0.000 description 3
- HVDGDHBAMCBBLR-UHFFFAOYSA-N enterolactone Chemical compound OC1=CC=CC(CC2C(C(=O)OC2)CC=2C=C(O)C=CC=2)=C1 HVDGDHBAMCBBLR-UHFFFAOYSA-N 0.000 description 3
- 229960002179 ephedrine Drugs 0.000 description 3
- VUCAHVBMSFIGAI-ZFINNJDLSA-M estrone sodium sulfate Chemical compound [Na+].[O-]S(=O)(=O)OC1=CC=C2[C@H]3CC[C@](C)(C(CC4)=O)[C@@H]4[C@@H]3CCC2=C1 VUCAHVBMSFIGAI-ZFINNJDLSA-M 0.000 description 3
- 239000007937 lozenge Substances 0.000 description 3
- 239000000843 powder Substances 0.000 description 3
- 229960000747 sodium estrone sulfate Drugs 0.000 description 3
- OUGSRCWSHMWPQE-WMZOPIPTSA-N (13s,14s)-3-hydroxy-13-methyl-7,11,12,14,15,16-hexahydro-6h-cyclopenta[a]phenanthren-17-one Chemical compound OC1=CC=C2C(CC[C@]3([C@H]4CCC3=O)C)=C4CCC2=C1 OUGSRCWSHMWPQE-WMZOPIPTSA-N 0.000 description 2
- QTWJRLJHJPIABL-UHFFFAOYSA-N 2-methylphenol;3-methylphenol;4-methylphenol Chemical compound CC1=CC=C(O)C=C1.CC1=CC=CC(O)=C1.CC1=CC=CC=C1O QTWJRLJHJPIABL-UHFFFAOYSA-N 0.000 description 2
- 241000255925 Diptera Species 0.000 description 2
- 108010010803 Gelatin Proteins 0.000 description 2
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 description 2
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- 230000002411 adverse Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 229930003836 cresol Natural products 0.000 description 2
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- 235000011852 gelatine desserts Nutrition 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
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- UBXAKNTVXQMEAG-UHFFFAOYSA-L strontium sulfate Chemical compound [Sr+2].[O-]S([O-])(=O)=O UBXAKNTVXQMEAG-UHFFFAOYSA-L 0.000 description 2
- 239000000758 substrate Substances 0.000 description 2
- 229910021653 sulphate ion Inorganic materials 0.000 description 2
- HUUTWYHKKBIOMQ-UHFFFAOYSA-N 3-[(3-hydroxyphenyl)methyl]-3h-furan-2-one Chemical compound OC1=CC=CC(CC2C(OC=C2)=O)=C1 HUUTWYHKKBIOMQ-UHFFFAOYSA-N 0.000 description 1
- 125000004208 3-hydroxyphenyl group Chemical group [H]OC1=C([H])C([H])=C([H])C(*)=C1[H] 0.000 description 1
- 244000144730 Amygdalus persica Species 0.000 description 1
- 206010003439 Artificial menopause Diseases 0.000 description 1
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 1
- 235000014647 Lens culinaris subsp culinaris Nutrition 0.000 description 1
- 244000043158 Lens esculenta Species 0.000 description 1
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- UPYKUZBSLRQECL-UKMVMLAPSA-N Lycopene Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1C(=C)CCCC1(C)C)C=CC=C(/C)C=CC2C(=C)CCCC2(C)C UPYKUZBSLRQECL-UKMVMLAPSA-N 0.000 description 1
- JEVVKJMRZMXFBT-XWDZUXABSA-N Lycophyll Natural products OC/C(=C/CC/C(=C\C=C\C(=C/C=C/C(=C\C=C\C=C(/C=C/C=C(\C=C\C=C(/CC/C=C(/CO)\C)\C)/C)\C)/C)\C)/C)/C JEVVKJMRZMXFBT-XWDZUXABSA-N 0.000 description 1
- UFWIBTONFRDIAS-UHFFFAOYSA-N Naphthalene Chemical compound C1=CC=CC2=CC=CC=C21 UFWIBTONFRDIAS-UHFFFAOYSA-N 0.000 description 1
- 229930192627 Naphthoquinone Natural products 0.000 description 1
- 244000131316 Panax pseudoginseng Species 0.000 description 1
- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 description 1
- 235000003140 Panax quinquefolius Nutrition 0.000 description 1
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- 229910000831 Steel Inorganic materials 0.000 description 1
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- 239000002671 adjuvant Substances 0.000 description 1
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- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 229910052802 copper Inorganic materials 0.000 description 1
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- 238000002657 hormone replacement therapy Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-M hydroxide Chemical compound [OH-] XLYOFNOQVPJJNP-UHFFFAOYSA-M 0.000 description 1
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- 150000002597 lactoses Chemical class 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- OAIJSZIZWZSQBC-GYZMGTAESA-N lycopene Chemical compound CC(C)=CCC\C(C)=C\C=C\C(\C)=C\C=C\C(\C)=C\C=C\C=C(/C)\C=C\C=C(/C)\C=C\C=C(/C)CCC=C(C)C OAIJSZIZWZSQBC-GYZMGTAESA-N 0.000 description 1
- 229960004999 lycopene Drugs 0.000 description 1
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- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 239000006082 mold release agent Substances 0.000 description 1
- 150000002791 naphthoquinones Chemical class 0.000 description 1
- 229930014626 natural product Natural products 0.000 description 1
- 230000009965 odorless effect Effects 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N phenol group Chemical group C1(=CC=CC=C1)O ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 1
- 238000006116 polymerization reaction Methods 0.000 description 1
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- 229920003124 powdered cellulose Polymers 0.000 description 1
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- 238000002203 pretreatment Methods 0.000 description 1
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- 239000011734 sodium Substances 0.000 description 1
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Diabetes (AREA)
- Reproductive Health (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP01129840 | 2001-12-14 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| TW200408400A TW200408400A (en) | 2004-06-01 |
| TWI332400B true TWI332400B (en) | 2010-11-01 |
Family
ID=8179550
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW091134752A TWI332400B (en) | 2001-12-14 | 2002-11-29 | Preformulation for the tableting of natural mixtures of conjugated estrogens |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US8273728B2 (enExample) |
| EP (1) | EP1458363B1 (enExample) |
| JP (1) | JP4695838B2 (enExample) |
| CN (2) | CN100502839C (enExample) |
| AR (1) | AR037642A1 (enExample) |
| AU (1) | AU2002358682B2 (enExample) |
| BR (1) | BR0214954A (enExample) |
| CA (1) | CA2470209A1 (enExample) |
| ES (1) | ES2403218T3 (enExample) |
| MX (1) | MXPA04005767A (enExample) |
| PL (1) | PL205544B1 (enExample) |
| TW (1) | TWI332400B (enExample) |
| WO (1) | WO2003051337A1 (enExample) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9586335B2 (en) * | 2010-01-27 | 2017-03-07 | Sd3, Llc | Blade guard with dust collection |
| TWI332400B (en) * | 2001-12-14 | 2010-11-01 | Solvay Pharm Gmbh | Preformulation for the tableting of natural mixtures of conjugated estrogens |
| US8349819B2 (en) | 2002-10-09 | 2013-01-08 | Dr. Reddy's Laboratories New York, Inc. | Steroid extraction process from urine sources |
| US6992075B2 (en) * | 2003-04-04 | 2006-01-31 | Barr Laboratories, Inc. | C(14) estrogenic compounds |
| US8497258B2 (en) | 2005-11-12 | 2013-07-30 | The Regents Of The University Of California | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract |
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| US3487152A (en) * | 1967-02-07 | 1969-12-30 | Hoffmann La Roche | Tablets containing 7 - chloro - 2 - methylamino - 5 - phenyl - 3h - 1,4 - benzodiazepine-4-oxide and conjugated estrogenic substances |
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-
2002
- 2002-11-29 TW TW091134752A patent/TWI332400B/zh not_active IP Right Cessation
- 2002-12-04 AR ARP020104698A patent/AR037642A1/es unknown
- 2002-12-12 CA CA002470209A patent/CA2470209A1/en not_active Abandoned
- 2002-12-12 CN CNB2006101684418A patent/CN100502839C/zh not_active Expired - Fee Related
- 2002-12-12 PL PL368730A patent/PL205544B1/pl unknown
- 2002-12-12 MX MXPA04005767A patent/MXPA04005767A/es active IP Right Grant
- 2002-12-12 CN CNB028262077A patent/CN1298313C/zh not_active Expired - Fee Related
- 2002-12-12 WO PCT/EP2002/014104 patent/WO2003051337A1/de not_active Ceased
- 2002-12-12 EP EP02792980A patent/EP1458363B1/de not_active Expired - Lifetime
- 2002-12-12 AU AU2002358682A patent/AU2002358682B2/en not_active Ceased
- 2002-12-12 BR BR0214954-0A patent/BR0214954A/pt not_active IP Right Cessation
- 2002-12-12 ES ES02792980T patent/ES2403218T3/es not_active Expired - Lifetime
- 2002-12-12 JP JP2003552270A patent/JP4695838B2/ja not_active Expired - Fee Related
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Also Published As
| Publication number | Publication date |
|---|---|
| PL368730A1 (en) | 2005-04-04 |
| CN100502839C (zh) | 2009-06-24 |
| CN1298313C (zh) | 2007-02-07 |
| TW200408400A (en) | 2004-06-01 |
| CN1607944A (zh) | 2005-04-20 |
| HK1075007A1 (en) | 2005-12-02 |
| CA2470209A1 (en) | 2003-06-26 |
| CN1977862A (zh) | 2007-06-13 |
| ES2403218T3 (es) | 2013-05-16 |
| AU2002358682A1 (en) | 2003-06-30 |
| JP4695838B2 (ja) | 2011-06-08 |
| AU2002358682B2 (en) | 2009-03-26 |
| BR0214954A (pt) | 2004-12-14 |
| JP2005516923A (ja) | 2005-06-09 |
| US20120237666A1 (en) | 2012-09-20 |
| US8329679B2 (en) | 2012-12-11 |
| EP1458363B1 (de) | 2013-01-16 |
| HK1104220A1 (zh) | 2008-01-11 |
| WO2003051337A1 (de) | 2003-06-26 |
| PL205544B1 (pl) | 2010-04-30 |
| MXPA04005767A (es) | 2004-09-10 |
| AR037642A1 (es) | 2004-11-17 |
| US8273728B2 (en) | 2012-09-25 |
| EP1458363A1 (de) | 2004-09-22 |
| US20050009800A1 (en) | 2005-01-13 |
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