CN1204859C - 用于雌二醇与另一种类固醇物质共同给药的透皮释药基质 - Google Patents
用于雌二醇与另一种类固醇物质共同给药的透皮释药基质 Download PDFInfo
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- CN1204859C CN1204859C CNB971965633A CN97196563A CN1204859C CN 1204859 C CN1204859 C CN 1204859C CN B971965633 A CNB971965633 A CN B971965633A CN 97196563 A CN97196563 A CN 97196563A CN 1204859 C CN1204859 C CN 1204859C
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- 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
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- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
- A61K9/7061—Polyacrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
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- 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
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- 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
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- 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
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- 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
- A61P5/26—Androgens
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- 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
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Description
制剂ID | TSR胶粘剂 | NEA | E2 | ARLACEL80 |
%w/w | %w/w | %w/w | %w/w | |
待测制剂 | ||||
1.Lot#040695-1 | 88.5 | 1.5 | 0.0 | 10.0 |
2.Lot#040695-2 | 87.0 | 3.0 | 0.0 | 10.0 |
3.Lot#040695-3 | 84.0 | 6.0 | 0.0 | 10.0 |
参比制剂 | ||||
4.参比#95Z007NEA参比制剂 | 77.8 | 6.0 | 6.2 | 10.0 |
制剂ID | 皮肤/池的# | Q96* | 比例+ |
待测制剂 | |||
1.Lot#040695-1 | 6/24 | 8.4±2.5 | 0.27±0.06 |
2.Lot#040695-2 | 6/24 | 17.3±3.8 | 0.55±0.10 |
3.Lot#040695-3 | 6/24 | 32.9±8.9 | 1.00±0.08 |
制剂ID | TSR胶粘剂 | NEA | E2 | ARLACEL80 |
%w/w | %w/w | %w/w | %w/w | |
待测制剂 | ||||
5.Lot#040695-4 | 87.0 | 0.0 | 3.0 | 10.0 |
6.Lot#040695-8 | 83.8 | 0.0 | 6.2 | 10.0 |
7.Lot#040695-12 | 81.0 | 0.0 | 9.0 | 10.0 |
参比制剂 | ||||
8.参比#94Z003E2参比制剂 | 93.5* | 0.0 | 1.5 | 5.0 |
制剂ID | 皮肤/池的# | Q96* | 比例+ |
待测制剂 | |||
5.Lot#040695-4 | 6/24 | 6.1±1.7 | 0.29±0.06 |
6.Lot#040695-8 | 6/24 | 13.4±4.0 | 0.64±0.08 |
7.Lot#040695-12 | 6/24 | 20.9±5.6 | 1.0±0.16 |
制剂ID | TSR胶粘剂 | NEA | E2 | ARLACEL80 |
%w/w | %w/w | %w/w | %w/w | |
待测制剂 | ||||
9.Lot#040695-5 | 85.5 | 1.5 | 3.0 | 10.0 |
10.Lot#040695-6 | 84.0 | 3.0 | 3.0 | 10.0 |
11.Lot#040695-7 | 81.0 | 6.0 | 3.0 | 10.0 |
12.Lot#040695-9 | 82.3 | 1.5 | 6.2 | 10.0 |
13.Lot#040695-10 | 80.8 | 3.0 | 6.2 | 10.0 |
14.Lot#040695-11 | 77.8 | 6.0 | 6.2 | 10.0 |
15.Lot#040695-12 | 79.5 | 1.5 | 9.0 | 10.0 |
16.Lot#040695-14 | 78.0 | 3.0 | 9.0 | 10.0 |
17.Lot#040695-15 | 75.0 | 6.0 | 9.0 | 10.0 |
参比制剂 | ||||
4.参比#95Z007NEA参比制剂 | 77.8 | 6.0 | 6.2 | 10.0 |
8.参比#94Z003E2参比制剂 | 93.5* | 0.0 | 1.5 | 5.0 |
制剂ID | 皮肤/扩散池的# | NEA数据 | E2数据 | ||||
Q96* | Q96(参比)X | 比例 | Q96* | Q96(参比)X | 比例 | ||
9.Lot#040695-5 | 7/28 | 7.7±3.6 | 25.7±11.0 | 0.29±0.02 | 5.4±2.4 | 18.7±6.8 | 0.28±0.03 |
10.Lot#040695-6 | 7/28 | 15.4±6.3 | 25.7±11.0 | 0.6±0.08 | 5.7±2.3 | 18.7±6.8 | 0.30±0.02 |
11.Lot#040695-7 | 7/28 | 27.6±11.0 | 25.7±11.0 | 1.1±0.09 | 5.4±2.5 | 18.7±6.8 | 0.28±0.04 |
12.Lot#040695-9 | 5/20 | 7.0±1.9 | 27.8±7.7 | 0.25±0.03 | 10.1±2.7 | 15.8±5.5 | 0.65±0.10 |
13.Lot#040695-10 | 5/20 | 14.2±4.2 | 27.8±7.7 | 0.51±0.05 | 10.4±3.5 | 15.8±5.5 | 0.66±0.03 |
14.Lot#040695-11 | 5/20 | 27.8±7.7 | 27.8±7.7 | 1.0±0.0 | 10.2±3.0 | 15.8±5.5 | 0.66±0.06 |
15.Lot#040695-13 | 6/24 | 8.9±2.6 | 37.4±22.3 | 0.28±0.10 | 20.3±7.5 | 24.7±16.3 | 0.97±0.30 |
16.Lot#040695-14 | 6/24 | 18.3±8.7 | 37.4±22.3 | 0.53±0.12 | 23.0±13,5 | 24.7±16.3 | 0.99±0.17 |
17.Lot#040695-15 | 6/24 | 32.4±18.0 | 37.4±22.3 | 0.90±0.12 | 21,3±13.2 | 24.7±16.3 | 0.89±0.17 |
制剂ID | DUROTAK87-2516胶粘剂 | NEA | E2 | ARLACEL80 |
%w/w | %w/w | %w/w | %w/w | |
待测制剂 | ||||
1.Lot#013096-1 | 88.0 | 2.0 | 0.0 | 10.0 |
2.Lot#013096-2 | 86.0 | 4.0 | 0.0 | 10.0 |
3.Lot#013096-3 | 84.0 | 6.0 | 0.0 | 10.0 |
4.Lot#013096-4 | 82.0 | 8.0 | 0.0 | 10.0 |
参比制剂 | ||||
5.参比#95Z098NEA/E2参比制剂 | 77.6 | 6.0 | 6.4 | 10.0 |
制剂ID | 皮肤/扩散池的# | Q24* | 比例+ |
待测制剂 | |||
1.Lot#013096-1 | 3/12 | 1.8±0.7 | 0.5±0.2 |
2.Lot#013096-2 | 3/12 | 3.5±1.1 | 0.9±0.3 |
3.Lot#013096-3 | 3/12 | 5.4±0.7 | 1.4±0.4 |
4.Lot#013096-4 | 3/12 | 8.6±4.7 | 2.3±1.8 |
制剂ID | DUROTAK87-2516胶粘剂 | NEA | E2 | ARLACEL80 |
%w/w | %w/w | %w/w | %w/w | |
待测制剂 | ||||
6.Lot#013096-5 | 89.0 | 0.0 | 1.0 | 10.0 |
7.Lot#013096-10 | 88.0 | 0.0 | 2.0 | 10.0 |
8.Lot#013096-15 | 86.0 | 0.0 | 4.0 | 10.0 |
参比制剂 | ||||
4.参比#95Z098NEA/E2参比制剂 | 77.6* | 6.0 | 6.4 | 10.0 |
制剂ID | 皮肤/扩散池的# | Q24* | 比例+ |
待测制剂 | |||
6.Lot#013096-5 | 3/12 | 3.5±1.1 | 1.4±0.5 |
7.Lot#013096-10 | 3/12 | 6.2±1.1 | 2.4±0.3 |
8.Lot#013096-15 | 3/12 | 9.0±3.0 | 3.5±1.0 |
制剂ID | DUROTAK87-2516胶粘剂 | NEA | E2 | ARLACEL80 |
%w/w | %w/w | %w/w | %w/w | |
待测制剂 | ||||
9.Lot#013096-6 | 87.0 | 2.0 | 1.0 | 10.0 |
10.Lot#013096-7 | 85.0 | 4.0 | 1.0 | 10.0 |
11.Lot#013096-8 | 83.0 | 6.0 | 1.0 | 10.0 |
12.Lot#013096-9 | 81.0 | 8.0 | 1.0 | 10.0 |
13.Lot#013096-11 | 86.0 | 2.0 | 2.0 | 10.0 |
14.Lot#013096-12 | 84.0 | 4.0 | 2.0 | 10.0 |
15.Lot#013096-13 | 82.0 | 6.0 | 2.0 | 10.0 |
16.Lot#013096-14 | 80.0 | 8.0 | 2.0 | 10.0 |
17.Lot#013096-16 | 84.0 | 2.0 | 4.0 | 10.0 |
18.Lot#013096-17 | 82.0 | 4.0 | 4.0 | 10.0 |
19.Lot#013096-18 | 80.0 | 6.0 | 4.0 | 10.0 |
20.Lot#013096-19 | 78.0 | 8.0 | 4.0 | 10.0 |
参比制剂 | ||||
5.参比#95Z098NEA/E2参比制剂 | 77.6* | 6.0 | 6.4 | 10.0 |
制剂ID | 皮肤/扩散池的# | NEA数据 | E2数据 | ||||
Q24* | Q24(参比)X | 比例 | Q24* | Q24(参比)X | 比例+ | ||
待测制剂 | |||||||
9.Lot#013096-6 | 3/12 | 4.6±1.3 | 7.6±2.2 | 0.6±0.1 | 5.3±1.5 | 3.3±1.0 | 1.6±0.3 |
10.Lot#013096-7 | 3/12 | 9.4±2.1 | 7.6±2.2 | 1.2±0.2 | 5.3±1.2 | 3.3±1.0 | 1.6±0.2 |
11.Lot#013096-8 | 3/12 | 13.8±4.8 | 7.6±2.2 | 1.8±0.5 | 5.1±1.7 | 3.3±1.0 | 1.5±0.3 |
12.Lot#013096-9 | 3/12 | 17.5±5.6 | 7.6±2.2 | 2.3±0.6 | 5.1±1.7 | 3.3±1.0 | 1.5±0.3 |
13.Lot#013096-11 | 3/12 | 2.5±0.5 | 6.1±2.6 | 0.4±0.1 | 5.9±1.3 | 2.8±1.2 | 2.2±0.6 |
14.Lot#013096-12 | 3/12 | 4.8±1.2 | 6.1±2.6 | 0.8±0.3 | 5.3±1.4 | 2.8±1.2 | 2.0±0.7 |
15.Lot#013096-13 | 3/12 | 7.7±1.8 | 6.1±2.6 | 1.4±0.5 | 5.5±1.3 | 2.8±1.2 | 2.1±0.8 |
16.Lot#013096-14 | 3/12 | 7.8±2.7 | 6.1±2.6 | 1.3±0.6 | 4.2±1.6 | 2.8±1.2 | 1.6±0.8 |
17.Lot#013096-16 | 3/12 | 2.8±0.7 | 8.1±2.4 | 0.4±0.04 | 12.8±2.7 | 3.2±0.8 | 4.0±0.4 |
18.Lot#013096-17 | 3/12 | 5.6±1.5 | 8.1±2.4 | 0.7±0.2 | 11.8±3.0 | 3.2±0.8 | 3.8±1.2 |
19.Lot#013096-18 | 3/12 | 7.4±1.5 | 8.1±2.4 | 0.9±0.2 | 9.6±1.9 | 3.2±0.8 | 3.1±0.6 |
20.Lot#013096-19 | 3/12 | 8.2±2.2 | 8.1±2.4 | 1.1±0.2 | 6.9±1.4 | 3.2±0.8 | 2.2±0.4 |
制剂ID | TSR胶粘剂 | TS | E2 | ARLACE L80 |
%w/w | %w/w | %w/w | %w/w | |
待测制剂 | ||||
1.Lot#012496-1 | 87.5 | 2.5 | 0.0 | 10.0 |
2.Lot#012496-2 | 86.25 | 3.75 | 0.0 | 10.0 |
3.Lot#012496-3 | 85.0 | 5.0 | 0.0 | 10.0 |
参比制剂 | ||||
4.参比#95Z082TSR参比制剂 | 75.75 | 3.75 | 10.5 | 10.0 |
制剂ID | 皮肤/扩散池的# | Q24* | 比例+ |
待测制剂 | |||
1.Lot#012496-1 | 3/12 | 15.6±6.6 | 0.63±0.09 |
2.Lot#012496-2 | 3/12 | 25.7±13.4 | 1.01±0.20 |
3.Lot#012496-3 | 3/12 | 31.8±15.3 | 1.28±0.29 |
制剂ID | TSR胶粘剂 | TS | E2 | ARLACEL80 |
%w/w | %w/w | %w/w | %w/w | |
待测制剂 | ||||
5.Lot#012496-4 | 87.0 | 0.0 | 3.0 | 10.0 |
6.Lot#012496-8 | 84.0 | 0.0 | 6.0 | 10.0 |
7.Lot#012496-12 | 79.5 | 0.0 | 10.5 | 10.0 |
参比制剂 | ||||
8.参比#95Z135E2参比制剂 | 93.5* | 0.0 | 1.5 | 5.0 |
制剂ID | 皮肤/扩散池的# | Q24* | 比例+ |
待测制剂 | |||
5.Lot#012496-4 | 3/12 | 2.6±0.7 | 0.28±0.06 |
6.Lot#012496-8 | 3/12 | 5.4±0.9 | 0.60±0.14 |
7.Lot#012496-12 | 3/12 | 9.3±1.6 | 1.02±0.18 |
制剂ID | TSR胶粘剂 | TS | E2 | ARLACEL80 |
%w/w | %w/w | %w/w | %w/w | |
待测制剂 | ||||
9.Lot#012496-5 | 84.5 | 2.5 | 3.0 | 10.0 |
10.Lot#012496-6 | 83.25 | 3.75 | 3.0 | 10.0 |
11.Lot#012496-7 | 82.0 | 5.0 | 3.0 | 10.0 |
12.Lot#012496-9 | 81.5 | 2.5 | 6.0 | 10.0 |
13.Lot#012496-10 | 80.25 | 3.75 | 6.0 | 10.0 |
14.Lot#012496-11 | 79.0 | 5.0 | 6.0 | 10.0 |
15.Lot#012496-13 | 77.0 | 2.5 | 10.5 | 10.0 |
16.Lot#012496-14 | 75.75 | 3.75 | 10.5 | 10.0 |
17.Lot#012496-15 | 74.5 | 5.0 | 10.5 | 10.0 |
参比制剂 | ||||
4.参比#95Z082TE参比制剂 | 75.75 | 3.75 | 10.5 | 10.0 |
8.参比#95Z135E2参比制剂 | 93.5* | 0.0 | 1.5 | 5.0 |
制剂ID | 皮肤/扩散池的# | TS数据 | E2数据 | ||||
Q24* | Q24(参比)X | 比例 | Q24* | Q24(参比)X | 比例 | ||
待测制剂 | |||||||
9.Lot#012496-5 | 3/12 | 14.2±6.1 | 23.0±9.3 | 0.60±0.1 | 1.4±0.5 | 5.2±1.8 | 0.27±0.04 |
10.Lot#012496-6 | 3/12 | 24.2±9.0 | 23.0±9.3 | 1.06±0.2 | 1.5±0.5 | 5.2±1.8 | 0.29±0.06 |
11.Lot#012496-7 | 3/12 | 28.1±9.5 | 23.0±9.3 | 1.24±0.2 | 1.4±0.4 | 5.2±1.8 | 0.26±0.04 |
12.Lot#012496-9 | 3/10 | 13.2±2.9 | 23.2±8.4 | 0.58±0.2 | 2.6±0.5 | 4.7±1.6 | 0.57±0.14 |
13.Lot#012496-10 | 3/10 | 18.2±4.5 | 23.2±8.4 | 0.81±0.3 | 2.4±0.6 | 4.7±1.6 | 0.54±0.20 |
14.Lot#012496-11 | 3/11 | 26.3±7.9 | 23.2±8.4 | 1.13±0.2 | 2.7±0.7 | 4.7±1.6 | 0.58±0.12 |
15.Lot#012496-13 | 3/12 | 14.4±7.8 | 22.5±10.0 | 0.61±0.1 | 6.2±3.2 | 5.9±2.4 | 0.99±0.19 |
16.Lot#012496-14 | 3/12 | 21.4±10.9 | 22.5±10.0 | 0.93±0.1 | 6.2±3.1 | 5.9±2.4 | 0.99±0.15 |
17.Lot#012496-15 | 3/12 | 26.6±10.6 | 22.5±10.0 | 1.20±0.3 | 6.0±2.2 | 5.9±2.4 | 1.0±0.28 |
Claims (5)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/683,892 US5783208A (en) | 1996-07-19 | 1996-07-19 | Transdermal drug delivery matrix for coadministering estradiol and another steroid |
US08/683,892 | 1996-07-19 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB2004100831783A Division CN100536835C (zh) | 1996-07-19 | 1997-07-02 | 用于雌二醇与另一种类固醇物质共同给药的透皮释药基质 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1225568A CN1225568A (zh) | 1999-08-11 |
CN1204859C true CN1204859C (zh) | 2005-06-08 |
Family
ID=24745888
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB2004100831783A Expired - Fee Related CN100536835C (zh) | 1996-07-19 | 1997-07-02 | 用于雌二醇与另一种类固醇物质共同给药的透皮释药基质 |
CNB971965633A Expired - Fee Related CN1204859C (zh) | 1996-07-19 | 1997-07-02 | 用于雌二醇与另一种类固醇物质共同给药的透皮释药基质 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB2004100831783A Expired - Fee Related CN100536835C (zh) | 1996-07-19 | 1997-07-02 | 用于雌二醇与另一种类固醇物质共同给药的透皮释药基质 |
Country Status (21)
Country | Link |
---|---|
US (1) | US5783208A (zh) |
EP (1) | EP0921774B1 (zh) |
JP (2) | JP4212115B2 (zh) |
KR (1) | KR100628796B1 (zh) |
CN (2) | CN100536835C (zh) |
AT (1) | ATE339172T1 (zh) |
AU (1) | AU714590B2 (zh) |
BR (1) | BR9710738A (zh) |
CA (1) | CA2259532C (zh) |
DE (1) | DE69736671T2 (zh) |
DK (1) | DK0921774T3 (zh) |
ES (1) | ES2271970T3 (zh) |
HK (2) | HK1020864A1 (zh) |
HU (1) | HUP9904369A3 (zh) |
IL (1) | IL127708A (zh) |
NO (1) | NO325232B1 (zh) |
NZ (1) | NZ333558A (zh) |
PL (1) | PL188009B1 (zh) |
PT (1) | PT921774E (zh) |
WO (1) | WO1998003137A1 (zh) |
ZA (1) | ZA976035B (zh) |
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