CY1124104T1 - Δισκιο διασπειρομενο στο στομα περιεχον οιστετρολη - Google Patents
Δισκιο διασπειρομενο στο στομα περιεχον οιστετροληInfo
- Publication number
- CY1124104T1 CY1124104T1 CY20211100379T CY211100379T CY1124104T1 CY 1124104 T1 CY1124104 T1 CY 1124104T1 CY 20211100379 T CY20211100379 T CY 20211100379T CY 211100379 T CY211100379 T CY 211100379T CY 1124104 T1 CY1124104 T1 CY 1124104T1
- Authority
- CY
- Cyprus
- Prior art keywords
- particles
- dosage unit
- estetrol
- weight
- liquid
- Prior art date
Links
Classifications
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/2004—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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
- A61P15/18—Feminine contraceptives
-
- 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)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Zoology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Gynecology & Obstetrics (AREA)
- Diabetes (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Η εφεύρεση παρέχει μία στερεά φαρμακευτική μονάδα δόσης διασπειρόμενη στο στόμα που έχει βάρος μεταξύ 30 και 1.000 mg, όπου η εν λόγω μονάδα δόσης περιέχει τουλάχιστον 100 μg μίας συνιστώσας οιστετρόλης που επιλέγεται από οιστετρόλη, εστέρες οιστετρόλης και συνδυασμούς αυτών• όπου η στερεά μονάδα δόσης μπορεί να ληφθεί μέσω μίας διεργασίας που περιλαμβάνει: την παροχή ενός υγρού φόρτωσης που περιλαμβάνει οργανικό διαλύτη, συνιστώσα οιστετρόλης και προαιρετικά ένα ή περισσότερα άλλα φαρμακευτικά αποδεκτά συστατικά• την ανάμιξη 1 μέρους κατά βάρος του υγρού φόρτωσης με 0,5-20 μέρη κατά βάρος των σωματιδίων του φορέα για την παραγωγή υγρών σωματιδίων• την απομάκρυνση του οργανικού διαλύτη από τα υγρά σωματίδια για την παραγωγή φορτωμένων σωματιδίων• την προαιρετική ανάμιξη των φορτωμένων σωματιδίων με ένα ή περισσότερα έκδοχα δισκιοποίησης• και τον σχηματισμό των φορτωμένων σωματιδίων ή του μίγματος των φορτωμένων σωματιδίων και του ενός ή των περισσότερων εκδόχων δισκιοποίησης σε μία στερεά μονάδα δόσης. Η στερεά μονάδα δόσης είναι εύκολο να κατασκευασθεί και είναι τέλεια προσαρμοσμένη για υπογλώσσια, ενδοστοματική ή υποχειλική χορήγηση.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP15172751 | 2015-06-18 | ||
PCT/EP2016/064071 WO2016203009A1 (en) | 2015-06-18 | 2016-06-17 | Orodispersible tablet containing estetrol |
Publications (1)
Publication Number | Publication Date |
---|---|
CY1124104T1 true CY1124104T1 (el) | 2022-05-27 |
Family
ID=53476700
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CY20211100379T CY1124104T1 (el) | 2015-06-18 | 2021-05-05 | Δισκιο διασπειρομενο στο στομα περιεχον οιστετρολη |
Country Status (18)
Country | Link |
---|---|
US (1) | US10894014B2 (el) |
EP (1) | EP3310345B1 (el) |
JP (1) | JP6866561B2 (el) |
CN (1) | CN107810001A (el) |
CA (1) | CA2988485A1 (el) |
CY (1) | CY1124104T1 (el) |
DK (1) | DK3310345T3 (el) |
ES (1) | ES2877186T3 (el) |
HR (1) | HRP20210668T1 (el) |
HU (1) | HUE054589T2 (el) |
LT (1) | LT3310345T (el) |
MA (1) | MA44205B1 (el) |
MD (1) | MD3310345T2 (el) |
PL (1) | PL3310345T3 (el) |
PT (1) | PT3310345T (el) |
RS (1) | RS61812B1 (el) |
SI (1) | SI3310345T1 (el) |
WO (1) | WO2016203009A1 (el) |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
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BR112013030830B1 (pt) | 2011-06-01 | 2019-12-03 | Estetra S A | processo para a preparação de um composto de fórmula (i) e processo de preparação de estetrol |
KR101957937B1 (ko) | 2011-06-01 | 2019-03-14 | 에스테트라 에스.피.알.엘. | 에스테트롤 중간체의 제조 방법 |
EP2383279A1 (en) | 2011-07-19 | 2011-11-02 | Pantarhei Bioscience B.V. | Process for the preparation of estetrol |
PL3310333T3 (pl) | 2015-06-18 | 2020-07-13 | Estetra Sprl | Ulegająca rozpadowi w jamie ustnej jednostka dawkowana zawierająca składnik estetrolowy |
ES2877186T3 (es) | 2015-06-18 | 2021-11-16 | Estetra Sprl | Comprimido orodispersable que contiene estetrol |
ES2877476T3 (es) | 2015-06-18 | 2021-11-16 | Estetra Sprl | Comprimido orodispersable que contiene estetrol |
PL3106148T3 (pl) | 2015-06-18 | 2018-08-31 | Mithra Pharmaceuticals S A | Jednostka dawkowania ulegająca rozpadowi w jamie ustnej zawierająca składnik estetrolowy |
KR20220144885A (ko) | 2016-08-05 | 2022-10-27 | 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 | 월경통 및 생리통의 관리방법 |
JOP20200260A1 (ar) | 2018-04-19 | 2019-10-19 | Estetra Sprl | مركبات واستخداماتها للتخفيف من الأعراض المصاحبة لانقطاع الطمث |
TWI801561B (zh) | 2018-04-19 | 2023-05-11 | 比利時商依思特拉私人有限責任公司 | 化合物及其用於緩解絕經相關症狀的用途 |
HU231240B1 (hu) | 2019-09-03 | 2022-04-28 | Richter Gedeon Nyrt. | Ipari eljárás nagytisztaságú ösztetrol hatóanyag előállítására |
EP4056638A4 (en) * | 2019-11-07 | 2022-11-30 | Asahi Kasei Kabushiki Kaisha | CELLULOSIC COMPOSITION, TABLET AND DISCOMPOSING TABLET IN THE MOUTH |
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ES2877186T3 (es) | 2015-06-18 | 2021-11-16 | Estetra Sprl | Comprimido orodispersable que contiene estetrol |
PL3106148T3 (pl) | 2015-06-18 | 2018-08-31 | Mithra Pharmaceuticals S A | Jednostka dawkowania ulegająca rozpadowi w jamie ustnej zawierająca składnik estetrolowy |
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ES2877476T3 (es) | 2015-06-18 | 2021-11-16 | Estetra Sprl | Comprimido orodispersable que contiene estetrol |
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UA126746C2 (uk) | 2018-02-07 | 2023-01-18 | Естетра Спрл | Композиція контрацептива зі зниженими ефектами щодо серцево-судинної системи |
-
2016
- 2016-06-17 ES ES16729601T patent/ES2877186T3/es active Active
- 2016-06-17 LT LTEP16729601.1T patent/LT3310345T/lt unknown
- 2016-06-17 SI SI201631167T patent/SI3310345T1/sl unknown
- 2016-06-17 JP JP2017564396A patent/JP6866561B2/ja active Active
- 2016-06-17 MA MA44205A patent/MA44205B1/fr unknown
- 2016-06-17 CA CA2988485A patent/CA2988485A1/en not_active Abandoned
- 2016-06-17 MD MDE20180402T patent/MD3310345T2/ro unknown
- 2016-06-17 PL PL16729601T patent/PL3310345T3/pl unknown
- 2016-06-17 EP EP16729601.1A patent/EP3310345B1/en active Active
- 2016-06-17 RS RS20210512A patent/RS61812B1/sr unknown
- 2016-06-17 HU HUE16729601A patent/HUE054589T2/hu unknown
- 2016-06-17 CN CN201680035673.8A patent/CN107810001A/zh active Pending
- 2016-06-17 PT PT167296011T patent/PT3310345T/pt unknown
- 2016-06-17 DK DK16729601.1T patent/DK3310345T3/da active
- 2016-06-17 WO PCT/EP2016/064071 patent/WO2016203009A1/en active Application Filing
- 2016-06-17 US US15/737,233 patent/US10894014B2/en active Active
-
2021
- 2021-04-26 HR HRP20210668TT patent/HRP20210668T1/hr unknown
- 2021-05-05 CY CY20211100379T patent/CY1124104T1/el unknown
Also Published As
Publication number | Publication date |
---|---|
PT3310345T (pt) | 2021-05-28 |
PL3310345T3 (pl) | 2021-10-18 |
LT3310345T (lt) | 2021-06-25 |
RS61812B1 (sr) | 2021-06-30 |
EP3310345A1 (en) | 2018-04-25 |
SI3310345T1 (sl) | 2021-05-31 |
ES2877186T3 (es) | 2021-11-16 |
CA2988485A1 (en) | 2016-12-22 |
US10894014B2 (en) | 2021-01-19 |
EP3310345B1 (en) | 2021-03-31 |
MA44205A (fr) | 2018-04-25 |
CN107810001A (zh) | 2018-03-16 |
HRP20210668T1 (hr) | 2021-05-28 |
JP2018517718A (ja) | 2018-07-05 |
WO2016203009A1 (en) | 2016-12-22 |
HUE054589T2 (hu) | 2021-09-28 |
DK3310345T3 (da) | 2021-05-25 |
MA44205B1 (fr) | 2021-04-30 |
MD3310345T2 (ro) | 2021-07-31 |
JP6866561B2 (ja) | 2021-04-28 |
US20180185271A1 (en) | 2018-07-05 |
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