PE20191465A1 - PHARMACEUTICAL COMPOSITION INCLUDING 2,5-DIHYDROXYBENZENOSULPHONIC ACID OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE SALTS IN THE FORM OF INDIVIDUALIZED SUPPLY UNITS AND RELATED MANUFACTURING PROCEDURES - Google Patents
PHARMACEUTICAL COMPOSITION INCLUDING 2,5-DIHYDROXYBENZENOSULPHONIC ACID OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE SALTS IN THE FORM OF INDIVIDUALIZED SUPPLY UNITS AND RELATED MANUFACTURING PROCEDURESInfo
- Publication number
- PE20191465A1 PE20191465A1 PE2019001494A PE2019001494A PE20191465A1 PE 20191465 A1 PE20191465 A1 PE 20191465A1 PE 2019001494 A PE2019001494 A PE 2019001494A PE 2019001494 A PE2019001494 A PE 2019001494A PE 20191465 A1 PE20191465 A1 PE 20191465A1
- Authority
- PE
- Peru
- Prior art keywords
- release composition
- acid
- pharmaceutical composition
- composition
- pharmaceutically acceptable
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 150000003839 salts Chemical class 0.000 title abstract 3
- 239000002253 acid Substances 0.000 title abstract 2
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 238000000034 method Methods 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 abstract 8
- 230000002035 prolonged effect Effects 0.000 abstract 5
- 239000012729 immediate-release (IR) formulation Substances 0.000 abstract 4
- 102000008946 Fibrinogen Human genes 0.000 abstract 2
- 108010049003 Fibrinogen Proteins 0.000 abstract 2
- 229940012952 fibrinogen Drugs 0.000 abstract 2
- 238000011282 treatment Methods 0.000 abstract 2
- IKQCSJBQLWJEPU-UHFFFAOYSA-N 2,5-dihydroxybenzenesulfonic acid Chemical compound OC1=CC=C(O)C(S(O)(=O)=O)=C1 IKQCSJBQLWJEPU-UHFFFAOYSA-N 0.000 abstract 1
- 206010012689 Diabetic retinopathy Diseases 0.000 abstract 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 abstract 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 abstract 1
- 239000002671 adjuvant Substances 0.000 abstract 1
- 239000008280 blood Substances 0.000 abstract 1
- 210000004369 blood Anatomy 0.000 abstract 1
- 201000002816 chronic venous insufficiency Diseases 0.000 abstract 1
- 201000010099 disease Diseases 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 abstract 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 abstract 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 abstract 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 abstract 1
- 239000008108 microcrystalline cellulose Substances 0.000 abstract 1
- 229940016286 microcrystalline cellulose Drugs 0.000 abstract 1
- 238000011321 prophylaxis Methods 0.000 abstract 1
- 201000002282 venous insufficiency Diseases 0.000 abstract 1
Classifications
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
-
- 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
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
Landscapes
- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
Abstract
Referido a una composicion farmaceutica que comprende acido 2,5-dihidroxibencenosulfonico o una de sus sales farmaceuticamente aceptables en forma de unidades individualizadas de suministro; en donde una parte de dicho acido o una de sus sales, esta en forma de composicion de liberacion inmediata y otra parte esta en forma de composicion de liberacion prolongada; caracterizada porque dicha parte de composicion de liberacion inmediata comprende, adicionalmente entre un 8% p/p a 28% p/p, respecto del peso total de la parte de composicion de liberacion inmediata, de celulosa microcristalina; y otra parte esta en forma de composicion de liberacion prolongada, que comprende, adicionalmente entre un 10% p/p a 45% p/p, respecto del peso total de la parte de liberacion prolongada, de hidroxipropilmetilcelulosa y entre un 6,1% p/p a 20% p/p, respecto del peso total de la parte de composicion de liberacion prolongada, de hidroxipropilcelulosa. La proporcion entre la parte de composicion de liberacion inmediata y la parte de composicion de liberacion prolongada esta comprendida entre 24:76 y 40:60. Tambien se refiere a un procedimiento para la fabricacion de dicha composicion farmaceutica. Se utiliza para la reduccion de fibrinogeno en sangre de humanos, asi como para la profilaxis y tratamiento de enfermedades causadas por niveles elevados de fibrinogeno, asi como estados varicosos primarios, insuficiencia venosa cronica, entre otros; o coadyuvante en el tratamiento de la retinopatia diabetica.Refers to a pharmaceutical composition comprising 2,5-dihydroxybenzenesulfonic acid or one of its pharmaceutically acceptable salts in the form of individualized delivery units; wherein a part of said acid or one of its salts is in the form of an immediate release composition and another part is in the form of a prolonged release composition; characterized in that said immediate release composition part additionally comprises between 8% w / w to 28% w / w, relative to the total weight of the immediate release composition part, of microcrystalline cellulose; and another part is in the form of a prolonged release composition, which additionally comprises between 10% w / p to 45% w / w, with respect to the total weight of the prolonged release part, of hydroxypropyl methylcellulose and between 6.1% w / pa 20% w / w, relative to the total weight of the part of the composition with prolonged release, of hydroxypropylcellulose. The ratio between the immediate release composition part and the prolonged release composition part is between 24:76 and 40:60. It also refers to a process for the manufacture of said pharmaceutical composition. It is used for the reduction of fibrinogen in human blood, as well as for the prophylaxis and treatment of diseases caused by high levels of fibrinogen, as well as primary varicose states, chronic venous insufficiency, among others; or adjuvant in the treatment of diabetic retinopathy.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ES201730225A ES2680293B1 (en) | 2017-02-22 | 2017-02-22 | Pharmaceutical composition comprising 2,5-dihydroxybenzenesulfonic acid or a pharmaceutically acceptable salt thereof in the form of individualized delivery units and corresponding manufacturing process |
| PCT/ES2018/070123 WO2018154161A1 (en) | 2017-02-22 | 2018-02-20 | Pharmaceutical composition comprising 2,5-dihydroxybenzenesulfonic acid or a pharmaceutically acceptable salt thereof in the form of personalised supply units and the corresponding manufacturing method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20191465A1 true PE20191465A1 (en) | 2019-10-16 |
Family
ID=63252461
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2019001494A PE20191465A1 (en) | 2017-02-22 | 2018-02-20 | PHARMACEUTICAL COMPOSITION INCLUDING 2,5-DIHYDROXYBENZENOSULPHONIC ACID OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE SALTS IN THE FORM OF INDIVIDUALIZED SUPPLY UNITS AND RELATED MANUFACTURING PROCEDURES |
Country Status (4)
| Country | Link |
|---|---|
| CN (1) | CN110290784A (en) |
| ES (1) | ES2680293B1 (en) |
| PE (1) | PE20191465A1 (en) |
| WO (1) | WO2018154161A1 (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114601816B (en) * | 2021-10-09 | 2022-09-02 | 北京惠之衡生物科技有限公司 | Calcium dobesilate capsule composition and preparation method thereof |
| CN115581681A (en) * | 2022-06-10 | 2023-01-10 | 海南林恒制药股份有限公司 | Novel calcium dobesilate capsule and preparation method thereof |
| CN119868327A (en) * | 2025-03-17 | 2025-04-25 | 中国药科大学 | Application of calcium dobesilate in preparation of medicines for preventing or treating chemotherapeutic phlebitis |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2208123A1 (en) * | 2002-11-29 | 2004-06-01 | Laboratorios Del Dr. Esteve, S.A. | Use of 2,5-dihydroxybenzenesulfonic compounds for the treatment of disorders based on an impairment of no production and/or of regulation of edhf function |
| CN1939291A (en) * | 2006-09-29 | 2007-04-04 | 何岩 | Hydroxyphenyl sulfonated calcium slow-releasing preparation |
| CN103169679A (en) * | 2011-12-26 | 2013-06-26 | 上海复星医药产业发展有限公司 | Calcium dobesilate medical composition with high drug loading capacity |
| CN103271895A (en) * | 2012-03-14 | 2013-09-04 | 南京先宇科技有限公司 | Stable calcium dobesilate containing pharmaceutical composition and preparation method thereof |
| WO2016092560A2 (en) * | 2014-12-09 | 2016-06-16 | Eris Lifesciences Pvt Ltd. | Dual release bilayer tablets comprising metformin |
-
2017
- 2017-02-22 ES ES201730225A patent/ES2680293B1/en active Active
-
2018
- 2018-02-20 CN CN201880010868.6A patent/CN110290784A/en active Pending
- 2018-02-20 PE PE2019001494A patent/PE20191465A1/en unknown
- 2018-02-20 WO PCT/ES2018/070123 patent/WO2018154161A1/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| WO2018154161A1 (en) | 2018-08-30 |
| CN110290784A (en) | 2019-09-27 |
| ES2680293A1 (en) | 2018-09-05 |
| BR112019016778A2 (en) | 2020-03-31 |
| ES2680293B1 (en) | 2019-08-22 |
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