BR112018015481A2 - processo para preparar um complexo de ciclodextrina e ingrediente farmacêutico ativo - Google Patents
processo para preparar um complexo de ciclodextrina e ingrediente farmacêutico ativoInfo
- Publication number
- BR112018015481A2 BR112018015481A2 BR112018015481-4A BR112018015481A BR112018015481A2 BR 112018015481 A2 BR112018015481 A2 BR 112018015481A2 BR 112018015481 A BR112018015481 A BR 112018015481A BR 112018015481 A2 BR112018015481 A2 BR 112018015481A2
- Authority
- BR
- Brazil
- Prior art keywords
- solution
- preparing
- active pharmaceutical
- pharmaceutical ingredient
- cyclodextrin
- Prior art date
Links
- 229920000858 Cyclodextrin Polymers 0.000 title abstract 4
- 239000008186 active pharmaceutical agent Substances 0.000 title abstract 4
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 title abstract 4
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 238000000034 method Methods 0.000 abstract 3
- 238000010668 complexation reaction Methods 0.000 abstract 2
- 239000000725 suspension Substances 0.000 abstract 2
- 210000001124 body fluid Anatomy 0.000 abstract 1
- 239000010839 body fluid Substances 0.000 abstract 1
- 238000004090 dissolution Methods 0.000 abstract 1
- 238000001035 drying Methods 0.000 abstract 1
- 239000000843 powder Substances 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/724—Cyclodextrins
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
-
- 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
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
trata-se de um processo de complexação entre uma ciclodextrina e ingredientes farmacêuticos ativos, e compreende um processo para preparar um complexo de pelo menos uma ciclodextrina e pelo menos um ingrediente farmacêutico ativo que compreende as etapas de: a. preparar uma primeira solução (solução a) que compreende pelo menos uma ciclodextrina e pelo menos um solvente; b. preparar uma segunda solução (solução b) que compreende pelo menos um api dissolvido, parcialmente dissolvido ou suspenso; c. misturar a dita solução a e a dita solução b por meio de um sistema de microfluidização para produzir uma solução e/ou suspensão de pelo menos um do dito complexo; d. isolar a dita solução e/ou suspensão e/ou, opcionalmente, secar a mesma; e e. coletar opcionalmente uma forma em pó do complexo. o processo descrito tem alta produtividade com rendimentos maiores de complexação em menos tempo que métodos da técnica anterior. os complexos obtidos pela invenção são caracterizados por terem dissolução e/ou biodisponibilidade aprimoradas do ingrediente farmacêutico ativo em fluidos corporais.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PT109117 | 2016-01-28 | ||
PT10911716A PT109117B (pt) | 2016-01-28 | 2016-01-28 | Complexação de ingredientes ativos farmacêuticos |
PCT/GB2017/050210 WO2017129988A1 (en) | 2016-01-28 | 2017-01-27 | Continuous complexation of active pharmaceutical ingredients |
Publications (2)
Publication Number | Publication Date |
---|---|
BR112018015481A2 true BR112018015481A2 (pt) | 2018-12-18 |
BR112018015481B1 BR112018015481B1 (pt) | 2024-04-09 |
Family
ID=
Also Published As
Publication number | Publication date |
---|---|
CN108778338A (zh) | 2018-11-09 |
PT109117A (pt) | 2017-07-28 |
EP3400017B1 (en) | 2020-02-19 |
JP7038057B2 (ja) | 2022-03-17 |
AU2017211520B2 (en) | 2022-01-27 |
JP2019507127A (ja) | 2019-03-14 |
CN108778338B (zh) | 2022-04-01 |
EP3400017A1 (en) | 2018-11-14 |
CA3011820C (en) | 2023-12-19 |
CA3011820A1 (en) | 2017-08-03 |
PT109117B (pt) | 2019-02-01 |
US20190060486A1 (en) | 2019-02-28 |
IL260766B (en) | 2020-11-30 |
US11759529B2 (en) | 2023-09-19 |
PL3400017T3 (pl) | 2020-07-13 |
HUE048601T2 (hu) | 2020-07-28 |
AU2017211520A1 (en) | 2018-08-16 |
WO2017129988A1 (en) | 2017-08-03 |
DK3400017T3 (da) | 2020-05-18 |
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