CN106265536A - Bortezomib pharmaceutical composition and preparation method thereof - Google Patents
Bortezomib pharmaceutical composition and preparation method thereof Download PDFInfo
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/69—Boron compounds
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- 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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
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Abstract
The present invention relates to a kind of containing bortezomib pharmaceutical composition and preparation method thereof.Pharmaceutical composition of the present invention comprises bortezomib, mannitol, meglumine and histidine, substantially increases bortezomib dissolubility, shortens the drug solution preparing time, and stability is more excellent.Present invention process is simple, is suitable for industrialized production.
Description
Technical field
The invention belongs to field of medicine preparations, be specifically related to a kind of containing bortezomib pharmaceutical composition and preparation method thereof.
Background technology
Bortezomib (Bortezomib), chemical name is [(1R)-3-methyl isophthalic acid-[[(2S)-1-oxygen-3-phenyl-2-
[(pyrazinecarboxamide) amino] propyl group] amino] butyl] boric acid, trade name Bortezomib (Velcade), by U.S. Millennium
Pharmaceuticals company researches and develops.Bortezomib be in mammalian cell 26S proteasome chymotrypsinlike activity can
Retroactive inhibition agent, has cytotoxicity to polytype cancerous cell, and at present listing dosage form is freeze-dried powder, specification be 1mg and
3.5mg, is mainly used in the treatment of multiple bone marrow cancer.
Patent CN103212055B relates to pharmaceutical composition of a kind of bortezomib and preparation method thereof.Invention drug regimen
Containing bortezomib, the tert-butyl alcohol, sodium chloride and excipient, wherein, described bortezomib, the tert-butyl alcohol, sodium chloride and figuration in thing
The mass ratio of agent is 1:0.5:1～5:5～20.The tert-butyl alcohol can make bortezomib rapid solution such that it is able to many with mannitol etc.
Unit's alcohols excipient reaction forms more stable borate, and then the solution stability of bortezomib lyophilized injectable powder own is asked
Topic；And the addition of sodium chloride ensure that its normal physiology, biochemical activity and function in vivo.But bortezomib and mannitol
Formed and still need to the longer time with Nitranitol.
Patent CN102784114A, by bortezomib and excipient mixed grinding, makes both be sufficiently mixed, and adds injection
After water, continue stirring to all dissolving, thus avoid using heating and the method such as ultrasonic that bortezomib is dissolved, then have
Imitate the increase of impurity during avoiding making up a prescription.
Patent CN102292086B uses bortezomib and tromethane to make lyophilized formulations, and tromethane has and helps
Molten effect, but tromethane is originally as alkalescence, need to add acid and be adjusted to human body acceptable pH scope.
Sample prepared by above-mentioned prescription and technique, still suffers from problems with: 1. bortezomib is oxidizable, in process for preparation easily
There is oxidation reaction, cause having related substance quickly to increase；2. bortezomib water solublity is poor, and forming Nitranitol with mannitol needs
Want the long period, cause extending setup time 3. bortezomib the most sensitive to moisture, moisture impact higher in lyophilizing finished product
Other indexs of product.
Therefore, it is necessary to exploitation one can improve bortezomib dissolution time, shorten the drug solution preparing time compositions and
Its preparation method, said composition and preparation method can improve the stability of bortezomib, and simple for process, are suitable for industrialization
Produce.
Summary of the invention
In order to solve above-mentioned technical problem, the invention provides a kind of containing bortezomib pharmaceutical composition and preparation side thereof
Method.First purpose of the present invention is to provide and a kind of improves bortezomib dissolution time, shortens drug solution preparing time and can
Improve bortezomib pharmaceutical composition of medicine stability and preparation method thereof；Another object of the present invention is to provide a kind of technique
Simple, it is suitable for the preparation method containing bortezomib pharmaceutical composition of industrialized production.
Specifically, the present invention is mainly implemented by below scheme:
The invention provides a kind of stable pharmaceutical composition, described compositions includes the bortezomib of effective dose, props up
Support agent mannitol, cosolvent meglumine or or its pharmaceutically acceptable pharmaceutic adjuvant.
Preferably, described bortezomib is 1:5～10 with the weight ratio of mannitol.
Preferably, described bortezomib is 1:0.5～0.8 with the weight ratio of meglumine, preferably 1:0.5～0.65.
Preferably, described bortezomib pharmaceutical composition also comprises stabilizer, and wherein, stabilizer is selected from histidine, paddy ammonia
Acid or glutathion.
Preferably, described bortezomib is 1:0.1～1 with the weight ratio of stabilizer, preferably 0.5～1.
Preferably, in described bortezomib pharmaceutical composition, the percentage by weight of each component is as follows:
Preferably, in described bortezomib pharmaceutical composition, the percentage by weight of each component is as follows:
Preferably, in described bortezomib pharmaceutical composition, the percentage by weight of each component is as follows:
On the other hand, present invention also offers the preparation method of bortezomib pharmaceutical composition, comprise the following steps:
(1), during bortezomib t-butanol solution adds aqueous megiumine solution water, stirring is to dissolving；
(2) in step (1), mannitol is added；
(3) optional, add stabilizer；
(4) add the water of recipe quantity, filter, fill, lyophilizing.
Preferably, comprise the following steps:
(1), during bortezomib t-butanol solution adds aqueous megiumine solution water, stirring is to dissolving；
(2) benefit injects water to the water for injection of 80% recipe quantity, adds mannitol in step (1), and stirring is to the most molten
Solve；
(3) optional, add stabilizer；
(4) benefit injects water to the water for injection of 100% recipe quantity, stirs, obtains intermediate medicinal liquid；
(5) intermediate medicinal liquid filters 0.2 μm filter pressing filter membrane through nitrogen pressure, and subpackage is in injection bottle, lyophilization, pressure
Plug, rolls lid, packaging, obtains bortezomib lyophilized injectable powder.
Preferably, described freezing dry process is as follows:
In the pre-freeze stage :-45 DEG C are incubated 2～4 hours ,-25 DEG C are incubated 3～6 hours；
Once distillation :-30 DEG C keep 8～12 hours ,-20 DEG C keep 20～26 hours ,-10 DEG C keep 3～6 hours, 0 DEG C
Keep 4 hours；
Redrying: 30 DEG C keep 4～6 hours.
The present invention is by adding meglumine and by controlling the weight ratio of bortezomib and meglumine, it is achieved that bortezomib
Rapid solution；Additionally by add the aminoacid, particularly histidine such as histidine, glutamic acid or glutathion addition and
The optimization of preparation technology, substantially increases the stability of the compositions of bortezomib.
Detailed description of the invention
Following example further describe technical scheme.The embodiment of the present invention illustrates that the present invention does
Go out rather than limitation of the present invention, thus under the method premise of the present invention, technical scheme is modified or
Equivalent belongs to protection scope of the present invention.
Embodiment 1
Preparation method:
Under room temperature condition, 1.0g bortezomib is dissolved in the 50mL tert-butyl alcohol, and 0.5g meglumine is dissolved in 100mL water for injection, slow
Slowly adding to bortezomib t-butanol solution, mend and inject water to 800ml, add mannitol 6.0g, stirring is extremely dissolved, and mends
Inject water to 1000ml, obtain intermediate medicinal liquid；Intermediate medicinal liquid filters 0.2 μm filter pressing filter membrane, and subpackage 1ml through nitrogen pressure
To injection bottle, lyophilization, tamponade, roll lid, packaging, obtain lyophilized injectable powder.Wherein freezing dry process is as follows: pre-freeze
In the stage :-45 DEG C are incubated 2.5 hours ,-25 DEG C are incubated 3 hours；Once distillation :-30 DEG C keep 11 hours, and-20 DEG C of holdings 25.5 are little
Time ,-10 DEG C keep 4 hours, and 0 DEG C keeps 4 hours；Redrying: 30 DEG C keep 5 hours.
Embodiment 2
Preparation method:
Under room temperature condition, 1.0g bortezomib is dissolved in the 50mL tert-butyl alcohol, and 0.6g meglumine is dissolved in 100mL water for injection, slow
Slowly adding to bortezomib t-butanol solution, mend and inject water to 800ml, add mannitol 8.0g, stirring is extremely dissolved, and mends
Inject water to 1000ml, obtain intermediate medicinal liquid；Intermediate medicinal liquid filters 0.2 μm filter pressing filter membrane, and subpackage 1ml through nitrogen pressure
To injection bottle, lyophilization, tamponade, roll lid, packaging, obtain lyophilized injectable powder.Freeze-drying process uses 1 time lyophilizing of embodiment
Technique.
Embodiment 3
Preparation method:
Under room temperature condition, 1.5g bortezomib is dissolved in the 100mL tert-butyl alcohol, and 0.8g meglumine is dissolved in 150mL water for injection, slow
Slowly add to bortezomib t-butanol solution, mend and inject water to 800ml, add mannitol 8.0g and 0.2g histidine,
Stirring, to dissolving, is mended and is injected water to 1000ml, obtain intermediate medicinal liquid；Intermediate medicinal liquid filters 0.2 μm filter pressing through nitrogen pressure
Filter membrane, and subpackage 1ml is in injection bottle, lyophilization, tamponade, rolls lid, packaging, obtains lyophilized injectable powder.Freeze-drying process is adopted
By 1 time lyophilizing technique of embodiment.
Embodiment 4
Preparation method:
Under room temperature condition, 1.5g bortezomib is dissolved in the 100mL tert-butyl alcohol, and 0.8g meglumine is dissolved in 150mL water for injection, slow
Slowly add to bortezomib t-butanol solution, mend and inject water to 800ml, add mannitol 8.0g and 0.7g histidine,
Stirring, to dissolving, is mended and is injected water to 1000ml, obtain intermediate medicinal liquid；Intermediate medicinal liquid filters 0.2 μm filter pressing through nitrogen pressure
Filter membrane, and subpackage 1ml is in injection bottle, lyophilization, tamponade, rolls lid, packaging, obtains lyophilized injectable powder.Freeze-drying process is adopted
By 1 time lyophilizing technique of embodiment.
Embodiment 5
Preparation method:
Under room temperature condition, 3.5g bortezomib is dissolved in the 200mL tert-butyl alcohol, and 2.1g meglumine is dissolved in 250mL water for injection, slow
Slowly add to bortezomib t-butanol solution, mend and inject water to 800ml, add mannitol 20.0g and 3.0g histidine,
Stirring, to dissolving, is mended and is injected water to 1000ml, obtain intermediate medicinal liquid；Intermediate medicinal liquid filters 0.2 μm filter pressing through nitrogen pressure
Filter membrane, and subpackage 1ml is in injection bottle, lyophilization, tamponade, rolls lid, packaging, obtains lyophilized injectable powder.Freeze-drying process is adopted
By 1 time lyophilizing technique of embodiment.
Embodiment 6
Preparation method:
Under room temperature condition, 3.5g bortezomib is dissolved in the 200mL tert-butyl alcohol, and 2.1g meglumine is dissolved in 250mL water for injection, slow
Slowly add to bortezomib t-butanol solution, mend and inject water to 800ml, add mannitol 22.0g and 3.0g glutamic acid,
Stirring, to dissolving, is mended and is injected water to 1000ml, obtain intermediate medicinal liquid；Intermediate medicinal liquid filters 0.2 μm filter pressing through nitrogen pressure
Filter membrane, and subpackage 1ml is in injection bottle, lyophilization, tamponade, rolls lid, packaging, obtains lyophilized injectable powder.Freeze-drying process is adopted
By 1 time lyophilizing technique of embodiment.
Embodiment 7
Preparation method:
Under room temperature condition, 3.5g bortezomib is dissolved in the 200mL tert-butyl alcohol, and 1.9g meglumine is dissolved in 250mL water for injection, slow
Slowly add to bortezomib t-butanol solution, mend and inject water to 800ml, add mannitol 20.0g and 3.0g gluathione
Peptide, stirring, to dissolving, is mended and is injected water to 1000ml, obtain intermediate medicinal liquid；Intermediate medicinal liquid filters 0.2 μm pressure through nitrogen pressure
Filter filter membrane, and subpackage 1ml is in injection bottle, lyophilization, tamponade, rolls lid, packaging, obtains lyophilized injectable powder.Freeze-drying process
Use 1 time lyophilizing technique of embodiment.
Test example 1 preparation nature is investigated
Test example 2 stability of solution is investigated
After embodiment 1-7 gained sample is redissolved with the sodium chloride solution of 0.9%, place 24 hours under room temperature condition, 2-8
Placing 72 hours at DEG C, investigate its stability of solution, experimental result is shown in Table 3
By test 2 it can be seen that the bortezomib solution of the present invention, particularly embodiment 3-5, put at ambient temperature
Putting placement at 24 hours, 2-8 DEG C is stable in 72 hours, meets the requirement of injection preparation.
Embodiment 1-7 products obtained therefrom is put 40 DEG C, and humidity is to place 6 months under the conditions of 75%, investigates its stability, experiment
The results are shown in Table 3
Table 3 stability test result
Be can be seen that by the above results, embodiment 1-7 bortezomib freeze-dried powder is multiple, and dissolution time is short, moisture is low and is placing
Journey is basically unchanged；By adding the addition of stabilizer, particularly histidine, it is the most miscellaneous and changes of contents is less, good stability.
Claims (12)
1. bortezomib pharmaceutical composition, comprises bortezomib, mannitol, meglumine or it is pharmaceutically acceptable medicinal auxiliary
Material.
Bortezomib pharmaceutical composition the most according to claim 1, it is characterised in that described bortezomib compositions is also wrapped
Containing stabilizer.
Bortezomib pharmaceutical composition the most according to claim 1, it is characterised in that described bortezomib and mannitol
Weight ratio is 1:5～10.
Bortezomib pharmaceutical composition the most according to claim 1, it is characterised in that described bortezomib and meglumine
Weight ratio is than for 1:0.5～0.8, preferably 1:0.5～0.65.
Bortezomib pharmaceutical composition the most according to claim 2, it is characterised in that described bortezomib and stabilizer
Weight ratio is 1:0.1～1, preferably 1:0.5～1.
Bortezomib pharmaceutical composition the most according to claim 1 and 2, it is characterised in that the percentage by weight of each component
As follows:
Bortezomib 5～15%
Mannitol 65～85%
Meglumine 2～10%
Stabilizer 0～10%.
Bortezomib pharmaceutical composition the most according to claim 6, it is characterised in that the weight percent of each component is such as
Under:
Bortezomib 10～15%
Mannitol 70～85%
Meglumine 5～10%
Stabilizer 0～10%.
Bortezomib pharmaceutical composition the most according to claim 6, it is characterised in that the weight percent of each component is such as
Under:
Bortezomib 10～15%
Mannitol 70～85%
Meglumine 5～10%
Stabilizer 5～10%.
Bortezomib pharmaceutical composition the most according to claim 6, it is characterised in that described stabilizer selected from histidine,
Glutamic acid or glutathion.
10. the preparation method of bortezomib pharmaceutical composition, comprises the following steps:
(1), during bortezomib t-butanol solution adds aqueous megiumine solution water, stirring is to dissolving；
(2) in step (1), mannitol is added；
(3) optional, add stabilizer；
(4) add the water of recipe quantity, filter, fill, lyophilizing.
The preparation method of 11. bortezomib pharmaceutical compositions according to claim 10, it is characterised in that include following step
Rapid:
(1), during bortezomib t-butanol solution adds aqueous megiumine solution water, stirring is to dissolving；
(2) benefit injects water to the water for injection of 80% recipe quantity, adds mannitol in step (1), and stirring is to dissolving；
(3) optional, add stabilizer；
(4) benefit injects water to the water for injection of 100% recipe quantity, stirs, obtains intermediate medicinal liquid；
(5) intermediate medicinal liquid filters 0.2 μm filter pressing filter membrane through nitrogen pressure, and subpackage is in injection bottle, lyophilization, tamponade,
Roll lid, packaging, obtain bortezomib lyophilized injectable powder.
12. preparation methoies according to claim 10, it is characterised in that described freezing dry process is as follows:
In the pre-freeze stage :-45 DEG C are incubated 2 ~ 4 hours ,-25 DEG C are incubated 3 ~ 6 hours,
Once distillation :-30 DEG C keep 8 ~ 12 hours, and-20 DEG C keep 20 ~ 26 hours, and-10 DEG C keep 3 ~ 6 hours, and 0 DEG C keeps 4
Hour；
Redrying: 30 DEG C keep 4 ~ 6 hours.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107260690A (en) * | 2017-06-22 | 2017-10-20 | 江苏豪森药业集团有限公司 | Lyophilized formulations of Decitabine and preparation method thereof |
| CN112741894A (en) * | 2019-10-31 | 2021-05-04 | 江苏恒瑞医药股份有限公司 | Novel echinocandin antifungal agent pharmaceutical composition |
| US20230102141A1 (en) * | 2021-09-24 | 2023-03-30 | MAIA Pharmaceuticals, Inc. | Bortezomib compositions |
| JP7423028B2 (en) | 2017-11-01 | 2024-01-29 | 日医工岐阜工場株式会社 | Lyophilized pharmaceutical composition containing bortezomib |
| US12005069B2 (en) | 2023-08-28 | 2024-06-11 | MAIA Pharmaceuticals, Inc. | Bortezomib compositions |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107260690A (en) * | 2017-06-22 | 2017-10-20 | 江苏豪森药业集团有限公司 | Lyophilized formulations of Decitabine and preparation method thereof |
| JP7423028B2 (en) | 2017-11-01 | 2024-01-29 | 日医工岐阜工場株式会社 | Lyophilized pharmaceutical composition containing bortezomib |
| CN112741894A (en) * | 2019-10-31 | 2021-05-04 | 江苏恒瑞医药股份有限公司 | Novel echinocandin antifungal agent pharmaceutical composition |
| US20230102141A1 (en) * | 2021-09-24 | 2023-03-30 | MAIA Pharmaceuticals, Inc. | Bortezomib compositions |
| US11672813B2 (en) * | 2021-09-24 | 2023-06-13 | MAIA Pharmaceuticals, Inc. | Bortezomib compositions |
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| US12005069B2 (en) | 2023-08-28 | 2024-06-11 | MAIA Pharmaceuticals, Inc. | Bortezomib compositions |
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| Publication number | Publication date |
|---|---|
| CN106265536B (en) | 2019-01-11 |
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