CN107982216A - A kind of pomalidomide self-micro emulsion formulation and preparation method thereof - Google Patents
A kind of pomalidomide self-micro emulsion formulation and preparation method thereof Download PDFInfo
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- CN107982216A CN107982216A CN201711298744.6A CN201711298744A CN107982216A CN 107982216 A CN107982216 A CN 107982216A CN 201711298744 A CN201711298744 A CN 201711298744A CN 107982216 A CN107982216 A CN 107982216A
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- pomalidomide
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- micro emulsion
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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
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
- A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
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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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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Abstract
The invention discloses a kind of pomalidomide self-micro emulsion formulation and preparation method thereof, it is that Solid Self-microemulsion preparation is further made with excipient by pomalidomide, oil phase, emulsifying agent, assistant for emulsifying agent composition liquid self-micro emulsion formulation, or by gained liquid self-micro emulsion formulation.
Description
Technical field
The invention belongs to pharmaceutical technology field, and in particular to a kind of pomalidomide self-micro emulsion formulation and preparation method thereof.
Background technology
U.S. FDA approval on January 8th, 2013 Pomalyst（Pomalidomide, pomalidomide）Treat other anticarcinogens
The multiple myeloma patients that the state of an illness is still in progress after treatment.
Huppert's disease is a kind of leukemia, mainly influences older population, is induced from the thick liquid cell of marrow.According to American National
Cancer research institute estimates, there are about 2.17 ten thousand Americans every year and is diagnosed with Huppert's disease, 1.071 ten thousand are died of this
Kind disease.
Pomalyst is a kind of pill, it adjusts the immune system of human body, destroys cancer cell and suppresses its growth.It is suitable
For previously at least having received two kinds of medicines, including lenalidomide（lenalidomide）And bortezomib
（bortezomib）, to treating no response（Fail of the effect）It is in progress with after last time is treated in 60 days（Recur and refractory
Property）Patient.Pomalyst is immunomodulator one kind, after lenalidomide and Thalidomide（thalidomide）Afterwards
Three medicines.Multiple myeloma needs " customizing ", to meet the needs of patient out of the ordinary, Pomalyst be approved for
The invalid patient of other medicines treatment provides new selection.In July, 2012, FDA once ratify Kyprolis
（carfilzomib）Treat Huppert's disease.Similar with Kyprolis, Pomalyst is also to be examined by the acceleration of FDA
Program gets the Green Light, and obtains seldom used medicine treatment.The security and validity of Pomalyst has 221 recurrences or difficult at one
Assessed in the clinical test that the property controlled multiple myeloma patients participate in.The purpose of the experiment is observation cancer after treatment
The patient's number to disappear completely or partially（Objective response rate, or ORR）.Patient be probabilistically assigned receive independent Pomalyst or
Pomalyst adds low dose corticosteroid dexamethasone（dexamethasone）.The results show：Receive that Pomalyst is single to be controlled
The patient 7.4% for the treatment of reaches ORR.Response time median is not yet drawn a conclusion in these patients（Still there is response during statistics）.
Pomalyst, which adds in the patient that low dose dexamethasone is treated, 29.2% display ORR, response duration time median 7.4
Month.The label of Pomalyst reminds patient and the medical staff medicine to be used to pregnant woman with one plus frame caveat, because
It may result in the Severe birth defect of threat to life, which may cause blood clotting.
Since Pomalyst is risky to fetus, Pomalyst is planned by risk assessment and abatement（REMS）Allot：Press
According to REMS requirements, doctor signs with patient.Particular without pregnancy can conceptive female patient, need to make pregnancy tests and to keep away
Pregnant, male patient must take contraceptives as requested.Pharmacy need to according to REMS certifications, the medicine can only prescription to being met the requirements
Patient.Common side effect has the white blood corpuscle for resisting infection（Neutrophil leucocyte）Reduce, tired and weak, red blood cell count(RBC)
Reduce（Anaemia）, constipation, diarrhea, decrease of platelet decline（Thrombopenia）, the infection of the upper respiratory tract, back pain and hair
Burn.
Clinical advantage 1, II clinical trial phase prove pomalidomide（2mg/d）Combined with Dexamethasone（40mg/ weeks）To RRMM
There are the effect of fine and tolerance.2nd, the clinical test of III phase demonstrates POM+LoDEX Regimen Chemotherapies RRMM, especially right
Lenalidomide and（Or）The RRMM of bortezomib drug resistant, there is the effect of encouraging and controllable toxic side effect.
The content of the invention
It is an object of the invention to provide a kind of pomalidomide self-micro emulsion formulation and preparation method thereof, it is remarkably improved pool
Horse degree amine dissolution in vitro and vivo biodistribution utilization rate, and raw material is easy to get, preparation process simple possible, yield is high, cost is low, can
To realize industrialization large-scale production, there is significant economic benefit.
To achieve the above object, the present invention adopts the following technical scheme that：
A kind of pomalidomide self-micro emulsion formulation, it is specially a kind of liquid self-micro emulsion formulation or a kind of Solid Self-microemulsion preparation.
The liquid self-micro emulsion formulation is made of pomalidomide, oil phase, emulsifying agent, assistant for emulsifying agent；Its each raw material used is pressed
Percetage by weight is calculated as：Pomalidomide 0.1% ~ 10%, oil phase 5% ~ 80%, emulsifying agent 5% ~ 60%, assistant for emulsifying agent 5% ~ 60%, each raw material
The sum of percetage by weight is 100%；
Wherein, the oil phase is Sunsoft 8090, oleic acid LABRAFIL M 1944CS, ethyl oleate, caprylic capric triglycerin
One or more in ester, oleic acid；
The emulsifying agent is Labraso, Tween-80, Solutol HS15, polyoxy second
One or more in 35 castor oil of alkene, the rilanit special of polyethylene glycol -40；
The assistant for emulsifying agent is diethylene glycol monoethyl ether, the one or more in propane diols, polyethylene glycol 400, glycerine.
The preparation method of the liquid self-micro emulsion formulation is that pomalidomide is added in oil phase, emulsifying agent or assistant for emulsifying agent
After dissolving, add other raw materials and be uniformly mixed, using conventional method it is filling in soft capsule to obtain the final product.
The Solid Self-microemulsion preparation be by by the liquid that pomalidomide, oil phase, emulsifying agent, assistant for emulsifying agent form from micro emulsion
Preparation is further made with excipient；The weight ratio of liquid self-micro emulsion formulation and excipient used is 1:1~1:60；
Wherein, the excipient is microcrystalline cellulose, lactose, PVP K30, one kind in silica or several
Kind.
The preparation method of the Solid Self-microemulsion preparation is that pomalidomide is added in oil phase, emulsifying agent or assistant for emulsifying agent
After dissolving, other raw materials that addition prepares needed for liquid self-micro emulsion formulation are uniformly mixed, then by obtained liquid self-micro emulsion formulation
It is uniformly mixed with excipient, piece agent is prepared using direct powder compression；Or dry granulation or wet granulation technology are used, will
It is mixed with other auxiliary materials, tabletting prepares piece agent；Or pellet is prepared into by extrusion spheronization method, centrifugal granulation, load hard
In capsule；
Other described auxiliary materials include disintegrant, adhesive, lubricant.
The remarkable advantage of the present invention is：Self-micro emulsifying medicament delivery system can be such that pomalidomide is kept in preparation and intestinal fluid
Dissolved state, and the micro emulsion drop formed after self-emulsifying has minimum particle diameter, ensure that larger dispersion degree, is remarkably improved
Solubility and dissolution rate of the pomalidomide in gastro-intestinal Fluid；Lipid excipient in prescription can promote chylomicron to secrete, and then
Promote pomalidomide through lymphatic transport.
Pomalidomide is prepared into self-micro emulsion formulation and can reach raising dissolution in vitro and vivo biodistribution utilization rate by the present invention
Effect, and raw material is easy to get needed for preparation, preparation process simple possible, and yield is high, cost is low, it is possible to achieve industrialization is extensive
Production, has significant economic benefit.
Embodiment
In order to make content of the present invention easily facilitate understanding, with reference to embodiment to of the present invention
Technical solution is described further, but the present invention is not limited only to this.
Embodiment 1：The preparation of pomalidomide self-microemulsion soft capsules
| Pomalidomide | 0.2g |
| Sunsoft 8090 | 100g |
| Labraso | 50g |
| Diethylene glycol monoethyl ether | 50g |
Preparation process：
Pomalidomide is added in Sunsoft 8090 and is stirred to dissolve, sequentially adds caprylic capric polyethylene glycol glycerol
Ester, diethylene glycol monoethyl ether, stirring make it after mixing, it is filling in soft capsule to obtain the final product.
Embodiment 2：The preparation of pomalidomide self-microemulsion soft capsules
| Pomalidomide | 0.2g |
| Oleic acid LABRAFIL M 1944CS | 100g |
| Ethyl oleate | 50g |
| Tween-80 | 25g |
| Propane diols | 25g |
Preparation process：
Will pomalidomide add oleic acid LABRAFIL M 1944CS in stir to dissolve, sequentially add ethyl oleate, tween-
80th, propane diols, stirring make it after mixing, it is filling in soft capsule to obtain the final product.
Embodiment 3：The preparation of pomalidomide self-microemulsion soft capsules
| Pomalidomide | 0.2g |
| Solutol HS15 | 75g |
| Sad certain herbaceous plants with big flowers acid glyceryl ester | 50g |
| Oleic acid | 25g |
| Emulsifier EL-35 | 25g |
| Polyethylene glycol 400 | 25g |
Preparation process：
Pomalidomide is added in Solutol HS15 and is stirred to dissolve, sequentially adds sad certain herbaceous plants with big flowers acid three
Glyceride, oleic acid, Emulsifier EL-35, polyethylene glycol 400, stirring make it after mixing, filling to be in soft capsule
.
Embodiment 4：The preparation of pomalidomide Solid Self-microemulsion piece
| Pomalidomide | 0.5g |
| Diethylene glycol monoethyl ether | 75g |
| Sunsoft 8090 | 10g |
| Sad certain herbaceous plants with big flowers acid polyethylene glycol glyceride | 15g |
| Microcrystalline cellulose | 85g |
| Sodium carboxymethyl starch | 15g |
Preparation process：
Pomalidomide is added in diethylene glycol monoethyl ether and is stirred to dissolve, sequentially adds Sunsoft 8090, pungent
Sour certain herbaceous plants with big flowers acid polyethylene glycol glyceride, stirring make it after mixing, add microcrystalline cellulose, sodium carboxymethyl starch, wet granulation
Tabletting, to obtain the final product.
Embodiment 5：The preparation of pomalidomide Solid Self-microemulsion piece
| Pomalidomide | 1g |
| Oleic acid LABRAFIL M 1944CS | 35g |
| Ethyl oleate | 10g |
| Tween-80 | 15g |
| Propane diols | 15g |
| Lactose | 95g |
| Crosslinked polyvinylpyrrolidone | 15g |
| Magnesium stearate | 5g |
Preparation process：
After oleic acid LABRAFIL M 1944CS, ethyl oleate mix, pomalidomide is added thereto and is stirred to dissolve, then added successively
Enter Tween-80, propane diols, stirring makes it after mixing, addition lactose, crosslinked polyvinylpyrrolidone, after dry granulation, adds
Enter magnesium stearate tabletting, to obtain the final product.
Embodiment 6：The preparation of pomalidomide Solid Self-microemulsion piece
| Pomalidomide | 0.5g |
| Caprylic capric glyceryl ester | 35g |
| Oleic acid | 10g |
| Solutol HS15 | 15g |
| The rilanit special of polyethylene glycol -40 | 15g |
| Lactose | 95g |
| Crosslinked polyvinylpyrrolidone | 15g |
| Silica | 5g |
Preparation process：
After caprylic capric glyceryl ester, oleic acid mix, pomalidomide is added thereto and is stirred to dissolve, sequentially adds poly- second
Glycol 15- hydroxy stearic acid esters, the rilanit special of polyethylene glycol -40, stirring make it after mixing, add lactose, crosslinking gathers
Vinylpyrrolidone, silica, direct powder compression, to obtain the final product.
Embodiment 7：The preparation of pomalidomide Solid Self-microemulsion micro pill capsule
| Pomalidomide | 1g |
| Diethylene glycol monoethyl ether | 70g |
| Sunsoft 8090 | 5g |
| Labraso | 5g |
| Microcrystalline cellulose | 75g |
| Lactose | 25g |
| Sodium carboxymethyl starch | 10g |
Preparation process：
Pomalidomide is added in diethylene glycol monoethyl ether and is stirred to dissolve, sequentially adds Sunsoft 8090, pungent
Sour capric acid LABRAFIL M 1944CS, stirring make it after mixing, add microcrystalline cellulose, lactose, sodium carboxymethyl starch, mix
Even, extrusion spheronization method is prepared into pellet, it is encapsulated to obtain the final product.
Embodiment 8：The preparation of pomalidomide Solid Self-microemulsion micro pill capsule
| Pomalidomide | 0.2g |
| Oleic acid LABRAFIL M 1944CS | 50g |
| Ethyl oleate | 25g |
| Tween-80 | 5g |
| Propane diols | 5g |
| Microcrystalline cellulose | 95g |
| Sodium carboxymethyl starch | 10g |
Preparation process：
After oleic acid LABRAFIL M 1944CS, ethyl oleate mix, pomalidomide is added thereto and is stirred to dissolve, then added successively
Enter Tween-80, propane diols, stirring makes it after mixing, adds microcrystalline cellulose, sodium carboxymethyl starch, mixes, is viscous using water
Mixture prepares pellet using centrifugal granulation, it is encapsulated to obtain the final product.
Embodiment 9：The preparation of pomalidomide Solid Self-microemulsion micro pill capsule
| Pomalidomide | 0.3g |
| Diethylene glycol monoethyl ether | 70g |
| Caprylic capric glyceryl ester | 5g |
| Solutol HS15 | 5g |
| Emulsifier EL-35 | 5g |
| Microcrystalline cellulose | 95g |
| Sodium carboxymethyl starch | 10g |
Preparation process：
Will pomalidomide add diethylene glycol monoethyl ether in stir to dissolve, sequentially add caprylic capric glyceryl ester,
Solutol HS15, Emulsifier EL-35, stirring make it after mixing, add microcrystalline cellulose, carboxylic
Methyl starch sodium, mixes, and extrusion spheronization method prepares pellet, it is encapsulated to obtain the final product.
Claims (6)
- A kind of 1. pomalidomide self-micro emulsion formulation, it is characterised in that：The pomalidomide self-micro emulsion formulation is liquid from micro emulsion system Agent, it is made of pomalidomide, oil phase, emulsifying agent, assistant for emulsifying agent.
- A kind of 2. pomalidomide self-micro emulsion formulation, it is characterised in that：The pomalidomide self-micro emulsion formulation is Solid Self-microemulsion system Agent, after it forms liquid self-micro emulsion formulation by pomalidomide, oil phase, emulsifying agent, assistant for emulsifying agent, further with excipient system Into.
- 3. pomalidomide self-micro emulsion formulation according to claim 1 or claim 2, it is characterised in that：It is each used in liquid self-micro emulsion formulation Raw material percentage is：Pomalidomide 0.1% ~ 10%, oil phase 5% ~ 80%, emulsifying agent 5% ~ 60%, assistant for emulsifying agent 5% ~ 60%, The sum of each raw material weight percentage is 100%；Wherein, the oil phase is Sunsoft 8090, oleic acid LABRAFIL M 1944CS, ethyl oleate, caprylic capric triglycerin One or more in ester, oleic acid；The emulsifying agent is Labraso, Tween-80, Solutol HS15, polyoxy second One or more in 35 castor oil of alkene, the rilanit special of polyethylene glycol -40；The assistant for emulsifying agent is diethylene glycol monoethyl ether, the one or more in propane diols, polyethylene glycol 400, glycerine.
- 4. pomalidomide self-micro emulsion formulation according to claim 2, it is characterised in that：Liquid self-micro emulsion formulation and excipient Weight ratio is 1:1~1:60；The excipient is microcrystalline cellulose, the one or more in lactose, PVP K30, silica.
- A kind of 5. preparation method of pomalidomide self-micro emulsion formulation as claimed in claim 1, it is characterised in that：By pomalidomide plus Enter into oil phase, emulsifying agent or assistant for emulsifying agent dissolving after, add other raw materials and be uniformly mixed, it is filling in soft capsule to obtain the final product.
- A kind of 6. preparation method of pomalidomide self-micro emulsion formulation as claimed in claim 2, it is characterised in that：By pomalidomide plus After entering into oil phase, emulsifying agent or assistant for emulsifying agent dissolving, other raw materials mixing that addition is prepared needed for liquid self-micro emulsion formulation is equal It is even, then obtained liquid self-micro emulsion formulation is uniformly mixed with excipient, piece agent is prepared using direct powder compression；Or adopt With dry granulation or wet granulation technology, it is mixed with other auxiliary materials, tabletting prepares piece agent；Or by extrusion spheronization method, Centrifugal granulation is prepared into pellet, is fitted into hard shell capsules；Other described auxiliary materials include disintegrant, adhesive, lubricant.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201711298744.6A CN107982216A (en) | 2017-12-08 | 2017-12-08 | A kind of pomalidomide self-micro emulsion formulation and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711298744.6A CN107982216A (en) | 2017-12-08 | 2017-12-08 | A kind of pomalidomide self-micro emulsion formulation and preparation method thereof |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010135396A2 (en) * | 2009-05-19 | 2010-11-25 | Celgene Corporation | Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione |
| CN104042590A (en) * | 2014-07-02 | 2014-09-17 | 南京卡文迪许生物工程技术有限公司 | Stable pomalidomide capsule and preparation method thereof |
| CN104224723A (en) * | 2014-10-14 | 2014-12-24 | 北京科莱博医药开发有限责任公司 | Pomalidomide nanoparticle and preparation and preparation method thereof |
| CN105640886A (en) * | 2016-03-17 | 2016-06-08 | 中国人民解放军南京军区福州总医院 | Sirolimus self-microemulsion preparation and preparation method thereof |
-
2017
- 2017-12-08 CN CN201711298744.6A patent/CN107982216A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010135396A2 (en) * | 2009-05-19 | 2010-11-25 | Celgene Corporation | Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione |
| CN104042590A (en) * | 2014-07-02 | 2014-09-17 | 南京卡文迪许生物工程技术有限公司 | Stable pomalidomide capsule and preparation method thereof |
| CN104224723A (en) * | 2014-10-14 | 2014-12-24 | 北京科莱博医药开发有限责任公司 | Pomalidomide nanoparticle and preparation and preparation method thereof |
| CN105640886A (en) * | 2016-03-17 | 2016-06-08 | 中国人民解放军南京军区福州总医院 | Sirolimus self-microemulsion preparation and preparation method thereof |
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Application publication date: 20180504 |