CN107929245A - A kind of ranolazine solid dispersion preparation and preparation method thereof - Google Patents
A kind of ranolazine solid dispersion preparation and preparation method thereof Download PDFInfo
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- CN107929245A CN107929245A CN201711283513.8A CN201711283513A CN107929245A CN 107929245 A CN107929245 A CN 107929245A CN 201711283513 A CN201711283513 A CN 201711283513A CN 107929245 A CN107929245 A CN 107929245A
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- Prior art keywords
- ranolazine
- lubricant
- parts
- povidone
- solid dispersions
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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
- A61K9/14—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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K31/495—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
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
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- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention relates to field of medicine preparations, specifically discloses a kind of ranolazine solid dispersion preparation and preparation method thereof.Ranolazine solid dispersion preparation of the present invention includes ranolazine, povidone, specific lubricant and specific disintegrant and diluent.Result of extraction, bioavilability and the stability of invention formulation, beneficial to the industrialized production of ranolazine solid dispersion preparation.
Description
Technical field
The present invention relates to field of medicine preparations, and in particular to a kind of ranolazine solid dispersion preparation and preparation method thereof.
Background technology
Ranolazine has antianginal and function of resisting myocardial ischemia, its specific mechanism of action is unclear.Researches show that
It can partly suppress fatty acid oxidation, but can also influence the electrical conduction of heart at the same time, cause the QT interval related with dosage to be prolonged
It is long.Ranolazine be only limited to take the antianginal drugs such as long acting nitrate, calcium ion channel blocker and beta 2 receptor retarding agent without
The patient of effect uses.Clinical test shows that the effect that male patient takes ranolazine is better than women,
The adverse reactions such as dizzy, headache, constipation and nausea occur in long-term use.
Ranolazine is a kind of new chemical entities compound, is the first treatment chronic angina medicine that FDA ratifies over 10 years
Thing.Different from existing antianginal drug, ranolazine is partial fatty acid oxidation enzyme inhibitor, on heart rate and blood pressure without influence,
Can effectively allevating angina pectoris, and do not change other kinetic parameters of medicine, the quality of life of patient with angina pectoris can be improved.
According to the estimation U.S. of American heart association, about 6,800,000 people are diagnosed with angina pectoris, Chinese patients people every year
Number up to more than 4 000 ten thousand, therefore ranolazine has very big market development potential.
The content of the invention
It is an object of the invention to provide a kind of ranolazine solid dispersion preparation and preparation method thereof, the present invention provides such as
Lower technical solution：
A kind of ranolazine solid dispersion particles agent, including ranolazine, povidone and lubricant；
The lubricant in talcum powder, magnesium stearate, silica, sodium stearyl fumarate, lauryl sodium sulfate one
Kind is two or more.
In certain embodiments of the present invention, the lubricant can be further selected from talcum powder, magnesium stearate, titanium dioxide
One kind in silicon, sodium stearyl fumarate, lauryl sodium sulfate, two or three；Further, the lubricant is optional
From：
Two kinds of lauryl sodium sulfate and magnesium stearate；
Two kinds of lauryl sodium sulfate and talcum powder；
Two kinds of silica and magnesium stearate；Or three kinds of lauryl sodium sulfate, silica and magnesium stearate.
Wherein, do not limited for the ratio between a variety of lubricants, but in certain embodiments of the present invention, 12
Ratio between sodium alkyl sulfate and magnesium stearate, silica is 1:1:4, the ratio between lauryl sodium sulfate and talcum powder
Example is 1:2.
In certain embodiments of the present invention, in parts by weight, all formulations include 10-50 parts of ranolazines, 20-
200 parts of povidone and 2-6 parts of lubricants；The parts by weight can be represented in a concrete fashion using any conventional unit of weight,
Such as microgram, milligram, gram, kilogram, two, jin, kilogram, for example, in the form of specific manifestation of the granule by mg for parts by weight,
Including 50-200mg ranolazines, 20-200mg povidone and 2-6mg lubricants.
In certain embodiments of the present invention, the povidone further selected from 30 POVIDONE K 30 BP/USP 25, PVP K30 or
30 POVIDONE K 30 BP/USP 90.
In certain embodiments of the present invention, the composition of the granule further can be as follows：
Granule filling capsule shells of the present invention are capsule preparations, therefore present invention also offers a kind of ranolazine solid point
Granular media capsule, including granule of the present invention and capsule shells.
Present invention also offers the preparation method of the granule, ranolazine, povidone and partial lubrication agent is mixed logical
Cross melt extrusion method and prepare solid dispersions, then add rest lubricant and obtain the granule；Or by ranolazine and
Povidone is dissolved in organic solvent, is prepared solid dispersions by solvent evaporated method or spray drying process, is added lubricant
After obtain the granule；
Wherein, when being prepared by melt extrusion method, the partial lubrication agent refers not only to an a kind of part for lubricant, but also
Refer to a certain lubricant during a variety of lubricants, preferably prepared with silica containing a variety of lubricants by melt extrusion method,
Using silica as the partial lubrication agent.
In addition, the present invention also provides a kind of ranolazine solid dispersions tablet, including ranolazine, povidone, lubricant, collapse
Solve agent and diluent；
The lubricant in talcum powder, magnesium stearate, silica, sodium stearyl fumarate, lauryl sodium sulfate one
Kind is two or more；
The disintegrant is selected from crospovidone, Ac-Di-Sol, sodium carboxymethyl starch, low substituted hydroxy-propyl fiber
It is more than one or both of element；
The diluent be selected from microcrystalline cellulose, starch, pregelatinized starch, lactose, mannitol, one or both of dextrin with
On.
In certain embodiments of the present invention, the povidone further selected from 30 POVIDONE K 30 BP/USP 25, PVP K30 or
30 POVIDONE K 30 BP/USP 90.
In certain embodiments of the present invention, the composition of the tablet further can be as follows：
Mode one：
| Component | Parts by weight |
| Ranolazine | 50 |
| PVP K30 | 100 |
| Microcrystalline cellulose 102 | 50 |
| Ac-Di-Sol | 20 |
| Lauryl sodium sulfate | 10 |
| Silica | 2 |
| Piece weight | 232 |
Mode two：
| Component | Parts by weight |
| Ranolazine | 20 |
| PVP K30 | 100 |
| Microcrystalline cellulose 102 | 50 |
| Ac-Di-Sol | 20 |
| Lauryl sodium sulfate | 10 |
| Silica | 2 |
| Piece weight | 207 |
Mode three：
| Component | Parts by weight |
| Ranolazine | 70 |
| PVP K30 | 100 |
| Microcrystalline cellulose 102 | 50 |
| Ac-Di-Sol | 20 |
| Lauryl sodium sulfate | 10 |
| Silica | 2 |
| Piece weight | 252 |
Present invention also offers the preparation method of the tablet, ranolazine and povidone are dissolved in organic solvent, and by molten
Agent evaporation or spray drying process prepare solid dispersions, then add lubricant, disintegrant and diluent mixed pressuring plate,
Obtain the tablet；Or ranolazine, povidone and partial lubrication agent mixing are prepared into solid by melt extrusion method and disperseed
Body, then adds disintegrant, diluent and rest lubricant mixed pressuring plate, obtains the tablet；
Wherein, when being prepared by melt extrusion method, the partial lubrication agent refers not only to an a kind of part for lubricant, but also
Refer to a certain lubricant during a variety of lubricants, preferably prepared with silica containing a variety of lubricants by melt extrusion method,
Using silica as the partial lubrication agent.
Embodiment
The invention discloses a kind of ranolazine solid dispersion preparation and preparation method thereof, method is as follows：
1st, melt extrusion method
The ranolazine and povidone of recipe quantity are taken, adds partial lubrication agent, is mixed, is put and the mixing is extruded in double screw extruder
Thing, in extrusion, melt is deaerated through row extruded tube applying vacuum, through two to turning calender roller, by the extrudate
Calendering, then to being cooled down before grinding, obtains solid dispersions.
2nd, spray drying process
By the ranolazine of recipe quantity, povidone, (acetone is dissolved in organic solvent：Methanol v/v=1:1-2), spray drying, into
85-90 DEG C of air temperature, air quantity 20-25kg/hr, atomizing pressure 0.5-0.75bar, atomization gas flow 1.5-2.0kg/hr, feed flow
Flow 4.5-5.0ml/min, obtained spray-dried powders put at 45-60 DEG C vacuum drying 24 it is small when, obtain solid dispersions.
3rd, solvent evaporated method
By the ranolazine of recipe quantity, povidone, (acetone is dissolved in organic solvent：Absolute ethyl alcohol v/v=2:1st, acetone：Dichloromethane
Alkane v/v=3:1st, methanol：Dichloromethane v/v=4:1 or acetone：Methanol v/v=3:1) in solvent, the water-bath at 55-60 DEG C,
Vacuum 0.07-0.08MPa, is recovered under reduced pressure organic solvent, after being in thick, continues reduced vacuum drying 1-3h, is transferred to true
80 mesh sieves are crossed in empty drying box, after 40-65 DEG C of dry 48h to crush, and obtain solid dispersions.
With reference to embodiment, the present invention is further explained.
Embodiment 1：Ranolazine solid dispersions tablet
Prescription：
| Component | Parts by weight |
| Ranolazine | 75 |
| PVP K30 | 100 |
| Microcrystalline cellulose 102 | 50 |
| Ac-Di-Sol | 20 |
| Lauryl sodium sulfate | 10 |
| Silica | 2 |
| Piece weight | 257 |
Preparation process：Solvent evaporated method
Ranolazine, the PVP K30 of recipe quantity will be taken, be dissolved in acetone：Methanol (1:3) in solvent, subtract at 60 DEG C in water-bath
Pressure volatilization, vacuum 0.07-0.08MPa, is recovered under reduced pressure organic solvent, after being in thick, continues reduced vacuum drying 1h, turns
Enter in vacuum drying chamber, 80 mesh sieves are crossed after 40 DEG C of dry 48h and are crushed, obtain solid dispersions.
By the microcrystalline cellulose pH102 of obtained solid dispersions addition recipe quantity, Ac-Di-Sol, 12
Sodium alkyl sulfate, silica, mixing, direct tablet compressing.
Embodiment 2：Ranolazine solid dispersions tablet
Prescription：
| Component | Parts by weight |
| Ranolazine | 25 |
| PVP K30 | 100 |
| Microcrystalline cellulose 102 | 50 |
| Ac-Di-Sol | 20 |
| Lauryl sodium sulfate | 10 |
| Talcum powder | 2 |
| Piece weight | 212 |
Preparation process：Solvent evaporated method
Ranolazine, the PVP K30 of recipe quantity are taken, is dissolved in methanol：Dichloromethane (4:1) in solvent, the water-bath at 60 DEG C, very
Reciprocal of duty cycle 0.07-0.08MPa, is recovered under reduced pressure organic solvent, after being in thick, continues reduced vacuum drying 1h, is transferred to vacuum and does
80 mesh sieves are crossed in dry case, after 40 DEG C of dry 48h to crush, and obtain solid dispersions.
Obtained solid dispersions are added to microcrystalline cellulose pH102, crospovidone, the dodecyl sulphate of recipe quantity
Sodium, talcum powder, mixing, direct tablet compressing.
Embodiment 3：Ranolazine solid dispersions tablet
Prescription：
| Component | Parts by weight |
| Ranolazine | 50 |
| PVP K30 | 100 |
| Microcrystalline cellulose 102 | 50 |
| Ac-Di-Sol | 20 |
| Lauryl sodium sulfate | 10 |
| Silica | 2 |
| Piece weight | 232 |
Preparation process：Solvent evaporated method
By the ranolazine of recipe quantity, PVP K30, acetone is dissolved in：Dichloromethane (3:1) in solvent, the water-bath at 55 DEG C, very
Reciprocal of duty cycle 0.07-0.08MPa, is recovered under reduced pressure organic solvent, after being in thick, continues reduced vacuum drying 3h, is transferred to vacuum and does
80 mesh sieves are crossed in dry case, after 60 DEG C of dry 48h to crush, and obtain solid dispersions.
Obtained solid dispersions are added to pregelatinized starch, low-substituted hydroxypropyl cellulose, the dodecyl of recipe quantity
Sodium sulphate, silica, mixing, direct tablet compressing.
Embodiment 4：Ranolazine solid dispersions tablet
Prescription：
| Component | Parts by weight |
| Ranolazine | 25 |
| PVP K30 | 100 |
| Lactose | 50 |
| Sodium carboxymethyl starch | 20 |
| Lauryl sodium sulfate | 10 |
| Silica | 2 |
| Piece weight | 212 |
Preparation process：Spray drying process
By the ranolazine of recipe quantity, PVP K30, acetone is dissolved in：Methanol (1:1) in solvent, spray drying, inlet air temperature 85
DEG C, air quantity 25kg/hr, atomizing pressure 0.5bar, atomization gas flow 1.5kg/hr, for flow quantity 4.5ml/min, obtained spraying
Dried powder be placed at 45 DEG C vacuum drying 24 it is small when, obtain solid dispersions.
Lactose, sodium carboxymethyl starch, lauryl sodium sulfate, the silica of solid dispersions addition recipe quantity will be obtained,
Mixing, direct tablet compressing.
Embodiment 5：Ranolazine solid dispersion particles agent
Prescription：
| Component | Parts by weight |
| Ranolazine | 55 |
| PVP K30 | 100 |
| Microcrystalline cellulose 102 | 50 |
| Ac-Di-Sol | 20 |
| Lauryl sodium sulfate | 10 |
| Silica | 2 |
| Piece weight | 237 |
Preparation method：Solvent evaporated method
By the ranolazine of recipe quantity, PVP K30, acetone is dissolved in：Absolute ethyl alcohol (2:1) in solvent, microcrystalline cellulose is added
102nd, Ac-Di-Sol dissolves, and the water-bath at 60 DEG C, vacuum 0.07-0.08MPa, is recovered under reduced pressure organic solvent,
After being in thick, continue reduced vacuum drying 3h, be transferred in vacuum drying chamber, 80 mesh sieves are crossed after 65 DEG C of dry 48h and are crushed, are obtained
Solid dispersions.
Obtained solid dispersions are added to microcrystalline cellulose 102, Ac-Di-Sol, the dodecane of recipe quantity
Base sodium sulphate and silica, mix, packing, up to granule.
Embodiment 6：Ranolazine solid dispersions capsule
Prescription：
| Component | Parts by weight |
| Ranolazine | 100 |
| PVP K30 | 100 |
| Microcrystalline cellulose 102 | 50 |
| Ac-Di-Sol | 20 |
| Lauryl sodium sulfate | 10 |
| Silica | 2 |
| Piece weight | 282 |
Preparation method：Spray drying process
By the ranolazine of recipe quantity, 30 POVIDONE K 30 BP/USP 90, acetone is dissolved in：Methanol (1:2) in solvent, spray drying, inlet air temperature 90
DEG C, air quantity 20kg/hr, atomizing pressure 0.75bar, atomization gas flow 2.0kg/hr, for flow quantity 5.0ml/min, obtained spray
Mist dried powder be placed at 60 DEG C vacuum drying 24 it is small when, obtain solid dispersions.
Obtained solid dispersions are added to eicosyl sodium sulphate, the magnesium stearate of recipe quantity, mixing, obtains particle
Agent, it is capsule preparations to pour into 3# capsules.
Claims (10)
1. a kind of ranolazine solid dispersion particles agent, it is characterised in that including ranolazine, povidone and lubricant；
The lubricant in talcum powder, magnesium stearate, silica, sodium stearyl fumarate, lauryl sodium sulfate one
Kind is two or more.
2. granule according to claim 1, it is characterised in that the lubricant is selected from talcum powder, magnesium stearate, titanium dioxide
One kind in silicon, sodium stearyl fumarate, lauryl sodium sulfate, two or three.
3. granule according to claim 1, it is characterised in that in parts by weight, including 10-50 parts of ranolazines, 20-200
Part povidone and 2-6 parts of lubricants.
4. the preparation method of granule described in claim 1, it is characterised in that mix ranolazine, povidone and partial lubrication agent
It is even that solid dispersions are prepared by melt extrusion method, then add rest lubricant and obtain the granule；Or by Reynolds
Piperazine and povidone are dissolved in organic solvent, and solid dispersions, addition profit are prepared by solvent evaporated method or spray drying process
The granule is obtained after lubrication prescription；
The lubricant in talcum powder, magnesium stearate, silica, sodium stearyl fumarate, lauryl sodium sulfate one
Kind is two or more.
5. preparation method according to claim 4, it is characterised in that in parts by weight, each parts by weight of raw materials is 10-50 parts of thunders
Promise piperazine, 20-200 part povidone and 2-6 parts of lubricants.
A kind of 6. ranolazine solid dispersions capsule, it is characterised in that including granule described in claim 1-3 any one and
Capsule shells.
7. a kind of ranolazine solid dispersions tablet, it is characterised in that including ranolazine, povidone, lubricant, disintegrant and dilute
Release agent；
The lubricant in talcum powder, magnesium stearate, silica, sodium stearyl fumarate, lauryl sodium sulfate one
Kind is two or more；
The disintegrant is selected from crospovidone, Ac-Di-Sol, sodium carboxymethyl starch, low substituted hydroxy-propyl fiber
It is more than one or both of element；
The diluent be selected from microcrystalline cellulose, starch, pregelatinized starch, lactose, mannitol, one or both of dextrin with
On.
8. tablet according to claim 7, it is characterised in that the lubricant is selected from talcum powder, magnesium stearate, titanium dioxide
One kind in silicon, sodium stearyl fumarate, lauryl sodium sulfate, two or three.
9. it is characterized in that, in parts by weight, including 10-50 parts of ranolazines, 20-150 parts of povidone, 2-6 parts of lubricants, 6-10
Part disintegrant and 20-80 parts of diluents.
10. the preparation method of tablet described in claim 7, it is characterised in that ranolazine and povidone are dissolved in organic solvent,
And solid dispersions are prepared by solvent evaporated method or spray drying process, then add lubricant, disintegrant and diluent
Mixed pressuring plate, obtains the tablet；Or ranolazine, povidone and partial lubrication agent are mixed and prepared by melt extrusion method
Solid dispersions, then add disintegrant, diluent and rest lubricant mixed pressuring plate, obtain the tablet；
The lubricant in talcum powder, magnesium stearate, silica, sodium stearyl fumarate, lauryl sodium sulfate one
Kind is two or more；
It is fine that the disintegrant is selected from crospovidone, Ac-Di-Sol, sodium carboxymethyl starch or low substituted hydroxy-propyl
Dimension element；
The diluent be selected from microcrystalline cellulose, starch, pregelatinized starch, lactose, mannitol, one or both of dextrin with
On.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711283513.8A CN107929245A (en) | 2017-12-07 | 2017-12-07 | A kind of ranolazine solid dispersion preparation and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711283513.8A CN107929245A (en) | 2017-12-07 | 2017-12-07 | A kind of ranolazine solid dispersion preparation and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107929245A true CN107929245A (en) | 2018-04-20 |
Family
ID=61945150
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711283513.8A Pending CN107929245A (en) | 2017-12-07 | 2017-12-07 | A kind of ranolazine solid dispersion preparation and preparation method thereof |
Country Status (1)
| Country | Link |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101066253A (en) * | 2007-06-07 | 2007-11-07 | 北京本草天源药物研究院 | Slow releasing ranolazine tablet |
| CN106176618A (en) * | 2016-09-18 | 2016-12-07 | 佛山市弘泰药物研发有限公司 | A kind of Roflumilast solid dispersion preparation and preparation method thereof |
-
2017
- 2017-12-07 CN CN201711283513.8A patent/CN107929245A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101066253A (en) * | 2007-06-07 | 2007-11-07 | 北京本草天源药物研究院 | Slow releasing ranolazine tablet |
| CN106176618A (en) * | 2016-09-18 | 2016-12-07 | 佛山市弘泰药物研发有限公司 | A kind of Roflumilast solid dispersion preparation and preparation method thereof |
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