CN106727392A - A kind of 9-hydroxy-risperidone sustained-release tablet and preparation method thereof - Google Patents
A kind of 9-hydroxy-risperidone sustained-release tablet and preparation method thereof Download PDFInfo
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- CN106727392A CN106727392A CN201611159383.2A CN201611159383A CN106727392A CN 106727392 A CN106727392 A CN 106727392A CN 201611159383 A CN201611159383 A CN 201611159383A CN 106727392 A CN106727392 A CN 106727392A
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- hydroxy
- risperidone
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- sustained
- release tablet
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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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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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
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
-
- 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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- 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
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Abstract
The present invention provides a kind of 9-hydroxy-risperidone sustained-release tablet and preparation method thereof, and the preparation method is comprised the following steps：Binder solution is configured to using polymer binder and solvent；9-hydroxy-risperidone bulk drug is scattered in binder solution and forms suspension；The suspension and auxiliary material are pelletized, is dried, whole grain；The particle that will be obtained is tabletted, obtains the 9-hydroxy-risperidone sustained-release tablet.The Risperdal sustained-release tablet prepared using the inventive method can reach excellent uniformity of dosage units；Simultaneously because 9-hydroxy-risperidone bulk drug does not have the process recrystallized after dissolving in whole process, therefore the particle diameter distribution before the 9-hydroxy-risperidone particle diameter distribution that ensure that in final sustained release tablets is not pelletized with 9-hydroxy-risperidone bulk drug is consistent, so that the releasing properties and therapeutic effect of medicine are more controllable.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, it is related to a kind of 9-hydroxy-risperidone sustained-release tablet and preparation method thereof.
Background technology
In the production process of oral solid formulation, uniformity of dosage units of the active medicine in final products (preparation) is to comment
One of one important indicator of drug quality of valency, the uneven therapeutic effect that may not only cause medicine of medicament contg is unstable
It is fixed, it is serious in the case of possibly even cause medicine to work or produce serious side effect.
Uniformity of dosage units is even more important for the medicine of low dosage, and dosage is low first necessarily causes medicine to account for whole preparation
Percentage very little (for example accounts for whole weight of formulation less than 1%), therefore disperses difficulty in the formulation higher medicaments uniformity, its
Secondary such medicine only needs very low dosage to can reach therapeutic effect, that is, activity is higher in itself to mean its medicine, so if
Actual content is more slightly higher than sign content, can bring about the risk of side effect.Therefore for the medicine of low dosage, uniformity of dosage units is
One very important quality index.
9-hydroxy-risperidone is that one kind treats schizoid medicine, its sustained release tablets (trade name InvegaTM) include 4 rule
Lattice, respectively 1.5mg, 3mg, 6mg and 9mg, belong to low-dose drugs, and by taking 1.5mg specifications as an example, its medicament contg is less than 1%,
This brings challenge with regard to the uniformity of dosage units of drug.
How to be uniformly distributed among preparation for low dose of medicine, had been reported that in document.In existing document,
Using active medicine is dissolved, then drug solution is sprayed onto the method in auxiliary material, so that medicaments uniformity disperses.But the party
Method is not appropriate for for 9-hydroxy-risperidone sustained release tablets, and it is poorly water soluble drugs that reason is 9-hydroxy-risperidone, the granular size of medicine and
Crystalline form will influence medicine infiltration rate in vivo, if the side being sprayed onto again after 9-hydroxy-risperidone is dissolved using solvent on auxiliary material
Method, when solvent volatilization, when medicine is recrystallized, will change the original particle diameter distribution of 9-hydroxy-risperidone bulk drug, and be possible to change
Become the crystalline form of 9-hydroxy-risperidone, consequently, it is possible to being impacted to the release behavior and therapeutic effect of tablet.
CN1684670A discloses the method and formulation for control release Paliperidone, wherein in disclosed preparation method
It is that the 9-hydroxy-risperidone bulk drug of drying regime and auxiliary material are added in fluid bed, top spray granulation is then carried out with binder solution
To prepare medicine-containing particle.One of the method has the disadvantage that dry 9-hydroxy-risperidone bulk drug is easy to be agglomerated into small group, it is impossible to completely
Dispersion, while during granulation, some drugs may due on the inwall or filter bag that adhere to fluid bed without participating in
Granulation, causes the method it cannot be guaranteed that prepared medicine-containing particle has preferably uniformity of dosage units.
Therefore, in the art, expecting exploitation, a kind of to enable to 9-hydroxy-risperidone sustained release tablets to possess excellent content uniform
The formulation preparation method of degree.
The content of the invention
In view of the shortcomings of the prior art, it is an object of the invention to provide a kind of 9-hydroxy-risperidone sustained-release tablet and its preparation side
Method.The 9-hydroxy-risperidone sustained-release tablet obtained by preparation method of the invention has excellent uniformity of dosage units.
It is that, up to this purpose, the present invention uses following technical scheme：
On the one hand, the present invention provides a kind of preparation method of 9-hydroxy-risperidone sustained-release tablet, the described method comprises the following steps：
(1) it is configured to binder solution using polymer binder and solvent；
(2) 9-hydroxy-risperidone bulk drug is scattered in binder solution and forms suspension；
(3) pelletized using step (2) suspension and auxiliary material, dried, whole grain；
(4) particle for obtaining step (3) is tabletted, obtains the 9-hydroxy-risperidone sustained-release tablet.
Preferably, the solvent is the poor solvent of 9-hydroxy-risperidone, it is further preferred that the solvent is water.
In the present invention, it is very crucial for the selection of solvent, it is impossible to select the good solvent of 9-hydroxy-risperidone, for example
Some organic solvents, although these good solvents can well dissolve 9-hydroxy-risperidone, but when solvent volatilization, medicine recrystallization
When, the original particle diameter distribution of 9-hydroxy-risperidone bulk drug will be changed, and it is possible to change the crystalline form of 9-hydroxy-risperidone, consequently, it is possible to
Release behavior and therapeutic effect to tablet are impacted.The present invention overcomes above-mentioned technology to ask by selecting a kind of poor solvent
Topic, the solvent is insoluble to 9-hydroxy-risperidone bulk drug, so as to ensure that 9-hydroxy-risperidone bulk drug is present in the state of solid particle
In suspension, so that the shape of 9-hydroxy-risperidone bulk drug does not change before granulation and after granulation, the preferred water of the poor solvent.
Preferably, step (1) described polymer binder is PVP and/or Hydroxypropyl methylcellulose.
In the present invention, it is necessary to polymer binder is used with 9-hydroxy-risperidone simultaneously, otherwise due to 9-hydroxy-risperidone raw material
Insoluble in solvent, 9-hydroxy-risperidone bulk drug can form agglomerate to medicine in being added to solvent, it is difficult to 9-hydroxy-risperidone is uniformly disperseed,
And have polymer binder, be increased after the high molecular adhesive dissolving affine between solution and 9-hydroxy-risperidone bulk drug
Property, so that 9-hydroxy-risperidone uniformly can disperse in the solution.
Preferably, the mass ratio of the polymer binder and solvent is 0.1~50:100, such as 0.2:100,0.5:
100,1:100,2:100,3:100,5:100,8:100,10:100,20:100,30:100,40:100 etc., preferably 1~30:
100, further preferred 5~20:100.If polymer binder consumption is too many in the present invention, cause solution viscosity too
Greatly, the uniformity of dosage units of the preparation to preparing has a negative impact.
Preferably, step (2) the 9-hydroxy-risperidone bulk drug and the relative usage of binder solution are 0.1~10:100,
Such as 0.2:100、0.5:100、1:100、2:100、3:100、4:100、5:100、6:100、7:100、8:100 or 9:100.
In the present invention, step (3) granulation uses to enter the method that step (2) described suspension is sprayed to auxiliary material
OK.
Preferably, step (3) described auxiliary material is polyoxyethylene, PVP, Hydroxypropyl methylcellulose, hydroxypropyl cellulose, chlorine
Change in sodium, potassium chloride, sucrose, lactose, mannitol or sodium alginate any one or at least two combination.
On the other hand, the invention provides the 9-hydroxy-risperidone sustained-release tablet prepared by made as described above method.
Relative to prior art, the invention has the advantages that：
The Risperdal sustained-release tablet prepared using the inventive method, due to bulk drug 9-hydroxy-risperidone be dispersed in it is viscous
Suspension is formed in mixture solution, it is ensured that whole bulk drugs is involved in granulation, and is uniformly dispersed, uniformity of dosage units mark
Quasi- deviation is less than 1.5%, therefore can reach excellent uniformity of dosage units；Simultaneously because 9-hydroxy-risperidone bulk drug is in whole process
In there is no the process recrystallized after dissolving, therefore ensure that the 9-hydroxy-risperidone particle diameter distribution in final sustained release tablets and 9-hydroxy-risperidone are former
Particle diameter distribution before material medicine is not pelletized is consistent, so that the releasing properties and therapeutic effect of medicine are more controllable.
Specific embodiment
Technical scheme is further illustrated below by specific embodiment.Those skilled in the art should be bright
, the embodiment be only to aid in understand the present invention, be not construed as to concrete restriction of the invention.
Embodiment 1
In the present embodiment, 9-hydroxy-risperidone sustained-release tablet is prepared by the following method, following steps are specifically included：
(1) 50g PVP K30s and 500g water are configured to the PVP aqueous solution；
(2) 6g 9-hydroxy-risperidones bulk drug is added under stirring and handkerchief profit is formed in the solution that step (1) is prepared
Piperazine ketone suspension；
(3) 901g polyoxyethylene N80 and 40g sodium chloride is added in fluidised bed granulator, with prepared in step (2)
Suspension carry out top spray granulation；Obtained particle is carried out into Comil whole grains, the mixing of 3g magnesium stearates is subsequently adding, is contained
Medicine particle.
(4) it is medicine-containing particle is tabletted suitably to rush, obtain 9-hydroxy-risperidone sustained-release tablet.
The uniformity of dosage units result of the 9-hydroxy-risperidone sustained-release tablet that the present embodiment is prepared is as shown in table 1：
Table 1
Embodiment 2
In the present embodiment, 9-hydroxy-risperidone sustained-release tablet is prepared by the following method, following steps are specifically included：
(1) 50g Hydroxypropyl methylcelluloses E5 and 500g water are configured to the aqueous solution；
(2) 24g 9-hydroxy-risperidones bulk drug is added under stirring and handkerchief profit is formed in the solution that step (1) is prepared
Piperazine ketone suspension；
(3) by 923g polyoxyethylene N80 to fluidised bed granulator, pushed up with suspension prepared in step (2)
Spray grain；Obtained particle is carried out into Comil whole grains, the mixing of 3g magnesium stearates is subsequently adding, medicine-containing particle is obtained.
(4) it is medicine-containing particle is tabletted suitably to rush.
The uniformity of dosage units result of the 9-hydroxy-risperidone sustained-release tablet that the present embodiment is prepared is as shown in table 2：
Table 2
Embodiment 3
In the present embodiment, 9-hydroxy-risperidone sustained-release tablet is prepared by the following method, following steps are specifically included：
(1) 5g Hydroxypropyl methylcelluloses E5 and 500g water are configured to the PVP aqueous solution；
(2) 5g 9-hydroxy-risperidones bulk drug is added under stirring and handkerchief profit is formed in the solution that step (1) is prepared
Piperazine ketone suspension；
(3) 950g Hydroxypropyl methylcellulose K100LV CR and 40g sodium chloride is added in fluidised bed granulator, with step
(2) prepared suspension carries out top spray granulation in；Obtained particle is carried out into Comil whole grains, 3g magnesium stearates are subsequently adding
Mixing, obtains medicine-containing particle.
(4) it is medicine-containing particle is tabletted suitably to rush, obtain 9-hydroxy-risperidone sustained-release tablet.
The uniformity of dosage units result of the 9-hydroxy-risperidone sustained-release tablet that the present embodiment is prepared is as shown in table 3：
Table 3
| Piece number | Content (%) |
| 1 | 100.8 |
| 2 | 101.0 |
| 3 | 100.5 |
| 4 | 101.2 |
| 5 | 99.8 |
| 6 | 99.1 |
| 7 | 99.7 |
| 8 | 100.4 |
| 9 | 98.3 |
| 10 | 101.5 |
| Minimum value | 98.3 |
| Maximum | 101.5 |
| Average value | 100.2 |
| Relative standard deviation | 1.0% |
Embodiment 4
In the present embodiment, 9-hydroxy-risperidone sustained-release tablet is prepared by the following method, following steps are specifically included：
(1) by the mixture (mixed proportion 1 of 150g Hydroxypropyl methylcelluloses E5 and PVP K30:1) it is configured to 500g water
The PVP aqueous solution；
(2) 25g 9-hydroxy-risperidones bulk drug is added under stirring and handkerchief profit is formed in the solution that step (1) is prepared
Piperazine ketone suspension；
(3) 865g hydroxypropyl cellulose K100LV CR and 60g mannitol is added in fluidised bed granulator, with step
(2) prepared suspension carries out top spray granulation in；Obtained particle is carried out into Comil whole grains, 3g magnesium stearates are subsequently adding
Mixing, obtains medicine-containing particle.
(4) it is medicine-containing particle is tabletted suitably to rush, obtain 9-hydroxy-risperidone sustained-release tablet.
The uniformity of dosage units result of the 9-hydroxy-risperidone sustained-release tablet that the present embodiment is prepared is as shown in table 4：
Table 4
| Piece number | Content (%) |
| 1 | 101.8 |
| 2 | 100.2 |
| 3 | 100.1 |
| 4 | 101.1 |
| 5 | 99.5 |
| 6 | 100 |
| 7 | 99.7 |
| 8 | 101.4 |
| 9 | 99.4 |
| 10 | 99.7 |
| Minimum value | 99.4 |
| Maximum | 101.8 |
| Average value | 100.3 |
| Relative standard deviation | 0.8% |
The uniformity of dosage units test result of the 9-hydroxy-risperidone sustained-release tablet prepared by above example 1-4 can be seen
Go out, 9-hydroxy-risperidone sustained-release tablet prepared by the present invention has excellent uniformity of dosage units.
Applicant states that the present invention illustrates method detailed of the invention by above-described embodiment, but the present invention not office
It is limited to above-mentioned method detailed, that is, does not mean that the present invention has to rely on above-mentioned method detailed and could implement.Art
Technical staff it will be clearly understood that any improvement in the present invention, equivalence replacement and auxiliary element to each raw material of product of the present invention
Addition, selection of concrete mode etc., within the scope of all falling within protection scope of the present invention and disclosing.
Claims (10)
1. a kind of preparation method of 9-hydroxy-risperidone sustained-release tablet, it is characterised in that the described method comprises the following steps：
(1) it is configured to binder solution using polymer binder and solvent；
(2) 9-hydroxy-risperidone bulk drug is scattered in binder solution and forms suspension；
(3) pelletized using step (2) suspension and auxiliary material, dried, whole grain；
(4) particle for obtaining step (3) is tabletted, obtains the 9-hydroxy-risperidone sustained-release tablet.
2. preparation method according to claim 1, it is characterised in that the solvent is the poor solvent of 9-hydroxy-risperidone.
3. preparation method according to claim 2, it is characterised in that the solvent is water.
4. the preparation method according to any one of claim 1-3, it is characterised in that step (1) described high molecular bonding
Agent is selected from any one in polyoxyethylene, Hydroxypropyl methylcellulose, hydroxypropyl cellulose, PVP, copolyvidone or sodium alginate
Kind or at least two combination.
5. preparation method according to claim 4, it is characterised in that step (1) described polymer binder is PVP
And/or Hydroxypropyl methylcellulose.
6. the preparation method according to any one of claim 1-5, it is characterised in that the polymer binder and solvent
Mass ratio be 0.1~50:100, preferably 1~30:100, further preferred 5~20:100.
7. the preparation method according to any one of claim 1-6, it is characterised in that step (2) 9-hydroxy-risperidone is former
Material medicine is 0.1~10 with the mass ratio of adhesive:100.
8. the preparation method according to any one of claim 1-7, it is characterised in that step (3) granulation will be using will
The method that step (2) described suspension is sprayed to auxiliary material is carried out.
9. the preparation method according to any one of claim 1-8, it is characterised in that step (3) described auxiliary material is polyoxy
Ethene, PVP, Hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium chloride, potassium chloride, sucrose, lactose, mannitol or alginic acid
In sodium any one or at least two combination.
10. the 9-hydroxy-risperidone sustained-release tablet that the preparation method according to any one of claim 1-9 is prepared.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611159383.2A CN106727392A (en) | 2016-12-15 | 2016-12-15 | A kind of 9-hydroxy-risperidone sustained-release tablet and preparation method thereof |
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| CN201611159383.2A CN106727392A (en) | 2016-12-15 | 2016-12-15 | A kind of 9-hydroxy-risperidone sustained-release tablet and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110251475A (en) * | 2019-07-25 | 2019-09-20 | 沈阳东星医药科技有限公司 | A kind of 9-hydroxy-risperidone tablet and preparation method thereof |
| CN113521021A (en) * | 2021-08-12 | 2021-10-22 | 江苏万珺医药科技有限公司 | Tablet containing rupatadine fumarate and preparation method thereof |
| CN116270515A (en) * | 2023-02-09 | 2023-06-23 | 北京诚济制药股份有限公司 | Preparation method for improving quality of beraprost sodium tablet product |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1684670A (en) * | 2002-07-29 | 2005-10-19 | 阿尔扎公司 | Methods and dosage forms for controlled delivery of paliperidone |
| CN103565769A (en) * | 2012-07-18 | 2014-02-12 | 石药集团中奇制药技术（石家庄）有限公司 | Nifedipine controlled release composition and preparation method thereof |
-
2016
- 2016-12-15 CN CN201611159383.2A patent/CN106727392A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1684670A (en) * | 2002-07-29 | 2005-10-19 | 阿尔扎公司 | Methods and dosage forms for controlled delivery of paliperidone |
| CN103565769A (en) * | 2012-07-18 | 2014-02-12 | 石药集团中奇制药技术（石家庄）有限公司 | Nifedipine controlled release composition and preparation method thereof |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110251475A (en) * | 2019-07-25 | 2019-09-20 | 沈阳东星医药科技有限公司 | A kind of 9-hydroxy-risperidone tablet and preparation method thereof |
| CN110251475B (en) * | 2019-07-25 | 2021-07-16 | 沈阳信康药物研究有限公司 | Paliperidone tablet and preparation method thereof |
| CN113521021A (en) * | 2021-08-12 | 2021-10-22 | 江苏万珺医药科技有限公司 | Tablet containing rupatadine fumarate and preparation method thereof |
| CN113521021B (en) * | 2021-08-12 | 2023-02-28 | 江苏万珺医药科技有限公司 | Tablet containing rupatadine fumarate and preparation method thereof |
| CN116270515A (en) * | 2023-02-09 | 2023-06-23 | 北京诚济制药股份有限公司 | Preparation method for improving quality of beraprost sodium tablet product |
| CN116270515B (en) * | 2023-02-09 | 2023-08-18 | 北京诚济制药股份有限公司 | Preparation method for improving quality of beraprost sodium tablet product |
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