CN104257622B - Paliperidone controlled-release tablet and preparation method thereof - Google Patents
Paliperidone controlled-release tablet and preparation method thereof Download PDFInfo
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- CN104257622B CN104257622B CN201410543391.1A CN201410543391A CN104257622B CN 104257622 B CN104257622 B CN 104257622B CN 201410543391 A CN201410543391 A CN 201410543391A CN 104257622 B CN104257622 B CN 104257622B
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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
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
Abstract
The invention provides a paliperidone controlled-release preparation, which comprises a single-layer tablet core containing paliperidone, two layers of coatings formed by one or more coating polymers and coated on the single-layer tablet core for controlling drug release, and a third protective layer optionally formed by one or more coating polymers. The invention also provides a preparation method of the paliperidone controlled-release preparation. The method controls the release of paliperidone by combining two controlled release mechanisms of the gel framework and the membrane-controlled coating, has simpler production process, does not use organic solvent in the production process, is green and environment-friendly, and is more beneficial to industrial production.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a paliperidone oral controlled-release tablet and a preparation method thereof.
Background
Paliperidone (9-hydroxyrisperidone) is a novel atypical antipsychotic belonging to the derivatives of benzisoxazoles, which is currently believed to act through a mechanism that interferes with signal transduction of neurotransmitters in the brain of patients by blocking dopamine, 5-hydroxytryptamine and adrenergic receptors. The oral bioavailability of the paliperidone is 28%, the plasma protein binding rate is 74%, the terminal elimination and half-life period is about 23 hours, and the paliperidone has better curative effect on schizophrenia clinically. Has the following structural formula:
the clinical application of the medicament for treating the nervous system diseases has the following main problems: adverse reactions are large, particularly, the adverse reactions are obvious in the initial stage of taking medicine, the tolerance of patients is poor, and the patients are easy to stop taking the medicine midway; the common preparation requires dose titration (i.e. slowly increasing the dose) at the initial stage of taking to reduce the occurrence of adverse reactions, but is inconvenient to take. In order to solve the clinical application problems, various controlled release technologies are applied to the nervous system drug administration to develop controlled release preparations, for example, the preparation prepared by the osmotic pump controlled release technology has the advantages of less influence of factors such as medium environment pH value, gastrointestinal motility, food and the like, small individual difference, good in-vivo and in-vitro correlation, stable blood, small adverse reaction, few drug taking times of patients, high compliance and the like.
Paliperidone was developed by qiangsheng, usa, using osmotic pump technology from Alza corporation. Chinese patent application No. 03822948.X (method and dosage form for controlled release of paliperidone) discloses a technique for paliperidone controlled release tablets. The preparation adopts a dosage form of three-layer osmotic pump tablets, the preparation process is very complicated, and the three-layer tablet comprises a push layer and two drug-containing layers with different drug proportions. The preparation process of the preparation is as follows: 1) firstly, respectively granulating two medicine-containing layer particles and two propelling layer particles by a wet granulation process to respectively obtain two medicine-containing layer particles and two propelling layer particles; 2) tabletting the two drug-containing layer granules and the propelling layer by using a three-layer tablet machine to obtain a paliperidone three-layer tablet; 3) carrying out isolation coating on the paliperidone three-layer tablet; 4) the isolation coating of the paliperidone trilayer tablet is coated with cellulose acetate and polyethylene glycol for controlled release of the osmotic pump tablet, the cellulose acetate is dissolved in acetone for coating in the coating process, and the concentration of the coating solution is within 10 percent; 5) laser drilling is carried out on the osmotic pump tablet to provide an outlet for drug release, and two laser holes are needed to be drilled on one surface of the tablet when the paliperidone controlled release tablet is originally ground; 6) and coating the outer protective layer on the laser-punched paliperidone osmotic pump tablet. This technique has the following disadvantages: 1) the technology requires a three-layer tablet press with special tablet press equipment; 2) the paliperidone is coated by controlled release by using an organic solvent acetone, so that a large amount of acetone is consumed, and the conventional coating equipment lacks an acetone recovery device, so that the acetone is directly discharged into the atmosphere to cause pollution; 3) the paliperidone tablet is subjected to laser drilling by a laser drilling machine, and two holes need to be drilled on one surface of the paliperidone tablet.
Because the requirement of three-layer tabletting on the precision of equipment is very high, the literature has carried out technological improvement on the paliperidone controlled release tablet, for example, Chinese application No. 200910199425.9 (a controlled release preparation of benzisoxazole derivatives and a preparation method thereof) discloses a paliperidone double-layer osmotic pump tablet and a preparation method thereof, but special tabletting equipment double-layer tabletting machine and organic solvent acetone are still needed for carrying out controlled release coating.
The preparation process of the paliperidone controlled release tablet disclosed at present needs a double-layer tablet press or a three-layer tablet press, and the tabletting process is accurately controlled to avoid the problem of content uniformity, so that the production cost is high, and the risk of producing unqualified tablets is high; in addition, the semi-permeable membrane material cellulose acetate needs to be dissolved in acetone, a large amount of organic solvent needs to be used, the conventional coating equipment does not have an organic solvent recovery system, the acetone is directly discharged, the environment is not protected, the environment is polluted, and the operation cost is high even if the organic solvent recovery system is arranged; the paliperidone osmotic pump tablet needs laser drilling, domestic laser drilling equipment is not mature, the problems of drilling leakage, insufficient drilling depth and the like are easily caused, and the product is easy to have hidden quality troubles.
Therefore, there is still a need to provide a new solutionThe proposal overcomes the defects to ensure that the paliperidone is orally taken Medicine for treating chronic gastritisThe tablet has beautiful surface and qualified quality, and meanwhile, the paliperidone has good stability and dissolution behavior, and low price, thereby being beneficial to commercial production.
Disclosure of Invention
An oral controlled release tablet containing paliperidone, characterized in that the tablet comprises: a) a single layer core comprising paliperidone or a pharmaceutically acceptable salt or ester thereof; b) a first coating layer coated on the single-layer tablet core, wherein the first coating layer comprises 0-61% of polyvinyl acetate, 22-54% of polyethylene glycol-polyvinyl alcohol copolymer, 12-40% of talcum powder and 2-7% of triethyl citrate, and the first coating layer accounts for 5-20% of the weight of the tablet core, preferably 5-15%; c) a second coating, wherein the coating comprises 60.6-69% of polyvinyl acetate, 10-18.2% of polyethylene glycol-polyvinyl alcohol copolymer, 12.9-20% of talcum powder and 3-7% of triethyl citrate, and the second coating accounts for 5-20% of the weight of the tablet core, and preferably accounts for 10-20%;
the invention discovers that the paliperidone controlled release tablet prepared by taking polyoxyethylene as a gel framework and polyvinyl acetate as a membrane control material has an increasing drug release behavior and has a basically consistent release behavior in release media with different pH values, namely the release behavior unrelated to pH. The paliperidone controlled-release tablet with the ascending release behavior is prepared into a single-layer tablet, and expensive multi-layer tabletting equipment is not needed; coating by using the aqueous dispersion without using an organic solvent; the release behavior can be adjusted by adjusting the proportion of the pore-forming agent, and laser drilling is not needed, so that compared with the prior art, the novel paliperidone controlled release tablet has simpler production process, is more environment-friendly and is easier to industrialize.
The paliperidone controlled-release tablet comprises a single-layer tablet core, paliperidone, a gel framework high polymer material and a lubricant.
The dosage of the paliperidone in the single-layer tablet core of the paliperidone controlled release tablet is 1mg to 12 mg.
The paliperidone controlled release tablet comprises a single-layer tablet core and is composed of paliperidone, polyoxyethylene and magnesium stearate or sodium stearyl fumarate.
The paliperidone controlled-release tablet of the invention comprises a single-layer tablet core which is composed of 0.75-6.7% of paliperidone, 90-99% of polyoxyethylene and 0.5-2% of magnesium stearate or sodium stearyl fumarate.
The molecular weight of polyoxyethylene used by the single-layer tablet core in the paliperidone controlled-release tablet is 100000-1000000, and the polyoxyethylene can be a mixture of one, two or more than two kinds of polyoxyethylene with different molecular weights. Polyoxyethylene of a single molecular weight is preferred. The polyoxyethylene used in the invention can contain 0-3% of silicon dioxide, preferably a product with the trade name of DOW company of Baoyile, and because the silicon dioxide is contained and the polyoxyethylene particles have good fluidity, the tablet core can be produced by adopting a direct tabletting process, and the tablet core is produced by avoiding using a wet granulation process which has higher energy consumption and influences the polyoxyethylene.
In addition, the invention provides a preparation method of a single-layer tablet core of the paliperidone controlled release tablet, which comprises the following specific steps:
a) mixing paliperidone and polyoxyethylene, sieving, and mixing;
b) adding magnesium stearate or sodium stearyl fumarate into the uniform mixture of paliperidone and polyoxyethylene obtained in step a), and continuously mixing;
c) compressing the homogeneous blend of paliperidone, polyoxyethylene, magnesium stearate, or sodium stearyl fumarate from step b) to obtain a single-layered paliperidone core.
In addition, the invention also provides a preparation method of the paliperidone controlled-release tablet, which comprises the following steps:
a) mixing paliperidone, polyoxyethylene, magnesium stearate or sodium stearyl fumarate, sieving, mixing, and directly tabletting to obtain single-layer tablet core;
b) coating the tablet core with a first coating layer, wherein the first coating layer comprises 0-61% of polyvinyl acetate, 22-54% of polyethylene glycol-polyvinyl alcohol copolymer, 12-40% of talcum powder and 2-7% of triethyl citrate, and the first coating layer accounts for 5-20% of the weight of the tablet core, and is preferably 5-15%;
c) coating the coated tablet obtained in the step b) with a second coating layer, wherein the second coating layer comprises 60.6-69% of polyvinyl acetate, 10-18.2% of polyethylene glycol-polyvinyl alcohol copolymer, 12.9-20% of talcum powder and 3-7% of triethyl citrate, and the second coating layer accounts for 5-20% of the weight of the tablet core, and is preferably 10-20%;
d) optionally coating the tablets coated by the above steps with a third outer protective coating layer, which is a gastric-soluble coating.
The preparation method of the paliperidone controlled release tablet can be preferably prepared by using a porous pan coating machine. Fluidized bed coating and spray coating may also be used.
The method for preparing the paliperidone controlled release tablet comprises the steps of coating the first coating layer, the second coating layer and the outer protective layer by using the coating polymer. In particular, a second coating layer for sustained release comprising polyvinyl acetate as a film-forming material, coated with an aqueous dispersion of the company BASF under the trade name Kollicoat SR30D, without using an organic solvent, and containing polyvinyl acetate in an amount of 30% w/w of the amount of Kollicoat SR 30D; polyethylene glycol-polyvinyl alcohol copolymer A product of BASF company under the trade name Kollicoat IR was used.
Detailed Description
The following specific examples are given for a more complete understanding of the present invention, but the present invention is not limited to the following examples.
Example 1:
remarking: wherein Kollicoat SR30D is a 30% aqueous dispersion of Kollicoat SR, such that the weight gain of Kollicoat SR30D times 30% is the weight gain of Kollicoat SR in the coating layer, as follows.
Example 1 the preparation method was:
a) mixing paliperidone and polyoxyethylene, sieving, and mixing;
b) adding magnesium stearate into the uniform mixture of paliperidone and polyoxyethylene obtained in the step a) and continuously mixing;
c) tabletting the homogeneous paliperidone, polyoxyethylene, magnesium stearate mixture obtained in step b) to obtain a single-layer paliperidone core.
d) Weighing kollicoat IR, triethyl citrate and talcum powder according to the formula of the first layer, uniformly dispersing in a proper amount of purified water, adding the dispersion into kollicoat SR30D, and uniformly stirring to form a coating solution.
e) Putting the paliperidone tablet core obtained in the step c into an efficient coating pan, coating by using the coating liquid obtained in the step d), and drying after the weight of the target coating is increased.
f) Weighing kollicoat IR, triethyl citrate and talcum powder according to the prescription of the sustained-release layer, uniformly dispersing in a proper amount of purified water, adding the dispersion into kollicoat SR30D, and uniformly stirring to form a coating solution.
g) Putting the paliperidone coated tablet obtained in the step e into a high-efficiency coating pan, coating by using the coating liquid obtained in the step f), and drying after the weight of the target coating is increased.
h) Weighing OPADRY according to the prescription amount of the protective layer
And II, uniformly dispersing the coating powder in a proper amount of purified water, and uniformly stirring to form a coating solution. Putting the paliperidone coated tablet obtained in the step g) into a high-efficiency coating pan, coating and protecting, and drying after the target coating weight is increased to obtain the paliperidone controlled release tablet.
The release profile of this example is shown in FIG. 1, using the FDA recommended method, using paddle method, 50rpm, release medium pH 1.0[ NaCl (0.2% w/w) in 0.0825N HCl ], release medium volume 500ml, and release measurements taken at 1, 2, 4, 6, 8, 12, 14, 18 and 24 hours.
Example 2:
the preparation process comprises the following steps: (same as example 1).
Example 3:
the preparation process comprises the following steps: (same as example 1).
Example 4:
the preparation process comprises the following steps: (example 1).
Example 5:
the preparation process comprises the following steps: (same as example 1).
Example 6:
the preparation process comprises the following steps:
a) mixing paliperidone and polyoxyethylene, sieving, and mixing;
b) adding magnesium stearate into the uniform mixture of paliperidone and polyoxyethylene obtained in the step a) and continuously mixing;
c) compressing the homogeneous paliperidone, polyoxyethylene, magnesium stearate, or mixture thereof obtained in step b) to obtain a single-layered paliperidone core.
d) Weighing kollicoat IR, triethyl citrate and talcum powder according to the prescription of the bottom layer, and uniformly dispersing in a proper amount of purified water to form a coating solution.
e) Putting the paliperidone tablet core obtained in the step c into an efficient coating pan, coating by using the coating liquid obtained in the step d), and drying after the weight of the target coating is increased.
f) Weighing kollicoat IR, triethyl citrate and talcum powder according to the prescription of the sustained-release layer, uniformly dispersing in a proper amount of purified water, adding the dispersion into kollicoat SR30D, and uniformly stirring to form a coating solution.
g) Putting the paliperidone coated tablet obtained in the step e into a high-efficiency coating pan, coating by using the coating liquid obtained in the step f), and drying after the weight of the target coating is increased.
h) Weighing OPADRY according to the prescription amount of the protective layer
And II, uniformly dispersing the coating powder in a proper amount of purified water, and uniformly stirring to form a coating solution. Putting the paliperidone coated tablet obtained in the step g) into a high-efficiency coating pan, coating and protecting, and drying after the target coating weight is increased to obtain the paliperidone controlled release tablet.
The release profile of this example is shown in FIG. 2, using the FDA recommended method, using paddle method, 50rpm, release medium pH 1.0, pH4.5 and pH6.8, release medium volume 500ml, at 1, 2, 4, 6, 8, 12, 14, 18 and 24 hours sampling to determine the release.
Example 7:
the preparation process is the same as in example 1.
The release profile of this example is shown in FIG. 3, using the FDA recommended method, using paddle method, 50rpm, the release medium is pH 1.0, pH4.5 and pH6.8 medium, the volume of the release medium is 500ml, and the release is determined by sampling at 1, 2, 4, 6, 8, 12, 14, 18 and 24 hours.
Example 8:
the preparation process is the same as in example 1.
Example 9
The preparation process is the same as in example 1.
The release profiles of examples 8 and 9 are shown in FIG. 4, using the FDA recommended method, using paddle method, 50rpm, the release medium is pH 1.0[ NaCl (0.2% w/w) in 0.0825N HCl ], the volume of the release medium is 500ml, and the release is determined by sampling at 1, 2, 4, 6, 8, 12, 14, 18 and 24 hours.
Claims (7)
1. An oral controlled release tablet containing paliperidone, characterized in that the tablet comprises:
a) a single-layer tablet core containing paliperidone or pharmaceutically acceptable salts or esters thereof, wherein the single-layer tablet core consists of 0.75-6.7% of paliperidone, 90-99% of polyoxyethylene and 0.5-2% of magnesium stearate or hard sodium fumarate;
b) a first coating layer coated on the single-layer tablet core, wherein the first coating layer comprises 0-61% of polyvinyl acetate, 22-54% of polyethylene glycol-polyvinyl alcohol copolymer, 12-40% of talcum powder and 2-7% of triethyl citrate, and the first coating layer accounts for 5-20% of the weight of the tablet core;
c) a second coating, wherein the coating comprises 60.6-69% of polyvinyl acetate, 10-18.2% of polyethylene glycol-polyvinyl alcohol copolymer, 12.9-20% of talcum powder and 3-7% of triethyl citrate, and the second coating accounts for 5-20% of the weight of the tablet core.
2. The paliperidone oral controlled release tablet of claim 1, wherein the amount of paliperidone in the single-layer core is 1mg to 12 mg.
3. The paliperidone oral controlled release tablet of claim 1, wherein the polyoxyethylene molecular weight for the single-layer core is 10 to 100 ten thousand.
4. The paliperidone oral controlled-release tablet of claim 1, wherein the polyoxyethylene used for the single-layer tablet core may contain 0-3% of silicon dioxide.
5. The paliperidone oral controlled-release tablet of claim 1, wherein the preparation method of the single-layer tablet core comprises the following steps:
a) mixing paliperidone and polyoxyethylene, sieving, and mixing;
b) adding magnesium stearate or sodium stearyl fumarate into the uniform mixture of paliperidone and polyoxyethylene obtained in step a), and continuously mixing;
c) compressing the homogeneous blend of paliperidone, polyoxyethylene, magnesium stearate, or sodium stearyl fumarate from step b) to obtain a single-layered paliperidone core.
6. A method for preparing the paliperidone oral controlled-release tablet of claim 1, comprising:
a) mixing paliperidone, polyoxyethylene, magnesium stearate or sodium stearyl fumarate, sieving, mixing, and directly tabletting to obtain single-layer tablet core;
b) coating the tablet core with a first coating layer, wherein the first coating layer comprises 0-61% of polyvinyl acetate, 22-54% of polyethylene glycol-polyvinyl alcohol copolymer, 12-40% of talcum powder and 2-7% of triethyl citrate, and the first coating layer accounts for 5-20% of the weight of the tablet core;
c) coating the coated tablet obtained in the step b) with a second coating layer, wherein the second coating layer comprises 60.6-69% of polyvinyl acetate, 10-18.2% of polyethylene glycol-polyvinyl alcohol copolymer, 12.9-20% of talcum powder and 3-7% of triethyl citrate, and the second coating layer accounts for 5-20% of the weight of the tablet core;
d) optionally coating the tablets coated by the steps with a third outer protective coating layer to prepare the paliperidone controlled release tablet, wherein the third coating layer is a gastric-soluble coating.
7. The process for preparing paliperidone oral controlled-release tablet of claim 6, characterized in that the coating layer is coated in the form of an aqueous dispersion of a coating polymer.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410543391.1A CN104257622B (en) | 2014-10-01 | 2014-10-01 | Paliperidone controlled-release tablet and preparation method thereof |
| PCT/CN2015/090365 WO2016050160A1 (en) | 2014-10-01 | 2015-09-23 | Paliperidone oral controlled-release tablet and preparation method thereof |
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| CN201410543391.1A CN104257622B (en) | 2014-10-01 | 2014-10-01 | Paliperidone controlled-release tablet and preparation method thereof |
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| CN104257622B true CN104257622B (en) | 2020-02-07 |
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| CN104257622B (en) * | 2014-10-01 | 2020-02-07 | 浙江华海药业股份有限公司 | Paliperidone controlled-release tablet and preparation method thereof |
| CN107412180B (en) * | 2017-06-17 | 2020-05-26 | 江西医学高等专科学校 | Paliperidone core-coated tablet and preparation method thereof |
| CN113616610B (en) * | 2021-07-30 | 2023-05-12 | 石药集团欧意药业有限公司 | Paliperidone sustained release tablet and preparation method thereof |
| CN116983274B (en) * | 2023-07-28 | 2024-02-27 | 山东则正医药技术有限公司 | Single-layer coated paliperidone sustained release tablet and preparation method thereof |
Citations (3)
| 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 |
| CN101711752A (en) * | 2009-11-26 | 2010-05-26 | 中国科学院上海药物研究所 | Controlled release preparation of benzo-isoxazole derivant and preparation method thereof |
| CN103271889A (en) * | 2013-05-23 | 2013-09-04 | 沈阳药科大学 | Novel paliperidone progressively-increased release osmotic pump preparation and preparation method thereof |
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| EP2161019A1 (en) * | 2008-09-05 | 2010-03-10 | KRKA, D.D., Novo Mesto | Prolonged release multiparticulate pharmaceutical composition comprising paliperidone |
| US20110052687A1 (en) * | 2009-08-26 | 2011-03-03 | Glenmark Generics Ltd | Extended release pharmaceutical composition of paliperidone |
| US20130034605A1 (en) * | 2011-08-01 | 2013-02-07 | Micro Labs Limited | Extended release pharmaceutical compositions containing paliperidone |
| CN104257622B (en) * | 2014-10-01 | 2020-02-07 | 浙江华海药业股份有限公司 | Paliperidone controlled-release tablet and preparation method thereof |
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Patent Citations (3)
| 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 |
| CN101711752A (en) * | 2009-11-26 | 2010-05-26 | 中国科学院上海药物研究所 | Controlled release preparation of benzo-isoxazole derivant and preparation method thereof |
| CN103271889A (en) * | 2013-05-23 | 2013-09-04 | 沈阳药科大学 | Novel paliperidone progressively-increased release osmotic pump preparation and preparation method thereof |
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| WO2016050160A1 (en) | 2016-04-07 |
| CN104257622A (en) | 2015-01-07 |
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