CN107281151A - Paliperidone osmotic pump type controlled release tablets - Google Patents

Paliperidone osmotic pump type controlled release tablets Download PDF

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Publication number
CN107281151A
CN107281151A CN201610198807.XA CN201610198807A CN107281151A CN 107281151 A CN107281151 A CN 107281151A CN 201610198807 A CN201610198807 A CN 201610198807A CN 107281151 A CN107281151 A CN 107281151A
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CN
China
Prior art keywords
coating
osmotic pump
paliperidone
controlled release
layer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201610198807.XA
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Chinese (zh)
Inventor
严洁
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tianjin Hankang Pharmaceutical Biotechnology Co Ltd
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Tianjin Hankang Pharmaceutical Biotechnology Co Ltd
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Filing date
Publication date
Application filed by Tianjin Hankang Pharmaceutical Biotechnology Co Ltd filed Critical Tianjin Hankang Pharmaceutical Biotechnology Co Ltd
Priority to CN201610198807.XA priority Critical patent/CN107281151A/en
Publication of CN107281151A publication Critical patent/CN107281151A/en
Pending legal-status Critical Current

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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
    • A61K9/20—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
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention provides a kind of new Paliperidone osmotic pump type controlled release tablets, using cellulose acetate and polyethylene glycol as pellicle filmogen, pellicle aging phenomenon can be overcome, stable rate of release is obtained, and reduce medicament residue.Dronedarone Oros preparation release performance that the present invention is provided is excellent, stability is high, places there will not be obvious aging phenomenon for a long time, meet the market demand.

Description

Paliperidone osmotic pump type controlled release tablets
Technical field
The present invention relates to a kind of Paliperidone osmotic pump type controlled release tablets, using cellulose acetate-polyethylene glycol as semi-transparent Membrane material, belongs to field of pharmaceutical preparations.
Background technology
Paliperidone is used clinically for schizoid treatment.The entitled 4- of paliperidone intermediate English language Chemical（6- fluoro-3a,7a-dihydrobenzo[d]isoxazol-3-yl）-1-(2-(9-hydroxy-2-methyl-4-oxo-3, 4,6,7,8,9-hexahydro-2H-pyrido [1,2-a] pyrimidin-3-yl) ethyl) piperidine 1-oxide, Molecular formula is C23H27FN4O4.Developed by Johnson Co., ratify in December, 2006 to list through U.S. FDA.Research shows that it can Effectively postpone schizoid recurrence rate, can be used in the acute short-term and long-term maintenance treatment of schizophrenia and mitigate illness Long-term use can effectively stablize conditions of patients.Clinical experiments have proved that it has to schizophrenia positive symptom and negative symptoms Curative effect.
It can reach high peak serum concentration after being taken due to general formulation in a short time, and the blood medicine in next medication Concentration is again very low, particularly early morning of ischaemic most serious, the weak curative effect of general formulation, the side reaction brought to patient compared with Greatly, therefore need to research and develop a kind of Paliperidone Oros preparation to meet market needs.
The important performance of Oros preparation is the control to insoluble drug release.Choosing the material of osmotic pump preparation is The key of the item data is controlled, obtained finished product osmotic pump preparation is aimed at not only within a period of time just prepared, its Release performance is good, and after storage a period of time, still can there is good release performance, and the later half of the term of validity is provided in medicine Phase, release performance will not be decreased obviously, that is, be not in aging phenomenon.
Paliperidone Oros preparation release performance that the present invention is provided is excellent, stability is high, places for a long time Obvious aging phenomenon is not had, meets the market demand.
The content of the invention
In order to overcome the defect of prior art, it can not be limited the invention provides one kind by storage time and in the term of validity Inside remain the novel two-chamber type Paliperidone osmotic pump controlled release tablet of stable release performance.We are by semipermeable membrane material Carefully study and select, it has unexpectedly been found that, pellicle is combined as pellicle filmogen using cellulose acetate and PVP, Aging phenomenon can be overcome, the double chamber type Paliperidone osmotic pump type controlled release tablets being made using the pellicle of this kind of material, not only The release that medicine can be made slow and constant, extends the effective blood drug concentration time, and blood concentration can be made more steady, reduces not Good reaction, and release performance can be kept stable in its expiration date of drug, drug release residual is small.
Therefore, the purpose of the present invention, which is first consisted in, can not be limited by storage time and be begun before the deadline there is provided one kind The double chamber type Paliperidone osmotic pump type controlled release tablets of stable release performance are kept eventually.
The label of Paliperidone osmotic pump controlled release tablet of the present invention, is double-layer tablets, and one layer is medicated layer, and another layer is to help Layer is pushed away, can be constituted using the auxiliary material of two-chamber osmotic pump controlled-release tablet well known in the art.Wherein, upper strata medicated layer by medicine, Promote osmo active substance and other auxiliary materials are constituted；Lower floor boosting layer by hydrophilic expanded polymer, promote osmo active substance and other Auxiliary material and coloring agent composition, then in double-layer tablets outsourcing with pellicle, and an aperture is made a call to laser in upper strata (medicated layer), it is optional Ground carries out film coating.
As one of preferred embodiment of the present invention, the invention provides a kind of Paliperidone with ageing resistace Osmotic pump controlled release tablet, with following prescription：
1), Core formulation, in terms of 1000：
Medicated layer：
Paliperidone 5-10g
Sucrose 120g
Pregelatinized starch 15g
Microcrystalline cellulose 60g
Sodium carboxymethylcellulose 45g
Magnesium stearate 2g
Boosting layer：
Hydroxypropyl methyl cellulose 28g
Sodium chloride 46g
Sucrose 34g
PEO 50g
Magnesium stearate 1g
2), pellicle coating fluid prescription
Cellulose acetate 54g
Polyethylene glycol 13g ~ 15g
Ethanol 1000ml
3), film-coating coating fluid prescription
Coating powder 10g soluble in the stomach
Water 100ml
In above-mentioned prescription, preferably the sharp ketone of handkerchief piperazine is 5g, 10g, most preferably 6g, correspondence 6mg specification.
Above-mentioned embodiment it is further preferred, Paliperidone osmotic pump controlled release tablet of the invention has following pellicle coating solution Prescription：
Cellulose acetate 54g
Polyethylene glycol 14g
Ethanol 1000ml
It is preferred that the coating weight gain of pellicle is 17%~19%.The preparation work of Paliperidone osmotic pump controlled release tablet of the present invention Skill, can carry out concrete operations according to the known technology of osmotic pump type controlled release tablets, such as mixing, granulation, tabletting, coating.
(1) medicated layer particle is prepared：The each component of the medicated layer of recipe quantity is sieved, is well mixed by equivalent method of progressively increasing Afterwards, medicated layer particle is prepared using wet granulation process；
(2) boosting layer particle is prepared：By each component sieving of the boosting layer of recipe quantity, after being well mixed, using wet granulation process Prepare boosting layer particle；
(3) double-deck core is suppressed：Boosting layer particle made from medicated layer particle made from step (1) and step (2) is taken, by prescription Amount suppresses double-deck core with bi-layer tablet press；
(4) semi-transparent clothing film is wrapped：Double-deck core made from step (3) is coated with pellicle coating solution, to increase weight it is qualified after, Through drying, semi-transparent film coating piece is made；
(5) release hole is beaten：More than one is beaten in the medicated layer side laser of semi-transparent film coating piece made from step (4) or machinery Release hole；
(6) moistureproof clothing film is wrapped：Carried out in the obtained semi-transparent film coating piece external application film-coating coating solution for having beaten release hole of step (5) Be coated, to increase weight it is qualified after, through drying, quality inspection, packaging is made Paliperidone osmotic pump controlled release tablet.
In addition, improve the method for Paliperidone osmotic pump type controlled release tablets ageing resistace present invention also offers a kind of, its It is characterized in the weight using cellulose acetate-polyethylene glycol composition as semipermeable membrane material, wherein cellulose acetate/polyethylene glycol Amount is than being 54: 13 ~ 15g, and preferably the weight ratio of the two is 54：14.
Embodiment
Embodiment 1
First, prescription
1), Core formulation, in terms of 1000：
Medicated layer：
Paliperidone 6g
Sucrose 120g
Pregelatinized starch 15g
Microcrystalline cellulose 60g
Sodium carboxymethylcellulose 45g
Magnesium stearate 2g
Boosting layer：
Hydroxypropyl methyl cellulose 28g
Sodium chloride 46g
Sucrose 34g
PEO 50g
Magnesium stearate 1g
2), pellicle coating fluid prescription
Cellulose acetate 54g
The g of polyethylene glycol 14
Ethanol 1000ml
3), film-coating coating fluid prescription
Coating powder 10g soluble in the stomach
Water 100ml
2nd, detailed preparation technology
1st, Paliperidone label preparation technology：Label is double-layer tablets, and one layer is medicated layer, and another layer is boosting layer.
Preparation technology is as follows：
(1) medicated layer particle is prepared：The each component of the medicated layer of recipe quantity is sieved, by equivalent progressively increase method it is well mixed after, adopt Medicated layer particle is prepared with wet granulation process；
(2) boosting layer particle is prepared：By each component sieving of the boosting layer of recipe quantity, after being well mixed, using wet granulation process Prepare boosting layer particle；
(3) double-deck core is suppressed：Boosting layer particle made from medicated layer particle made from step (1) and step (2) is taken, by prescription Amount suppresses double-deck core with bi-layer tablet press；
(4) semi-transparent clothing film is wrapped：Double-deck core made from step (3) is coated with pellicle coating solution, to increase weight it is qualified after, Through drying, semi-transparent film coating piece is made；
(5) release hole is beaten：More than one is beaten in the medicated layer side laser of semi-transparent film coating piece made from step (4) or machinery Release hole；
(6) moistureproof clothing film is wrapped：Carried out in the obtained semi-transparent film coating piece external application film-coating coating solution for having beaten release hole of step (5) Be coated, to increase weight it is qualified after, through drying, quality inspection, packaging is made Paliperidone osmotic pump controlled release tablet.
Embodiment 2
1), Core formulation, in terms of 1000：
Medicated layer：
Paliperidone 6g
Sucrose 120g
Pregelatinized starch 15g
Microcrystalline cellulose 60g
Sodium carboxymethylcellulose 45g
Magnesium stearate 2g
Boosting layer：
Hydroxypropyl methyl cellulose 28g
Sodium chloride 46g
Sucrose 34g
PEO 50g
Magnesium stearate 1g
2), pellicle coating fluid prescription
Cellulose acetate 54g
Polyethylene glycol 15g
Ethanol 1000ml
3), film-coating coating fluid prescription
Coating powder 10g soluble in the stomach
Water 100ml
2nd, detailed preparation technology be the same as Example 1
Embodiment 3
First, prescription
1), Core formulation, in terms of 1000：
Medicated layer：
Paliperidone 6g
Sucrose 120g
Pregelatinized starch 15g
Microcrystalline cellulose 60g
Sodium carboxymethylcellulose 45g
Magnesium stearate 2g
Boosting layer：
Hydroxypropyl methyl cellulose 28g
Sodium chloride 46g
Sucrose 34g
PEO 50g
Magnesium stearate 1g
2), pellicle coating fluid prescription
Cellulose acetate 54g
The g of polyethylene glycol 13
Ethanol 1000ml
3), film-coating coating fluid prescription
Coating powder 10g soluble in the stomach
Water 100ml
2nd, detailed preparation technology be the same as Example 1
Comparative example 1
First, prescription
1), Core formulation, in terms of 1000：
Medicated layer：
Paliperidone 6g
Sucrose 120g
Pregelatinized starch 15g
Microcrystalline cellulose 60g
Sodium carboxymethylcellulose 45g
Magnesium stearate 2g
Boosting layer：
Hydroxypropyl methyl cellulose 28g
Sodium chloride 46g
Sucrose 34g
PEO 50g
Magnesium stearate 1g
2), pellicle coating fluid prescription
Cellulose acetate 30g
The g of polyethylene glycol 30
Ethanol 1000ml
3), film-coating coating fluid prescription
Coating powder 10g soluble in the stomach
Water 100ml
2nd, detailed preparation technology be the same as Example 1
Comparative example 2
First, prescription
1), Core formulation, in terms of 1000：
Medicated layer：
Paliperidone 6g
Sucrose 120g
Pregelatinized starch 15g
Microcrystalline cellulose 60g
Sodium carboxymethylcellulose 45g
Magnesium stearate 2g
Boosting layer：
Hydroxypropyl methyl cellulose 28g
Sodium chloride 46g
Sucrose 34g
PEO 50g
Magnesium stearate 1g
2), pellicle coating fluid prescription
Cellulose acetate 54g
The g of PVP 13
Ethanol 1000ml
3), film-coating coating fluid prescription
Coating powder 10g soluble in the stomach
Water 100ml
2nd, detailed preparation technology be the same as Example 1
The measure and result of test example 1, release and content are surveyed according to the release that annex in China's coastal port is previously mentioned Determine release and content that method and high performance liquid chromatography determine embodiment 1-3 and comparative example 1-3 respectively
Release and assay results are shown in Table 1：
The embodiment 1-3 of table 1 and comparative example 1- releases and assay result
As a result show, the Paliperidone osmotic pump controlled release tablet release performance of embodiment 1 is good, long-term place shows without aging substantially As.Test example 2, the experiment of film loss of weight：
Experimental method：Remove after outermost layer film-coating, pellicle is peeled off from label, remove the label powder of residual in the above End, weighs, and is put into the stripping rotor containing 500ml distilled water, 37 DEG C, by two annex XC dissolution rates of China's coastal port The first method (Rotating shaker) operation is determined, rotating speed is 50 turns per minute, respectively at 1h, 2h sampling, 50 DEG C of drying are let cool to room temperature, Weigh.Calculate loss of weight ratio.
Calculation formula：Film loss of weight percentage (%)=(1-WT/W0The W of) × 100%T：After different sampling time point drying Film weight；W0：The initial weight of film, as a result see the table below 2：
Film loss of weight result after the placement for a long time of the room temperature of table 2
The experiment of film loss of weight shows, employs the Paliperidone tablet that specific auxiliary material is prepared（Embodiment 1-3）Film stabilization Property and permeability are optimal.
It can be seen from experimental data in the case where each Ingredient Amount is identical, the either amounts of components ratio of inclusion compound Example changes, or auxiliary material type is changed, or auxiliary material type does not change but changes the usage ratio of component, is prepared into To Paliperidone osmotic pump controlled release tablet pellicle loss of weight have significant change, the stability of film is significantly reduced.

Claims (4)

1. a kind of Paliperidone osmotic pump type controlled release tablets, it is characterized in that pellicle is used as half using cellulose acetate and polyethylene glycol Permeable membrane filmogen.
2. Paliperidone osmotic pump type controlled release tablets as claimed in claim 1, it is characterized in that with following prescription：
1), Core formulation, in terms of 1000：
Medicated layer：
Paliperidone 5-10g
Sucrose 120g
Pregelatinized starch 15g
Microcrystalline cellulose 60g
Sodium carboxymethylcellulose 45g
Magnesium stearate 2g
Boosting layer：
Hydroxypropyl methyl cellulose 28g
Sodium chloride 46g
Sucrose 34g
PEO 50g
Magnesium stearate 1g
2), pellicle coating fluid prescription
Cellulose acetate 54g
Polyethylene glycol 13g ~ 15g
Ethanol 1000ml
3), film-coating coating fluid prescription
Coating powder 10g soluble in the stomach
Water 100ml.
3. Paliperidone osmotic pump type controlled release tablets as claimed in claim 1, it is characterized in that with following pellicle coating solution Side：
Cellulose acetate 54g
Polyethylene glycol 14g
Ethanol 1000ml.
4. a kind of preparation method of Paliperidone osmotic pump type controlled release tablets, it is characterised in that this method comprises the following steps： (1) Prepare medicated layer particle：The each component of the medicated layer of recipe quantity is sieved, by equivalent progressively increase method it is well mixed after, using wet method system Grain method prepares medicated layer particle；
(2) boosting layer particle is prepared：By each component sieving of the boosting layer of recipe quantity, after being well mixed, using wet granulation process Prepare boosting layer particle；
(3) double-deck core is suppressed：Boosting layer particle made from medicated layer particle made from step (1) and step (2) is taken, by prescription Amount suppresses double-deck core with bi-layer tablet press；
(4) semi-transparent clothing film is wrapped：Double-deck core made from step (3) is coated with pellicle coating solution, to increase weight it is qualified after, Through drying, semi-transparent film coating piece is made；
(5) release hole is beaten：More than one is beaten in the medicated layer side laser of semi-transparent film coating piece made from step (4) or machinery Release hole；(6) moistureproof clothing film is wrapped：In the obtained semi-transparent film coating piece external application film-coating coating solution for having beaten release hole of step (5) Be coated, to increase weight it is qualified after, through drying, quality inspection, packaging is made Pa Panli according to any one of claims 1 to 8 Ketone osmotic pump controlled release tablet.
CN201610198807.XA 2016-04-01 2016-04-01 Paliperidone osmotic pump type controlled release tablets Pending CN107281151A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201610198807.XA CN107281151A (en) 2016-04-01 2016-04-01 Paliperidone osmotic pump type controlled release tablets

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201610198807.XA CN107281151A (en) 2016-04-01 2016-04-01 Paliperidone osmotic pump type controlled release tablets

Publications (1)

Publication Number Publication Date
CN107281151A true CN107281151A (en) 2017-10-24

Family

ID=60087994

Family Applications (1)

Application Number Title Priority Date Filing Date
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Country Status (1)

Country Link
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114983961A (en) * 2022-06-30 2022-09-02 苏州中化药品工业有限公司 Paliperidone sustained-release tablet and preparation method thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114983961A (en) * 2022-06-30 2022-09-02 苏州中化药品工业有限公司 Paliperidone sustained-release tablet and preparation method thereof
CN114983961B (en) * 2022-06-30 2024-05-10 苏州中化药品工业有限公司 Paliperidone sustained release tablet and preparation method thereof

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