CN110613691A - Orally disintegrating tablet containing PEG-DSPE-memantine hydrochloride compound - Google Patents
Orally disintegrating tablet containing PEG-DSPE-memantine hydrochloride compound Download PDFInfo
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- CN110613691A CN110613691A CN201810630856.5A CN201810630856A CN110613691A CN 110613691 A CN110613691 A CN 110613691A CN 201810630856 A CN201810630856 A CN 201810630856A CN 110613691 A CN110613691 A CN 110613691A
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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
- A61K31/13—Amines
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/127—Liposomes
- A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/127—Liposomes
- A61K9/1277—Processes for preparing; Proliposomes
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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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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Abstract
The application provides an orally disintegrating tablet containing PEG-DSPE-memantine hydrochloride compound and a preparation method thereof, wherein memantine hydrochloride and amphiphilic polymer material PEG-DSPE with different molecular weights are prepared into polymer micelles by a self-assembly solvent evaporation method, the micelles are freeze-dried by adopting a freeze-drying technology to obtain freeze-dried powder, and the orally disintegrating tablet is prepared by adopting a powder direct compression process. The implementation of the application aims to improve the mouth feel of memantine hydrochloride and improve the medicine taking compliance of patients.
Description
Technical Field
The application belongs to the technical field of medicines, and particularly relates to an orally disintegrating tablet containing PEG-DSPE-memantine hydrochloride compound and a preparation method thereof.
Background
Senile dementia (alzheimer's disease) is one of the common diseases of the elderly, mainly manifested by impaired memory and impaired recognition, a progressive neurodegenerative disorder, and has become the fourth killer in humans after cardiovascular diseases, cancer and stroke. Aiming at the senile dementia patients, the current clinical commonly used medicines are a cerebral circulation improving agent and a cholinergic reinforcing agent, but the two medicines only aim at mild and moderate patients and are ineffective for severe senile dementia patients, so the market prospect of the memantine hydrochloride as the only current medicine for treating moderate and severe patients is consistently good, and the development is extremely promising.
Memantine hydrochloride was developed by Merz, germany, as conventional tablets, capsules and oral liquids. The memantine hydrochloride has obvious bitter taste, and the medicine taking compliance is a key factor for severe senile dementia patients. Therefore, the development of the memantine hydrochloride preparation which has quick response, convenient taking and easy industrialized production is very important for treating the senile dementia patients.
Orally disintegrating tablets are tablets which can be swallowed to achieve the effect in the stomach by means of swallowing after the tablets are placed on the tongue surface and rapidly dissolved or disintegrated in saliva without water or a small amount of water or chewing. Compared with the common tablet, the orally disintegrating tablet has the advantages of quick response, high bioavailability, convenient taking, low first-pass effect and the like, and is more suitable for the old, children and patients in special environments with dysphagia or inconvenient drinking and the like.
Based on the method, the memantine hydrochloride is included by adopting the polymeric micelle under specific conditions, then the micelle is freeze-dried by adopting a freeze-drying technology to obtain freeze-dried powder, and finally the powder is prepared into the orally disintegrating tablet by adopting a powder direct compression process. The process has the advantages of easy industrialization, good taste masking effect, high stability and the like.
Disclosure of Invention
An orally disintegrating tablet containing PEG-DSPE-memantine hydrochloride compound comprises 10% -50% of PEG-DSPE-memantine hydrochloride compound and 50% -90% of other auxiliary materials.
Further, the molecular weight of PEG in the PEG-DSPE-memantine hydrochloride compound is 2000-6000.
Further, the molecular weight of PEG in the PEG-DSPE-memantine hydrochloride compound is 3000-5000.
Further, the weight ratio of memantine hydrochloride to PEG-DSPE is 1:1-1: 10.
Further, the weight ratio of memantine hydrochloride to PEG-DSPE is 1: 5.
Further, the preparation method of the orally disintegrating tablet containing the PEG-DSPE-memantine hydrochloride compound comprises the steps of preparing polymer micelles by using a self-assembly solvent evaporation method through memantine hydrochloride and PEG-DSPE, freeze-drying the micelles by using a freeze-drying technology to obtain freeze-dried powder, and then preparing the orally disintegrating tablet by using a powder direct compression process.
Further, the PEG-DSPE-memantine hydrochloride compound is characterized in that the preparation method of the polymer micelle solid preparation is a self-assembly solvent evaporation method, and the specific steps are as follows:
(1) dissolving PEG-DSPE and memantine hydrochloride in organic solvent, and rotary evaporating under reduced pressure in eggplant-shaped bottle at appropriate temperature to remove organic solvent to obtain uniform film.
(2) Adding preheated buffer solution into the uniform film, and rotating and hydrating in a water bath.
(3) And (3) granulating the obtained polymer micelle through a microporous filter membrane, and freeze-drying the filtrate through a freeze dryer to obtain drug-loaded polymer micelle powder.
Further, the organic solvent added in the PEG-DSPE-memantine hydrochloride compound comprises one or a mixed solvent of ethanol and chloroform, preferably ethanol.
Further, in the preparation process of the PEG-DSPE-memantine hydrochloride compound, the buffer salt solution is selected from a phosphate buffer solution with the pH value of 7.0-7.4, and is preferably a phosphate buffer solution with the pH value of 7.4.
Detailed Description
For a better understanding of the present invention, the present invention and advantages and benefits thereof will be described and illustrated in detail below by way of examples and experimental data of the present invention, which are not intended to limit the present invention.
Example 1
The preparation process comprises the following steps:
fully dissolving PEG6000-DSPE and memantine hydrochloride in a prescription amount in ethanol, performing reduced pressure rotary evaporation for 1h at 37 ℃ in an eggplant-shaped bottle to remove an organic solvent to obtain a uniform film, adding a buffer solution preheated at 37 ℃, performing rotary hydration in a water bath kettle at 37 ℃, granulating the obtained geopolymer micelle through a 0.45-micron microporous filter membrane, and freeze-drying the filtrate by a freeze dryer to obtain drug-loaded polymer micelle powder.
The prepared drug-loaded polymer micelle powder is uniformly mixed with lactose, microcrystalline cellulose, croscarmellose sodium, menthol and sucralose according to the prescription amount in sequence. And adding magnesium stearate with the prescribed amount into the mixture, uniformly mixing, and pressing into tablets.
Example 2
The preparation process comprises the following steps:
fully dissolving PEG2000-DSPE and memantine hydrochloride in a prescription amount in ethanol, performing reduced pressure rotary evaporation for 1h at 37 ℃ in an eggplant-shaped bottle to remove an organic solvent to obtain a uniform film, adding a buffer solution preheated at 37 ℃, performing rotary hydration in a water bath kettle at 37 ℃, granulating the obtained geopolymer micelle through a 0.45-micron microporous filter membrane, and freeze-drying the filtrate by a freeze dryer to obtain drug-loaded polymer micelle powder.
The prepared drug-loaded polymer micelle powder is uniformly mixed with mannitol, microcrystalline cellulose, croscarmellose sodium, menthol and sucralose according to the prescription amount in sequence. And adding magnesium stearate with the prescribed amount into the mixture, uniformly mixing, and pressing into tablets.
Example 3
The preparation process comprises the following steps:
fully dissolving PEG3000-DSPE and memantine hydrochloride in a prescription amount in ethanol, performing reduced pressure rotary evaporation for 1h at 37 ℃ in an eggplant-shaped bottle to remove an organic solvent to obtain a uniform film, adding a buffer solution preheated at 37 ℃, performing rotary hydration in a water bath kettle at 37 ℃, granulating the obtained geopolymer micelle through a 0.45-micron microporous filter membrane, and freeze-drying the filtrate by a freeze dryer to obtain drug-loaded polymer micelle powder.
The prepared drug-loaded polymer micelle powder is uniformly mixed with mannitol, microcrystalline cellulose, croscarmellose sodium, menthol and aspartame according to the prescription amount in sequence. And adding magnesium stearate with the prescribed amount into the mixture, uniformly mixing, and pressing into tablets.
Example 4
The preparation process comprises the following steps:
fully dissolving PEG5000-DSPE and memantine hydrochloride in a prescription amount in ethanol, performing reduced pressure rotary evaporation for 1h at 37 ℃ in an eggplant-shaped bottle to remove an organic solvent to obtain a uniform film, adding a buffer solution preheated at 37 ℃, performing rotary hydration in a water bath kettle at 37 ℃, granulating the obtained geopolymer micelle through a 0.45-micron microporous filter membrane, and freeze-drying the filtrate by a freeze dryer to obtain drug-loaded polymer micelle powder.
The prepared drug-loaded polymer micelle powder is uniformly mixed with lactose, microcrystalline cellulose, croscarmellose sodium, menthol and sucralose according to the prescription amount in sequence. And adding magnesium stearate with the prescribed amount into the mixture, uniformly mixing, and pressing into tablets.
Example 5
The preparation process comprises the following steps:
fully dissolving PEG5000-DSPE and memantine hydrochloride in a prescription amount in ethanol, performing reduced pressure rotary evaporation for 1h at 37 ℃ in an eggplant-shaped bottle to remove an organic solvent to obtain a uniform film, adding a buffer solution preheated at 37 ℃, performing rotary hydration in a water bath kettle at 37 ℃, granulating the obtained geopolymer micelle through a 0.45-micron microporous filter membrane, and freeze-drying the filtrate by a freeze dryer to obtain drug-loaded polymer micelle powder.
The prepared drug-loaded polymer micelle powder is uniformly mixed with mannitol, microcrystalline cellulose, croscarmellose sodium, menthol and aspartame according to the prescription amount in sequence. And adding magnesium stearate with the prescribed amount into the mixture, uniformly mixing, and pressing into tablets.
Comparative example 1
The preparation process comprises the following steps:
fully dissolving PEG1000-DSPE and memantine hydrochloride in a prescription amount in ethanol, performing reduced pressure rotary evaporation for 1h at 37 ℃ in an eggplant-shaped bottle to remove an organic solvent to obtain a uniform film, adding a buffer solution preheated at 37 ℃, performing rotary hydration in a water bath kettle at 37 ℃, granulating the obtained geopolymer micelle through a 0.45-micron microporous filter membrane, and freeze-drying the filtrate by a freeze dryer to obtain drug-loaded polymer micelle powder.
The prepared drug-loaded polymer micelle powder is uniformly mixed with lactose, microcrystalline cellulose, croscarmellose sodium, menthol and sucralose according to the prescription amount in sequence. And adding magnesium stearate with the prescribed amount into the mixture, uniformly mixing, and pressing into tablets.
Comparative example 2
The preparation process comprises the following steps:
fully dissolving PEG7000-DSPE and memantine hydrochloride in a prescription amount in ethanol, performing reduced pressure rotary evaporation for 1h in an eggplant-shaped bottle at 37 ℃ to remove organic solvent to obtain a uniform film, adding a buffer solution preheated at 37 ℃, performing rotary hydration in a water bath kettle at 37 ℃, granulating the obtained geopolymer micelle through a 0.45-micron microporous filter membrane, and freeze-drying the filtrate by a freeze dryer to obtain drug-loaded polymer micelle powder.
The prepared drug-loaded polymer micelle powder is uniformly mixed with lactose, microcrystalline cellulose, croscarmellose sodium, menthol and sucralose according to the prescription amount in sequence. And adding magnesium stearate with the prescribed amount into the mixture, uniformly mixing, and pressing into tablets.
Comparative example 3
The preparation process comprises the following steps:
fully dissolving PEG5000-DSPE and memantine hydrochloride in a prescription amount in ethanol, performing reduced pressure rotary evaporation for 1h at 37 ℃ in an eggplant-shaped bottle to remove an organic solvent to obtain a uniform film, adding a buffer solution preheated at 37 ℃, performing rotary hydration in a water bath kettle at 37 ℃, granulating the obtained geopolymer micelle through a 0.45-micron microporous filter membrane, and freeze-drying the filtrate by a freeze dryer to obtain drug-loaded polymer micelle powder.
The prepared drug-loaded polymer micelle powder is uniformly mixed with lactose, microcrystalline cellulose, croscarmellose sodium, menthol and sucralose according to the prescription amount in sequence. And adding magnesium stearate with the prescribed amount into the mixture, uniformly mixing, and pressing into tablets.
TABLE 1 Memantine hydrochloride orally disintegrating tablet taste and disintegration time
Claims (10)
1. An orally disintegrating tablet containing PEG-DSPE-memantine hydrochloride compound comprises 10% -50% of PEG-DSPE-memantine hydrochloride compound and 50% -90% of other auxiliary materials.
2. The orally disintegrating tablet comprising a PEG-DSPE-memantine hydrochloride complex as claimed in claim 1, wherein the molecular weight of PEG in the PEG-DSPE-memantine hydrochloride complex is 2000-6000.
3. The orally disintegrating tablet comprising a PEG-DSPE-memantine hydrochloride complex as claimed in claim 1, wherein the molecular weight of PEG in the PEG-DSPE-memantine hydrochloride complex is 3000-5000.
4. The PEG-DSPE-memantine hydrochloride complex according to claim 2, wherein the weight ratio of memantine hydrochloride to PEG-DSPE is 1:1-1: 10.
5. The PEG-DSPE-memantine hydrochloride complex according to claim 2, wherein the weight ratio of memantine hydrochloride to PEG-DSPE is 1: 5.
6. The orally disintegrating tablet containing PEG-DSPE-memantine hydrochloride complex according to claim 1, wherein the preparation method comprises preparing memantine hydrochloride and PEG-DSPE into polymer micelle by self-assembly solvent evaporation method, freeze-drying the micelle by freeze-drying technique to obtain freeze-dried powder, and then preparing the orally disintegrating tablet by powder direct compression technique.
7. The PEG-DSPE-memantine hydrochloride compound according to claim 4, wherein the preparation method of the polymer micelle solid preparation is a self-assembly solvent evaporation method, and the specific steps are as follows:
(1) fully dissolving PEG-DSPE and memantine hydrochloride in an organic solvent, and removing the organic solvent by reduced pressure rotary evaporation in an eggplant-shaped bottle at a proper temperature to obtain a uniform film;
(2) adding preheated buffer solution into the uniform film, and rotationally hydrating in a water bath;
(3) and (3) granulating the obtained polymer micelle through a microporous filter membrane, and freeze-drying the filtrate through a freeze dryer to obtain drug-loaded polymer micelle powder.
8. The PEG-DSPE-memantine hydrochloride complex according to claim 5, wherein the added organic solvent comprises one or a mixture of ethanol and chloroform, preferably ethanol.
9. PEG-DSPE-memantine hydrochloride complex according to claim 5, characterized in that the buffered salt solution is selected from phosphate buffered solutions with pH value of 7.0-7.4, preferably 7.4.
10. The orally disintegrating tablet containing PEG-DSPE-memantine hydrochloride complex according to claim 1, characterized in that the pharmaceutical excipients added include but are not limited to fillers, disintegrants, lubricants, glidants, flavors; wherein fillers include, but are not limited to, lactose, mannitol, microcrystalline cellulose; disintegrants include, but are not limited to, sodium carboxymethyl starch, croscarmellose sodium, low substituted celluloses, and flavoring agents include, but are not limited to, aspartame, acesulfame potassium, menthol.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810630856.5A CN110613691A (en) | 2018-06-19 | 2018-06-19 | Orally disintegrating tablet containing PEG-DSPE-memantine hydrochloride compound |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810630856.5A CN110613691A (en) | 2018-06-19 | 2018-06-19 | Orally disintegrating tablet containing PEG-DSPE-memantine hydrochloride compound |
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| CN110613691A true CN110613691A (en) | 2019-12-27 |
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| CN201810630856.5A Pending CN110613691A (en) | 2018-06-19 | 2018-06-19 | Orally disintegrating tablet containing PEG-DSPE-memantine hydrochloride compound |
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Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1709229A (en) * | 2005-06-10 | 2005-12-21 | 北京阜康仁生物制药科技有限公司 | Memantine hydrochloride orally disintegrating tablet and its preparing method |
| US20080008743A1 (en) * | 2006-07-06 | 2008-01-10 | Forest Laboratories Holdings Limited | Orally Dissolving Formulations of Memantine |
| CN101204378A (en) * | 2006-12-19 | 2008-06-25 | 北京德众万全药物技术开发有限公司 | Memantine hydrochloride oral medicine compound and its preparation method |
| CN101460150A (en) * | 2006-03-31 | 2009-06-17 | 鲁比康研究私人有限公司 | Directly compressible composite for orally disintegrating tablets |
| WO2009084017A2 (en) * | 2007-10-10 | 2009-07-09 | Rubicon Research Private Limited | Taste-masked orally disintegrating tablets of memantine hydrochloride |
| EP2198857A1 (en) * | 2008-12-19 | 2010-06-23 | Ratiopharm GmbH | Oral dispersible tablet |
| CN104244930A (en) * | 2012-04-24 | 2014-12-24 | 第一三共株式会社 | Orally disintegrating tablet and method for producing same |
-
2018
- 2018-06-19 CN CN201810630856.5A patent/CN110613691A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1709229A (en) * | 2005-06-10 | 2005-12-21 | 北京阜康仁生物制药科技有限公司 | Memantine hydrochloride orally disintegrating tablet and its preparing method |
| CN101460150A (en) * | 2006-03-31 | 2009-06-17 | 鲁比康研究私人有限公司 | Directly compressible composite for orally disintegrating tablets |
| US20080008743A1 (en) * | 2006-07-06 | 2008-01-10 | Forest Laboratories Holdings Limited | Orally Dissolving Formulations of Memantine |
| CN101204378A (en) * | 2006-12-19 | 2008-06-25 | 北京德众万全药物技术开发有限公司 | Memantine hydrochloride oral medicine compound and its preparation method |
| WO2009084017A2 (en) * | 2007-10-10 | 2009-07-09 | Rubicon Research Private Limited | Taste-masked orally disintegrating tablets of memantine hydrochloride |
| EP2198857A1 (en) * | 2008-12-19 | 2010-06-23 | Ratiopharm GmbH | Oral dispersible tablet |
| CN104244930A (en) * | 2012-04-24 | 2014-12-24 | 第一三共株式会社 | Orally disintegrating tablet and method for producing same |
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