CN101401796A - Pramipexole orally disintegrating tablets and preparation method thereof - Google Patents
Pramipexole orally disintegrating tablets and preparation method thereof Download PDFInfo
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- CN101401796A CN101401796A CNA2008102265938A CN200810226593A CN101401796A CN 101401796 A CN101401796 A CN 101401796A CN A2008102265938 A CNA2008102265938 A CN A2008102265938A CN 200810226593 A CN200810226593 A CN 200810226593A CN 101401796 A CN101401796 A CN 101401796A
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Abstract
The invention relates to the technical field of pharmaceutical preparation, in particular to an orally disintegrating tablet containing pramipexole and a method for preparing the same, wherein the orally disintegrating tablet comprises effective amount of the pramipexole and a pharmaceutic adjuvant which is acceptable in pharmacy and can rapidly collapse and release drugs in an oral cavity. The orally disintegrating tablet containing the pramipexole has the advantages of faster action speed compared with the prior tablets and capsulated drugs, has convenient use and good taste in taking, and is more suitable for children, the elderly, and patients who can not swallow solid medicines.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition of composition of pramipexole, more particularly, the present invention relates to a kind of pramipexole orally disintegrating tablets.The invention still further relates to the preparation method of described pramipexole orally disintegrating tablets.
Background technology
Pramipexole is by the exploitation of German Boehringer Ingelheim company, and in the listing of FDA approval on May 10th, 1997 pramipexole, trade name Mirapex is sold by Boehringer Ingelheim company and Pharmacia company jointly in the U.S..It is FDA ratifies to be used for parkinson in the past first in 6 years a medicine.
Pramipexole right and wrong Ergota analog derivative, its major advantage is: act on the DA-2 receptor pramipexole high selectivity; Can use the treatment parkinson separately in early days; can share the treatment parkinson late period with dopamine; the external while is used for the treatment of RLS disease (restless leg syndrome) for pramipexole and studies; think effectively; and pramipexole has protective effect to the nerve of dopamine; the treatment of neuroprotective and RLS disease is its unique advantage, can delay the development of the state of an illness greatly, has guaranteed patient's health.After oral, pramipexole absorbs rapidly, reaches peak concentration in 2 hours, and absolute bioavailability is approximately 90%.Eliminating the half-life in the old people is 12 hours, and 90% medicine mainly passes through urine excretion with the prototype drug secretion.
Oral cavity disintegration tablet is the novel solid preparation of foreign study exploitation in recent ten years, refers in the oral cavity to be disintegratable or complete molten tablet in 1 minute.This dosage form mainly is to select suitable fast disintegrant, by the existing certain rigidity of its tablet of making, certain sedimentation is arranged again, do not need water when taking or only need low amounts of water, also need not to chew, medicine places on the tongue, meet saliva dissolving or disintegrate rapidly, medicine borrows swallowing act to go into the stomach onset.Oral cavity disintegration tablet is compared with conventional tablet, and a kind of new instructions of taking can be provided, and can make things convenient for patient's medication, especially as dysphagia person (as old man, child), or patient's medication of water inconvenience under the special environment.
The tablet listing of the existing pramipexole in domestic market at present, but the research of relevant oral cavity disintegration tablet dosage form does not appear in the newspapers.
Summary of the invention
Purpose of the present invention just is a kind of stable in properties, evident in efficacy is provided, and is suitable for the pramipexole orally disintegrating tablets of patient's use of child, old people and the solid chemicals of can not swallowing.
Another order of the present invention is to provide the preparation method of above-mentioned pramipexole orally disintegrating tablets, and it adopts modern technology of preparing, but commercial scale, high efficiency production, and it is stable that product quality keeps.
The technical scheme that technical solution problem of the present invention is adopted is, a kind of pramipexole orally disintegrating tablets, comprise pramipexole active ingredient and medicinal acceptable auxiliary, the percentage by weight that it is characterized in that pramipexole is 0.1～10%, the percentage by weight of adjuvant is 90～99.9%, adjuvant contains disintegrating agent, filler, correctives, sweeting agent, the percentage by weight of disintegrating agent is 5～40%, the percentage by weight of filler is 10～60%, the percentage by weight of correctives is 0.1～1%, and the percentage by weight of sweeting agent is 1～30%.
It is 0.5～5% pramipexole that described pramipexole orally disintegrating tablets preferably contains percentage by weight, 95～99.5% adjuvant.
The present invention is according to the difference of preparation method, can select for use in the component in the various uses adjuvant partly or entirely.
When the percentage by weight of pramipexole less than 1% the time, the adjuvant of described pramipexole orally disintegrating tablets can contain odor mask, also can not contain odor mask; When the percentage by weight of pramipexole greater than 5% the time, the adjuvant of described pramipexole orally disintegrating tablets also contains odor mask, odor mask is selected from a kind of or wherein several mixture in acrylic resin copolymer, Magnesiumaluminumsilicate, gelatin, guar gum, arabic gum, xanthan gum, paraffin, the Brazil wax, and accounting for the oral cavity disintegration tablet percentage by weight is 5～20%.
The adjuvant of described pramipexole orally disintegrating tablets also contains lubricant, and lubricant is selected from a kind of or wherein several mixture in micropowder silica gel, magnesium stearate, the Pulvis Talci, and accounting for the oral cavity disintegration tablet percentage by weight is 0.5～5%.
The adjuvant of described pramipexole orally disintegrating tablets also contains binding agent, binding agent is selected from a kind of or wherein several mixture in syrup, starch slurry, carboxymethylcellulose sodium solution, the povidone solution, and accounting for the total formulation weight percentage ratio of oral cavity disintegration tablet is 1～5%.
The disintegrating agent of described pramipexole orally disintegrating tablets is selected from a kind of or wherein several mixture in polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, Novagel RCN-15 (mixture of 85% microcrystalline Cellulose and 15% guar gum), carboxymethylcellulose calcium, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, the corn starch.
The filler of described pramipexole orally disintegrating tablets is selected from a kind of or wherein several mixture in lactose, microcrystalline Cellulose, pregelatinized Starch, mannitol, sorbitol, xylitol, the erythritol.
The correctives of described pramipexole orally disintegrating tablets is selected from a kind of or wherein several mixture in Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, blue berry, Fructus Musae, Fructus Ananadis comosi, honey peach, the maltose essence.
The sweeting agent of described pramipexole orally disintegrating tablets selects a kind of or wherein several mixture in white saccharin sodium, sucrose, aspartame, the steviol glycosides; Simultaneously, a kind of or wherein several mixture of saccharin sodium, aspartame, steviol glycosides is not more than percentage by weight 10%.
The preparation method of pramipexole orally disintegrating tablets can be freeze-drying, powder pressing method, wet granule compression tablet method.Concrete method for making is as follows:
The key step of freeze-drying is: with pramipexole and disintegrating agent, filler, correctives, sweeting agent mix homogeneously, and add the suitable quantity of water dilution, fully mixing places suitable sheet shape mould, puts into the freeze dryer lyophilization, is shaped to the material bone dry.Or the aqueous solution of pramipexole and odor mask is even, add disintegrating agent, filler, correctives, sweeting agent, and add the suitable quantity of water dilution, fully mixing places suitable sheet shape mould, puts into the freeze dryer lyophilization, is shaped to the material bone dry.
The key step of powder pressing method is: disintegrating agent, filler, sweeting agent, correctives are sieved, and with the pramipexole mix homogeneously, tabletting is shaped behind the adding lubricant.Or pramipexole added the aqueous solution of odor mask, and mixed 1～2 hour, in 40 ℃ of dryings 12 hours, crushing screening behind the bone dry; With disintegrating agent, filler, sweeting agent, correctives sieve with crushing screening after pramipexole carry out mix homogeneously, add lubricant after tabletting be shaped.
The key step of wet granule compression tablet method is: with pramipexole and part disintegrating agent, filler, correctives, sweeting agent, mix homogeneously, add suitable amount of adhesive system soft material, granulation, oven dry, granulate add surplus disintegrating agent and lubricant, the tabletting shaping.Or pramipexole added the aqueous solution of odor mask, and mixed 1～2 hour, in 40 ℃ of dryings 12 hours, crushing screening behind the bone dry; With the pramipexole behind the crushing screening and part disintegrating agent, filler, rectify and hide agent, sweeting agent mix homogeneously, add suitable amount of adhesive system soft material, granulate, oven dry, granulate adds surplus disintegrating agent and lubricant, the tabletting shaping.
Use the pramipexole orally disintegrating tablets of freeze-drying preparation, place lingual surface to dissolve rapidly, disintegration time was less than 10 seconds, use the oral cavity disintegration tablet of pressed powder and wet granule compression tablet gained, enter the oral cavity based on disintegrate, disintegration time is less than 40 seconds, the equal good mouthfeel of all components, acidity, sugariness suit no grittiness.
The pramipexole orally disintegrating tablets that the present invention makes has the following advantages:
The first, disintegrate is rapid, and is rapid-action.The present invention can be in 45 seconds in mouth disintegrate fast, make the rapid stripping of medicine, compare with pramipexole conventional tablet or capsule, shortened dissolution time, accelerate its absorption, make medicine can bring into play the whole body therapeutic effect rapidly.
The second, drug absorption is abundant.The present invention before reaching gastrointestinal tract rapidly disintegrate also be dispersed into trickle granule, cause medicine to distribute in the gastrointestinal tract large tracts of land, absorption point increases, and absorbs more fully, so also helps improving bioavailability of medicament.
The 3rd, medication is convenient, good mouthfeel.The present invention needn't use water delivery service, saliva can make oral cavity disintegration tablet disintegrate or dissolving, both can resemble ordinary tablet swallows, can be placed in the water again and take after the disintegrate, also can need not to take medicine with water swallow, can take whenever and wherever possible, provide a great convenience condition, can guarantee that more medicine takes on time for the patient takes medicine.
The 4th, the present invention has refrigerant Herba Menthae and fruit aroma and does not have obvious abnormal flavour after taste masking is handled, no sand type, help improving the patient take medicine compliance.
The specific embodiment
Pramipexole orally disintegrating tablets of the present invention comprises pramipexole active component and medicinal acceptable auxiliary, and adjuvant can contain the mixture of disintegrating agent, filler, odor mask, correctives, sweeting agent, lubricant, binding agent.Its component composition can be:
Pramipexole: 0.1～10%; Disintegrating agent: 5～40%; Filler: 10～60%; Lubricant: 0.5～5%; Odor mask: 5～20%; Correctives: 0.1～1%; Sweeting agent: 1～30%; Binding agent: 1～5%.
Preferred ingredient is that to contain percentage by weight be 0.5～5% pramipexole, 95～99.5%% adjuvant.
In the specific implementation, according to the difference of preparation method, in the component in the above various uses adjuvant of optional usefulness partly or entirely.
By specific embodiment given below, can further be well understood to the present invention, but they not limitation of the invention.
Embodiment 1 pramipexole orally disintegrating tablets and preparation method thereof
Component:
Composition (supplementary material) consumption (percentage by weight, %)
Pramipexole 0.5
Polyvinylpolypyrrolidone 6
Microcrystalline Cellulose pH301 30
Lactose 30
Sucrose 25
Saccharin sodium 2
Eudragit E udragit L30D-55 5.5
Flavoring orange essence 1
Preparation method:
Pramipexole is added in the Eudragit L30D-55 suspension, add appropriate amount of deionized water, stir, add polyvinylpolypyrrolidone, microcrystalline Cellulose, lactose, sucrose, saccharin sodium and flavoring orange essence successively, the limit edged stirs, be heated to 30～40 ℃, mixed 1 hour, and became uniform suspension, be poured in the suitable mould and carry out lyophilization, lyophilizing is shaped and finishes back press seal, packing.
Embodiment 2 pramipexole orally disintegrating tablets and preparation method thereof
Component:
Composition (supplementary material) consumption (percentage by weight, %)
Pramipexole 1
Mannitol 10
Pregelatinized Starch 10
Guar gum 5
Arabic gum 10
Erythritol 40
Microcrystalline Cellulose 14
Sucrose 9.8
Vanilla 0.2
Preparation method:
Pramipexole is added in the mixed liquor of guar gum and arabic gum, add suitable quantity of water, stir, add mannitol, erythritol and sucrose, to dissolving fully, add pregelatinized Starch, microcrystalline Cellulose and vanilla, the limit edged stirs, and mixes 1 hour, become uniform suspension liquid, be poured in the suitable mould and carry out lyophilization, lyophilizing is shaped and finishes back press seal, packing.
Embodiment 3 pramipexole orally disintegrating tablets and preparation method thereof
Component:
Composition (supplementary material) consumption (percentage by weight, %)
Pramipexole 1
Gelatin 20
Xylitol 18
Aspartame 4.9
Novagel?RCN--15 50
Cross-linking sodium carboxymethyl cellulose 6
Honey peach essence 0.1
Preparation method:
Pramipexole, gelatin, xylitol, aspartame, cross-linking sodium carboxymethyl cellulose, RCN-15 in the component are suspended in the water, stirred 1 hour, make suspension, be poured in the suitable mould, carry out lyophilization, lyophilizing is shaped and finishes back press seal, packing.
Embodiment 4 pramipexole orally disintegrating tablets and preparation method thereof
Component:
Composition (supplementary material) consumption (percentage by weight, %)
Pramipexole 2
Cross-linking sodium carboxymethyl cellulose 5
Starch 25
Sorbitol 35
Steviol glycosides 0.5
Sucrose 29.5
Flavoring pineapple essence 2
Micropowder silica gel 1
Preparation method:
100 mesh sieves are crossed in pramipexole, sorbitol, steviol glycosides, sucrose, micropowder silica gel respectively, earlier with pramipexole and steviol glycosides, sucrose, flavoring pineapple essence, micropowder silica gel mix homogeneously, progressively increase and mix with cross-linking sodium carboxymethyl cellulose, starch, sorbitol equivalent again, placed three-dimensional mixer 15 minutes, abundant mix homogeneously, tabletting is shaped.
Embodiment 5 pramipexole orally disintegrating tablets and preparation method thereof
Component:
Composition (supplementary material) consumption (percentage by weight, %)
Pramipexole 5
Magnesiumaluminumsilicate 10
Low-substituted hydroxypropyl cellulose 27
Lactose 3
Mannitol 50
Fructus Citri Limoniae essence 1
Aspartame 2.5
Magnesium stearate 1.5
Make each method:
Pramipexole is added in the aqueous solution of Magnesiumaluminumsilicate, mix,, or to bone dry, pulverize, cross 100 mesh sieves in 40 ℃ of dryings 12 hours; Low-substituted hydroxypropyl cellulose, lactose, mannitol are crossed 100 mesh sieves, and with Fructus Citri Limoniae essence, aspartame, the magnesium stearate equivalent mix homogeneously that progressively increases, with the pretreatment powder mixing of pramipexole, direct compression is shaped then.
Claims (4)
1, a kind of preparation method of pramipexole orally disintegrating tablets contains pramipexole active ingredient and medicinal acceptable auxiliary, and the percentage by weight of pramipexole is 0.1～10%, and the percentage by weight of adjuvant is 90～99.9%; Adjuvant is selected from disintegrating agent, filler, correctives, sweeting agent, odor mask; Described disintegrating agent is selected from a kind of or wherein several mixture in the mixture, carboxymethylcellulose calcium, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, corn starch of polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, 85% microcrystalline Cellulose and 15% guar gum, and the percentage by weight of disintegrating agent is 5～40%; Described filler is selected from a kind of or wherein several mixture in lactose, pregelatinized Starch, mannitol, sorbitol, xylitol, the erythritol, and the percentage by weight of filler is 10～60%; Described correctives is selected from a kind of or wherein several mixture in Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, blue berry, Fructus Musae, Fructus Ananadis comosi, honey peach, the maltose essence, and the percentage by weight of correctives is 0.1～1%; Described sweeting agent is selected from a kind of or wherein several mixture in saccharin sodium, sucrose, aspartame, the steviol glycosides, the percentage by weight of sweeting agent is 1～30%, simultaneously, a kind of or wherein several mixture of saccharin sodium, aspartame, steviol glycosides is not more than total weight percent 5%; Described odor mask is selected from a kind of or wherein several mixture in acrylic resin copolymer, Magnesiumaluminumsilicate, gelatin, guar gum, arabic gum, xanthan gum, paraffin, the Brazil wax, and the percentage by weight of odor mask is 5～20%; The main method step is: pramipexole added the aqueous solution of odor mask, mixed 1～2 hour, and in 40 ℃ of dryings 12 hours, crushing screening behind the bone dry; With disintegrating agent, filler, sweeting agent, correctives sieve with crushing screening after the pramipexole mix homogeneously, add lubricant after tabletting be shaped.
2. method according to claim 1 is characterized in that adjuvant also contains lubricant, and lubricant is selected from a kind of or wherein several mixture in micropowder silica gel, magnesium stearate, the Pulvis Talci, and accounting for the oral cavity disintegration tablet percentage by weight is 0.5～5%.
3. method according to claim 2, it is characterized in that adjuvant also contains binding agent, binding agent selects a kind of or wherein several mixture in white sugar syrup, starch slurry, carboxymethylcellulose sodium solution, the povidone solution, and accounting for the oral cavity disintegration tablet percentage by weight is 1～5%.
4. method according to claim 3, the main method step is: pramipexole added the aqueous solution of odor mask, mixed 1～2 hour, in 40 ℃ of dryings 12 hours, crushing screening behind the bone dry; With the pramipexole behind the crushing screening and part disintegrating agent, filler, correctives, sweeting agent mix homogeneously, add suitable amount of adhesive system soft material, granulate, oven dry, granulate adds surplus disintegrating agent and lubricant, tabletting is shaped and separates sheet, it is characterized in that selecting for use wetting agent, is water or ethanol and wetting agent is selected for use, or water and alcoholic acid mixture.
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2008102265938A CN101401796A (en) | 2008-11-17 | 2008-11-17 | Pramipexole orally disintegrating tablets and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2008102265938A CN101401796A (en) | 2008-11-17 | 2008-11-17 | Pramipexole orally disintegrating tablets and preparation method thereof |
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| CN101401796A true CN101401796A (en) | 2009-04-08 |
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| CNA2008102265938A Pending CN101401796A (en) | 2008-11-17 | 2008-11-17 | Pramipexole orally disintegrating tablets and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2308464A1 (en) * | 2009-10-06 | 2011-04-13 | Sanovel Ilac Sanayi ve Ticaret A.S. | Orally disintegrating compositions of pramipexole |
| CN102772403A (en) * | 2011-05-10 | 2012-11-14 | 浙江京新药业股份有限公司 | Preparation method for pramipexole preparation |
| CN103040781A (en) * | 2013-01-04 | 2013-04-17 | 杭州朱养心药业有限公司 | Pramipexole dihydrochloride tablet composition and preparation method thereof |
| CN105012253A (en) * | 2014-04-24 | 2015-11-04 | 南京长澳医药科技有限公司 | Pramipexole dihydrochloride orally disintegrating tablets and preparation method for same |
| CN105147627A (en) * | 2015-08-19 | 2015-12-16 | 天津红日药业股份有限公司 | Medicine composition containing pramipexole dihydrochloride and preparation method thereof |
-
2008
- 2008-11-17 CN CNA2008102265938A patent/CN101401796A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2308464A1 (en) * | 2009-10-06 | 2011-04-13 | Sanovel Ilac Sanayi ve Ticaret A.S. | Orally disintegrating compositions of pramipexole |
| CN102772403A (en) * | 2011-05-10 | 2012-11-14 | 浙江京新药业股份有限公司 | Preparation method for pramipexole preparation |
| CN102772403B (en) * | 2011-05-10 | 2015-11-25 | 浙江京新药业股份有限公司 | Pramipexole preparation and preparation method thereof |
| CN103040781A (en) * | 2013-01-04 | 2013-04-17 | 杭州朱养心药业有限公司 | Pramipexole dihydrochloride tablet composition and preparation method thereof |
| CN105012253A (en) * | 2014-04-24 | 2015-11-04 | 南京长澳医药科技有限公司 | Pramipexole dihydrochloride orally disintegrating tablets and preparation method for same |
| CN105147627A (en) * | 2015-08-19 | 2015-12-16 | 天津红日药业股份有限公司 | Medicine composition containing pramipexole dihydrochloride and preparation method thereof |
| CN105147627B (en) * | 2015-08-19 | 2019-04-12 | 天津红日药业股份有限公司 | A kind of pharmaceutical composition and preparation method thereof containing body of Pramipexole dihydrochloride |
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Open date: 20090408 |