CN1903183A - Dispersion tablets of telbivudine and its prepn. method - Google Patents
Dispersion tablets of telbivudine and its prepn. method Download PDFInfo
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- CN1903183A CN1903183A CN 200610100935 CN200610100935A CN1903183A CN 1903183 A CN1903183 A CN 1903183A CN 200610100935 CN200610100935 CN 200610100935 CN 200610100935 A CN200610100935 A CN 200610100935A CN 1903183 A CN1903183 A CN 1903183A
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- sodium
- sebivo
- cellulose
- disintegrating agent
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Abstract
A dispersing tablet of Tibifuding is prepared from Tibifuding and the medicinal carrier chosen from disintegrant, filler, surfactant, wet adhesive and lubricant through wet granulating and tabletting.
Description
Technical field the invention belongs to medical technical field, relates to a kind of novel form that contains Sebivo and preparation method thereof, is dispersion tablets of telbivudine and preparation method thereof specifically.
The background technology Sebivo is a species specificity, nucleoside analog optionally, is also referred to as LdT, the special Telbivudine of English name, and its chemical name is 1-(2 '-deoxidation-β-L-arabinofuranosyl base)-thymus pyrimidine, molecular structural formula is as follows:
Molecular formula C
10H
14N
2O
5Sebivo has very strong inhibitory action to hepatitis B (HBV) virus, according to the external model that infects based on HBV, and the tentative infected animal model of hepatitis B infection, demonstrate efficient, safe therapeutical effect.
International publication WO00/09531 (its in China Patent No. 99809553.2, publication number CN1320128) discloses Sebivo at the purposes of treatment hepatitis B virus infection and pharmaceutical composition etc.
The water solublity of Sebivo is relatively poor, is unfavorable for the preparation of pharmaceutical preparation and the application of medicine.
Dispersible tablet is a kind of novel pharmaceutical formulation that development in recent years is got up, British Pharmacopoeia 1993 editions and Chinese Pharmacopoeia 2000 editions are also included record with this novel drugs dosage form of dispersible tablet, compare ordinary tablet, dispersible tablet requires temperature at the disintegrate medium in 20 ± 2 ℃, disintegration, the granule after the disintegrate should be all by 710 μ m screen clothes (No. 2 sieves) less than 3 minutes.Take dispersible tablet and have advantages such as drug release rate is fast, bioavailability is high, untoward reaction is few, clinical application both can be swallowed as ordinary tablet, can put into again and take after water disperses rapidly, can also chewing or containing to suck of having taken, portably use conveniently, have the advantage of tablet and liquid preparation concurrently, very convenient old people of the tablet of this quick dissolved, quick effect and dysphagia person use.
Sebivo poorly water-soluble, oral post-absorption slowly and bioavailability lower, do not see as yet both at home and abroad about the report of its tablet formulation and documents and materials etc.
The poorly water-soluble of summary of the invention Sebivo, oral bioavailability is lower, absorbs slowly, and onset is also slow.The purpose of this invention is to provide the medicinal preparation for oral administration that a kind of adjuvant was easy to get, prepared Sebivo simple, with low cost, and disintegration rate is fast, Sebivo the peroral dosage form---dispersion tablets of telbivudine that helps improving bioavailability of medicament and onset speed, taking convenience, and preparation method thereof.
The invention provides a kind of dispersible tablet drug dosage form, it is characterized in that containing Sebivo.
Dispersion tablets of telbivudine of the present invention also comprises pharmaceutically suitable carrier except the principal agent Sebivo, in weight percent content, wherein contain Sebivo and pharmaceutically suitable carrier of 2～60%;
Preferably contain Sebivo and pharmaceutically suitable carrier of 10～50%;
Especially preferably contain Sebivo and pharmaceutically suitable carrier of 20～40%.
Should be clear and definite, indication of the present invention " Sebivo " also comprises solvate, hydrate, various crystal formation, officinal salt of Sebivo etc.; Described above these all are the existence form of Sebivo as active ingredient, do not change its pharmacological action, in this application documents, if there is not specified otherwise, think that all the form of these salt or associated complex is equivalent, identical, consistent with Sebivo, and can mutual alternative.
Wherein, in the dispersion tablets of telbivudine of the present invention, pharmaceutically suitable carrier comprises one or more in disintegrating agent, filler, surfactant, wet adhesive, the lubricant.
The key of dispersible tablet is its disintegration rate in water, so the selection of the disintegrating agent system in the tablet is extremely important, at least a carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (L-HPC), sodium carboxymethyl cellulose (CMC-Na), crospolyvinylpyrrolidone (PVPP), cross-linking sodium carboxymethyl cellulose (cCMC-Na), crosslinked carboxymethyl fecula sodium (cCMS-Na), microcrystalline Cellulose (MCC), the carboxymethylcellulose calcium (CMC-Ca) of being selected from of the disintegrating agent that the present invention chooses;
Filler is in order to increase the weight and volume of dispersible tablet, be beneficial to molding and dilution active ingredient, at least a microcrystalline Cellulose, sucrose, starch, lactose, dextrin, mannitol, sorbitol, pregelatinized Starch, xylitol, fructose, maltose alcohol, dextran, glucose, calcium sulfate, the calcium hydrogen phosphate of being selected from of the filler of dispersible tablet of the present invention;
Surfactant can improve the dispersion and the stripping of active ingredient Sebivo in the dispersible tablet, also can promote the disintegrate of dispersible tablet, the surfactant of dispersible tablet of the present invention selects at least a from sodium lauryl sulphate, cetyl sulfo-sodium succinate, Tweens (polyoxyethylene sorbitan fatty acid ester class, comprise tween 20, Tween-40, Tween-60, Tween-65, tween 80, tween 85 etc.), (the fatty acid esters of sorbitan class comprises Arlacel-20 to spans, Arlacel-40, Arlacel-60, Arlacel-65, Arlacel-80, Arlacel-85 etc.), sodium dioctyl sulfosuccinate;
Wet adhesive is to be convenient to wet granulation and the adherent pharmaceutic adjuvant of tabletting, at least a water, ethanol, polyethylene pyrrole slightly alkane ketone, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, the various cellulose of being selected from of the wet adhesive of dispersible tablet of the present invention;
Lubricant is in order to feed in raw material smoothly and slice, to make the pharmaceutic adjuvant of tablet smooth and beautiful appearance, at least a magnesium stearate, calcium stearate, stearic acid, Pulvis Talci, silicon dioxide, micropowder silica gel, Polyethylene Glycol, the Stepanol MG of being selected from of the lubricant of dispersible tablet of the present invention.
In addition, in order to improve the taste of tablet, can also add an amount of correctives,, glycyrrhizin sweet, sucralose, saccharin sodium, stevioside, xylitol, fructose, citric acid, vanillin, medicinal essence etc. as A Siba, in order to guarantee the stable of principal agent or active ingredient, can also add an amount of antioxidant and antiseptic etc.More than these pharmaceutic adjuvants and usage all be as well known to those skilled in the art and familiar.
Especially, a kind of dispersion tablets of telbivudine provided by the invention is characterized in that every weight is 50～800mg, contains following composition by weight percentage:
--5～50% Sebivo,
--2～20% disintegrating agent, and at least a carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, microcrystalline Cellulose, the carboxymethylcellulose calcium of being selected from of disintegrating agent
--10～60% filler, and at least a microcrystalline Cellulose, sucrose, starch, lactose, dextrin, mannitol, sorbitol, pregelatinized Starch, xylitol, fructose, maltose alcohol, dextran, glucose, calcium sulfate, the calcium hydrogen phosphate of being selected from of filler.
Except above-mentioned composition, can also contain other needs or suitable composition, for example surfactant, wet adhesive, lubricant, correctives, antioxidant and antiseptic etc. in the dispersible tablet certainly.
Especially, a kind of dispersion tablets of telbivudine provided by the invention is characterized in that every weight is 100～650mg, contains following composition by weight percentage:
--5～55% Sebivo,
--1～50% disintegrating agent, and at least a carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, microcrystalline Cellulose, the carboxymethylcellulose calcium of being selected from of disintegrating agent
--10～50% filler, and at least a microcrystalline Cellulose, sucrose, starch, lactose, dextrin, mannitol, sorbitol, pregelatinized Starch, xylitol, fructose, maltose alcohol, dextran, glucose, calcium sulfate, the calcium hydrogen phosphate of being selected from of filler.
Except above-mentioned composition, can also contain other needs or suitable composition, for example surfactant, wet adhesive, lubricant, correctives, antioxidant and antiseptic etc. in the dispersible tablet certainly.
The preparation method of dispersible tablet of the present invention is close with the preparation method of conventional tablet, adopts wet granule compression tablet, and its preparation method comprises:
(1) earlier medicine and pharmaceutic adjuvant are processed pulverizing respectively, make its fineness more than 80 orders, preferred 100 orders, 120 orders or 200 purpose grain size categories;
(2) Sebivo with recipe quantity mixes with filler, does not add or adds earlier partly or whole disintegrating agent;
(3) add wet adhesive and make soft material, make wet granular, drying, granulate adds all or residue part disintegrating agent, adds the lubricant mixing again, and tabletting promptly gets dispersion tablets of telbivudine.
In preparation process, disintegrating agent is made granule with the prescription powder, is referred to as addition in the disintegrating agent; Disintegrating agent mixes the back tabletting and is referred to as the outer addition of disintegrating agent with dried granules.Add in the disintegrating agent and add the speed that all can influence the dispersible tablet disintegrate, can adopt interior addition, also can adopt outer addition, can also in add, add common use; interiorly add, when adding common use, disintegrating agent can be identical, also can be different.
Correctives, antioxidant and antiseptic can add before granulation, also can be after granulation, add before the tabletting, and these preparations and processing method all are as well known to those skilled in the art and familiar.
The dispersible tablet of Sebivo provided by the invention, in temperature was 20 ℃ water, all can through check, be generally less than 170 seconds disintegration less than 3 minutes disintegration, even less than 120 seconds, and the granule after the disintegrate all can be all by No. 2 screen clothes.
Adopt the technology of the present invention that Sebivo is made as dispersible tablet, adjuvant is easy to get, preparation is simple, and is with low cost, not only expanded the dosage form scope of Sebivo, the sharp dispersion tablets of telbivudine of the present invention, not only adjuvant is easy to get, prepares simple, with low cost, and the disintegration rate of dispersible tablet is fast, absorb fast, can improve bioavailability of medicament and blood drug level, thereby the raising curative effect of medication, and carry, taking convenience.
Therefore, the present invention also provides a kind of hepatitis b virus infected method for the treatment of, this method comprises and gives the patient oral dispersion tablets of telbivudine agent of the present invention, be particularly useful for blood HBVDNA tests positive and alanine aminotransferase ALT and detect the hepatitis B patient that is higher than normal value, hepatitis B virus duplication is active in the explanation body because the HBVDNA positive and ALT raise, hepatic tissue is encroached on, and adopting this moment the dispersible tablet of Sebivo of the present invention to carry out anti-HBV treatment is appropriate and necessity.
The specific embodiment is come dispersion tablets of telbivudine of the present invention done further by the following examples and is specified, but does not represent the embodiment limitation of the present invention.
Embodiment 1. prescriptions: composition weight percent content
Sebivo 25%
Lactose is an amount of
Pregelatinized Starch 17%
Microcrystalline Cellulose 31%
Low-substituted hydroxypropyl cellulose 7%
Sodium lauryl sulphate 0.8%
Polyvinylpyrrolidone aqueous solution an amount of (in polyvinylpyrrolidone)
Magnesium stearate 1%
Preparation method: earlier above-mentioned material pulverize separately is crossed 100 mesh sieves.With Sebivo, lactose, pregelatinized Starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, the abundant mix homogeneously of sodium lauryl sulphate, add an amount of polyvinylpyrrolidone aqueous solution and make soft material, oven dry after 20 mesh sieves are granulated, 20 mesh sieve granulate, add the magnesium stearate mixing, the control tablet weight, tabletting promptly gets dispersion tablets of telbivudine.
Further, by above-mentioned percentage composition design recipe quantity, can make every heavy 100mg (containing Sebivo 25mg), 200mg (containing Sebivo 50mg), 400mg (containing Sebivo 100mg), 500mg (containing Sebivo 125mg), 800mg (containing Sebivo 200mg).
Embodiment 2. prescriptions: composition weight percent content
Sebivo 50%
Mannitol is an amount of
Carboxymethyl starch sodium 10%
Microcrystalline Cellulose 15%
Tween 80 1.1%
Water is an amount of
Stepanol MG 2.1%
Preparation method: earlier above-mentioned material pulverize separately is crossed 100 mesh sieves.With Sebivo, mannitol, carboxymethyl starch sodium, the abundant mix homogeneously of microcrystalline Cellulose, the aqueous solution that adds tween 80 is made soft material, oven dry after 40 mesh sieves are granulated, 40 mesh sieve granulate, add the Stepanol MG mixing, the control tablet weight, tabletting promptly gets dispersion tablets of telbivudine.
Embodiment 3. prescriptions: composition weight percent content
Sebivo 40%
Microcrystalline Cellulose 19%
Mannitol is an amount of
Low-substituted hydroxypropyl cellulose 7%
Polyvinylpyrrolidone aqueous solution an amount of (in polyvinylpyrrolidone)
Crospolyvinylpyrrolidone 5%
Magnesium stearate 1%
Preparation method: earlier above-mentioned material pulverize separately is crossed 100 mesh sieves.With Sebivo, microcrystalline Cellulose, mannitol, the abundant mix homogeneously of low-substituted hydroxypropyl cellulose, add an amount of polyvinylpyrrolidone aqueous solution and make soft material, oven dry after 20 mesh sieves are granulated, 20 mesh sieve granulate, add crospolyvinylpyrrolidone and magnesium stearate mixing, the control tablet weight, tabletting promptly gets dispersion tablets of telbivudine.This example is for adding in the disintegrating agent low-substituted hydroxypropyl cellulose and adding the crospolyvinylpyrrolidone use in conjunction, and in addition, microcrystalline Cellulose also plays the part effect of disintegrating agent.
Embodiment 4. prescriptions: composition weight percent content
Sebivo 15%
Lactose 35%
Microcrystalline Cellulose 35%
Carboxymethyl starch sodium 5%
Cetyl sulfo-sodium succinate 1.2%
A Siba is sweet an amount of
Vanillin is an amount of
Polyvinylpyrrolidone aqueous solution an amount of (in polyvinylpyrrolidone)
Magnesium stearate 1%
Preparation method: earlier above-mentioned material pulverize separately is crossed 100 mesh sieves.With Sebivo, lactose, microcrystalline Cellulose, carboxymethyl starch sodium, cetyl sulfo-sodium succinate, sweet, the abundant mix homogeneously of vanillin of A Siba, add an amount of polyvinylpyrrolidone aqueous solution and make soft material, oven dry after 20 mesh sieves are granulated, 20 mesh sieve granulate, add the magnesium stearate mixing, the control tablet weight, tabletting promptly gets the dispersion tablets of telbivudine with fragrant and sweet taste.
Embodiment 5.
The dispersible tablet of the foregoing description preparation, in temperature was 20 ℃ water, disintegration was all less than 150 seconds, even less than 80 seconds, and the granule after the disintegrate all can be all by No. 2 screen clothes.
Embodiment 6.
The dispersion tablets of telbivudine of getting in the embodiment of the invention to be provided gives the patient and orally uses, and is used for the treatment of hepatitis b virus infectedly, is particularly useful for blood HBVDNA tests positive and alanine aminotransferase ALT and detects the hepatitis B patient that is higher than normal value.
Claims (11)
1. a dispersible tablet drug dosage form is characterized in that containing Sebivo.
2. dispersible tablet according to claim 1 is characterized in that containing Sebivo and pharmaceutically suitable carrier of 2～60% by weight percentage.
3. dispersible tablet according to claim 1 is characterized in that containing Sebivo and pharmaceutically suitable carrier of 10～50% by weight percentage.
4. dispersible tablet according to claim 1 is characterized in that containing Sebivo and pharmaceutically suitable carrier of 20～40% by weight percentage.
5. according to the described dispersible tablet of claim 1 to 4, it is characterized in that pharmaceutically suitable carrier comprises one or more in disintegrating agent, filler, surfactant, wet adhesive, the lubricant.
6. according to claim 5, it is characterized in that at least a carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, microcrystalline Cellulose, the carboxymethylcellulose calcium of being selected from of disintegrating agent;
At least a microcrystalline Cellulose, sucrose, starch, lactose, dextrin, mannitol, sorbitol, pregelatinized Starch, xylitol, fructose, maltose alcohol, dextran, glucose, calcium sulfate, the calcium hydrogen phosphate of being selected from of filler;
Surfactant selects at least a from sodium lauryl sulphate, cetyl sulfo-sodium succinate, Tweens, spans, sodium dioctyl sulfosuccinate;
At least a water, ethanol, polyethylene pyrrole slightly alkane ketone, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, the various cellulose of being selected from of wet adhesive;
At least a magnesium stearate, calcium stearate, stearic acid, Pulvis Talci, silicon dioxide, micropowder silica gel, Polyethylene Glycol, the Stepanol MG of being selected from of lubricant.
7. a dispersion tablets of telbivudine is characterized in that every weight is 50～800mg, contains following composition by weight percentage:
--5～50% Sebivo,
--2～20% disintegrating agent, and at least a carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, microcrystalline Cellulose, the carboxymethylcellulose calcium of being selected from of disintegrating agent
--10～60% filler, and at least a microcrystalline Cellulose, sucrose, starch, lactose, dextrin, mannitol, sorbitol, pregelatinized Starch, xylitol, fructose, maltose alcohol, dextran, glucose, calcium sulfate, the calcium hydrogen phosphate of being selected from of filler.
8. a dispersion tablets of telbivudine is characterized in that every weight is 100～650mg, contains following composition by weight percentage:
--5～55% Sebivo,
--1～50% disintegrating agent, and at least a carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, microcrystalline Cellulose, the carboxymethylcellulose calcium of being selected from of disintegrating agent
--10～50% filler, and at least a microcrystalline Cellulose, sucrose, starch, lactose, dextrin, mannitol, sorbitol, pregelatinized Starch, xylitol, fructose, maltose alcohol, dextran, glucose, calcium sulfate, the calcium hydrogen phosphate of being selected from of filler.
9. the preparation method of any described dispersible tablet in the claim 1,2,3,4,7,8, it comprises:
(1) earlier medicine and pharmaceutic adjuvant are processed pulverizing respectively, make its fineness more than 80 orders, preferred 100 orders, 120 orders or 200 purpose grain size categories;
(2) Sebivo with recipe quantity mixes with filler, does not add or adds earlier partly or whole disintegrating agent;
(3) add wet adhesive and make soft material, make wet granular, drying, granulate adds all or residue part disintegrating agent, adds the lubricant mixing again, and tabletting promptly gets dispersion tablets of telbivudine.
10. preparation method according to claim 9, the adding mode that it is characterized in that disintegrating agent add, add in can being or inside and outsidely all add.
11. comprising, the method that treatment is hepatitis b virus infected, this method give any described dispersible tablet in the oral claim 1 of patient, 2,3,4,7,8.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610100935 CN1903183A (en) | 2006-07-28 | 2006-07-28 | Dispersion tablets of telbivudine and its prepn. method |
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| CN 200610100935 CN1903183A (en) | 2006-07-28 | 2006-07-28 | Dispersion tablets of telbivudine and its prepn. method |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103908465A (en) * | 2012-12-29 | 2014-07-09 | 安徽贝克生物制药有限公司 | Zidovudine-lamivudine tablet easy to dissolve out and preparation method thereof |
| CN104000793A (en) * | 2014-04-15 | 2014-08-27 | 孙文娟 | Telbivudine tablet and preparation method thereof |
| CN104644576A (en) * | 2013-11-23 | 2015-05-27 | 天津市汉康医药生物技术有限公司 | Telbivudine orally-disintegrating tablet and preparation method thereof |
| CN107550866A (en) * | 2016-06-30 | 2018-01-09 | 康普药业股份有限公司 | A kind of Sebivo preparation |
| CN108159010A (en) * | 2018-03-20 | 2018-06-15 | 李益香 | A kind of drug Sebivo preparation and its preparation process being used for anti-hepatitis virus |
| CN110680806A (en) * | 2018-07-04 | 2020-01-14 | 郑州泰丰制药有限公司 | Preparation method of telbivudine particles |
-
2006
- 2006-07-28 CN CN 200610100935 patent/CN1903183A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103908465A (en) * | 2012-12-29 | 2014-07-09 | 安徽贝克生物制药有限公司 | Zidovudine-lamivudine tablet easy to dissolve out and preparation method thereof |
| CN103908465B (en) * | 2012-12-29 | 2016-05-11 | 安徽贝克生物制药有限公司 | A kind of two husband's stators of neat Duola's rice that are easy to stripping and preparation method thereof |
| CN104644576A (en) * | 2013-11-23 | 2015-05-27 | 天津市汉康医药生物技术有限公司 | Telbivudine orally-disintegrating tablet and preparation method thereof |
| CN104000793A (en) * | 2014-04-15 | 2014-08-27 | 孙文娟 | Telbivudine tablet and preparation method thereof |
| CN107550866A (en) * | 2016-06-30 | 2018-01-09 | 康普药业股份有限公司 | A kind of Sebivo preparation |
| CN108159010A (en) * | 2018-03-20 | 2018-06-15 | 李益香 | A kind of drug Sebivo preparation and its preparation process being used for anti-hepatitis virus |
| CN110680806A (en) * | 2018-07-04 | 2020-01-14 | 郑州泰丰制药有限公司 | Preparation method of telbivudine particles |
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Application publication date: 20070131 |