CN1634073A - Orally disintegrating tablet of levofloxacin and its pharmaceutical salt - Google Patents
Orally disintegrating tablet of levofloxacin and its pharmaceutical salt Download PDFInfo
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- CN1634073A CN1634073A CN 200410079331 CN200410079331A CN1634073A CN 1634073 A CN1634073 A CN 1634073A CN 200410079331 CN200410079331 CN 200410079331 CN 200410079331 A CN200410079331 A CN 200410079331A CN 1634073 A CN1634073 A CN 1634073A
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- levofloxacin
- oral cavity
- disintegration tablet
- cavity disintegration
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Abstract
The invention relates to an orally disintegrating tablet of levofloxacin and its pharmaceutical salt which comprises physiologically effective amount of Levofloxacin or its medicinal salts and / or pharmaceutically acceptable carriers suitable for preparing orally disintegrating tablet, wherein the pharmaceutically acceptable carriers suitable for preparing orally disintegrating tablet include macromolecular material, bulking agent, crumbling agent, effervescent agent, lubricating agent, flavoring agent and other pharmaceutically acceptable carriers suitable for preparing orally disintegrating tablets.
Description
Technical field:
The present invention relates to field of medicaments, be particularly related to levofloxacin and biological or pharmaceutically acceptable be the pharmaceutical salts of active component with the levofloxacin, comprise oral cavity disintegration tablet of levofloxacin hydrochloride, levofloxacin lactate, Levofloxacin M. S. A and preparation method thereof.When the patient took this medicine, water or only need to take medicine with low amounts of water not need not to chew, and disintegrate in 5 seconds to 60 seconds in the oral cavity is borrowed and swallowed power, and medicine is gone into the stomach onset.
Background technology:
Oral cavity disintegration tablet is a kind of new pharmaceutical dosage forms, English " Orally disintegratingtables " by name.U.S. FDA has been ratified this dosage form listing, and reason is: make things convenient for part crowd medication, as the patient's medication under old man, child, dysphagia or the special environment.
Oral cavity disintegration tablet definition: be that a kind of water that do not need in the oral cavity can disintegrate or dissolved tablet.Specification requirement: 1. should be in the oral cavity rapidly disintegrate, no grittiness, good mouthfeel, swallow easily, to the oral mucosa nonirritant.Should stipulate under the character item in the quality standard: disintegrate rapidly, no grittiness, good mouthfeel in the oral cavity; 2. set up suitable disintegration time mensuration method and limit, and be incorporated into standard; 3. to insoluble medicine, should set up suitable dissolution determination method and limit; 4. other should meet general rule requirement under the tablet item.
The characteristics of oral cavity disintegration tablet: 1. absorption is fast, bioavailability is high; 2. instructions of taking does not need water 3. intestinal is residual few, few side effects; 4. avoid the first pass effect of liver sausage.
Levofloxacin or its pharmaceutical salts are quinolione class antibiotic, and its antibacterial activity is about 2～8 times of ofloxacin.Has has a broad antifungal spectrum, the characteristics that antibacterial action is strong, to most of enterobacteriaceae lactobacteriaceaes, as escherichia coli, Klebsiella, Serratia, Proteus, Shigella, Salmonella, citrobacter, acinetobacter and Pseudomonas aeruginosa, hemophilus influenza, gram-negative bacterias such as gonococcus have stronger antibacterial activity, for example levofloxacin hydrochloride is very responsive to clinical isolating Bacillus typhi and dysentery bacterium, levofloxacin lactate is to having shown very strong antibacterial activity to Shigella in the gram negative bacteria, very responsive to Salmonella, to part methicillin-sensitivity staphylococcus, streptococcus pneumoniae, micrococcus scarlatinae, gram positive bacteria and legionella such as Hemolytic streptococcus, mycoplasma, chlamydia etc. also have good antibacterial action, but relatively poor to anaerobe and enterococcal effect.It mainly acts on the A subunit of bacterial cell DNA helicase, suppresses the synthetic of DNA and duplicates and cause antibacterial death.
The oral formulations of existing levofloxacin and pharmaceutical salts thereof comprises tablet, capsule etc., all to use water delivery service, and, levofloxacin and pharmaceutical salts thereof have the bitterness of strong row and have GI irritation, the invention provides a kind of levofloxacin and pharmaceutical salts oral cavity disintegration tablet thereof, this tablet get by direct compression, and advantage is patient when taking this medicine, not water or only need take medicine with low amounts of water, need not to chew, disintegrate in 5 seconds to 60 seconds in the oral cavity is borrowed and is swallowed power, and medicine is gone into the stomach onset, no bitterness, nonirritant is treated patient timely and effectively, saves trouble.
Summary of the invention:
The present invention makes oral cavity disintegration tablet with levofloxacin, levofloxacin hydrochloride, levofloxacin lactate and Levofloxacin M. S. A, has technically overcome bitter taste of drug, and disintegrate has rapidly improved bioavailability of medicament greatly in the oral cavity.
Levofloxacin oral cavity disintegration tablet of the present invention by active component levofloxacin or its pharmaceutical salts as: levofloxacin hydrochloride, levofloxacin lactate, Levofloxacin M. S. A and auxiliary element are formed.Every contains active component 0.05-0.2g, is preferably 0.1g (in levofloxacin), and all the other are auxiliary element.Auxiliary element is the medicine acceptable carrier that is fit to make oral cavity disintegration tablet, mainly comprises macromolecular material, filler, disintegrating agent, effervescent, lubricant, correctives etc.Feature of the present invention also is to adopt packaging technique and preconditioning technique to prepare the microcapsule of levofloxacin, and then makes oral cavity disintegration tablet.
Oral cavity disintegration tablet require disintegrate rapidly, no husky large sense, good mouthfeel, swallow easily, to the oral mucosa nonirritant, so having relatively high expectations adjuvant.Adjuvant commonly used has: acrylic resin, ethyl cellulose, gelatin, cellulose, acrylate copolymer, ethylene copolymer, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, carboxymethyl starch sodium, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, handle agar, citric acid, sodium bicarbonate, mannitol, Camphora, lactose, erythrol, maltose alcohol, saccharin sodium, protein sugar, sucrose, Mentholum, aspartame, xylitol, mannitol, protein sugar, stevioside, sucrose, sorbitol, vitamin C, sodium sulfite, sodium sulfite, pyrosulfite, sodium thiosulfate, different VC, thiourea, cysteine, methionine, thiacetic acid., thioglycerol, butylated hydroxyarisol, two fourth cresols, PG, tocopherol, lecithin, sodium lauryl sulphate, Pulvis Talci, magnesium stearate, micropowder silica gel, Opadry
II, ethanol, water, gelatin, aspartame, Fructus Citri tangerinae essence, adjuvants such as Herba Menthae essence.
Select adjuvant significant to oral cavity disintegration tablet, preferred adjuvant can make disintegrate rapidly, no husky large sense, good mouthfeel, swallow easily, to the oral mucosa nonirritant, the present invention selects adjuvant, serves as preferred with microcrystalline Cellulose (MCC), mannitol, crospolyvinylpyrrolidone (PVPP), low-substituted hydroxypropyl cellulose (L-HPC), citric acid, sodium bicarbonate, magnesium stearate, micropowder silica gel, gelatin, acrylic resin, aspartame, flavoring orange essence, Herba Menthae essence.
Oral cavity disintegration tablet of the present invention preferably consists of:
Levofloxacin or its pharmaceutical salts 20-50%
Macromolecular material 1-10%
Filler 30-70%
Disintegrating agent 2-15%
Effervescent 2-10%
Correctives 0.5-15%
Lubricant 0.1-3%
Wherein macromolecular material is used to wrap up levofloxacin or its pharmaceutical salts, to cover bitterness, described macromolecular material is selected from: gelatin, acrylic resin, ethyl cellulose, filler is selected from: microcrystalline Cellulose, lactose, mannitol, disintegrating agent is selected from: low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, carboxymethyl starch sodium, effervescent is selected from: citric acid, sodium bicarbonate, correctives are selected from, aspartame, Fructus Citri tangerinae essence, Herba Menthae essence, and lubricant is selected from: magnesium stearate, micropowder silica gel.
Particularly preferred prescription consists of: be made up of following prescription for 1000, every contains active component and is about 0.1g (in levofloxacin)
Levofloxacin M. S. A 128g
Acrylic resin 12.8g
Mannitol 71.2g
Microcrystalline Cellulose 60g
Low-replacement hydroxypropyl cellulose 5g
Crospolyvinylpyrrolidone 10g
Sodium bicarbonate 4g
Citric acid 5g
Aspartame 2g
Magnesium stearate 1g
Micropowder silica gel 1g
More than Pei Fang oral cavity disintegration tablet be with levofloxacin or its pharmaceutical salts as: levofloxacin hydrochloride, levofloxacin lactate or Levofloxacin M. S. A are rolled into micron-sized granule with macromolecular material and further make oral cavity disintegration tablet again, the oral cavity disintegration tablet that this levofloxacin wraps up with macromolecular material, it consists of: the micron-sized granule that levofloxacin or its pharmaceutical salts are rolled into natural or synthetic macromolecular material is as active part, in addition the preferred filler of the present invention, disintegrating agent, effervescent, lubricant, correctives.
The micron-sized granule method for making that macromolecular material is rolled into is seen Fig. 1:
Wherein to join method as follows for [1] diluent: diluent is Na
2SO
4Solution, its concentration is by the Na in the cohesion bag system
2SO
4Concentration (as being a%) adds 1.5%[and gets (a+1.5) %], the diluent volume is 3 times of cohesion bag system cumulative volume, the diluent temperature is 15 ℃.Used diluent excessive concentration or low excessively can make the agglomerating or dissolving of cohesion capsular adhesion.
Also can adopt fluidized bed coating, medicine is rolled into microcapsule, preparation method as following microcapsule: IV150g is dissolved in 95% ethanol with macromolecule coating material acrylic resin, by fluid bed above-mentioned solution slowly is sprayed on medicine (1500g) surface, and medicine is wrapped up.Make microcapsule.
The microcapsule that above method makes with can make oral cavity disintegration tablet of the present invention by direct compression process after other adjuvant mixes.
Oral cavity disintegration tablet of the present invention, employing be the technical method preparation of pharmaceutics routine, as using direct compression process, wet method system granule is pressed disc method again.
Levofloxacin oral cavity disintegration tablet of the present invention, especially the oral cavity disintegration tablet that particularly preferred prescription is formed is compared with existing dosage form has plurality of advantages: when the patient takes this medicine, water or only need to take medicine not with low amounts of water, need not to chew, disintegrate in 5 seconds to 60 seconds in the oral cavity, borrow and swallow power, medicine is gone into the stomach onset.Take medicine and save trouble, save the trouble with the water delivery service medicine, treatment in time, and is effective; Make things convenient for part crowd medication, as the patient's medication under old man, child, dysphagia or the special environment.For the particularly preferred levofloxacin oral cavity disintegration tablet of the present invention, also have the following advantages especially: disintegrate is rapid, no grittiness, and no bitterness, good mouthfeel absorbs rapidly nonirritant, bioavailability height.
Description of drawings:
The micron-sized granule preparation flow chart that Fig. 1 is rolled into for macromolecular material.
The specific embodiment:
By the following examples, the invention will be further described.
Embodiment 1:
Adopt direct powder compression to prepare oral cavity disintegration tablet, it is as follows to write out a prescription:
Levofloxacin hydrochloride 112
Lactose 30g
Mannitol 53g
Microcrystalline Cellulose 80g
Low-replacement hydroxypropyl cellulose 20g
Magnesium stearate 1g
Micropowder silica gel 1g
Aspartame 1g
Fructus Citri tangerinae essence 2g
Said medicine and adjuvant crossed respectively mix direct compression behind 80 mesh sieves and promptly get 1000.The oral cavity disintegration tablet smooth in appearance that this prescription makes be disintegratable in the rapid 10s of disintegrate, but mouthfeel is general.
Embodiment 2:
Adopt the direct compression method to prepare oral cavity disintegration tablet.Disintegrating agent is selected microcrystalline Cellulose, low-replacement hydroxypropyl cellulose and crospolyvinylpyrrolidone.The proportioning of microcrystalline Cellulose/low-replacement hydroxypropyl cellulose/crospolyvinylpyrrolidone is: 9: 1: 2, correctives was selected aspartame and Herba Menthae essence.
Method is as follows:
With Levofloxacin M. S. A 128g, mannitol 83g, microcrystalline Cellulose 45g, low-replacement hydroxypropyl cellulose 5g, crospolyvinylpyrrolidone 10g, sodium bicarbonate 10g, citric acid 12g, aspartame 3g, Herba Menthae essence 2g, magnesium stearate 2g.Medicine and adjuvant mixing direct compression are promptly got 1000.The oral cavity disintegration tablet that makes, the rapid disintegrate of 30s does not have husky large sense, no bitterness.
Embodiment 3:
Disintegrating agent is selected microcrystalline Cellulose and crospolyvinylpyrrolidone for use, and proportioning is 9: 1; With gelatin, mannitol and aspartame is correctives, and the proportioning of gelatin/mannitol/Aspartane is 0.5: 1: 0.1.With sodium bicarbonate and citric acid is effervescent.It is as follows to write out a prescription:
Dlactic acid levofloxacin 125g
Mannitol 37g
Microcrystalline Cellulose 90g
Crospolyvinylpyrrolidone 10g
Sodium bicarbonate 8g
Citric acid 10g
Gelatin 15g
Magnesium stearate 2g
Aspartame 3g
Preparation method: medicine and gelatin, mannitol (3g) and aspartame are crossed 60 mesh sieves respectively, gelatin is dissolved in an amount of distilled water, heating makes its dissolving.Under agitation medicine, mannitol (3g) and aspartame are added, put 70～80 ℃ of stirring evaporates to dryness in the water-bath, crushing screening.Promptly get 1000 with other adjuvant mixing direct compression.The oral cavity disintegration tablet smooth in appearance that makes, glossy; Disintegrate is rapid, does not have husky large sense, and mouthfeel is general.
Embodiment 4:
Adopt method for pretreating, promptly use natural or synthetic high molecular polymer (gelatin, cellulose, acrylate copolymer or ethylene copolymer etc.) that medicine is rolled into the micron order granule, to improve the disagreeable taste of medicine.This test adopts single coacervation with gelatin medicine to be wrapped up.Concrete grammar is as follows:
Take by weighing in the gelatin 20g adding 300ml distilled water and soak swelling, melt into rubber cement in 70 ℃ of water-baths is dissolved in levofloxacin hydrochloride 112g in the gelatin solution, stirs.Acetum 50 ℃ of addings 10% is regulated PH to 3.5～3.8, slowly adds 20% Na under middling speed stirs
2SO
4(160ml) make the capsule cohesion.Add the diluent (the diluent temperature is 15 ℃) of 3 times of amounts, make the capsule sedimentation.NaOH with 20% regulates PH to 8～9, in adding 37% formalin (50ml) below 15 ℃ capsule is solidified.Leave standstill, sucking filtration is put the vacuum drying oven drying in 55 ℃, promptly gets microcapsule.
Add mannitol 48g then, microcrystalline Cellulose (MCC) 80g, crospolyvinylpyrrolidone (PVPP) 20g, citric acid 8g, sodium bicarbonate 6g, aspartame 2g, Fructus Citri tangerinae essence 2g, magnesium stearate 2g, direct compression promptly get 1000.
According to the oral cavity disintegration tablet that this prescription makes, disintegrate is rapid, does not have husky large sense, no bitterness.
Embodiment 5:
Adopt fluidized bed coating, medicine is rolled into direct compression behind the microcapsule.
1. the preparation of microcapsule
IV150g is dissolved in 95% ethanol with macromolecule coating material acrylic resin, by fluid bed above-mentioned solution slowly is sprayed on medicine (1500g) surface, and medicine is wrapped up.Make microcapsule.
2. the microcapsule and other adjuvant mixing direct compression that make of tabletting.It is as follows to write out a prescription:
Levofloxacin M. S. A 128g
Acrylic resin 12.8g
Mannitol 71.2g
Microcrystalline Cellulose 60g
Low-replacement hydroxypropyl cellulose 5g
Crospolyvinylpyrrolidone 10g
Sodium bicarbonate 4g
Citric acid 5g
Aspartame 2g
Magnesium stearate 1g
Micropowder silica gel 1g
By the oral cavity disintegration tablet that this method makes, smooth in appearance, rapid at intraoral disintegration, disintegrate rapidly in the 40s.No husky large sense, non-stimulated in mouthful to oral mucosa, good mouthfeel.
Claims (10)
1, the oral cavity disintegration tablet of a kind of levofloxacin or its pharmaceutical salts is characterized in that, by the levofloxacin of physiology effective dose or its pharmaceutical salts and the medicine acceptable carrier that is fit to make oral cavity disintegration tablet form.
2, the oral cavity disintegration tablet of claim 1 is characterized in that, the described medicine acceptable carrier that is fit to make oral cavity disintegration tablet is macromolecular material, filler, disintegrating agent, effervescent, lubricant and correctives.
3, the oral cavity disintegration tablet of claim 2 is characterized in that, described medicine acceptable carrier is selected from: gelatin, acrylic resin, ethyl cellulose, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, carboxymethyl starch sodium, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, handle agar, citric acid, sodium bicarbonate, mannitol, Camphora, lactose, erythrol, maltose alcohol, saccharin sodium, protein sugar, sucrose, Mentholum, aspartame, xylitol, mannitol, protein sugar, stevioside, sucrose, sorbitol, vitamin C, sodium sulfite, sodium sulfite, pyrosulfite, sodium thiosulfate, different VC, thiourea, cysteine, methionine, thiacetic acid., thioglycerol, butylated hydroxyarisol, two fourth cresols, PG, tocopherol, lecithin, sodium lauryl sulphate, Pulvis Talci, magnesium stearate, micropowder silica gel, Opadry
II, ethanol, water, aspartame, Fructus Citri tangerinae essence, Herba Menthae essence.
4, the oral cavity disintegration tablet of claim 2 is characterized in that, it consists of:
Levofloxacin or its pharmaceutical salts 20-50%
Macromolecular material 1-10%
Filler 30-70%
Disintegrating agent 2-15%
Effervescent 2-10%
Correctives 0.5-15%
Lubricant 0.1-3%
5, the oral cavity disintegration tablet of claim 4, it is characterized in that described macromolecular material is selected from: gelatin, acrylic resin, ethyl cellulose, filler is selected from: microcrystalline Cellulose, lactose, mannitol, disintegrating agent is selected from: low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, carboxymethyl starch sodium, effervescent is selected from: citric acid, sodium bicarbonate, correctives are selected from aspartame, Fructus Citri tangerinae essence, Herba Menthae essence, and lubricant is selected from: magnesium stearate, micropowder silica gel.
6, the oral cavity disintegration tablet of claim 4 is characterized in that, form by following prescription for 1000,
Levofloxacin M. S. A 128g
Acrylic resin 12.8g
Mannitol 71.2g
Microcrystalline Cellulose 60g
Low-replacement hydroxypropyl cellulose 5g
Crospolyvinylpyrrolidone 10g
Sodium bicarbonate 4g
Citric acid 5g
Aspartame 2g
Magnesium stearate 1g
Micropowder silica gel 1g
7, the oral cavity disintegration tablet of claim 4 is characterized in that, form by following prescription for 1000,
Levofloxacin hydrochloride 112g
Gelatin 20g
Mannitol 48g
Microcrystalline Cellulose 80g
Crospolyvinylpyrrolidone 20g
Citric acid 8g
Sodium bicarbonate 6g
Aspartame 2g
Fructus Citri tangerinae essence 2g
Magnesium stearate 2g
8, the oral cavity disintegration tablet of claim 4 is characterized in that, the pharmaceutical salts of described levofloxacin is selected from: levofloxacin hydrochloride, levofloxacin lactate, Levofloxacin M. S. A.
9, the preparation method of the oral cavity disintegration tablet of claim 4 is characterized in that, medicine is rolled into microcapsule with macromolecular material, microcapsule and filler, disintegrating agent, effervescent, correctives, mix lubricant, tabletting.
10, the preparation method of claim 9, it is characterized in that the preparation process following steps of microcapsule: IV150g is dissolved in 95% ethanol with macromolecule coating material acrylic resin, by fluid bed above-mentioned solution slowly is sprayed on the 1500g medical surfaces, with the medicine parcel, make microcapsule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410079331 CN1634073A (en) | 2004-10-01 | 2004-10-01 | Orally disintegrating tablet of levofloxacin and its pharmaceutical salt |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410079331 CN1634073A (en) | 2004-10-01 | 2004-10-01 | Orally disintegrating tablet of levofloxacin and its pharmaceutical salt |
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| CN1634073A true CN1634073A (en) | 2005-07-06 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410079331 Pending CN1634073A (en) | 2004-10-01 | 2004-10-01 | Orally disintegrating tablet of levofloxacin and its pharmaceutical salt |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102784121A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Levofloxacin composition freeze-dried orally disintegrating tablets and preparation method thereof |
| CN104825411A (en) * | 2015-06-08 | 2015-08-12 | 孙莉新 | Levofloxacin mesylate orally disintegrating tablet and preparation method thereof |
| CN108567761A (en) * | 2018-07-25 | 2018-09-25 | 江苏黄河药业股份有限公司 | A kind of Levofloxacin Hydrochloride Capsules and preparation method thereof |
| WO2020255837A1 (en) * | 2019-06-17 | 2020-12-24 | 東和薬品株式会社 | Timed-elution masking particles and oral pharmaceutical composition containing same |
-
2004
- 2004-10-01 CN CN 200410079331 patent/CN1634073A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102784121A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Levofloxacin composition freeze-dried orally disintegrating tablets and preparation method thereof |
| CN104825411A (en) * | 2015-06-08 | 2015-08-12 | 孙莉新 | Levofloxacin mesylate orally disintegrating tablet and preparation method thereof |
| CN108567761A (en) * | 2018-07-25 | 2018-09-25 | 江苏黄河药业股份有限公司 | A kind of Levofloxacin Hydrochloride Capsules and preparation method thereof |
| WO2020255837A1 (en) * | 2019-06-17 | 2020-12-24 | 東和薬品株式会社 | Timed-elution masking particles and oral pharmaceutical composition containing same |
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