CN1634103A - Clarithromycin orally disintegrating tablet - Google Patents
Clarithromycin orally disintegrating tablet Download PDFInfo
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- CN1634103A CN1634103A CN 200410079333 CN200410079333A CN1634103A CN 1634103 A CN1634103 A CN 1634103A CN 200410079333 CN200410079333 CN 200410079333 CN 200410079333 A CN200410079333 A CN 200410079333A CN 1634103 A CN1634103 A CN 1634103A
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- oral cavity
- clarithromycin
- disintegration tablet
- cavity disintegration
- sodium
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Abstract
Disclosed is a Clarithromycin oral disintegrating tablet and its preparation process, wherein the oral disintegrating tablet comprises clarithromycin and its medicinal salt of physiological effective dose and pharmaceutically acceptable carrying agent suitable for preparing orally disintegrating tablet, the pharmaceutically acceptable carrying agents suitable for preparing orally disintegrating tablet include macromolecular material, bulking agent, crumbling agent, effervescent agent, lubricating agent, flavoring agent and other pharmaceutically acceptable carrying agents suitable for preparing orally disintegrating tablet.
Description
Technical field:
The present invention relates to pharmaceutical, particularly clarithromycin oral cavity disintegration tablet 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.
Clarithromycin is a macrolide antibiotics, mainly acts on gram positive bacteria and part gram negative bacteria, legionella pneumophilia, Campylobacter, mycoplasma, chlamydia, anaerobe etc.The in-vitro antibacterial experiment all is better than erythromycin to the external activity of legionella pneumophilia, branhamella catarrhalis, the special bacterium of hemorrhage deteriorated blood Bath, streptococcus pyogenes, clostridium, mycoplasma pneumoniae, ureaplasma urealyticum and sand holes chlamydia etc., streptococcus pneumoniae, hemophilus influenza and Mycobacterium leprae are presented bactericidal action, and the Mycobacterium avium complex has the slowing down proliferation function in the pair cell.Toxoplasma gondii also there is the growth inhibited effect.Clarithromycin has in vivo that tissue distribution is wide, the high pharmacokinetic characteristics that significantly is better than erythromycin of blood drug level, and its antibacterial action in vivo obviously is better than erythromycin.In vivo test shows that clarithromycin is strong more than 7 times than erythromycin to the endogenous protective effect of infection of staphylococcus aureus mice; endogenous protective effect to micrococcus scarlatinae, Diplococcus pneumoniae infecting mouse is also strong 6～8 times than erythromycin respectively; vivo bacteria corrosion action to bloodthirsty hemophilus influenza is better than erythromycin significantly, is its 17 times.
The oral formulations of existing clarithromycin comprises tablet, capsule etc., all to use water delivery service, and, clarithromycin and pharmaceutical salts thereof have the bitterness of strong row and have GI irritation, the invention provides a kind of clarithromycin oral cavity disintegration tablet, 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 clarithromycin, has technically overcome bitter taste of drug, and disintegrate has rapidly improved bioavailability of medicament greatly in the oral cavity.
Clarithromycin oral cavity disintegration tablet of the present invention is made up of active component clarithromycin and auxiliary element.Every contains active component 0.025-0.1g, 0.05g (in clarithromycin) preferably, 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 clarithromycin, 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:
Clamycin 2 0-30%
Macromolecular material 1-15%
Filler 30-60%
Disintegrating agent 2-15%
Effervescent 2-10%
Correctives 0.5-10%
Lubricant 0.1-3%
Wherein macromolecular material is used to wrap up clarithromycin, to cover bitterness, described macromolecular material is selected from: gelatin, acrylic resin, ethyl cellulose, and 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 the about 0.05g of active component (in clarithromycin)
Clarithromycin 50g
Acrylic resin IV 5g
Mannitol 72g
Microcrystalline Cellulose 45g
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 is clarithromycin to be rolled into micron-sized granule with macromolecular material further make oral cavity disintegration tablet again, the oral cavity disintegration tablet that this clarithromycin wraps up with macromolecular material, it consists of: the micron-sized granule that clarithromycin is rolled into natural or synthetic macromolecular material is as active part, the preferred filler of the present invention, disintegrating agent, effervescent, lubricant, correctives in addition, its method for making of micron-sized granule that macromolecular material is rolled into is as follows:
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.
Clarithromycin 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 clarithromycin 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.
The specific embodiment:
By the following examples, the invention will be further described.
Embodiment 1:
Prescription:
Clarithromycin 50g
Mannitol 64g
Microcrystalline Cellulose 56g
Crospolyvinylpyrrolidone 14g
Sodium bicarbonate 5g
Citric acid 6g
Magnesium stearate 2g
Aspartame 1g
Flavoring orange essence 2g
Make 1000 altogether
Preparation method: after clarithromycin, aspartame, flavoring orange essence and mannitol crossed 80 mesh sieves respectively, mix homogeneously.Take by weighing microcrystalline Cellulose, crospolyvinylpyrrolidone, sodium bicarbonate, citric acid, magnesium stearate by recipe quantity again and cross 80 mesh sieves, mix homogeneously respectively.Two kinds of powder mixes are sieved, make its mix homogeneously, promptly with suitable pressure tabletting.The oral cavity disintegration tablet smooth in appearance that makes is glossy, disintegrate disintegrate rapidly in 30s rapidly, and slice, thin piece hardness test 2.5～3.0kg, stripping quantity is 90.72% in the inherent 37 ℃ of water of dissolution test 30min.
Embodiment 2:
It is as follows to write out a prescription:
Clarithromycin 50g
Mannitol 70g
Microcrystalline Cellulose 45g
Low-replacement hydroxypropyl cellulose 5g
Crospolyvinylpyrrolidone 10g
Sodium bicarbonate 6g
Citric acid 8g
Micropowder silica gel 1g
Magnesium stearate 2g
Aspartame 1g
Herba Menthae essence 2g
Make 1000 altogether
Preparation method: take by weighing after recipe quantity clarithromycin, aspartame, Herba Menthae essence crosses 80 mesh sieves respectively mix homogeneously.Respectively other adjuvant is crossed mixing behind 80 mesh sieves again.The drug powder and the adjuvant powder mixing that will contain clarithromycin sieve, with suitable pressure tabletting promptly.The oral cavity disintegration tablet smooth in appearance that makes is glossy, disintegrate disintegrate in 24s rapidly, and slice, thin piece hardness 2.5～3.0kg, dissolution test 30min stripping quantity in 37 ℃ of aqueous mediums is 92.34%.
Embodiment 3:
It is as follows to write out a prescription:
Clarithromycin 50g
Mannitol 30g
Microcrystalline Cellulose 72g
Crospolyvinylpyrrolidone 8g
Sodium bicarbonate 10g
Citric acid 10g
Gelatin 15g
Magnesium stearate 2g
Aspartame 3g
Prepare 1000 altogether
Preparation method: clarithromycin and gelatin, mannitol and aspartame are crossed 60 mesh sieves respectively, gelatin is dissolved in an amount of distilled water, heating makes its dissolving.Under agitation clarithromycin, mannitol and aspartame are added, put 70～80 ℃ of stirring evaporates to dryness in the water-bath, crushing screening.After other adjuvant crossed 80 mesh sieves respectively, mix.The drug powder and the adjuvant powder mix homogeneously that will contain clarithromycin.With suitable pressure direct compression promptly.The oral cavity disintegration tablet disintegrate that makes disintegrate rapidly in 45s rapidly.Slice, thin piece hardness is at 2.5～3.0kg, and dissolution test 30min stripping quantity in 37 ℃ of water is 88.79%.
Embodiment 4:
1. the preparation of microcapsule
Take by weighing gelatin 8g and add 160ml distilled water immersion swelling, melt into rubber cement in 70 ℃ of water-baths is dissolved in clarithromycin 50g in the gelatin solution and stirs.Acetum 50 ℃ of addings 10% is regulated PH to 3.5～3.8, slowly adds 20% Na under middling speed stirs
2SO
4(20ml) 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 (30ml) below 15 ℃ capsule is solidified.Leave standstill, sucking filtration is put the vacuum drying oven drying in 55 ℃, promptly gets microcapsule.
Clarithromycin microcapsule 58g
Mannitol 43g
Microcrystalline Cellulose 66g
Low-replacement hydroxypropyl cellulose 12g
Sodium bicarbonate 8g
Citric acid 8g
Micropowder silica gel 1g
Magnesium stearate 2g
Aspartame 2g
Make 1000 altogether
2. tabletting is crossed 60 mesh sieves with the clarithromycin microcapsule that is wrapped.After mannitol, aspartame crossed 80 mesh sieves respectively, with clarithromycin microcapsule mix homogeneously.With other microcrystalline cellulose excipients, low-as to replace hydroxypropyl cellulose, sodium bicarbonate, citric acid, magnesium stearate to cross 80 mesh sieves respectively, with the mannitol that contains the clarithromycin microcapsule, aspartame powder mixes, sieve, promptly again with suitable pressure tabletting.The clarithromycin oral cavity disintegration tablet smooth in appearance that makes is glossy, good mouthfeel, and slice, thin piece hardness is 2.5～3.0kg, disintegrate is rapid, all disintegrates in 50s.Dissolution test, 30min stripping quantity in 37 ℃ of water is 84.31%
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.1000 tablet recipes are as follows:
Clarithromycin 50g
Acrylic resin IV 5g
Mannitol 72g
Microcrystalline Cellulose 45g
Low-replacement hydroxypropyl cellulose 5g
Crospolyvinylpyrrolidone 10g
Sodium bicarbonate 4g
Citric acid 5g
Aspartame 2g
Magnesium stearate 1g
Micropowder silica gel 1g
Preparation method: the clarithromycin microcapsule that is wrapped is sieved.With mannitol, aspartame, citric acid, respectively cross 80 mesh sieves after, with aspirin microcapsule mix homogeneously.Again with other microcrystalline cellulose excipients, low-as to replace hydroxypropyl cellulose, crospolyvinylpyrrolidone, sodium bicarbonate, magnesium stearate, micropowder silica gel to cross 80 mesh sieves respectively, with the mannitol that contains the clarithromycin microcapsule, aspartame, citric acid powder mixes, sieve, promptly with suitable pressure tabletting.The low-dosage aspirin oral cavity disintegration tablet smooth in appearance that makes is glossy, good mouthfeel, and slice, thin piece hardness is 2.5～3.0kg, disintegrate is rapid, all disintegrates in 45s.Dissolution test, 30min stripping quantity in 37 ℃ of water is 85.22%.
Claims (9)
1, a kind of oral cavity disintegration tablet of clarithromycin is characterized in that, by the clarithromycin of physiology effective dose 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:
Clamycin 2 0-30%
Macromolecular material 1-15%
Filler 30-70%
Disintegrating agent 2-15%
Effervescent 2-10%
Correctives 0.5-10%
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,
Clarithromycin 50g
Acrylic resin 5g
Mannitol 72g
Microcrystalline Cellulose 45g
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,
Clarithromycin 50g
Gelatin 8g
Mannitol 43g
Microcrystalline Cellulose 66g
Low-replacement hydroxypropyl cellulose 12g
Sodium bicarbonate 8g
Citric acid 8g
Micropowder silica gel 1g
Magnesium stearate 2g
Aspartame 2g
8, 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.
9, the preparation method of claim 8, 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 200410079333 CN1634103A (en) | 2004-10-01 | 2004-10-01 | Clarithromycin orally disintegrating tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410079333 CN1634103A (en) | 2004-10-01 | 2004-10-01 | Clarithromycin orally disintegrating tablet |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1634103A true CN1634103A (en) | 2005-07-06 |
Family
ID=34847102
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410079333 Pending CN1634103A (en) | 2004-10-01 | 2004-10-01 | Clarithromycin orally disintegrating tablet |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1634103A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114948886A (en) * | 2022-06-16 | 2022-08-30 | 南京正科医药股份有限公司 | Tadalafil orally disintegrating tablet and preparation method thereof |
-
2004
- 2004-10-01 CN CN 200410079333 patent/CN1634103A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114948886A (en) * | 2022-06-16 | 2022-08-30 | 南京正科医药股份有限公司 | Tadalafil orally disintegrating tablet and preparation method thereof |
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| WD01 | Invention patent application deemed withdrawn after publication |