CN1506043A - Quickly disintegrating tablet containing cadotril - Google Patents
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- CN1506043A CN1506043A CNA021280061A CN02128006A CN1506043A CN 1506043 A CN1506043 A CN 1506043A CN A021280061 A CNA021280061 A CN A021280061A CN 02128006 A CN02128006 A CN 02128006A CN 1506043 A CN1506043 A CN 1506043A
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Abstract
The present invention belongs to the field of pharmaceutical technology, and is one kind fast disintegrating tablet with active component cadotril. The tablet features its fast disintegrating in one minute after contacting saliva in oral cavity. It is prepared with active component cadotril as active component, disintegrating agent, stuffing, corrective, lubricant, adhesive and coloring agent and through mixing and tabletting. It has the features of fast disintegrating, convenient use and high leaching rate. The preparation has excipient mixture in 10-100 times the weight of the active component, disintegrating agent in 1-20 % of tablet weight and cosolvent in 0-20 % of tablet weight.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of rapid disintegration tablet that contains the active component cadotril.More properly say, the rapid disintegration tablet that the present invention relates to be a kind of can disintegrate fast in the oral cavity contacts saliva 1 minute, need not swallow, onset is rapid, is suitable for the treatment diarrheal oral drug preparation of pediatric pharmaceuticals.
Background technology
Oral cavity quickly disintegrating tablet (orally fast-disintegrating tablet, or orally rapidly-disintegrating tablet) is a kind of new pharmaceutical preparation of rising both at home and abroad over past ten years, and its main feature is: (1) taking convenience.The oral cavity rapid disintegration tablet can not need water, but only just administration under the effect of a small amount of saliva still can be swallowed or takes after disperseing as dispersible tablet disintegrate in water again in addition as conventional tablet.(2) disintegrate is rapid, and is rapid-action.In general, the oral cavity rapid disintegration tablet contacts in the oral cavity after the saliva should disintegrate in 1 minute, should disintegrate in 30 seconds in 37 ℃ of water of external slaking test instrument.After the disintegrate, absorption has been accelerated in medicine stripping promptly or be dispersed into granule, makes onset rapid.(3) bioavailability height.Because medicine promptly begins stripping in the oral cavity, and speed is very fast, thereby makes medicine in the systemic time lengthening of whole digestive tract, absorbtivity increases, the bioavailability height.This kind dosage form is particularly useful for: the inconvenient patient of (1) swallow tablet and capsule.About according to estimates 5% common this difficulty arranged per capita, do not cause therapeutic effect good or compliance is bad, especially child and elderly patients.The digestive tract disease patient causes and can't swallow or swallowing act causes serious vomiting reaction in addition.This dosage form also is applicable to the bed patient or work busy personage or traveller, especially when can't obtaining water.(2) in the time of need making the rapid onset of medicine.Some disease such as cardiovascular disease, asthma, allergy, pain etc. all require quick administration.Traditional dosage form such as conventional tablet or capsule or Sublingual tablet etc., producing drug effect all needs the above time of a few minutes, and patient symptom is removed timely because of can not get, and usually will bear affliction, sometimes even serious consequence can occur.The oral cavity rapid disintegration tablet promptly begins release in the oral cavity, medicine through port buccal mucosa can absorb, thereby onset time is shortened.
The preparation of oral cavity quick disintegrating slice mainly contains two kinds of methods: freeze-drying and pressing.It is that active constituents of medicine and various adjuvant or additive are made solution or suspension that freeze-drying prepares oral rapidly disintegrating chip technology (Zydis), inject the mould of definite shape, be frozen into solid rapidly, decompression makes water sublimed again, thereby form the tablet with loose structure, this kind tablet configuration is loose, interior rich small spaces, the dissolving that can absorb water rapidly generally can reach in 10 seconds in intraoral disintegration time.The drug main that adopts this technology to make the oral cavity rapid disintegration tablet will comprise: (J Pharm Pharmacol such as oxazepam, lorazepam, piroxicam, loperamide, famotidine, loratadine, enalapril, phenylpropanolamine/brompheniramine, ondansetron, Lizakuputan benzoate (RizatriptanBenzoate), domperidone, nitroglycerin, isosorbidi dinitras, nifedipine, difenidol hydrochloride, meclozine hydrochloride, 1998,50:375; PLA's Acta Pharmaceutica Sinica, 2000,16:206).With respect to Freeze Drying Technique, the oral cavity quick disintegrating slice porosity of pressing preparation is little, and disintegrate is slow slightly.But because freeze-drying needs special freeze drying equipment, complex process, the cost height produce the certain difficulty of existence in batches, and the tablet mechanical strength that makes is relatively poor, so pressing also is popular.The medicine that adopts pressing to make oral cavity quick disintegrating slice mainly contains Zolmitriptan (zomitriptan), that Puli of rice, baclofen, carbidopa/levodopa, carisoprodol (carisprodol) etc.The disintegration time of the quickly disintegrating tablet of pressing preparation depends mainly on selected disintegrating agent.Now normal adopt cross-linked carboxymethyl cellulose sodium with good disintegrating property, polyvinylpolypyrrolidone etc. (foreign medical science pharmacy fascicle, 1998,25:293).The consumption of filler and disintegrating agent has material impact to its disintegration time, the consumption of disintegrating agent reach as high as sheet heavy more than 15%.Filler is used lactose, mannitol, microcrystalline Cellulose etc. always.Medicine with bitterness can adopt the powder coating method earlier medicine to be hidden flavor, and repress is made oral cavity quick disintegrating slice (application for a patent for invention prospectus, publication number CNl328446A).
Cadotril (cadotril) is treatment diarrheal medicine, and traditional dosage form is tablet, capsule and granule.Tablet and capsule need be swallowed when taking, and are unsuitable for child's administration.Granule has bigger volume, administration inconvenience.
Summary of the invention
The oral cavity rapid disintegration tablet that the purpose of this invention is to provide a kind of cadotril is taken medicine to be applicable to the child, treatment infantile diarrhea, the inconvenience of avoiding general formulation such as tablet and granule to use.
The oral cavity rapid disintegration tablet of the cadotril that the present invention relates to, the preparation of employing pressing, for reaching the effect that the effect that utilizes saliva in the oral cavity is a disintegratable, adopt pharmaceutics technological selection prescription, make it can be in the oral cavity not reach disintegrate fast in time of 1 minute, be preferably less than 30 seconds with saliva.In external slaking test instrument (ZB-1C type intelligence disintegration tester, Radio Factory of Tianjin Univ.), should disintegrate in 30 seconds, be preferably less than 10 seconds.The invention has the advantages that when rapid disintegration tablet is taken, need not drink water that only the effect by saliva just can make disintegration of tablet, is applied to child's administration, has got rid of the inconvenience that brings because of dysphagia.Adding solubilizing agent accelerates stripping.
The rapid disintegration tablet that the present invention relates to, active component are cadotrils, and the technology of the present invention is applicable to racecadotril, left-handed cadotril, Retorphan and composition thereof.
For the infant of all ages and classes, the consumption of active component cadotril changes because of age or body weight, and the dosage of cadotril is 1～50mg in the oral cavity rapid disintegration tablet of the technology of the present invention preparation, is preferably 2～30mg.
The mixture that contains multiple excipient in the tablet of the present invention plays respectively and keeps sheet weight, sheet shape, disintegrate, solubilising, bonding, painted, moistening, flavored action.The weight ratio of cadotril and excipient is 1/10～1/100, is preferably 1/20～1/50.
Excipient in the tablet of the present invention is according to the requirement of tablet design, and is applicable to children, can contain filler, disintegrating agent, solubilizing agent, sweeting agent, binding agent, lubricant, coloring agent, effervescent.
Wherein filler is the excipient of large usage quantity in the tablet, and its consumption is all influential to the outward appearance of the mouldability of the stripping of the disintegrate of tablet, active component cadotril, tablet and tablet.In the filler 40%～90% of tablet total weight, be preferably 60～80%.Filler can be selected microcrystalline Cellulose, mannitol, lactose, xylitol, sucrose, glucose, starch, pregelatinized Starch, calcium sulfate, calcium carbonate, calcium phosphate, light magnesium oxide and composition thereof for use.Wherein lactose and mannitol are the tablet fillers of using always, and the tablet appearance of preparation is bright and clean, and compressibility is good, and tablet can reach suitable hardness, and mannitol has sweet flavor because of when dissolving heat absorption, therefore has refrigerant tasty and refreshing sensation in the oral cavity.Microcrystalline Cellulose has the effect of filler, disintegrating agent, binding agent, lubricant concurrently, adds the compressibility that proper proportion can improve the tablet powder body in the tablet.Mix use with microcrystalline Cellulose and other filleies with certain proportion, make tablet properties reach best, ratio is 5/95～95/5, is preferably 20/80～80/20.
Disintegrate is the principal character of tablet of the present invention fast, the disintegrating agent that one of quickly disintegrated power resources are in the tablet to be contained, disintegrating agent especially is selected from polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, hydroxypropyl starch, low-substituted hydroxypropyl cellulose and composition thereof, the hundred times that can expand rapidly after meeting water reaches the effect that tablet is burst apart.The disintegration time of tablet is dwindled with the consumption increase of disintegrating agent, and consumption is 1%～40% of a tablet total weight, is preferably 5%～20%.
The adding method of disintegrating agent has three kinds of interior additions, outer addition, inside and outside addition.
The power of disintegrate can also derive from the effervescent that contains in the tablet.Effervescent is made up of organic bronsted lowry acids and bases bronsted lowry.The consumption of effervescent accounts for 0%～40% of tablet total weight, is preferably 1%～10%.
Organic acid in the effervescent has citric acid, tartaric acid, succinic acid, lactic acid, glycolic, oxalic acid, gluconic acid, Citric anhydride, succinic anhydrides, winestone anhydride and composition thereof.
Alkali in the effervescent has sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, calcium carbonate, calcium bicarbonate, magnesium carbonate, brium carbonate and composition thereof.
Cadotril is an insoluble drug; with the oral problem that often has stripping of solid form; for increasing stripping; in tablet, add a certain amount of solubilizing agent or cosolvent, for example poloxamer (polyoxyethylene-polyoxypropylene copolymer); Tweens; spans; sodium lauryl sulphate; sodium hexadecyl sulfate; sodium stearyl sulfate; the dioctyl sodium sulfosuccinate; two basic sodium sulfosuccinates; dodecyl sodium sulfate; dodecylbenzene sodium sulfonate; sodium glycocholate; sodium taurocholate; beta-schardinger dextrin-; hydroxypropyl; nicotiamide; benzoic acid; sodium benzoate and composition thereof.Solubilizing agent or cosolvent can increase the moistening of cadotril, accelerate dissolution rate, guarantee the performance of drug effect.Its consumption is 1%～20% of a tablet total weight, is preferably 3%～10%.Test by dissolution test method (two appendix of Pharmacopoeia of the People's Republic of China version in 2000) in intellectual drug digestion instrument (Radio Factory of Tianjin Univ.), dissolution was not less than 80% in 45 minutes, preferably was not less than 90%; Dissolution was not less than 60% in 15 minutes, preferably was not less than 70%; Dissolution was not less than 30% in 5 minutes, preferably was not less than 40%.
Can contain binding agent or wetting agent in the excipient of tablet of the present invention, the kind of binding agent and consumption and usage have a significant impact the disintegrating property and the stripping of tablet.Can be the dry filler with adhesion characteristic, be suitable for becoming tablet with the direct compression prepared, can also be aqueous rubber cement, solution, has bonding or wetting action.Especially be selected from starch slurry, polyvidone rubber cement, hypromellose rubber cement, methylcellulose (sodium) rubber cement, carboxymethyl cellulose (sodium) rubber cement, water, ethanol and composition thereof.
Can contain sweeting agent and optional colorant, aromatic, lubricant in the excipient of tablet of the present invention.
Sweeting agent especially is selected from aspartame, acesulfame potassium, saccharin sodium, Neohesperidin Dihydrochalcone and composition thereof.Consumption is 1%～10% of a tablet total weight, is preferably 2%～5%.
Coloring agent, aromatic, lubricant are the kind that is usually used in preparing tablet in the pharmacy industry.
Tablet of the present invention has suitable hardness, can tolerate the various processing under the routine operation condition and its character is not produced bigger influence.Usually this hardness is between 20～70 newton.
Tablet of the present invention can be by the following method or other suitable method preparation.Earlier active component cadotril and various excipient were pulverized 80 eye mesh screens, after pressing the recipe quantity precision weighing, with cadotril and filler, disintegrating agent, solubilizing agent, sweeting agent, coloring agent mix homogeneously, add suitable amount of adhesive or wetting agent, make wet granular, must do granule after the uniform temperature drying, add lubricant, compacting forms.
The specific embodiment
Embodiment 1: quickly disintegrated tablet
By following set of dispense ratio preparation tablet.
Prescription:
Racecadotril 6.00mg
Microcrystalline Cellulose 35.00mg
Mannitol 70.00mg
Polyvinylpolypyrrolidone 12.00mg
Aspartame 2.00mg
Citric acid 3.00mg
Sodium bicarbonate 2.00mg
Poloxamer 6.00mg
5% polyvidone aqueous solution is an amount of
Magnesium stearate 1.40mg
This tablet prepares as follows.
Active component racecadotril in the prescription and listed each excipient are crossed 80 mesh sieves respectively.
With racecadotril, microcrystalline Cellulose, mannitol, polyvinylpolypyrrolidone, Radix Asparagi acyl phenylpropyl alcohol nitronic acid methyl ester, poloxamer mix homogeneously.
Add 5% polyvidone aqueous solution, the system soft material, 20 mesh sieves push the granulation of sieving.
Wet granular was put 60 ℃ of freeze-day with constant temperature 2 hours.
Dried granule 20 mesh sieve granulate.
Add magnesium stearate, mixing.
Be pressed into tablet on the single punch tablet machine with following characteristic:
Average sheet heavily is between 120mg～150mg;
Tensile strength is between 20～50 newton;
In intraoral average disintegration time less than 1 minute.Disintegration time was less than 30 seconds in disintegration tester.
By " the dissolution test method is investigated dissolution in two appendix of Pharmacopoeia of People's Republic of China version in 2000, and its dissolution is as shown in table 1.Dissolution was greater than 90% in 45 minutes; Dissolution was greater than 70% in 15 minutes; Dissolution was greater than 40% in 5 minutes.
The dissolution (%) of table 1 racecadotril oral cavity quickly disintegrating tablet
Time cup X ± SD
(minute) 1234
2 45.10 43.19 41.93 44.56 43.59±1.35
5 53.38 54.04 55.92 59.14 55.63±2.58
10 67.66 68.22 69.16 73.82 69.72±2.81
15 73.98 78.36 78.40 81.35 78.03±3.04
30 83.69 90.34 97.87 100.74 93.16±7.69
45 95.52 99.56 102.03 101.72 100.91±4.68
Embodiment 2: quickly disintegrated tablet
By following set of dispense ratio preparation tablet.
Prescription:
Racecadotril 6.00mg
Microcrystalline Cellulose 35.00mg
Mannitol 70.00mg
Polyvinylpolypyrrolidone 13.54mg
Aspartame 2.00mg
Citric acid 3.00mg
Sodium bicarbonate 2.00mg
Poloxamer 3.17mg
5% polyvidone aqueous solution is an amount of
Magnesium stearate 1.40mg
Method by embodiment 1 prepares tablet
In intraoral average disintegration time less than 0.5 minute.Disintegration time was less than 10 seconds in disintegration tester.
The present invention describes by above description and embodiment, more than is described as nonrestrictively, does not limit claim scope of the present invention.
Claims (10)
1. can be in the oral cavity do not reach quickly disintegrated tablet in time of 1 minute, it is characterized in that active component especially is selected from cadotril with saliva.
2. the tablet of claim 1, its active component cadotril can be racecadotril, left-handed cadotril, Retorphan and composition thereof.The weight ratio of active component and excipient mixture is 1/10 to 1/100, is preferably 1/20 to 1/50.
3. the tablet of claim 1 is characterized in that the excipient mixture that is contained comprises disintegrating agent, filler, sweeting agent, aromatic, effervescent, solubilizing agent, lubricant, binding agent, coloring agent.
4. the tablet of claim 3 is characterized in that the disintegrating agent that is contained especially is selected from polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, hydroxypropyl starch, low-substituted hydroxypropyl cellulose and composition thereof.Consumption is 1%～40% of a tablet total weight, is preferably 5%～20%.
5. the tablet of claim 3 is characterized in that contained filler especially is selected from microcrystalline Cellulose, mannitol, lactose, xylitol, sucrose, glucose, starch, pregelatinized Starch, calcium sulfate, calcium carbonate, calcium phosphate, light magnesium oxide and composition thereof.Filler loading accounts for 40%～90% of tablet total weight, is preferably 60～80%.The ratio of microcrystalline Cellulose and other filleies is 5/95～95/5, is preferably 20/80～80/20.
6. the tablet of claim 3 is characterized in that contained sweeting agent especially is selected from aspartame, acesulfame potassium, saccharin sodium, Neohesperidin Dihydrochalcone and composition thereof.Consumption is 1%～10% of a tablet total weight, is preferably 2%～5%.
7. the tablet of claim 3 is characterized in that the effervescent that is contained is made up of organic acid and alkali.The consumption of effervescent accounts for 0%～40% of tablet total weight, is preferably 1%～10%.
8. the tablet of claim 7 is characterized in that the organic acid that is contained especially is selected from citric acid, tartaric acid, succinic acid, lactic acid, glycolic, oxalic acid, gluconic acid, Citric anhydride, succinic anhydrides, winestone anhydride and composition thereof.
9. the tablet of claim 7 is characterized in that the alkali that is contained especially is selected from sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, calcium carbonate, calcium bicarbonate, magnesium carbonate, brium carbonate and composition thereof.
10. the tablet of claim 3 is characterized in that the solubilizing agent that is contained especially is selected from poloxamer, Tweens, spans, sodium lauryl sulphate, sodium hexadecyl sulfate, sodium stearyl sulfate, the basic sodium sulfosuccinate of dioctyl sodium sulfosuccinate, two, dodecyl sodium sulfate, dodecylbenzene sodium sulfonate, sodium glycocholate, sodium taurocholate, beta-schardinger dextrin-, hydroxypropyl, nicotiamide, benzoic acid, sodium benzoate and composition thereof.Its consumption is 1%～20% of a tablet total weight, is preferably 3%～10%.
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| Application Number | Priority Date | Filing Date | Title |
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| CNA021280061A CN1506043A (en) | 2002-12-11 | 2002-12-11 | Quickly disintegrating tablet containing cadotril |
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| Application Number | Priority Date | Filing Date | Title |
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| CNA021280061A CN1506043A (en) | 2002-12-11 | 2002-12-11 | Quickly disintegrating tablet containing cadotril |
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| CN1506043A true CN1506043A (en) | 2004-06-23 |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100341504C (en) * | 2004-12-01 | 2007-10-10 | 鲁南制药集团股份有限公司 | Zolmitriptan quick-release formulation |
| CN101829333A (en) * | 2010-05-27 | 2010-09-15 | 上海华茂药业有限公司 | New multi-functional auxiliary material for orally disintegrating tablets and preparation method thereof |
| CN104107213A (en) * | 2013-04-16 | 2014-10-22 | 江西普正制药有限公司 | Preparation method of Tibetan medicine Lamiophlomis rotata effervescent tablet |
| CN104224724A (en) * | 2013-06-08 | 2014-12-24 | 北京韩美药品有限公司 | Racecadotril granules and preparation technology thereof |
| CN105919982A (en) * | 2016-06-30 | 2016-09-07 | 合肥华方医药科技有限公司 | Racecadotril oral fast dissolving film and preparation method thereof |
| CN107921017A (en) * | 2015-08-07 | 2018-04-17 | 强生消费者公司 | The method treated using cadotril composition |
| EP4056171A1 (en) | 2021-03-12 | 2022-09-14 | Athena Pharmaceutiques SAS | Taste masked racecadotril tablet composition and process for preparation thereof |
-
2002
- 2002-12-11 CN CNA021280061A patent/CN1506043A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100341504C (en) * | 2004-12-01 | 2007-10-10 | 鲁南制药集团股份有限公司 | Zolmitriptan quick-release formulation |
| CN101829333A (en) * | 2010-05-27 | 2010-09-15 | 上海华茂药业有限公司 | New multi-functional auxiliary material for orally disintegrating tablets and preparation method thereof |
| CN101829333B (en) * | 2010-05-27 | 2012-01-25 | 上海华茂药业有限公司 | New multi-functional auxiliary material for orally disintegrating tablets and preparation method thereof |
| CN104107213A (en) * | 2013-04-16 | 2014-10-22 | 江西普正制药有限公司 | Preparation method of Tibetan medicine Lamiophlomis rotata effervescent tablet |
| CN104107213B (en) * | 2013-04-16 | 2019-01-11 | 江西普正制药有限公司 | The preparation method of Tibet medicine lamivphlomis root effervescent tablet |
| CN104224724A (en) * | 2013-06-08 | 2014-12-24 | 北京韩美药品有限公司 | Racecadotril granules and preparation technology thereof |
| CN107921017A (en) * | 2015-08-07 | 2018-04-17 | 强生消费者公司 | The method treated using cadotril composition |
| CN105919982A (en) * | 2016-06-30 | 2016-09-07 | 合肥华方医药科技有限公司 | Racecadotril oral fast dissolving film and preparation method thereof |
| EP4056171A1 (en) | 2021-03-12 | 2022-09-14 | Athena Pharmaceutiques SAS | Taste masked racecadotril tablet composition and process for preparation thereof |
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