CN102125528A - Domperidone orally disintegrating tablet - Google Patents
Domperidone orally disintegrating tablet Download PDFInfo
- Publication number
- CN102125528A CN102125528A CN201010027260XA CN201010027260A CN102125528A CN 102125528 A CN102125528 A CN 102125528A CN 201010027260X A CN201010027260X A CN 201010027260XA CN 201010027260 A CN201010027260 A CN 201010027260A CN 102125528 A CN102125528 A CN 102125528A
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- China
- Prior art keywords
- domperidone
- oral cavity
- cavity disintegration
- disintegration tablet
- calcium
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Abstract
The invention provides a domperidone orally disintegrating tablet, which is characterized in that the tablet contains a physiologically effective amount of domperidone and a necessary pharmaceutically applicable excipient; the weight percent of domperidone in the orally disintegrating tablet is 5%-10%, and the pharmaceutically applicable excipient is a mixture of a plurality of agents selected from fillers, odor masking agents, disintegrants, surfactants, adhesives, lubricants, and glidants. The domperidone orally disintegrating tablet of the invention has the advantages of quick disintegration, excellent mouthfeel, stable quality, and reliable curative effects, and can improve the compliance of medicine taking for patients.
Description
Technical field
The invention belongs to chemical pharmacy field, be specifically related to a kind of domperidone oral cavity disintegration tablet and preparation method thereof.
Background technology
Domperidone is a kind of synthetic benzimidazole analog derivative, and is similar to the propyl ketone phenyl on the structure.It is a kind of dopamine-receptor antagonist with resisting emesis effect, is difficult for entering brain by blood brain barrier.Domperidone acts on the outer chemoceptor trigger region of blood brain barrier, therefore acts on the central nervous system hardly; Domperidone selective exclusion dopamine 2 (DA2) receptor mainly acts on peripheral nervous system.Because the DA2 receptor is the gastrointestinal major receptors too, thus the DA2 receptor antagonist can to reduce the pipe smooth muscle of dopamine mediation lax.In gastrointestinal tract, domperidone can increase gastral power as a kind of dynamics-promoting medicine, can be used for preventing stomach-esophageal reflux, promotes gastric emptying, improves gastroduodenal sports coordination, prevents bile reflux, regulates and recover the motion of upper gastro-intestinal tract; Suppress to feel sick, vomit.
The domperidone preparation that uses clinically has common solid preparations such as tablet, capsule at present.As is well known, must be whole oral when these preparations use, there is defectives such as using inconvenience, dysphagia for patients.For the patient that needs are taken medicine for a long time, there is the compliance problem of more significantly taking medicine.
Oral cavity solid immediate release drug formulations, particularly to collapse the characteristics of medicinal tablet be to put into tablet on the tongue or other positions, oral cavity for oral instant, speed, refusing to obey under the regimen condition and can dissolve rapidly or disintegrate, the part medicine enters gastrointestinal tract through the swallowing act of nature, and part medicine then through port transmucosal absorption enters the body circulation.Its advantage is that release is fast, rapid-action, bioavailability is high, and such solid immediate release drug formulations is specially adapted to dysphagia, old man and pediatric patient and does not have the patient of drinking-water under the environment and take.Oral cavity disintegration tablet have take medicine conveniently, advantage reliable for effect.The present invention promptly provides a kind of oral cavity disintegration tablet of domperidone.
Summary of the invention
The invention provides a kind of oral cavity disintegration tablet of domperidone, it is rapid to have a disintegrate, and mouthfeel is good, steady quality, the reliable advantage of curative effect.
Another object of the present invention provides a kind of preparation method of domperidone oral cavity disintegration tablet of process stabilizing.
The present invention is achieved through the following technical solutions:
The domperidone oral cavity disintegration tablet contains the domperidone of percentage by weight 5%-10%, and the necessary excipient that pharmaceutically is suitable for.
In the selection of excipient, unless disturb the immediately disintegrable or the intensity of tablet, oral cavity disintegration tablet of the present invention can be selected excipient commonly used in the general formulation preparation.One or more mixture as filler, odor mask, disintegrating agent, surfactant, binding agent, lubricant and fluidizer.
Filler can be selected from one or more the combination of following material: starch, amylum pregelatinisatum, dextrin, sucrose, lactose, fructose, glucose, xylitol, mannitol, microcrystalline Cellulose, calcium carbonate, magnesium carbonate, calcium phosphate, calcium hydrogen phosphate, calcium sulfate, magnesium oxide, aluminium hydroxide, carboxymethylcellulose calcium, sodium carboxymethyl cellulose.Preferred sugar alcohols, amylum pregelatinisatum, calcium phosphate, calcium hydrogen phosphate, calcium sulfate, microcrystalline Cellulose.
Odor mask is selected from aspartame, stevioside, fructose, glucose, syrup, Mel, xylitol, mannitol, lactose, sorbitol, maltose alcohol, glycyrrhizin.
Especially, in the selection of disintegrating agent, the good disintegrating agent of disintegrating property be must select, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, low substituted hydroxy-propyl methylcellulose are selected from.
Surfactant can be selected from one or more the combination of following material: tween 80, poloxamer.
Binding agent can be selected from one or more the combination of following material: water, ethanol, hypromellose.
Lubricant can be selected from one or more the combination of following material: stearic acid, calcium stearate, magnesium stearate, zinc stearate, Pulvis Talci, glyceryl monostearate, glyceryl palmitostearate, Stepanol MG, Polyethylene Glycol, stearyl fumarate.
Fluidizer can be selected from one or more the combination of following material: silica sol, Powderd cellulose, magnesium trisilicate, Pulvis Talci.
The consumption of above-mentioned excipient can be the conventional amount used of preparation ordinary preparation.Wherein to account for the percentage by weight of tablet be 3%-8% to the disintegrating agent consumption.
Described carrier is not limited to mentioned kind, as long as be fit to the object of the invention, normally used additive all can be included in the prescription of the present invention when the preparation tablet.
The preparation method of domperidone oral cavity disintegration tablet of the present invention may further comprise the steps:
(1) all supplementary materials are crossed the 80-100 mesh sieve.
(2) with domperidone and the abundant mixing of all the other excipient.
(3) sieve with the 14-18 screen cloth.
(5) add fluidizer.
(6) tabletting, packing after the assay was approved.
Get 6 of the oral cavity disintegration tablets that prepare,, adopt dissolution method second subtraction unit, in stripping rotor, add the simulate saliva (distilled water is transferred pH with sodium hydroxide solution or hydrochloric acid solution) of 2ml pH6.7-7.0, add oral cavity disintegration tablet according to the drug release determination method.Hydrochloric acid solution (get sodium chloride 1g, add hydrochloric acid 3.5ml, the add water to 500ml) 500ml that adds the sodium chloride that is preheated to 37 ℃ behind the 5min, rotating speed are that per minute 100 changes, and operation in accordance with the law when 2h, is measured the acidproof situation of tablet.
Below the present invention is further detailed explanation by specific embodiment.As those skilled in the art should know that embodiment of being explained among the present invention and embodiment only provide with the purpose of giving an example, and do not constitute selection, preparation of compositions method to excipient in the concrete technical scheme, and the restriction of the purposes of compositions.
The specific embodiment
Embodiment 1
Domperidone 20g
Lactose 140g
Polyvinylpolypyrrolidone 10g
Hydroxypropyl cellulose 10g
Magnesium stearate 5g
Aspartame 10g
Micropowder silica gel 5g
Poloxamer alcoholic solution (50%) is an amount of
Preparation: all supplementary materials are crossed the 80-100 mesh sieve, with domperidone and the abundant mixing of all the other excipient, sieve with the 14-18 screen cloth, add fluidizer, tabletting, packing after the assay was approved.
Embodiment 2
Domperidone 10g
Lactose 150g
Sodium carboxymethyl cellulose 10g
Hydroxypropyl cellulose 10g
Magnesium stearate 5g
Aspartame 10g
Micropowder silica gel 5g
Poloxamer alcoholic solution (50%) is an amount of
Preparation: all supplementary materials are crossed the 80-100 mesh sieve, with domperidone and the abundant mixing of all the other excipient, sieve with the 14-18 screen cloth, add fluidizer, tabletting, packing after the assay was approved.
Embodiment 3
Domperidone 15g
Lactose 145g
Polyvinylpolypyrrolidone 10g
Hydroxypropyl cellulose 10g
Magnesium stearate 5g
Aspartame 10g
Micropowder silica gel 5g
Poloxamer alcoholic solution (50%) is an amount of
Preparation: all supplementary materials are crossed the 80-100 mesh sieve, with domperidone and the abundant mixing of all the other excipient, sieve with the 14-18 screen cloth, add fluidizer, tabletting, packing after the assay was approved.
Claims (10)
1. the domperidone oral cavity disintegration tablet is characterized in that, contains the domperidone of physiology effective dose, and the necessary excipient that pharmaceutically is suitable for.
2. domperidone oral cavity disintegration tablet as claimed in claim 1 is characterized in that, the percentage by weight that described domperidone accounts for oral cavity disintegration tablet is 5%-10%
3. domperidone oral cavity disintegration tablet as claimed in claim 1 is characterized in that, the described excipient that pharmaceutically is suitable for is selected from several mixture of filler, odor mask, disintegrating agent, surfactant, binding agent, lubricant and fluidizer.
4. domperidone oral cavity disintegration tablet as claimed in claim 3, it is characterized in that described filler is selected from one or more the combination of following material: starch, amylum pregelatinisatum, dextrin, sucrose, lactose, fructose, glucose, xylitol, mannitol, microcrystalline Cellulose, calcium carbonate, magnesium carbonate, calcium phosphate, calcium hydrogen phosphate, calcium sulfate, magnesium oxide, aluminium hydroxide, carboxymethylcellulose calcium, sodium carboxymethyl cellulose.Preferred sugar alcohols, amylum pregelatinisatum, calcium phosphate, calcium hydrogen phosphate, calcium sulfate, microcrystalline Cellulose.
5. domperidone oral cavity disintegration tablet as claimed in claim 3 is characterized in that, described disintegrating agent is selected from cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, low substituted hydroxy-propyl methylcellulose.
6. domperidone oral cavity disintegration tablet as claimed in claim 5 is characterized in that, the percentage by weight that described disintegrating agent consumption accounts for tablet is 3%-8%.
7. domperidone oral cavity disintegration tablet as claimed in claim 3 is characterized in that odor mask is selected from aspartame, stevioside, fructose, glucose, syrup, Mel, xylitol, mannitol, lactose, sorbitol, maltose alcohol, glycyrrhizin.
8. domperidone oral cavity disintegration tablet as claimed in claim 3 is characterized in that, described surfactant is selected from one or more the combination of following material: tween 80, poloxamer; Described binding agent is selected from one or more the combination of following material: water, ethanol, hypromellose.
9. domperidone oral cavity disintegration tablet as claimed in claim 3, it is characterized in that, described lubricant is selected from one or more the combination of following material: stearic acid, calcium stearate, magnesium stearate, zinc stearate, Pulvis Talci, glyceryl monostearate, glyceryl palmitostearate, Stepanol MG, Polyethylene Glycol, stearyl fumarate, described fluidizer are selected from one or more the combination of following material: silica sol, Powderd cellulose, magnesium trisilicate, Pulvis Talci.
10. as the preparation method of the arbitrary described domperidone oral cavity disintegration tablet of claim 1 to 9, may further comprise the steps:
(1) all supplementary materials are crossed the 80-100 mesh sieve;
(2) with domperidone and the abundant mixing of all the other excipient;
(3) sieve with the 14-18 screen cloth;
(5) add fluidizer;
(6) tabletting, packing after the assay was approved.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010027260XA CN102125528A (en) | 2010-01-12 | 2010-01-12 | Domperidone orally disintegrating tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010027260XA CN102125528A (en) | 2010-01-12 | 2010-01-12 | Domperidone orally disintegrating tablet |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102125528A true CN102125528A (en) | 2011-07-20 |
Family
ID=44263965
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201010027260XA Pending CN102125528A (en) | 2010-01-12 | 2010-01-12 | Domperidone orally disintegrating tablet |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102125528A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104027318A (en) * | 2014-06-13 | 2014-09-10 | 青岛市市立医院 | Domperidone tablet and preparation method thereof |
| CN105560199A (en) * | 2016-03-01 | 2016-05-11 | 山东司邦得制药有限公司 | Infantile domperidone orally disintegrating tablet and preparation method thereof |
| WO2020086950A1 (en) * | 2018-10-25 | 2020-04-30 | Cindome Pharma, Inc. | Formulations containing domperidone |
-
2010
- 2010-01-12 CN CN201010027260XA patent/CN102125528A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104027318A (en) * | 2014-06-13 | 2014-09-10 | 青岛市市立医院 | Domperidone tablet and preparation method thereof |
| CN105560199A (en) * | 2016-03-01 | 2016-05-11 | 山东司邦得制药有限公司 | Infantile domperidone orally disintegrating tablet and preparation method thereof |
| CN105560199B (en) * | 2016-03-01 | 2018-07-06 | 山东司邦得制药有限公司 | A kind of children's domperidone oral disintegrating tablet and preparation method thereof |
| WO2020086950A1 (en) * | 2018-10-25 | 2020-04-30 | Cindome Pharma, Inc. | Formulations containing domperidone |
| CN112969460A (en) * | 2018-10-25 | 2021-06-15 | 辛多美制药有限公司 | Preparation containing domperidone |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20110720 |