CN101032472A - Ibuprofen rapidly disintegrating tablet in oral cavity for pain treatment and preparing method thereof - Google Patents
Ibuprofen rapidly disintegrating tablet in oral cavity for pain treatment and preparing method thereof Download PDFInfo
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- CN101032472A CN101032472A CNA200710021385XA CN200710021385A CN101032472A CN 101032472 A CN101032472 A CN 101032472A CN A200710021385X A CNA200710021385X A CN A200710021385XA CN 200710021385 A CN200710021385 A CN 200710021385A CN 101032472 A CN101032472 A CN 101032472A
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- ibuprofen
- disintegrating tablets
- glycerol
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- acid ester
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Abstract
The orally disintegrated ibuprofen tablet consists of ibuprofen; glyceryl palmitate-stearate in the amount of 5-20 wt% of ibuprofen; excipient of mannitol, microcrystalline cellulose and/or lactose; and disintegrant of cross-linked polyvidone or carboxymethyl starch sodium as conventional disintegrant, and supplementary material NaHCO3 and citric acid to form effervescent disintegrant with high disintegrating speed and good taste. The orally disintegrated ibuprofen tablet may have aspartame, edible essence and edible color lake added to improve taste and look. The present invention also discloses its preparation process.
Description
Technical field:
The present invention relates to pharmaceutical, specifically, is ibuprofen oral disintegrating tablets of treatment flu, pain and preparation method thereof.
Background technology:
Ibuprofen is the phenylpropionic acid NSAID (non-steroidal anti-inflammatory drug), has stronger antiinflammatory, analgesia and refrigeration function.Ibuprofen is the trend of steady-state growth always on the medical market abroad, and it and acetaminophen, aspirin, diclofenac become four big pillar products on China antipyretic analgesic market together.But ibuprofen has the characteristic of oneself in clinical practice, is all antipyretic safely and effectively, and when body temperature was higher than 39.2 ℃, ibuprofen was than more effective with the acetaminophen of dosage, and fever time is longer.Pharmacodynamic study proves: the analgesia of this medicine, refrigeration function are respectively 28 times and 20 times of aspirin, its untoward reaction is lacked than aspirin and light, clinical practice through more than 30 years, ibuprofen has withstood the time and the masses' test, is used as the drug of first choice of current clinical anti-inflammatory joint disease.
At present in the preparation that with the ibuprofen is major ingredient, there are 13 kinds of dosage forms to be put into China's nonprescription drugs catalogue, it is one of maximum OTC antipyretic analgesic of preparation variety, in national basic medical medicine catalogue,, ibuprofen is one of three Class A products of non-steroidal anti-inflammatory analgesic.The sickness rate of said preparation indication in the crowd is up to more than 15%, and the current needs amount is big, and market potential is very wide.
Abroad the research to ibuprofen mainly is dispersant, sustained-release preparation, and record for Chinese Pharmacopoeia 95 editions, the conventional dosage forms GI irritation is big, bioavailability is low, and even feel sick, toxic and side effects such as vomiting, erythra are bigger, newly create dosage form ibuprofen oral disintegrating tablets characteristics to be: do not need water or need low amounts of water also to need not to chew, medicine places lingual surface, after the disintegrate, borrow swallowing act to go into the stomach onset rapidly.This is just bad for some function of deglutition, the patient and the old man of water intaking inconvenience, the child takes medicine that great convenience is provided.
Oral cavity disintegration tablet has many advantages: 1, absorption is fast, bioavailability is high.Oral cavity disintegration tablet can influence the rate of dissolution of medicine, particularly to the influence of insoluble medicine rate of dissolution, so make oral cavity disintegration tablet and can improve bioavailability of medicament, therefore, oral cavity disintegration tablet is applicable to the medicine of onset rapidly, and some war wound emergency treatment medicines, NSAID (non-steroidal anti-inflammatory drug), spasmolytic Bendectin and analgesic etc. all relatively are fit to make oral cavity disintegration tablet; Other medicine such as blood drug level are in for a long time than plateau, then easily produce drug resistance, make oral cavity disintegration tablet after, then can overcome this problem, produce excellent curative.2, taking convenience.Oral cavity disintegration tablet needn't be used water delivery service, and saliva can make its disintegrate or dissolving, both can swallow by conventional tablet, can be placed in the water again to take after the disintegrate, also can not need to take medicine with water swallow.Be particularly useful for the patient of old man, children's's dysphagia and the inconvenient person that fetches water and take medicine convenience is provided,, then can improve the drug compliance of child patient greatly, solve the problem that it is difficult that infant is taken medicine if adopt certain method to improve the mouthfeel of preparation in the preparation.3, intestinal is residual few, and side effect is low.Medicine arrives the gastrointestinal tract rapid disintegrate of energy before and is dispersed into trickle granule, causes medicine to distribute in the gastrointestinal tract large tracts of land, and absorption point increases, thereby has reduced medicine to the gastrointestinal local excitation.4, avoid the first pass effect of liver.Because oral cavity disintegration tablet is rapidly disintegrate in mouth, except that major part enters the gastrointestinal tract with swallowing act, also has considerable part to absorb through the oral cavity, thus rapid-action, first pass effect is little.
Because the ibuprofen crude drug itself has particularity, its acid can produce strong impulse to throat, so the requirement of the mouthfeel of ibuprofen oral disintegrating tablets is the difficult point of formulation and technology.In order to cover the acid of raw material, can use a large amount of correctivess usually, but this method not only can not effectively be improved mouthfeel for the ibuprofen oral cavity disintegration tablet, and disintegrate is had a negative impact, cause the ibuprofen oral disintegrating tablets disintegrate defective.This prescription hides flavor by the crude drug method for pretreating to principal agent, improves mouthfeel with the method that principal agent is hidden flavor, reduces the consumption of correctives, thus the requirement of the mouthfeel of taking into account and disintegrate.
The screening flavor technology that is usually used in the ibuprofen raw material is that coating hides flavor, and used coating material is generally ethyl cellulose, hydroxypropyl methylcellulose, and its preparation process is announced in patent CN1154482.
Summary of the invention:
The objective of the invention is: a kind of taking convenience is provided, and mouthfeel is good, the obvious results oral cavity disintegration tablet, and preparation method thereof.
Purpose of the present invention can be achieved through the following technical solutions.
A kind of ibuprofen oral disintegrating tablets, it is made up of ibuprofen and palmitic acid stearic acid ester of glycerol and excipient and disintegrating agent basically, the palmitic acid stearic acid ester of glycerol consumption is 5%～20% of an ibuprofen quality, and palmitic acid stearic acid ester of glycerol is wrapped in outside the ibuprofen microgranule.
Preferably mannitol is or/and microcrystalline Cellulose for above-mentioned ibuprofen oral disintegrating tablets, described excipient, and described disintegrating agent is polyvinylpolypyrrolidone preferably.
Above-mentioned ibuprofen oral disintegrating tablets can be added with gas-producing disintegrant in the described disintegrating agent.
Above-mentioned ibuprofen oral disintegrating tablets, described gas-producing disintegrant preferably is made up of sodium bicarbonate and citric acid.
Above-mentioned ibuprofen oral disintegrating tablets can be added with correctives in the component.
Above-mentioned ibuprofen oral disintegrating tablets can be added with edible essence in the component.
Above-mentioned ibuprofen oral disintegrating tablets can be added with edible color lake in the component.
A kind of method for making of above-mentioned ibuprofen oral disintegrating tablets, it is made up of the following step basically:
(1) with the ibuprofen and the palmitic acid stearic acid ester of glycerol mix homogeneously of formula ratio, under agitation be heated to 57～60 ℃ of fusion substrate and melt, continue to stir, slowly cool to room temperature, must be enclosed with the ibuprofen microgranule of palmitic acid stearic acid ester of glycerol,
(2) with excipient, disintegrating agent and other adjuvant pulverize separately, sieve,
(3) ibuprofen microgranule that step (1) is obtained and step (2) are processed excipient, disintegrating agent and other adjuvant mix homogeneously that obtains, and tabletting promptly gets ibuprofen oral disintegrating tablets of the present invention.
Preprocessing process of the present invention adopts melt granulation to realize.Melt granulation has a lot of advantages, as need not to provide liquid efficiently to granulate, reduce the production time, reduce cost, than traditional coating method, the screening flavor material that this screening flavor technology is selected for use is simple, equipment requirements is low, feasibility is strong.The granulation of melt granulation is melted into liquid the granulation by the lipid matrix or the solid-state lipid matrix of fused solution, glomeration or irregular, and ingredient is contained in the granule, and particle diameter is 500～2000um.
It is the emphasis and the difficult point of formulation and technology that the mouthfeel of oral cavity disintegration tablet and disintegrate require.Because the ibuprofen crude drug itself has acid, be designed to the oral cavity disintegration tablet patient and relatively be difficult to accept, the present invention adopts the crude drug method for pretreating to cover the disagreeable taste of medicine itself, and promptly with waxiness adjuvant parcel principal agent, the waxiness adjuvant adopts palmitic acid stearic acid ester of glycerol.Palmitic acid stearic acid ester of glycerol is used for ointment base more, in oral formulations, be used for matrix tablet sustained-release matrix, lubricant etc. more, in this prescription, be used to wrap up principal agent, avoided principal agent to contact with the direct of oral cavity, play the effect of covering the bad sense of taste, and because melt granulation both do not added liquid component, do not add a large amount of correctivess yet, can not have a negative impact the disintegrate effect of oral cavity disintegration tablet.The pretreatment of this product principal agent realizes by the method for melt granulation.Medicine and palmitic acid stearic acid ester of glycerol were at room temperature mixed 2～5 minutes; Under agitation heat up and melt, be warming up to the fusing point (57～60 ℃) of a little higher than fusion substrate; Stirring, simultaneously slow cool to room temperature.Need to prove: mixing speed is fast more, and grain diameter is more little.
Another characteristics of the present invention are to hide combining of flavor granule and gas-producing disintegrant.Hiding the flavor granule has granular sensation in mouth, and by gas-producing disintegrant aerogenesis effervescent principle in water, the adding of this type of adjuvant can effectively reduce hiding the sense of discomfort of flavor granule in mouth.
Ibuprofen oral disintegrating tablets of the present invention is because the principal agent ibuprofen is wrapped, so there is not the pungent poor taste of Denging, excipient adopts one or more in mannitol, microcrystalline Cellulose, the lactose in the prescription; Polyvinylpolypyrrolidone, carboxymethyl starch sodium are aided with NaHCO as conventional disintegrating agent
3, citric acid forms gas-producing disintegrant, improves mouthfeel when guaranteeing disintegration rate; Can add aspartame, edible essence in this product prescription, can add edible color lake simultaneously, can improve mouthfeel and outward appearance, make the patient be easy to accept.
The specific embodiment:
Implement 1 example:
Ibuprofen 100g
Palmitic acid stearic acid ester of glycerol 10g
Microcrystalline Cellulose 60g
Lactose 90g
Polyvinylpolypyrrolidone 30g
NaHCO
3 20g
Mannitol 30g
Citric acid 20g
Aspartame 10g
Starch 15g
Essence 0.6g
Color lake 0.5g
Make 1000
Preparation technology's flow process: principal agent and palmitic acid stearic acid ester of glycerol were at room temperature mixed 2～5 minutes, heat up in sizeable container and melt, the fusing point of a little higher than fusion substrate of temperature (57～60 ℃) stirs with the adjustable speed agitator, while is cool to room temperature slowly, gets the fine grained of principal agent.The adjuvant pulverize separately is crossed 100 mesh sieves in the prescription, takes by weighing the adjuvant of recipe quantity, with the granules of main drug mixing, mixes tablet machine on the gained intermediate material, and with less pressure, compacting is controlled slice, thin piece hardness 4～5kg.f., promptly in flakes.
Implement 2 examples:
Ibuprofen 100g
Palmitic acid stearic acid ester of glycerol 15g
Microcrystalline Cellulose 100g
Lactose 50g
Carboxymethyl starch sodium 40g
NaHCO
3 20g
Citric acid 20g
Aspartame 10g
Starch 15g
Essence 0.6g
Color lake 0.5g
Make 1000
Preparation technology's flow process: principal agent and palmitic acid stearic acid ester of glycerol were at room temperature mixed 2～5 minutes, heat up in sizeable container and melt, the fusing point of a little higher than fusion substrate of temperature (57～60 ℃) stirs with the adjustable speed agitator, while is cool to room temperature slowly, gets the fine grained of principal agent.The adjuvant pulverize separately is crossed 100 mesh sieves in the prescription, takes by weighing the adjuvant of recipe quantity, with the granules of main drug mixing, mixes tablet machine on the gained intermediate material, and with less pressure, compacting is controlled slice, thin piece hardness 4～5kg.f., promptly in flakes.
Implement 3 examples:
Ibuprofen 100g
Palmitic acid stearic acid ester of glycerol 10g
Microcrystalline Cellulose 50g
Lactose 100g
Polyvinylpolypyrrolidone 20g
NaHCO
3 30g
Mannitol 30g
Citric acid 30g
Aspartame 10g
Starch 15g
Essence 0.6g
Color lake 0.5g
Make 1000
Preparation technology's flow process: principal agent and palmitic acid stearic acid ester of glycerol were at room temperature mixed 2～5 minutes, heat up in sizeable container and melt, the fusing point of a little higher than fusion substrate of temperature (57～60 ℃) stirs with the adjustable speed agitator, while is cool to room temperature slowly, gets the fine grained of principal agent.The adjuvant pulverize separately is crossed 100 mesh sieves in the prescription, takes by weighing the adjuvant of recipe quantity, with the granules of main drug mixing, mixes tablet machine on the gained intermediate material, and with less pressure, compacting is controlled slice, thin piece hardness 4～5kg.f., promptly in flakes.
Implement 4 examples:
Ibuprofen 100g
Palmitic acid stearic acid ester of glycerol 5g
Microcrystalline Cellulose 80g
Lactose 20g
Polyvinylpolypyrrolidone 25g
NaHCO
3 20g
Mannitol 80g
Citric acid 20g
Aspartame 10g
Starch 15g
Essence 0.6g
Color lake 0.5g
Make 1000
Preparation technology's flow process: principal agent and palmitic acid stearic acid ester of glycerol were at room temperature mixed 2～5 minutes, heat up in sizeable container and melt, the fusing point of a little higher than fusion substrate of temperature (57～60 ℃) stirs with the adjustable speed agitator, while is cool to room temperature slowly, gets the fine grained of principal agent.The adjuvant pulverize separately is crossed 100 mesh sieves in the prescription, takes by weighing the adjuvant of recipe quantity, with the granules of main drug mixing, mixes tablet machine on the gained intermediate material, and with less pressure, compacting is controlled slice, thin piece hardness 4～5kg.f., promptly in flakes.
Implement 5 examples:
Ibuprofen 100g
Palmitic acid stearic acid ester of glycerol 20g
Microcrystalline Cellulose 60g
Lactose 90g
Carboxymethyl starch sodium 40g
NaHCO
3 20g
Mannitol 30g
Citric acid 20g
Aspartame 10g
Starch 15g
Essence 0.6g
Color lake 0.5g
Make 1000
Preparation technology's flow process: principal agent and palmitic acid stearic acid ester of glycerol were at room temperature mixed 2～5 minutes, heat up in sizeable container and melt, the fusing point of a little higher than fusion substrate of temperature (57～60 ℃) stirs with the adjustable speed agitator, while is cool to room temperature slowly, gets the fine grained of principal agent.The adjuvant pulverize separately is crossed 100 mesh sieves in the prescription, takes by weighing the adjuvant of recipe quantity, with the granules of main drug mixing, mixes tablet machine on the gained intermediate material, and with less pressure, compacting is controlled slice, thin piece hardness 4～5kg.f., promptly in flakes.
Implement 6 examples:
Ibuprofen 100g
Palmitic acid stearic acid ester of glycerol 15g
Microcrystalline Cellulose 150g
Polyvinylpolypyrrolidone 30g
NaHCO
3 20g
Citric acid 20g
Aspartame 10g
Starch 15g
Essence 0.6g
Color lake 0.5g
Make 1000
Preparation technology's flow process: principal agent and palmitic acid stearic acid ester of glycerol were at room temperature mixed 2～5 minutes, heat up in sizeable container and melt, the fusing point of a little higher than fusion substrate of temperature (57～60 ℃) stirs with the adjustable speed agitator, while is cool to room temperature slowly, gets the fine grained of principal agent.The adjuvant pulverize separately is crossed 100 mesh sieves in the prescription, takes by weighing the adjuvant of recipe quantity, with the granules of main drug mixing, mixes tablet machine on the gained intermediate material, and with less pressure, compacting is controlled slice, thin piece hardness 4～5kg.f., promptly in flakes.
The present invention can be used for treating heating or the cold symptoms that a variety of causes causes; Soft tissue injury, arthralgia, lumbago and backache, myalgia, headache, migraine, toothache; The oral cavity, postoperative pain such as eye etc.
Claims (8)
1. ibuprofen oral disintegrating tablets, it is characterized in that: it is made up of ibuprofen and palmitic acid stearic acid ester of glycerol and excipient and disintegrating agent basically, the palmitic acid stearic acid ester of glycerol consumption is 5%～20% of an ibuprofen quality, and palmitic acid stearic acid ester of glycerol is wrapped in outside the ibuprofen microgranule.
2. ibuprofen oral disintegrating tablets according to claim 1 is characterized in that: described excipient is a mannitol or/and microcrystalline Cellulose, and described disintegrating agent is polyvinylpolypyrrolidone or carboxymethyl starch sodium.
3. ibuprofen oral disintegrating tablets according to claim 1 is characterized in that: be added with gas-producing disintegrant in the described disintegrating agent.
4. ibuprofen oral disintegrating tablets according to claim 3 is characterized in that: described gas-producing disintegrant is made up of sodium bicarbonate and citric acid.
5. ibuprofen oral disintegrating tablets according to claim 1 is characterized in that: be added with correctives in the component.
6. ibuprofen oral disintegrating tablets according to claim 1 is characterized in that: be added with edible essence in the component.
7. ibuprofen oral disintegrating tablets according to claim 1 is characterized in that: be added with food coloring in the component.
8. the method for making of any described ibuprofen oral disintegrating tablets of claim 1 to 7 is characterized in that it is made up of the following step basically:
(1) with the ibuprofen and the palmitic acid stearic acid ester of glycerol mix homogeneously of formula ratio, under agitation be heated to 57～60 ℃ of fusion substrate and melt, continue to stir, slowly cool to room temperature, make the ibuprofen microgranule that is enclosed with palmitic acid stearic acid ester of glycerol,
(2) with excipient, disintegrating agent and other adjuvant pulverize separately, sieve,
(3) ibuprofen microgranule that step (1) is obtained and step (2) are processed excipient, disintegrating agent and other adjuvant mix homogeneously that obtains, and tabletting promptly gets ibuprofen oral disintegrating tablets.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA200710021385XA CN101032472A (en) | 2007-04-10 | 2007-04-10 | Ibuprofen rapidly disintegrating tablet in oral cavity for pain treatment and preparing method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA200710021385XA CN101032472A (en) | 2007-04-10 | 2007-04-10 | Ibuprofen rapidly disintegrating tablet in oral cavity for pain treatment and preparing method thereof |
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| CN101032472A true CN101032472A (en) | 2007-09-12 |
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|---|---|---|---|
| CNA200710021385XA Pending CN101032472A (en) | 2007-04-10 | 2007-04-10 | Ibuprofen rapidly disintegrating tablet in oral cavity for pain treatment and preparing method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102935078A (en) * | 2012-11-21 | 2013-02-20 | 北京润德康医药技术有限公司 | Ibuprofen oral dispersing film agent |
| CN103585641A (en) * | 2013-10-21 | 2014-02-19 | 海南卫康制药(潜山)有限公司 | Lipid coating and cyclodextrin inclusion synergic flavoring method and related preparation thereof |
| CN105816434A (en) * | 2016-04-19 | 2016-08-03 | 山东新华制药股份有限公司 | Ibuprofen granules and preparation method thereof |
| CN115089552A (en) * | 2022-06-10 | 2022-09-23 | 南京瑞捷医药科技有限公司 | An orally disintegrating tablet of ibuprofen |
| JP7594929B2 (en) | 2020-05-15 | 2024-12-05 | 花王株式会社 | Effervescent oral tablets in a sealed container |
-
2007
- 2007-04-10 CN CNA200710021385XA patent/CN101032472A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102935078A (en) * | 2012-11-21 | 2013-02-20 | 北京润德康医药技术有限公司 | Ibuprofen oral dispersing film agent |
| CN103585641A (en) * | 2013-10-21 | 2014-02-19 | 海南卫康制药(潜山)有限公司 | Lipid coating and cyclodextrin inclusion synergic flavoring method and related preparation thereof |
| CN105816434A (en) * | 2016-04-19 | 2016-08-03 | 山东新华制药股份有限公司 | Ibuprofen granules and preparation method thereof |
| CN105816434B (en) * | 2016-04-19 | 2019-09-17 | 山东新华制药股份有限公司 | Ibuprofen granule and preparation method thereof |
| JP7594929B2 (en) | 2020-05-15 | 2024-12-05 | 花王株式会社 | Effervescent oral tablets in a sealed container |
| CN115089552A (en) * | 2022-06-10 | 2022-09-23 | 南京瑞捷医药科技有限公司 | An orally disintegrating tablet of ibuprofen |
| CN115089552B (en) * | 2022-06-10 | 2024-03-29 | 南京瑞捷医药科技有限公司 | Ibuprofen orally disintegrating tablet |
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Open date: 20070912 |