CN1531921A - Powder coated medicine oral quick cracking tablet and its preparing method - Google Patents
Powder coated medicine oral quick cracking tablet and its preparing method Download PDFInfo
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- CN1531921A CN1531921A CNA031159311A CN03115931A CN1531921A CN 1531921 A CN1531921 A CN 1531921A CN A031159311 A CNA031159311 A CN A031159311A CN 03115931 A CN03115931 A CN 03115931A CN 1531921 A CN1531921 A CN 1531921A
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Abstract
The present invention belongs to the field of medicine preparation technology, and discloses a kind of powder coating oral quick disintegrating medicine tablet and its preparing process. By means of powder coating technology, the oral quick disintegrating tablet has high leaching degree, good taste and convenient taking. The method of the present invention is suitable for preparing various oral quick disintegrating medicine tablets in industrial scale.
Description
Technical field:
The invention belongs to medicine pharmaceutical technology field.Be specifically related to a kind of medicine oral cavity quick disintegrating slice through powder coating and preparation method thereof.
Background technology:
Oral administration solid system because of dosage accurately, carry with characteristics such as easy to use, that resistance to pressure is strong and generally used by people.The later stage seventies 20th century, drugs consumption market occur the new oral solid preparation--oral cavity quick disintegrating slice more and more is subjected to liking of patient with its unique advantages.The characteristics of this tablet are: 1. do not need water delivery service, run into the rapid disintegrate of saliva in mouth, give that some function of deglutition are bad, water intaking inconvenience and gulp down patient that water promptly vomits and comprise that young baby, gerontal patient and cancer chemotherapy patient take medicine convenience is provided.2. oral cavity quick disintegrating slice is because disintegration rate is fast, and long-pending increase of medical surfaces makes the dissolution rate of medicine also accelerate thereupon, can very fast absorption onset.Especially for insoluble drug, dissolution velocity will improve bioavailability soon greatly.Many low dosages (＜60mg), the less water soluble drug of molecular weight, when if the pKa value allows it to exist with the nonionic state under the pH environment of oral cavity, these medicines can be absorbed into blood by the biomembrane in oral cavity especially Sublingual, have therefore improved the absorption and the bioavailability of medicine.3. the conventional tablet disintegrate is slow, and the danger of esophageall obstruetion and tissue injury is bigger in oral process, and the big medicine of zest such as aspirin etc., and too high at the gastric local concentration, its probability of bringing out stomach and gastrointestinal hemorrhage also can be along with increase.And when making oral cavity quick disintegrating slice, its gastrointestinal rate of side effects reduces greatly.4. after the quick disintegrate of oral cavity quick disintegrating slice, the part medicine can pass through oral cavity, Sublingual and periglottis transhipment, is absorbed into blood.Nitroglycerin and progesterone and PEG mixing film-making, its fusing point near body temperature, can oral transmucosal in the oral cavity transhipment, avoided the first pass effect of hepar of medicine, this is easily especially meaningful by the destructive medicine of liver drug enzyme to steroid hormone class etc.
The oral rapidly disintegrating piece preparation method mainly contains: Freeze Drying Technique, effervescent technology, solid solution technology, spray drying technology and direct compression technology.Employing Freeze Drying Techniques such as Gregory have been made the pharmaceutical carrier of high porosity, and this carrier runs into the rapid disintegrate of saliva in the oral cavity.Subsequently, Japan Patent No.76420/1977 has adopted solution-type or pasty medicament mixture has been added to the 5%-80% freezing point in-30 ℃～-25 ℃ atent solvent, and in cold medium such as liquid nitrogen, freeze, low temperature (being lower than the solvent freezing point) lower sheeting, the method that volatilizes solvent by normal temperature air drying or lyophilization has prepared the tablet of high porosity again.But this method is tabletting at low temperatures, and the production cost height is not suitable for suitability for industrialized production.People's thinking has been opened up in the appearance of effervescent technology, the pharmaceutical work person is attempting using it for the preparation rapidly disintegrating formulation, its principle mainly is behind acid (citric acid, tartaric acid etc.) and carbonate or the bicarbonate chance water chemical action to take place to produce carbon dioxide, gas discharges the rapid disintegrate that has caused tablet from tablet inside, effervescent also can be covered the disagreeable taste of medicine, but a large amount of effervescents bubbles a mouthful interior generation to be felt, and only makes effervescent produce good effect by interior saliva being difficult to of mouth; Simultaneously because the existence of effervescent makes to the workshop requirement very high.Some new patented technologies appearred after the nineties in 20th century, be based on the thinking of preparation high porosity equally, some new techniques such as solid solution technology, spray drying technology etc. have been adopted, these methods all have some unique advantages, but production equipment is required height, and suitability for industrialized production all acquires a certain degree of difficulty.Recently, the flashtab company of Ethypharm company adopts direct compression process to prepare the oral cavity quick disintegrating slice drug-supplying system, and technology is simple, and adaptability is good, enjoys people to pay close attention to, and the method is applicable to some low doses and the preparation of the medicine oral cavity quick disintegrating slice of the good sense of taste is arranged.But for most drug, all has the bad sense of taste, direct compression process is made oral cavity quick disintegrating slice, run into saliva after, can rapid disintegrate and dissolving in the short time, make medicine be liquid or suspension state, thereby produce unhappy sensation in mouth, Cima company has adopted effervescent technology flavoring, and the very poor medicine of some sense of taste is difficult to reach promising result, simultaneously because the tablet quality is loose, transportation is frangible, need to adopt special terms of packing.Though the Flashtab of Ethpharm company then adopts crystallization or granule coating technology can correct the adverse drug sense of taste, the oral cavity quick disintegrating slice grittiness sense that coated granule is made.
Summary of the invention:
Technical problem to be solved by this invention is to overcome the deficiency of above-mentioned technology, designs a kind ofly to correct the adverse drug sense of taste and make oral cavity quick disintegrating slice and preparation method by the powder coating technology.The present invention be directly with drug powder with the coating material coating, grain diameter is 75-180 μ m behind the coating, makes oral cavity quick disintegrating slice 10-40 i.e. all disintegrates in the oral cavity in second, does not have the bad sense of taste and sand type.
The invention provides a kind of oral cavity quick disintegrating slice, comprise that active constituents of medicine 0.1-50%, coating material 0.1-20%, filler 40%-80%, correctives 0-2% and disintegrating agent 2-40% form.The said medicine active component is anti-infectives, antipyretic-antalgic anti-inflammatory agent, preventing or arresting vomiting medicine, H
2The compound preparation of a kind of or its composition in receptor antagonist, steroid hormone class medicine, painstaking effort tubing, the sedative hypnotic; Coating material is selected from acrylic resin, hydrogenated vegetable oil, Rikemal B 200, gelatin, ethylene copolymer, cyclodextrin or their mixture; Filler is selected from sorbitol, glucose, mannitol, lactose, galactose etc. or their mixture; Correctives is selected from orange flavor, Oleum Menthae Rotundifoliae, vanillin, Herba Menthae essence, Mentholum, Oleum menthae, aspartame, cyclamate or their mixture; Disintegrating agent comprises microcrystalline Cellulose, carboxymethyl starch sodium, crosslinked carboxymethyl fecula sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose or their mixture.
Another object of the present invention has provided a kind of preparation method of the medicine oral cavity quick disintegrating slice through powder coating, this method is that recipe quantity principal agent and an amount of filler were pulverized the 80-150 mesh sieve, or directly take by weighing principal agent and pulverized the 80-150 mesh sieve, put in the fluid bed, carry out powder coating with dissolving or fused coating material, make principal agent weightening finish 2-40%, correct the adverse drug sense of taste, medicine after the flavoring is crossed 80 mesh sieves, add the residue filler, correctives, mix homogeneously such as disintegrating agent, (or the principal agent after the flavoring is crossed 80 mesh sieves, with the residue filler, an amount of disintegrating agent, the correctives mix homogeneously is granulated, and dried granule mixes with other adjuvant such as disintegrating agent etc.), tabletting promptly gets oral cavity quick disintegrating slice.
Oral cavity quick disintegrating slice of the present invention, the disintegrating agent that adds during tabletting (microcrystalline Cellulose, crosslinked carboxymethyl fecula sodium, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose etc.) has intensive imbibition effect, can make moisture enter tablet inside fast, tablet 10-40 in second rapidly disintegrate become fine particle.Select filler for use.Be water-soluble material, can guarantee that its speed at short notice collapses.Therefore, oral cavity disintegration tablet of the present invention has following advantage than ordinary tablet: 1. dissolution in vitro improves (see Table 1, Fig. 1) greatly.2. adopt the powder coating technology that medicine is carried out flavoring, the more common oral cavity disintegration tablet of gained oral cavity disintegration tablet obviously improves, grain graininess is less behind the coating, and particle diameter is put and do not had sand type in the oral cavity below 180 μ m, the solution that can be dissolved into other adjuvants, enter digestive tract with swallowing act drug action take place, and adopt conventional granule coating technology flavoring, behind the coating grain diameter several to 1200 μ m, it is obvious to put in the oral cavity sand type, produces unplessantness displeasure to the pill taker.3. oral cavity quick disintegrating slice of the present invention, to some old peoples, child, the patient that swallows medicine and have obstacle and water intaking inconvenience takes medicine and bring great convenience, market prospect is wide.
The dissolution of table 1 oral cavity disintegration tablet and ordinary tablet (%) relatively
Time (min) oral cavity disintegration tablet ordinary tablet
2 47.52 2.56
4 82.36 8.65
6 87.97 31.77
8 96.54 34.12
10 99.44 38.96
20 - 55.56
60 - 72.12
120 - 90.23
Description of drawings:
The external stripping characteristic curve of Fig. 1, oral cavity disintegration tablet and ordinary tablet relatively
The specific embodiment:
Embodiment 1 is a principal agent with the ibuprofen, and other compositions are that adjuvant prepares oral cavity quick disintegrating slice, prescription:
Ibuprofen 200g
Eudragit E 100 20g
Mannitol 150g
Lactose 200g
Microcrystalline Cellulose 300g
Polyvinylpolypyrrolidone 60g
Orange flavor 5g
Aspartame 5g
Magnesium stearate 50g
Make 1000 altogether
Preparation method: ibuprofen was pulverized 80 mesh sieves, put in the fluid bed, with Eudragit E 100 solution coatings, make principal agent weightening finish 10%, medicine is crossed 80 mesh sieves behind the coating, takes by weighing recipe quantity mannitol, lactose, microcrystalline Cellulose, polyvinylpolypyrrolidone, orange flavor, aspartame, magnesium stearate and crosses 100 mesh sieves respectively, and is even with medicament mixed, tabletting promptly gets sheet and heavily is the fast disintegrating tablet of the ibuprofen oral of 1g.
Embodiment 2 is a principal agent with the granisetron, and other compositions are that adjuvant prepares oral cavity quick disintegrating slice, prescription:
Granisetron 5g
Rikemal B 200 1g
Lactose 300g
Microcrystalline Cellulose 100g
Crosslinked carboxymethyl fecula sodium 59g
Herba Menthae essence 5g
Cyclamate 5g
Magnesium stearate 25g
Make 1000 altogether
Preparation method: take by weighing the recipe quantity granisetron, an amount of lactose was pulverized 120 mesh sieves, take by weighing the recipe quantity fine powder, put in the fluid bed, with Rikemal B 200 hot melt coating, make principal agent weightening finish 20%, medicine is crossed 80 mesh sieves behind the coating, take by weighing recipe quantity microcrystalline Cellulose, crosslinked carboxymethyl fecula sodium, Herba Menthae essence, cyclamate, magnesium stearate and residue lactose and cross 100 mesh sieves respectively, even with medicament mixed, tabletting promptly gets sheet and heavily is the granisetron oral cavity quick disintegrating slice of 0.5g.
Embodiment 3 is a principal agent with the Roxithromycin, and other compositions are that adjuvant prepares oral cavity quick disintegrating slice, prescription:
Roxithromycin 125g
Eudragit E 100 25g
Sorbitol 250g
Lactose 280g
Carboxymethyl starch sodium 200g
Cross-linking sodium carboxymethyl cellulose 60g
Vanillin 5g
Aspartame 5g
Magnesium stearate 50g
Make 1000 altogether
Preparation method: Roxithromycin was pulverized 150 mesh sieves, take by weighing the recipe quantity fine powder, put in the fluid bed, with Eudragit E 100 coatings, make principal agent weightening finish 20%, medicine is crossed 80 mesh sieves behind the coating, and it is even to take by weighing recipe quantity sorbitol, lactose, carboxymethyl starch sodium, aspartame and medicament mixed, and 30 mesh sieves are granulated after the water-wet, dry, dried granule and recipe quantity vanillin, cross-linking sodium carboxymethyl cellulose, magnesium stearate mix homogeneously, tabletting promptly gets sheet and heavily is the fast disintegrating tablet of the roxithromycin oral of 1g.
Embodiment 4 is a principal agent with the ranitidine hydrochloride, and other compositions are that adjuvant prepares oral cavity quick disintegrating slice, prescription:
Ranitidine hydrochloride 150g
Rikemal B 200 30g
Sorbitol 250g
Lactose 275g
Carboxymethyl starch sodium 200g
Cross-linking sodium carboxymethyl cellulose 60g
Vanillin 5g
Aspartame 5g
Magnesium stearate 25g
Make 1000 altogether
Preparation method: ranitidine hydrochloride was pulverized 100 mesh sieves, take by weighing the recipe quantity fine powder, put in the fluid bed, with Rikemal B 200 hot melt coating, make principal agent weightening finish 20%, medicine is crossed 80 mesh sieves behind the coating, it is even to take by weighing recipe quantity sorbitol, lactose, carboxymethyl starch sodium, aspartame and medicament mixed, 30 mesh sieves are granulated after the water-wet, dry, dried granule and recipe quantity vanillin, cross-linking sodium carboxymethyl cellulose, magnesium stearate mix homogeneously, tabletting promptly gets sheet and heavily is the ranitidine hydrochloride oral cavity quick disintegrating slice of 1g.
Embodiment 5 is a principal agent with the estradiol, and other compositions are that adjuvant prepares oral cavity quick disintegrating slice, prescription:
Estradiol 20g
Gelatin 2g
Galactose 193g
Microcrystalline Cellulose 200g
Low-substituted hydroxypropyl cellulose 50g
The smart 5g of Herba Menthae Rotundifoliae
Cyclamate 5g
Magnesium stearate 25g
Make 1000 altogether
Preparation method: estradiol was pulverized 100 mesh sieves, take by weighing the recipe quantity fine powder, put in the fluid bed, with gelatine glaze, make principal agent weightening finish 10%, medicine is crossed 80 mesh sieves behind the coating, and it is even to take by weighing recipe quantity galactose, microcrystalline Cellulose, cyclamate and medicament mixed, and 30 mesh sieves are granulated after the water-wet, dry, dried granule and recipe quantity Herba Menthae Rotundifoliae essence, low-substituted hydroxypropyl cellulose, magnesium stearate mix homogeneously, tabletting promptly gets sheet and heavily is the estradiol oral cavity quick disintegrating slice of 0.5g.
Embodiment 6 is a principal agent with the oxazepam, and other compositions are that adjuvant prepares oral cavity quick disintegrating slice, prescription:
Oxazepam 15g
Eudragit E 100 3g
Glucose 197g
Microcrystalline Cellulose 200g
Low-substituted hydroxypropyl cellulose 50g
Herba Menthae essence 5g
Aspartame 5g
Magnesium stearate 25g
Make 1000 altogether
Preparation method: oxazepam was pulverized 100 mesh sieves, take by weighing the recipe quantity fine powder, put in the fluid bed, with Eudragit E 100 coatings, make principal agent weightening finish 20%, medicine is crossed 80 mesh sieves behind the coating, and it is even to take by weighing recipe quantity glucose, microcrystalline Cellulose, aspartame and medicament mixed, and 30 mesh sieves are granulated after the water-wet, dry, dried granule and recipe quantity Herba Menthae essence, low-substituted hydroxypropyl cellulose, magnesium stearate mix homogeneously, tabletting promptly gets sheet and heavily is the oxazepam oral cavity quick disintegrating slice of 0.5g.
Embodiment 7 is a principal agent with the captopril, and other compositions are that adjuvant prepares oral cavity quick disintegrating slice, prescription:
Captopril 25g
Eudragit E 100 5g
Lactose 300g
Microcrystalline Cellulose 100g
Crosslinked carboxymethyl fecula sodium 35g
Herba Menthae essence 5g
Cyclamate 5g
Magnesium stearate 25g
Make 1000 altogether
Preparation method: captopril was pulverized 100 mesh sieves, take by weighing the recipe quantity fine powder, put in the fluid bed, with Eudragit E 100 coatings, make principal agent weightening finish 20%, medicine is crossed 80 mesh sieves behind the coating, and it is even to take by weighing recipe quantity lactose, microcrystalline Cellulose, cyclamate and medicament mixed, and 30 mesh sieves are granulated after the water-wet, dry, dried granule and recipe quantity Herba Menthae essence, low-substituted hydroxypropyl cellulose, magnesium stearate mix homogeneously, tabletting promptly gets sheet and heavily is the captopril oral cavity quick disintegrating slice of 0.5g.
Claims (5)
1, a kind of oral cavity quick disintegrating slice through powder coating is characterized in that this oral cavity quick disintegrating slice comprises that active constituents of medicine 0.1-50%, coating material 0.1-20%, filler 40%-80%, correctives 0-2% and disintegrating agent 2-40% form.
2, a kind of preparation method of the oral cavity quick disintegrating slice through powder coating as claimed in claim 1, it is characterized in that this method is to take by weighing the prescription principal agent to pulverize the 80-150 mesh sieve with an amount of filler, or directly take by weighing principal agent and pulverized the 80-150 mesh sieve, put in the fluid bed, carry out powder coating with dissolving or fused coating material, make principal agent weightening finish 2-40%, correct the adverse drug sense of taste, medicine after the flavoring is crossed 80 mesh sieves, add the residue filler, correctives, mix homogeneously such as disintegrating agent, tabletting, or the principal agent after the flavoring crosses 80 mesh sieves, with the residue filler, an amount of disintegrating agent, the correctives mix homogeneously, granulate, dried granule and other adjuvant such as disintegrating agent, mixing such as lubricant, tabletting promptly gets oral cavity quick disintegrating slice.
3, a kind of preparation method of the oral cavity quick disintegrating slice through powder coating as claimed in claim 2 is characterized in that grain diameter is 75-180 μ m behind the coating.
4, a kind of oral cavity quick disintegrating slice through powder coating according to claim 1 is characterized in that wherein said active constituents of medicine is anti-infectives, antipyretic-antalgic anti-inflammatory agent, preventing or arresting vomiting medicine, H
2The compound preparation of a kind of or its composition in receptor antagonist, steroid hormone class medicine, painstaking effort tubing, the sedative hypnotic.
5, a kind of oral cavity quick disintegrating slice through powder coating according to claim 1 is characterized in that wherein said coating material is selected from acrylic resin, hydrogenated vegetable oil, Rikemal B 200, gelatin, ethylene copolymer, cyclodextrin or their mixture; Filler is selected from sorbitol, glucose, mannitol, lactose, galactose etc. or their mixture; Correctives is selected from orange flavor, Oleum Menthae Rotundifoliae, vanillin, Herba Menthae essence, Mentholum, Oleum menthae, aspartame, cyclamate or their mixture; Disintegrating agent comprises microcrystalline Cellulose, carboxymethyl starch sodium, crosslinked carboxymethyl fecula sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose or their mixture.
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| CNA031159311A CN1531921A (en) | 2003-03-21 | 2003-03-21 | Powder coated medicine oral quick cracking tablet and its preparing method |
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| CNA031159311A CN1531921A (en) | 2003-03-21 | 2003-03-21 | Powder coated medicine oral quick cracking tablet and its preparing method |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1303989C (en) * | 2004-10-25 | 2007-03-14 | 北京科信必成医药科技发展有限公司 | Zinc gluconate oral disintegrating tablet and its preparation process |
| CN101791297A (en) * | 2010-02-10 | 2010-08-04 | 中国药科大学 | Atorvastatin calcium oral disintegrating tablet and preparation method thereof |
| CN107007565A (en) * | 2017-03-17 | 2017-08-04 | 万全万特制药江苏有限公司 | A kind of Lurasidone HCl oral disintegrating tablet and preparation method thereof |
| CN107412174A (en) * | 2017-03-27 | 2017-12-01 | 北京万全德众医药生物技术有限公司 | A kind of Rupatadine fumarate oral disintegrating tablet and preparation method thereof |
| CN110917165A (en) * | 2019-12-26 | 2020-03-27 | 北京鑫开元医药科技有限公司海南分公司 | Ibuprofen orally disintegrating tablet and preparation method thereof |
| WO2022069956A1 (en) * | 2020-09-29 | 2022-04-07 | Millicent Pharma Limited | Orodispersible formulations |
-
2003
- 2003-03-21 CN CNA031159311A patent/CN1531921A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1303989C (en) * | 2004-10-25 | 2007-03-14 | 北京科信必成医药科技发展有限公司 | Zinc gluconate oral disintegrating tablet and its preparation process |
| CN101791297A (en) * | 2010-02-10 | 2010-08-04 | 中国药科大学 | Atorvastatin calcium oral disintegrating tablet and preparation method thereof |
| CN107007565A (en) * | 2017-03-17 | 2017-08-04 | 万全万特制药江苏有限公司 | A kind of Lurasidone HCl oral disintegrating tablet and preparation method thereof |
| CN107412174A (en) * | 2017-03-27 | 2017-12-01 | 北京万全德众医药生物技术有限公司 | A kind of Rupatadine fumarate oral disintegrating tablet and preparation method thereof |
| CN110917165A (en) * | 2019-12-26 | 2020-03-27 | 北京鑫开元医药科技有限公司海南分公司 | Ibuprofen orally disintegrating tablet and preparation method thereof |
| WO2022069956A1 (en) * | 2020-09-29 | 2022-04-07 | Millicent Pharma Limited | Orodispersible formulations |
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