CN102871976A - Tablet containing roflumilast as active ingredients and preparation method of tablet - Google Patents
Tablet containing roflumilast as active ingredients and preparation method of tablet Download PDFInfo
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- CN102871976A CN102871976A CN2012103749450A CN201210374945A CN102871976A CN 102871976 A CN102871976 A CN 102871976A CN 2012103749450 A CN2012103749450 A CN 2012103749450A CN 201210374945 A CN201210374945 A CN 201210374945A CN 102871976 A CN102871976 A CN 102871976A
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- roflumilast
- tablet
- ethanol
- water
- active component
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- MNDBXUUTURYVHR-UHFFFAOYSA-N roflumilast Chemical compound FC(F)OC1=CC=C(C(=O)NC=2C(=CN=CC=2Cl)Cl)C=C1OCC1CC1 MNDBXUUTURYVHR-UHFFFAOYSA-N 0.000 title claims abstract description 55
- 229960002586 roflumilast Drugs 0.000 title claims abstract description 55
- 238000002360 preparation method Methods 0.000 title claims abstract description 26
- 239000004480 active ingredient Substances 0.000 title abstract 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 68
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 36
- 239000003814 drug Substances 0.000 claims abstract description 33
- -1 hydroxypropyl methyl Chemical group 0.000 claims abstract description 26
- 239000011259 mixed solution Substances 0.000 claims abstract description 22
- 229940079593 drug Drugs 0.000 claims abstract description 20
- 239000011230 binding agent Substances 0.000 claims abstract description 18
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 17
- 239000002904 solvent Substances 0.000 claims abstract description 8
- 239000000080 wetting agent Substances 0.000 claims description 8
- 239000008187 granular material Substances 0.000 claims description 7
- 229920002261 Corn starch Polymers 0.000 claims description 6
- 239000008120 corn starch Substances 0.000 claims description 6
- 239000000203 mixture Substances 0.000 claims description 6
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims description 5
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 4
- 229930195725 Mannitol Natural products 0.000 claims description 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 4
- 229920000881 Modified starch Polymers 0.000 claims description 4
- 239000000594 mannitol Substances 0.000 claims description 4
- 235000010355 mannitol Nutrition 0.000 claims description 4
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 4
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 4
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 4
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 3
- 238000000034 method Methods 0.000 abstract description 9
- 238000004090 dissolution Methods 0.000 abstract description 8
- 230000000144 pharmacologic effect Effects 0.000 abstract description 4
- 238000005469 granulation Methods 0.000 abstract description 3
- 230000003179 granulation Effects 0.000 abstract description 3
- 239000003906 humectant Substances 0.000 abstract 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 abstract 1
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 description 9
- 239000000243 solution Substances 0.000 description 5
- 208000024891 symptom Diseases 0.000 description 3
- MSYGAHOHLUJIKV-UHFFFAOYSA-N 3,5-dimethyl-1-(3-nitrophenyl)-1h-pyrazole-4-carboxylic acid ethyl ester Chemical compound CC1=C(C(=O)OCC)C(C)=NN1C1=CC=CC([N+]([O-])=O)=C1 MSYGAHOHLUJIKV-UHFFFAOYSA-N 0.000 description 2
- 102000011017 Type 4 Cyclic Nucleotide Phosphodiesterases Human genes 0.000 description 2
- 108010037584 Type 4 Cyclic Nucleotide Phosphodiesterases Proteins 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000003112 inhibitor Substances 0.000 description 2
- 230000009325 pulmonary function Effects 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 206010011224 Cough Diseases 0.000 description 1
- 101100296720 Dictyostelium discoideum Pde4 gene Proteins 0.000 description 1
- 208000019693 Lung disease Diseases 0.000 description 1
- 101100082610 Plasmodium falciparum (isolate 3D7) PDEdelta gene Proteins 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 239000000556 agonist Substances 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 206010006451 bronchitis Diseases 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 239000003862 glucocorticoid Substances 0.000 description 1
- 208000019622 heart disease Diseases 0.000 description 1
- 230000036737 immune function Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 210000003097 mucus Anatomy 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 208000023504 respiratory system disease Diseases 0.000 description 1
- 230000036301 sexual development Effects 0.000 description 1
- 239000008279 sol Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
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Abstract
The invention discloses a tablet containing roflumilast as active ingredients and a preparation method of the tablet. The tablet comprises binders, other drug excipients, humectants, drug-loading solvents and the roflumilast, wherein the binders are hydroxypropyl methyl cellulose, and the humectants and drug preparations are mixed solution of ethanol and water. The tablet and the preparation method thereof have the advantages that the mixed solution of the ethanol and the water serves as the drug-loading solvents, and dissolved states of the active ingredients not subjected to micronization are controlled by utilizing difference of solubility of the roflumilast in the ethanol and the water and adjusting the proportion of the ethanol and the water; the roflumilast is dissolved out fast from preparations to achieve pharmacological action by using the hydroxypropyl methyl cellulosas as the binders and conjunctively adjusting and controlling the dissolution rate of the roflumilast from the tablets, the whole process does not need pretreatment and can be achieved by normal granulation and tabletting, and the technical process is simple while cost is saved.
Description
Technical field
The present invention relates to medical technical field, relate in particular to a kind of roflumilast that contains as tablet of active component and preparation method thereof.
Background technology
Chronic obstructive pulmonary disease (Chronic obstructive pulmonary diseases, COPD) be a kind of serious chronic respiratory system diseases, number of patients is many, case fatality rate is high, because it slowly carries out sexual development, have a strong impact on patient's work capacity and quality of life, COPD patient is after acute attack stage, though clinical symptoms is alleviated to some extent, but its pulmonary function is still continuing deterioration, and because self-defense and the reduction of immunologic function and the impact of extraneous various harmful factors, often repeatedly outbreak, and producing gradually various heart and lung diseases, present standard care medicine is B
2Adrenoceptor agonists, glucocorticoid and antibiotics.
Roflumilast (Roflumilast) is the new drug of the treatment COPD of FDA (Food and Drug Adminstration) (FDA) approval on March 1st, 2011 listing, belong to phosphodiesterase-4 (PDE-4) inhibitor, be applicable to suffer from serious COPD patient's cough and the mucus too much symptom relevant with bronchitis, roflumilast is first medicine for serious symptom COPD treatment, also is the first oral anti-inflammatory treatment medicine that develops specially for COPD patient.Clinical research shows, roflumilast can significantly be alleviated COPD, and sb.'s illness took a turn for the worse and improve pulmonary function, and consumption is lower, untoward reaction is less.
The bioavailability of medicine depends on the rate of release of medicine from dosage form basically, medicine discharges faster from preparation and just means its very fast performance drug effect, for sl. sol. medicine in water, bioavailability often is subjected to the restriction of dissolubility or dissolution rate, so that be difficult to produce suitable dosage form.It is active component that US Patent No. 2005159492 discloses a kind of PDE4 of containing inhibitor, contain PVP is conventional tablet of binding agent and preparation method thereof.Because the dissolubility of active component roflumilast is relatively poor, in order to obtain comparatively ideal dissolution rate, active component is carried out micronization, granulate as wetting agent with pure water, although the method can get a desired effect, still there is the comparatively loaded down with trivial details shortcoming of technique.
Summary of the invention
The purpose of this invention is to provide a kind of roflumilast that contains as tablet of active component and preparation method thereof, dissolution rate is slow to overcome in the existing preparation method, complex process and the high deficiency of running cost.
The technical scheme that realizes the object of the invention is as follows:
A kind of roflumilast that contains is as the tablet of active component, described tablet contains binding agent, other medicines excipient, wetting agent and medicine carrying solvent and roflumilast, described binding agent is hydroxypropyl emthylcellulose, and described wetting agent and pharmaceutical preparation are the mixed solution of ethanol and water; The mixed solution of described binding agent and ethanol and water can the dissolution rate of synergy regulation and control roflumilast from tablet.
Described other medicines excipient is selected from lower one or more: a Lactose hydrate, corn starch, microcrystalline Cellulose, mannitol, pregelatinized Starch.
Among the present invention, hydroxypropyl emthylcellulose is the low viscosity model, and preferred viscosity ranges is at 2 ~ 60 mPas; The ratio that described binding agent accounts for described other medicines excipient by weight percentage is 0.3% ~ 1.0%; The ratio that described binding agent accounts for the mixed solution of described ethanol and water by weight percentage is 1% ~ 5%.
Among the present invention, the volumetric concentration of described ethanol is 95%, and the mass ratio of ethanol and water is 12:1 ~ 5:1 in the mixed solution of described ethanol and water.
Above-mentioned contains roflumilast as the preparation method of the tablet of active component, may further comprise the steps:
(1) with described other medicines mixed with excipients;
(2) hydroxypropyl emthylcellulose and roflumilast are dissolved respectively or be suspended in the mixed solution of described ethanol and water;
(3) solution that obtains in the mixture that obtains in the step (1) and the step (2) is granulated in wet granulator or fluidised bed granulator, behind super-dry and granulate, carry out tabletting.
Beneficial effect of the present invention: the mixed solution of ethanol and water utilizes the deliquescent difference of roflumilast in the second alcohol and water as the medicine carrying solvent, controls dissolved state without micronized active component by the ratio of adjusting the second alcohol and water; Select simultaneously hydroxypropyl emthylcellulose as binding agent, the dissolution rate of combined regulating roflumilast from tablet, make its from preparation faster stripping to realize pharmacological action, whole process need not to carry out pretreatment, only can realize by common granulation and tabletting, not only simple process, and saving cost.
Description of drawings:
The below is described in further detail the present invention with reference to the accompanying drawings.
Fig. 1 be embodiment of the invention preparation contain roflumilast as the Dissolution of Tablet curve chart of active component.
The specific embodiment
Below by specific embodiment foregoing of the present invention is described in further detail again.But this should be interpreted as that the above-mentioned subject area of the present invention only limits to following embodiment.All technical schemes that realizes based on foregoing of the present invention all belong to the scope of protection of the invention.
Embodiment 1
The embodiment of the invention is described to be contained roflumilast and contains as the tablet of active component:
A: roflumilast (crossing 150 mesh sieves) 0.5 mg;
B a: Lactose hydrate 99.32 mg;
C: corn starch 26.78 mg;
D: hydroxypropyl emthylcellulose (viscosity 4 ~ 6mPs) 1 mg;
E: water 3 mg;
F: ethanol 22 mg;
Finally obtain: 128.2 mg/sheet.
The described roflumilast that contains of the embodiment of the invention may further comprise the steps as the preparation method of the tablet of active component:
(1) all drug excipients except hydroxypropyl emthylcellulose is mixed;
(2) hydroxypropyl emthylcellulose and roflumilast are dissolved respectively or be suspended in the mixed solution of ethanol and water;
(3) mixture that obtains in the step (1) is granulated in wet granulator with (2) middle solution that obtains, wet granular carries out tabletting behind super-dry and granulate, and sheet heavily is controlled at 128.2mg.
Embodiment 2
The embodiment of the invention is described to be contained roflumilast and contains as the tablet of active component:
A: roflumilast (crossing 150 mesh sieves) 0.5 mg;
B a: Lactose hydrate 99.32 mg;
C: corn starch 26.78 mg;
D: hydroxypropyl emthylcellulose (viscosity 4 ~ 6mPs) 1 mg;
E: water 3.6 mg;
F: ethanol 18 mg;
Finally obtain: 128.2 mg/sheet.
The described roflumilast that contains of the embodiment of the invention may further comprise the steps as the preparation method of the tablet of active component:
(1) all drug excipients except hydroxypropyl emthylcellulose is mixed;
(2) hydroxypropyl emthylcellulose and roflumilast are dissolved respectively or be suspended in the mixed solution of ethanol and water;
(3) mixture and the middle solution that obtains of step (2) that obtain in the step (1) are granulated in wet granulator, wet granular carries out tabletting behind super-dry and granulate, and sheet heavily is controlled at 128.2mg.
Embodiment 3
The embodiment of the invention is described to be contained roflumilast and contains as the tablet of active component:
A: roflumilast (crossing 150 mesh sieves) 0.5 mg;
B: microcrystalline Cellulose 105.32 mg;
C: pregelatinized Starch 20.18 mg;
D: hydroxypropyl emthylcellulose (viscosity 40 ~ 60mPs) 0.5 mg;
E: water 2 mg;
F: ethanol 30 mg;
Finally obtain: 126.5 mg/sheet.
The described roflumilast that contains of the embodiment of the invention may further comprise the steps as the preparation method of the tablet of active component:
(1) all drug excipients except hydroxypropyl emthylcellulose is mixed;
(2) hydroxypropyl emthylcellulose and roflumilast are dissolved respectively or be suspended in the mixed solution of ethanol and water;
(3) mixture and the middle solution that obtains of step (2) that obtain in the step (1) are granulated in fluidised bed granulator, wet granular carries out tabletting behind super-dry and granulate, and sheet heavily is controlled at 126.5mg.
Embodiment 4
The embodiment of the invention is described to be contained roflumilast and contains as the tablet of active component:
A: roflumilast (crossing 150 mesh sieves) 0.5 mg;
B: mannitol 79.32 mg;
C: corn starch 25.18 mg;
D: hydroxypropyl emthylcellulose (viscosity 3 ~ 7mPs) 1.1 mg;
E: water 2 mg;
F: ethanol 20 mg;
Finally obtain: 106.1 mg/sheet.
The described roflumilast that contains of the embodiment of the invention may further comprise the steps as the preparation method of the tablet of active component:
(1) all drug excipients except hydroxypropyl emthylcellulose is mixed;
(2) hydroxypropyl emthylcellulose and roflumilast are dissolved respectively or be suspended in the mixed solution of ethanol and water;
(3) mixture and the middle solution that obtains of step (2) that obtain in the step (1) are granulated in fluidised bed granulator, wet granular carries out tabletting behind super-dry and granulate, and sheet heavily is controlled at 106.1mg.
The invention provides the tablet that contains roflumilast for oral administration, the dissolubility of considering roflumilast is lower, for make its from preparation faster stripping to reach acceptable bioavailability, thereby the blood drug level that acquisition needs and desirable pharmacological action, the invention discloses with hydroxypropyl emthylcellulose as binding agent, prepare scheme with the mixed solution of second alcohol and water as the tablet of wetting agent and medicine carrying solvent, wherein, the mixed solution of second alcohol and water is as the medicine carrying solvent, its effect is to utilize the deliquescent larger difference of roflumilast in the second alcohol and water, controls dissolving or suspension without micronized active component by the ratio of adjusting the second alcohol and water; Select simultaneously hydroxypropyl emthylcellulose as binding agent, the dissolution rate of combined regulating roflumilast from tablet makes its faster the pharmacological action of stripping to realize ideal from preparation.And, because active component need not to carry out pretreatment, can realize the present invention by common granulation and tablet forming technique, simple process saves production cost.
Claims (10)
1. one kind contains roflumilast as the tablet of active component, described tablet contains binding agent, other medicines excipient, wetting agent and medicine carrying solvent and roflumilast, it is characterized in that: described binding agent is hydroxypropyl emthylcellulose, and described wetting agent and pharmaceutical preparation are the mixed solution of ethanol and water.
2. the roflumilast that contains according to claim 1 is characterized in that as the tablet of active component: described other medicines excipient is one or more in a Lactose hydrate, corn starch, microcrystalline Cellulose, mannitol, the pregelatinized Starch.
3. the roflumilast that contains according to claim 2 is characterized in that as the tablet of active component: the viscosity of described hydroxypropyl emthylcellulose is 2 ~ 60 mPas; The ratio that described binding agent accounts for described other medicines excipient by weight percentage is 0.3% ~ 1.0%.
4. the roflumilast that contains according to claim 3 is characterized in that as the tablet of active component: the volumetric concentration of described ethanol is 95%, and the mass ratio of ethanol and water is 12:1 ~ 5:1 in the mixed solution of described ethanol and water.
5. the roflumilast that contains according to claim 4 is characterized in that as the tablet of active component: the ratio that described binding agent accounts for described ethanol and the mixed solution of water by weight percentage is 1% ~ 5%.
6. one kind contains roflumilast as the preparation method of the tablet of active component, described tablet contains binding agent, other medicines excipient, wetting agent and medicine carrying solvent and roflumilast, it is characterized in that: described binding agent is hydroxypropyl emthylcellulose, described wetting agent and pharmaceutical preparation are the mixed solution of ethanol and water, and described preparation method may further comprise the steps:
(1) with described other medicines mixed with excipients;
(2) hydroxypropyl emthylcellulose and roflumilast are dissolved respectively or be suspended in the mixed solution of described ethanol and water;
(3) mixed solution that obtains in the mixture of the described other medicines excipient that obtains in the step (1) and the step (2) is granulated in granulator, behind super-dry and granulate, carry out tabletting.
7. the roflumilast that contains according to claim 6 is as the preparation method of the tablet of active component, it is characterized in that: the viscosity of described hydroxypropyl emthylcellulose is 2 ~ 60 mPas, and the ratio that hydroxypropyl emthylcellulose accounts for the other medicines excipient by weight percentage is 0.3% ~ 1.0%.
8. the roflumilast that contains according to claim 7 is characterized in that as the preparation method of the tablet of active component: the volumetric concentration of described ethanol is 95%, and the mass ratio of ethanol and water is 12:1 ~ 5:1 in the mixed solution of described ethanol and water.
9. the roflumilast that contains according to claim 8 is characterized in that as the preparation method of the tablet of active component: the ratio that described hydroxypropyl emthylcellulose accounts for described ethanol and the mixed solution of water by weight percentage is 1% ~ 5%.
10. the roflumilast that contains according to claim 9 is characterized in that as the preparation method of the tablet of active component: described other medicines excipient is one or more in a Lactose hydrate, corn starch, microcrystalline Cellulose, mannitol, the pregelatinized Starch.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012103749450A CN102871976A (en) | 2012-09-29 | 2012-09-29 | Tablet containing roflumilast as active ingredients and preparation method of tablet |
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|---|---|---|---|
| CN2012103749450A CN102871976A (en) | 2012-09-29 | 2012-09-29 | Tablet containing roflumilast as active ingredients and preparation method of tablet |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104107173A (en) * | 2014-06-27 | 2014-10-22 | 山东泰田新药开发有限公司 | Roflumilast tablet and preparation method thereof |
| CN104644584A (en) * | 2015-01-22 | 2015-05-27 | 扬子江药业集团有限公司 | Roflumilast tablet and preparation method thereof |
| CN106176639A (en) * | 2015-04-30 | 2016-12-07 | 四川科伦药物研究院有限公司 | A kind of method preparing Roflumilast tablet |
| EP3043798A4 (en) * | 2013-09-13 | 2017-04-12 | Hetero Research Foundation | Pharmaceutical compositions of roflumilast and process for preparation thereof |
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| CN102626410A (en) * | 2012-03-16 | 2012-08-08 | 北京万全阳光医学技术有限公司 | Pharmaceutical composition containing roflumilast |
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2012
- 2012-09-29 CN CN2012103749450A patent/CN102871976A/en active Pending
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| CN1635909A (en) * | 2002-02-20 | 2005-07-06 | 奥坦纳医药公司 | Oral dosage form comprising a PDE4 inhibitor as active ingredient and polyvinylpyrrolidone as excipient |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3043798A4 (en) * | 2013-09-13 | 2017-04-12 | Hetero Research Foundation | Pharmaceutical compositions of roflumilast and process for preparation thereof |
| CN104107173A (en) * | 2014-06-27 | 2014-10-22 | 山东泰田新药开发有限公司 | Roflumilast tablet and preparation method thereof |
| CN104107173B (en) * | 2014-06-27 | 2017-06-27 | 山东泰田新药开发有限公司 | A kind of roflumilast tablet and preparation method thereof |
| CN104644584A (en) * | 2015-01-22 | 2015-05-27 | 扬子江药业集团有限公司 | Roflumilast tablet and preparation method thereof |
| CN106176639A (en) * | 2015-04-30 | 2016-12-07 | 四川科伦药物研究院有限公司 | A kind of method preparing Roflumilast tablet |
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