CN102579393A - Solid composition for improving content uniformity and dissolution rate of imidafenacin - Google Patents
Solid composition for improving content uniformity and dissolution rate of imidafenacin Download PDFInfo
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- CN102579393A CN102579393A CN 201210071263 CN201210071263A CN102579393A CN 102579393 A CN102579393 A CN 102579393A CN 201210071263 CN201210071263 CN 201210071263 CN 201210071263 A CN201210071263 A CN 201210071263A CN 102579393 A CN102579393 A CN 102579393A
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- miaow
- naxin
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- microcrystalline cellulose
- cosolvent
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Abstract
The invention relates to a solid composition containing imidafenacin. The solid composition can improve the dissolubility and content uniformity of main medicines effectively.
Description
Technical field
The invention belongs to pharmaceutical technology, be specifically related to a kind of uniformity of dosage units and solid composite that promotes miaow Da Naxin stripping of improving.
Background technology
Miaow Da Naxin (4-(2-methyl isophthalic acid-imidazole radicals)-2,2-diphenyl butanamide) is the chemical compound with M-ChR M3 and M1 antagonism, and it is used as the medicine of overactive bladder.
Overactive bladder (symptomatic overactive lbadder; OAB) be a kind of common chronic lower urinary tract dysfunction, it is the syndrome of characteristic with urgent micturition (the intensive urine sense of separating is arranged), frequent micturition and urge incontinence that international anti-urinary incontinence association (ICS) is defined as it a kind of.The overacfivity bladder medicine " miaow Da Naxin " of Japan Fructus Pruni woods company receives its first whole world in June, 2007 in Japan and ratifies certainly to recommend; The anticholinergic side effects of this oral muscarine M1/M3 antagonist has clear improvement, and is the good medicine that is used to treat frequent micturition, urgent micturition and urinary incontinence.
Miaow Da Naxin is water-soluble hardly; And the principal agent specification is little; Traditional formulation and technology technology possibly exist that bioavailability is low, the defective problem of uniformity of dosage units; At present research worker possibly solve this problem through adopting methods such as preparation solid dispersion such as surface active agent solubilization such as sodium lauryl sulphate, Macrogol 4000 or 6000, still still can have the problem of less stable, complicated process of preparation.
Summary of the invention
The present invention aims to provide a kind of solid composite medicament, and the active component that contains is an acceptable salt on miaow Da Naxin and the pharmacology thereof, also contains other adjuvants in addition;
This solid composite that the present invention relates to; Be that miaow Da Naxin and hydrophilicity condiment are carried out the air-flow micronization according to certain ratio; Its particle size range is less than 5um; Wherein said hydrophilicity condiment can be pregelatinized Starch, mannitol, lactose, maltose, glucose etc., and the ratio of principal agent and hydrophilicity condiment is 1:5 ~ 20, is preferably 1:10;
The solid composite that the present invention relates to contains a kind of hydrophilic gel material as cosolvent, and this cosolvent is a hydroxypropyl cellulose, and its consumption is 1%-6%, is preferably 3%-5%;
This compositions that the present invention relates to, other contained adjuvants comprise excipient, disintegrating agent, adhesive, lubricant, coating material etc.;
This compositions that the present invention relates to, filler can be one or more the mixture in the cellulose families such as saccharides such as lactose, glucose, starch, microcrystalline Cellulose, and its percentage by weight is 30 ~ 80%, and preferred 40 ~ 60%;
This compositions that the present invention relates to; Disintegrating agent can be enumerated as one or more the mixture in cellulose families such as cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, carboxymethylcellulose calcium, microcrystalline Cellulose, carboxymethyl starch sodium, the polyvinylpolypyrrolidone etc., and its percentage by weight is 5%-50%;
This compositions that the present invention relates to, adhesive can be starch slurry, hydroxypropyl cellulose, hypromellose, polyvinylpyrrolidone etc., and its percentage by weight is 0.2 ~ 3%, preferred 0.2 ~ 0.5%;
This compositions that the present invention relates to, lubricant can be one or more the mixture in stearic acid and its metallic salt, Pulvis Talci, micropowder silica gel, the sucrose fatty acid ester etc.; Lubricant accounts for the 0.3%-2.0% of percentage by weight;
This compositions that the present invention relates to, coating material consists of hypromellose, titanium dioxide, Huang or red ferric oxide, palm wax;
This compositions that the present invention relates to can be prepared into oral solid formulation, like capsule, tablet etc., and is preferably tablet.
The specific embodiment
Embodiment 1: miaow reaches that new film preparation (in per 1000 amounts)
| Name of material | Part by weight (%) |
| Miaow Da Naxin | 0.07 |
| Pregelatinized Starch (filler) | 67.70 |
| Hydroxypropyl cellulose (cosolvent) | 3.00 |
| Microcrystalline Cellulose (filler, disintegrating agent) | 28.43 |
| Polyvidone (binding agent) | 0.30 |
| Magnesium stearate | 0.50 |
Preparation technology: miaow Da Naxin and pregelatinized Starch are carried out the feeble QI efflorescence in the ratio of 1:10, particle diameter average out to 2.5um, microcrystalline Cellulose is crossed 80 mesh sieves, and is subsequent use; With the miaow Da Naxin of recipe quantity and pregelatinized Starch altogether powder thing, surplus pregelatinized Starch, hyprolose, in add microcrystalline Cellulose and place quick mixer granulator, by the equivalent principle mix homogeneously that progressively increases; Open and stir, add 10% polyvidone aqueous solution and granulate, 18 mesh sieves are granulated; 50 ℃ of aeration-dryings, granule moisture content in 3.0%, 24 order granulate; With the prescription ratio add microcrystalline Cellulose, magnesium stearate and granule mix homogeneously, promptly get with Φ 7mm scrobicula stamping coating.
Contrast implements 1:
| Name of material | Part by weight (%) |
| Miaow Da Naxin | 0.07 |
| Pregelatinized Starch (filler) | 70.70 |
| Microcrystalline Cellulose (filler, disintegrating agent) | 28.43 |
| Polyvidone (binding agent) | 0.03 |
| Magnesium stearate | 0.50 |
Preparation technology: with the miaow Da Naxin of recipe quantity, pregelatinized Starch, in add microcrystalline Cellulose and place quick mixer granulator, by the equivalent principle mix homogeneously that progressively increases; Open and stir, add 10% polyvidone aqueous solution and granulate, 18 mesh sieves are granulated; 50 ℃ of aeration-dryings, granule moisture content in 3.0%, 24 order granulate; With the prescription ratio add microcrystalline Cellulose, magnesium stearate and granule mix homogeneously, with the stamping of Φ 7mm scrobicula, coating increases weight and about 3% promptly gets.
Measure the embodiment of the invention 1 according to dissolution determination method (two appendix of Chinese Pharmacopoeia version in 2010) and reach that new film with comparative example's 1 prepared miaow; Be that medium (reference fluid), rotating speed are 50rpm with 900ml, pH4.5 phosphate buffer respectively; Respectively at 5,10,15,30,45,60 minutes sampling test sample dissolutions, the result saw table 1:
Control formulation, embodiment 1 and the comparative example 1 dissolution % (n=6) in the pH4.5PBS medium:
| Time (min) | Control formulation | Embodiment 1 | The comparative example 1 |
| 5 | 70.78 | 69.54 | 43.49 |
| 10 | 82.51 | 83.28 | 50.18 |
| 15 | 86.83 | 85.52 | 59.74 |
| 30 | 90.87 | 87.88 | 68.04 |
| 45 | 90.58 | 91.87 | 71.53 |
| 60 | 91.58 | 91.82 | 72.30 |
Table 1
Respectively get 10 in the sample of embodiment 1 and comparative example's 1 preparation, check its uniformity of dosage units (according to two appendix XE of Chinese Pharmacopoeia version in 2010), the result sees table 2:
Embodiment 1 and comparative example's uniformity of dosage units check result (n=10):
| Time (min) | Embodiment 1 | The comparative example 1 |
| 1 | 102.0 | 89.7 |
| 2 | 100.7 | 90.4 |
| 3 | 102.3 | 110.5 |
| 4 | 101 | 101.4 |
| 5 | 100.1 | 87.9 |
| 6 | 100.5 | 107.4 |
| 7 | 99.64 | 99.5 |
| 8 | 100.8 | 102.6 |
| 9 | 100.6 | 100.4 |
| 10 | 99.9 | 85.9 |
| Average content (%) | 100.8 | 97.6 |
| A | 0.8 | 2.4 |
| S | 0.85 | 8.55 |
| A+1.80S | 2.33 | 12.99 |
Table 2
Embodiment 2: miaow reaches that new film preparation (in per 1000 amounts)
| Name of material | Part by weight (%) |
| Miaow Da Naxin | 0.05 |
| Lactose (filler) | 68.25 |
| Hydroxypropyl cellulose (cosolvent) | 5.00 |
| Microcrystalline Cellulose (filler, disintegrating agent) | 25.95 |
| Hydroxypropyl cellulose (binding agent) | 0.25 |
| Magnesium stearate (lubricant) | 0.50 |
Preparation technology: with miaow Da Naxin and lactose according to the ratio of 1:10 carry out comminution by gas stream, microcrystalline Cellulose is crossed 80 mesh sieves, and is subsequent use; With the miaow Da Naxin of recipe quantity and lactose altogether powder thing, surplus lactose, hydroxypropyl cellulose, in add microcrystalline Cellulose and place quick mixer granulator, by the equivalent principle mix homogeneously that progressively increases; Open and stir, add 2% hydroxypropyl cellulose aqueous solution and granulate, 18 mesh sieves are granulated; 50 ℃ of aeration-dryings, granule moisture content in 3.0%, 24 order granulate; With adding microcrystalline Cellulose, magnesium stearate in the prescription ratio,, promptly get with Φ 7mm scrobicula stamping coating with high efficient mixed machine and granule mix homogeneously.
Contrast implements 2:
| Name of material | Part by weight (%) |
| Miaow Da Naxin | 0.05 |
| Lactose (filler) | 72.80 |
| Microcrystalline Cellulose (filler, disintegrating agent) | 26.40 |
| Hydroxypropyl cellulose (binding agent) | 0.25 |
| Magnesium stearate (lubricant) | 0.50 |
Preparation technology: miaow Da Naxin, pregelatinized Starch, the microcrystalline Cellulose of recipe quantity are placed quick mixer granulator, by the equivalent principle mix homogeneously that progressively increases; Open and stir, add 2% hydroxypropyl cellulose aqueous solution and granulate, 18 mesh sieves are granulated; 50 ℃ of aeration-dryings, granule moisture content in 3.0%, 24 order granulate; Microcrystalline Cellulose, magnesium stearate with the prescription ratio with high efficient mixed machine and granule mix homogeneously, promptly get with the stamping of Φ 7mm scrobicula.
Measure the embodiment of the invention 2 according to dissolution determination method (two appendix of Chinese Pharmacopoeia version in 2010) and reach that new film with comparative example's 2 prepared miaows; Be that medium (reference fluid), rotating speed are 50rpm with 900ml, pH4.5 phosphate buffer respectively; Respectively at 5,10,15,30,45,60 minutes sampling test sample dissolutions, the result saw table 3:
Control formulation, embodiment 2 and the comparative example 2 dissolution % (n=6) in the pH4.5PBS medium:
| Time (min) | Control formulation | Embodiment 2 | The comparative example 2 |
| 5 | 69.67 | 69.58 | 48.71 |
| 10 | 81.91 | 81.29 | 53.68 |
| 15 | 87.05 | 87.46 | 59.49 |
| 30 | 91.04 | 90.12 | 65.47 |
| 45 | 91.25 | 92.17 | 71.98 |
| 60 | 91.58 | 93.04 | 73.54 |
Table 3
Embodiment 2 and comparative example's 2 uniformity of dosage units check results (n=10):
| Time (min) | Embodiment 2 | The comparative example 2 |
| 1 | 100.6 | 89.7 |
| 2 | 101.4 | 99.5 |
| 3 | 99.3 | 109.8 |
| 4 | 98.7 | 94.7 |
| 5 | 105.4 | 89.7 |
| 6 | 103.9 | 100.2 |
| 7 | 100.4 | 99.5 |
| 8 | 99.7 | 100.6 |
| 9 | 100.1 | 100.4 |
| 10 | 97.9 | 94.9 |
| Average content (%) | 100.7 | 97.9 |
| A | 0.70 | -2.10 |
| S | 2.31 | 5.96 |
| A+1.80S | 4.86 | 8.63 |
Table 4
Embodiment 3: miaow reaches that new film preparation (in per 1000 amounts)
| Name of material | Part by weight (%) |
| Miaow Da Naxin | 0.10 |
| Mannitol (filler) | 48.10 |
| Hydroxypropyl cellulose (cosolvent) | 4.00 |
| Microcrystalline Cellulose (filler, disintegrating agent) | 20.00 |
| Polyvidone (binding agent) | 0.40 |
| Polyvinylpolypyrrolidone (disintegrating agent) | 26.40 |
| Magnesium stearate (lubricant) | 1.00 |
Preparation technology: with miaow Da Naxin and mannitol according to the ratio of 1:12 carry out comminution by gas stream, microcrystalline Cellulose is crossed 80 mesh sieves, and is subsequent use; With the miaow Da Naxin of recipe quantity and mannitol altogether powder thing, surplus mannitol, hydroxypropyl cellulose, microcrystalline Cellulose place quick mixer granulator, by the equivalent principle mix homogeneously that progressively increases; Open and stir, add 10% polyvidone aqueous solution and granulate, 18 mesh sieves are granulated; 50 ℃ of aeration-dryings, granule moisture content in 3.0%, 24 order granulate; Polyvinylpolypyrrolidone, magnesium stearate with the prescription ratio with high efficient mixed machine and granule mix homogeneously, promptly get with Φ 7mm scrobicula stamping coating.
Contrast implements 3:
| Name of material | Part by weight (%) |
| Miaow Da Naxin | 0.10 |
| Mannitol (filler) | 52.10 |
| Microcrystalline Cellulose (filler, disintegrating agent) | 20.00 |
| Polyvidone (binding agent) | 0.40 |
| Polyvinylpolypyrrolidone (disintegrating agent) | 26.40 |
| Magnesium stearate (lubricant) | 1.00 |
Preparation technology: miaow Da Naxin, mannitol, the microcrystalline Cellulose of recipe quantity are placed quick mixer granulator, by the equivalent principle mix homogeneously that progressively increases; Open and stir, add 10% polyvidone aqueous solution and granulate, 18 mesh sieves are granulated; 50 ℃ of aeration-dryings, granule moisture content in 3.0%, 24 order granulate; Polyvinylpolypyrrolidone, magnesium stearate with the prescription ratio with high efficient mixed machine and granule mix homogeneously, promptly get with the stamping of Φ 7mm scrobicula.
Measure the embodiment of the invention 3 according to dissolution determination method (two appendix of Chinese Pharmacopoeia version in 2010) and reach that new film with comparative example's 3 prepared miaows; Be that medium (reference fluid), rotating speed are 50rpm with 900ml, pH4.5 phosphate buffer respectively; Respectively at 5,10,15,30,45,60 minutes sampling test sample dissolutions, the result saw table 5:
Control formulation, embodiment 3 and the comparative example 3 dissolution % (n=6) in the pH4.5PBS medium:
| Time (min) | Control formulation | Embodiment 3 | The comparative example 3 |
| 5 | 69.67 | 70.34 | 49.41 |
| 10 | 81.91 | 84.03 | 51.46 |
| 15 | 87.05 | 86.49 | 60.54 |
| 30 | 91.04 | 90.58 | 69.46 |
| 45 | 91.25 | 91.13 | 72.64 |
| 60 | 91.58 | 91.09 | 73.13 |
Table 5
Embodiment 3 and comparative example's 3 uniformity of dosage units check results (n=10):
| Time (min) | Embodiment 3 | The comparative example 3 |
| 1 | 105.1 | 91.6 |
| 2 | 100.2 | 92.7 |
| 3 | 101.3 | 111.9 |
| 4 | 97.4 | 101.7 |
| 5 | 96.7 | 88.3 |
| 6 | 102.5 | 106.4 |
| 7 | 100.4 | 99.2 |
| 8 | 99.6 | 101.6 |
| 9 | 100.6 | 108.4 |
| 10 | 98.5 | 84.9 |
| Average content (%) | 100.2 | 98.7 |
| A | 0.20 | -1.30 |
| S | 2.45 | 9.01 |
| A+1.80S | 4.61 | 14.92 |
Table 6
Embodiment 4: miaow reaches that new film preparation (in per 1000 amounts)
| Name of material | Part by weight (%) |
| Miaow Da Naxin | 0.10 |
| Mannitol (filler) | 78.65 |
| Hydroxypropyl cellulose (cosolvent) | 3.50 |
| Cross-linking sodium carboxymethyl cellulose (disintegrating agent) | 16.40 |
| Polyvidone (binding agent) | 0.35 |
| Magnesium stearate (lubricant) | 1.00 |
Preparation technology: the miaow Da Naxin and the mannitol that take by weighing recipe quantity carry out the air-flow micronization according to the 1:15 ratio, and is subsequent use; With the miaow Da Naxin of recipe quantity and mannitol altogether powder thing, surplus mannitol, hyprolose, in add cross-linking sodium carboxymethyl cellulose and place quick mixer granulator, by the equivalent principle mix homogeneously that progressively increases; Open and stir, add 10% polyvidone aqueous solution and granulate, 18 mesh sieves are granulated; 50 ℃ of aeration-dryings, granule moisture content in 3.0%, 24 order granulate; With the prescription ratio add cross-linking sodium carboxymethyl cellulose, magnesium stearate, with high efficient mixed machine and granule mix homogeneously, the filling capsule gets final product.
The comparative example 4: miaow reaches that new film preparation (in per 1000 amounts)
| Name of material | Part by weight (%) |
| Miaow Da Naxin | 0.10 |
| Mannitol (filler) | 82.15 |
| Cross-linking sodium carboxymethyl cellulose (disintegrating agent) | 16.40 |
| Polyvidone (binding agent) | 0.35 |
| Magnesium stearate (lubricant) | 1.00 |
Preparation technology: take by weighing recipe quantity miaow Da Naxin, mannitol, in add cross-linking sodium carboxymethyl cellulose and place quick mixer granulator, by the equivalent principle mix homogeneously that progressively increases; Open and stir, add 10% polyvidone aqueous solution and granulate, 18 mesh sieves are granulated; 50 ℃ of aeration-dryings, granule moisture content in 3.0%, 24 order granulate; With the prescription ratio add cross-linking sodium carboxymethyl cellulose, magnesium stearate, with high efficient mixed machine and granule mix homogeneously, the filling capsule gets final product.
Measure the embodiment of the invention 4 according to dissolution determination method (two appendix of Chinese Pharmacopoeia version in 2010) and reach that new film with comparative example's 3 prepared miaows; Be that medium (reference fluid), rotating speed are 50rpm with 900ml, pH4.5 phosphate buffer respectively; Respectively at 5,10,15,30,45,60 minutes sampling test sample dissolutions, the result saw table 7:
Control formulation, embodiment 4 and the comparative example 4 dissolution % (n=6) in the pH4.5PBS medium:
| Time (min) | Control formulation | Embodiment 4 | The comparative example 4 |
| 5 | 69.67 | 69.98 | 51.04 |
| 10 | 81.91 | 80.10 | 69.43 |
| 15 | 87.05 | 89.56 | 75.82 |
| 30 | 91.04 | 92.54 | 79.31 |
| 45 | 91.25 | 93.13 | 78.64 |
| 60 | 91.58 | 92.09 | 79.32 |
Table 7
Embodiment 4 and comparative example's 4 uniformity of dosage units check results (n=10):
| Time (min) | Embodiment 4 | The comparative example 4 |
| 1 | 102.1 | 86.32 |
| 2 | 99.3 | 98.64 |
| 3 | 98.9 | 108.24 |
| 4 | 100.4 | 89.65 |
| 5 | 103.7 | 90.79 |
| 6 | 105.4 | 104.90 |
| 7 | 102.7 | 93.95 |
| 8 | 100.3 | 106.81 |
| 9 | 99.6 | 95.84 |
| 10 | 100.4 | 110.50 |
| Average content (%) | 101.3 | 98.6 |
| A | 1.30 | -1.40 |
| S | 2.12 | 9.01 |
| A+1.80S | 5.12 | 14.04 |
Table 8
Claims (7)
1. a solid composite is characterised in that and contains hydrophilicity condiment and cosolvent, to improve dissolution and the uniformity of dosage units of miaow Da Naxin.
2. according to claim 1, this solid composite is characterised in that, miaow Da Naxin and hydrophilicity condiment are carried out the air-flow micronization, and its particle diameter is less than 5um.
3. according to claim 2, it is characterized in that hydrophilicity condiment is pregelatinized Starch, mannitol, lactose, maltose, glucose etc.
4. according to claim 2, miaow Da Naxin and hydrophilicity condiment percentage by weight are that 1:5 ~ 20 are preferably 1:10.
5. according to claim 1, this solid composite is characterised in that cosolvent is a kind of hydrophilic gel material.
6. according to claim 5, it is characterized in that the hydrophilic gel material is a hydroxypropyl cellulose.
7. hydroxypropyl cellulose according to claim 6 is as cosolvent, and the percentage ratio that its consumption accounts for gross weight is 1%-6%, is preferably 3%-5%.
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| CN 201210071263 CN102579393A (en) | 2012-03-19 | 2012-03-19 | Solid composition for improving content uniformity and dissolution rate of imidafenacin |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201210071263 CN102579393A (en) | 2012-03-19 | 2012-03-19 | Solid composition for improving content uniformity and dissolution rate of imidafenacin |
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| CN102579393A true CN102579393A (en) | 2012-07-18 |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102861010A (en) * | 2012-09-05 | 2013-01-09 | 天津市汉康医药生物技术有限公司 | Imidafenacin pharmaceutical composition with improved oral-taking absorbency |
| CN103054822A (en) * | 2012-12-28 | 2013-04-24 | 南京艾德凯腾生物医药有限责任公司 | Imidafenacin tablet and preparation method thereof |
| CN103479594A (en) * | 2013-09-29 | 2014-01-01 | 扬子江药业集团四川海蓉药业有限公司 | Imidafenacin film-coated tablet and preparation method thereof |
| CN104274422A (en) * | 2014-02-12 | 2015-01-14 | 天津市汉康医药生物技术有限公司 | Pharmaceutical composition containing imidafenacin |
| CN106580899A (en) * | 2016-11-02 | 2017-04-26 | 沈阳药科大学 | Method for preparing imidafenacin tablet |
| JP2018168106A (en) * | 2017-03-30 | 2018-11-01 | 杏林製薬株式会社 | Method for producing tablet containing imidafenacin by direct tableting |
-
2012
- 2012-03-19 CN CN 201210071263 patent/CN102579393A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102861010A (en) * | 2012-09-05 | 2013-01-09 | 天津市汉康医药生物技术有限公司 | Imidafenacin pharmaceutical composition with improved oral-taking absorbency |
| CN103054822A (en) * | 2012-12-28 | 2013-04-24 | 南京艾德凯腾生物医药有限责任公司 | Imidafenacin tablet and preparation method thereof |
| CN103054822B (en) * | 2012-12-28 | 2014-03-26 | 南京艾德凯腾生物医药有限责任公司 | Imidafenacin tablet and preparation method thereof |
| CN103479594A (en) * | 2013-09-29 | 2014-01-01 | 扬子江药业集团四川海蓉药业有限公司 | Imidafenacin film-coated tablet and preparation method thereof |
| CN104274422A (en) * | 2014-02-12 | 2015-01-14 | 天津市汉康医药生物技术有限公司 | Pharmaceutical composition containing imidafenacin |
| CN104274422B (en) * | 2014-02-12 | 2018-01-19 | 天津市汉康医药生物技术有限公司 | A kind of pharmaceutical composition containing imidafenacin |
| CN106580899A (en) * | 2016-11-02 | 2017-04-26 | 沈阳药科大学 | Method for preparing imidafenacin tablet |
| CN106580899B (en) * | 2016-11-02 | 2020-05-01 | 沈阳药科大学 | Method for preparing imidafenacin tablets |
| JP2018168106A (en) * | 2017-03-30 | 2018-11-01 | 杏林製薬株式会社 | Method for producing tablet containing imidafenacin by direct tableting |
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Application publication date: 20120718 |