CN103360392A - Dolasetron mesylate compound - Google Patents
Dolasetron mesylate compound Download PDFInfo
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- CN103360392A CN103360392A CN2013102514927A CN201310251492A CN103360392A CN 103360392 A CN103360392 A CN 103360392A CN 2013102514927 A CN2013102514927 A CN 2013102514927A CN 201310251492 A CN201310251492 A CN 201310251492A CN 103360392 A CN103360392 A CN 103360392A
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- dolasetron
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- dolasetron mesilate
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Abstract
The invention provides a dolasetron mesylate compound. The dolasetron mesylate compound is an effective 5-HT3 receptor antagonist, only has an effect on a 5-HT3 receptor, has no obvious effect on other 5-HT receptors, alpha or beta-adrenergic receptor, dopamine D2, muscarinic or nerve knocking element NK1 receptors and has high selectivity, good tolerance and multiple pharmacological actions. The dolasetron mesylate compound can be used for stopping the 5-HT3 receptor and inhibiting signals from being transmitted to central nerves and is an effective medicine for preventing tumor nausea and vomit after chemotherapy and an operation. The 5-HT3 receptor antagonist is put into the markets for many years. No serious adverse effects of the 5-HT3 receptor antagonist are reported, thus the good stability of the medicine is verified.
Description
Technical field
The invention belongs to the pharmaceutical technology field, relate to particularly a kind of dolasetron mesilate compound.
Background technology
Dolasetron is that French Marion Merrell Dow (MMD) institute is synthetic, the 5-HT that U.S. Marion Merrell Dow Inc produces
3Receptor antagonist.1988 and nineteen ninety SEPARATE APPLICATION European patent and United States Patent (USP).Understanding publication at medicine in France in 1989 publishes an article.The exploitation ranks of nineteen ninety-five Hoechst Marrion Roussel (HMR) company and Abbott company adding dolasetron in 1998.
Dolasetron mesilate is a kind of 5-HT of potent and high selectivity
3Receptor antagonist, it is to other 5-HT acceptor, α or B-adrenergic receptor, dopamine D
2, malicious deep alkali or neural knocking element NK1 acceptor is without obvious effect.The dolasetron mesilate better tolerance, toxicity is low, the acute toxicity LD of the oral and intravenous injection dolasetron of mouse
50Value is respectively 545mg/kg and 165mg/kg, and any bacterium and the mammalian cell system of testing do not had mutagenesis, and test rat and rabbit are not had teratogenesis.Clinical study shows that dolasetron mesilate can powerfully suppress the nauseating and vomiting that the cancer therapy drugs such as cis-platinum, Zorubicin and endoxan cause, and untoward reaction is slight.
Dolasetron carried out the III clinical trial phase as antiemetic in the U.S. in 1992,1994 and nineteen ninety-five report
Nauseating, vomiting III clinical trial phase result that the treatment chemotherapy is relevant with surgical operation.The dolasetron of 1995 first MMD companies
File an application first the listing in the U.S., be used for the treatment of feeling sick, vomitting of chemotherapy and patients after surgery.HMR company in 1996 proposes to be used for preventing that chemotherapy of tumors from causing the new drug application of the nausea and vomiting of telling patient in the U.S..HMR company in 1997 is at Germany's dolasetron that goes on the market
Tablet 50mg/ sheet (being equivalent to the 37mg dolasetron) and injection liquid 12.5mg/ bottle (being equivalent to the 9.3mg dolasetron) are applicable to feel sick after the treatment operation, vomiting; Tablet 200mg/ sheet (being equivalent to the 74mg dolasetron) is applicable to treat feeling sick after the chemotherapy, vomiting.HMR company and after agreeing in 1998 to be applicable to treat operation with Abbott company for many years listing of signature, feel sick, the injection liquid of vomiting and oral preparation
With
Agreement.
Summary of the invention
The object of the present invention is to provide a kind of dolasetron mesilate compound, it is characterized in that in its X-ray powder diffraction 18.7444,21.1035, and 24.0029 there are characteristic peak.
Above-mentioned dolasetron mesilate compound is characterized in that in its X-ray powder diffraction 13.7091,14.6752,17.3321,22.6352, and 27.3334,28.4501 and 29.3092 have characteristic peak.
Above-mentioned dolasetron mesilate compound is characterized in that and accompanying drawing 1 similar collection of illustrative plates.
Above-mentioned dolasetron mesilate compound is characterized in that and accompanying drawing 2 similar collection of illustrative plates.
The object of the present invention is to provide a kind of pharmaceutical composition, contain the above-mentioned described compound of effective dose claim 1-4 and the acceptable auxiliary material of pharmacy.
Auxiliary material described in the aforementioned pharmaceutical compositions is selected one or more in N.F,USP MANNITOL, Xylitol, sorbyl alcohol, hydrochloric acid, sulfuric acid, phosphoric acid, Citric Acid, acetic acid, toxilic acid and the lactic acid.
The object of the present invention is to provide the application in the nausea and vomiting after preparing treatment chemotherapy of tumors and gynaecology, surgical operation of above-mentioned dolasetron mesilate compound.
The object of the present invention is to provide the application in the nausea and vomiting medicine after preparing treatment chemotherapy of tumors and gynaecology, surgical operation of above-mentioned pharmaceutical composition.
Dolasetron mesilate of the present invention is 5-HT
3Receptor antagonist.It is a kind of only to 5-HT
3Acceptor and to other 5-HT acceptor, α or Beta-3 adrenergic receptor, dopamine D 2, malicious deep alkali or neurally kowtow plain NK1 acceptor without selectivity height, the better tolerance of obvious effect, the effective 5-HT with multiple pharmacological effect
3Receptor antagonist.It can block 5-HT
3Acceptor, Inhibitory signal are delivered to maincenter, are the active drugs of prophylaxis of tumours chemotherapy, Postoperative Nausea and Vomiting.5-HT
3Receptor antagonist is the product that goes on the market for many years, has no the serious adverse reaction report, confirms that such drug safety is good.
Description of drawings
The x-ray diffractogram of powder of Fig. 1 the compounds of this invention.
The differential thermal analysis collection of illustrative plates of Fig. 2 the compounds of this invention.
Embodiment
In order to understand better the present invention, the below will be described in detail and illustrate the present invention and advantage thereof by embodiments of the invention and experimental data, but these embodiment are not limited to the present invention.
Embodiment 1
With dolasetron mesilate 25g, 200 milliliters of ethyl ester ethyl esters are heated to 45 ℃, stir and make its dissolving, obtain settled solution, and concentration of reaction solution to 1/2 volume leaves standstill, cooling, precipitation compounds crystallization.
Powder x-ray diffraction: use the Cu-K radiation, the X-ray ray powder diffraction of this compound is seen accompanying drawing 1.Differential scanning calorimetric analysis: the differential thermal analysis collection of illustrative plates of this compound is seen accompanying drawing 2.
Embodiment 2
With dolasetron mesilate 25g, 150 milliliters of ethyl ester ethyl ester acetone mixed solvent (2: 1) are heated to 45 ℃, stir and make its dissolving, obtain settled solution, leave standstill cooling, precipitation compounds crystallization.
Powder x-ray diffraction: use the Cu-K radiation, the X-ray ray powder diffraction of this compound is seen accompanying drawing 1.Differential scanning calorimetric analysis: the differential thermal analysis collection of illustrative plates of this compound is seen accompanying drawing 2.
Embodiment 3
Prescription feeds intake:
| Dolasetron mesilate (embodiment 1) | 20.0g |
| N.F,USP MANNITOL | 38.2g |
| Water for injection | Add to 1000ml |
Take by weighing the N.F,USP MANNITOL of recipe quantity, after dissolving fully with the water for injection of the recipe quantity 70% that is chilled to room temperature, the dolasetron mesilate stirring and dissolving (dense joining) that adds recipe quantity, the medicinal carbon that adds dense part long-pending 0.05% (W/V) stirs, behind the standing adsorption 10min, filtering decarbonization; Add to the full amount of water for injection 95%, stir, regulate pH to 3.0 with the 0.1mol/L hydrochloric acid soln, benefit adds to the full amount of water for injection, and stirs; Its proterties of sampling and measuring, pH value, content and bacterial endotoxin, qualified rear smart filter, inflated with nitrogen, can, sealing by fusing 121 ℃ of moist heat sterilizations 12 minutes, and get final product.
Embodiment 4
Prescription feeds intake:
| Dolasetron mesilate (embodiment 1) | 20.0g |
| N.F,USP MANNITOL | 38.2g |
| Water for injection | Add to 1000ml |
Take by weighing the N.F,USP MANNITOL of recipe quantity, after dissolving fully with the water for injection of the recipe quantity 70% that is chilled to room temperature, the dolasetron mesilate stirring and dissolving (dense joining) that adds recipe quantity, the medicinal carbon that adds dense part long-pending 0.05% (W/V) stirs, behind the standing adsorption 10min, filtering decarbonization; Add to the full amount of water for injection 95%, stir, regulate pH to 3.5 with the 0.1mol/L hydrochloric acid soln, benefit adds to the full amount of water for injection, and stirs; Its proterties of sampling and measuring, pH value, content and bacterial endotoxin, qualified rear smart filter, inflated with nitrogen, can, sealing by fusing 121 ℃ of moist heat sterilizations 12 minutes, and get final product.
Embodiment 5
Prescription feeds intake:
| Dolasetron mesilate (embodiment 1) | 20.0g |
| N.F,USP MANNITOL | 38.2g |
| Water for injection | Add to 1000ml |
Take by weighing the N.F,USP MANNITOL of recipe quantity, after dissolving fully with the water for injection of the recipe quantity 70% that is chilled to room temperature, the dolasetron mesilate stirring and dissolving (dense joining) that adds recipe quantity, the medicinal carbon that adds dense part long-pending 0.05% (W/V) stirs, behind the standing adsorption 5min, filtering decarbonization; Add to the full amount of water for injection 95%, stir, regulate pH to 4.0 with the 0.1mol/L hydrochloric acid soln, benefit adds to the full amount of water for injection, and stirs; Its proterties of sampling and measuring, pH value, content and bacterial endotoxin, qualified rear smart filter, inflated with nitrogen, can, sealing by fusing 121 ℃ of moist heat sterilizations 12 minutes, and get final product.
Embodiment 6
Prescription feeds intake:
| Dolasetron mesilate (embodiment 1) | 20.0g |
| N.F,USP MANNITOL | 38.2g |
| Water for injection | Add to 1000ml |
Take by weighing the N.F,USP MANNITOL of recipe quantity, after dissolving fully with the water for injection of the recipe quantity 70% that is chilled to room temperature, the dolasetron mesilate stirring and dissolving (dense joining) that adds recipe quantity, the medicinal carbon that adds dense part long-pending 0.05% (W/V) stirs, behind the standing adsorption 15min, filtering decarbonization; Add to the full amount of water for injection 95%, stir, regulate pH to 4.5 with the 0.1mol/L hydrochloric acid soln, benefit adds to the full amount of water for injection, and stirs; Its proterties of sampling and measuring, pH value, content and bacterial endotoxin, qualified rear smart filter, inflated with nitrogen, can, sealing by fusing 121 ℃ of moist heat sterilizations 12 minutes, and get final product.
Embodiment 7
Prescription feeds intake:
| Dolasetron mesilate (embodiment 1) | 20.0g |
| N.F,USP MANNITOL | 38.2g |
| Water for injection | Add to 1000ml |
Take by weighing the N.F,USP MANNITOL of recipe quantity, after dissolving fully with the water for injection of the recipe quantity 70% that is chilled to room temperature, the dolasetron mesilate stirring and dissolving (dense joining) that adds recipe quantity, the medicinal carbon that adds dense part long-pending 0.05% (W/V) stirs, behind the standing adsorption 10min, filtering decarbonization; Add to the full amount of water for injection 95%, stir, regulate pH to 3.7 with the 0.1mol/L hydrochloric acid soln, benefit adds to the full amount of water for injection, and stirs; Its proterties of sampling and measuring, pH value, content and bacterial endotoxin, qualified rear smart filter, inflated with nitrogen, can, sealing by fusing 115 ℃ of moist heat sterilizations 30 minutes, and get final product.
Embodiment 8
Prescription feeds intake:
| Dolasetron mesilate (embodiment 1) | 20.0g |
| N.F,USP MANNITOL | 38.2g |
| Water for injection | Add to 1000ml |
Take by weighing the N.F,USP MANNITOL of recipe quantity, after dissolving fully with the water for injection of the recipe quantity 70% that is chilled to room temperature, the dolasetron mesilate stirring and dissolving (dense joining) that adds recipe quantity, the medicinal carbon that adds dense part long-pending 0.05% (W/V) stirs, behind the standing adsorption 10min, filtering decarbonization; Add to the full amount of water for injection 95%, stir, regulate pH to 3.9 with the 0.1mol/L hydrochloric acid soln, benefit adds to the full amount of water for injection, and stirs; Its proterties of sampling and measuring, pH value, content and bacterial endotoxin, qualified rear smart filter, inflated with nitrogen, can, sealing by fusing 115 ℃ of moist heat sterilizations 30 minutes, and get final product.
Embodiment 9
Prescription feeds intake:
| Dolasetron mesilate (embodiment 1) | 12.5g |
| N.F,USP MANNITOL | 38.2g |
| Water for injection | Add to 1000ml |
Take by weighing the N.F,USP MANNITOL of recipe quantity, after dissolving fully with the water for injection of the recipe quantity 70% that is chilled to room temperature, the dolasetron mesilate stirring and dissolving (dense joining) that adds recipe quantity, the medicinal carbon that adds dense part long-pending 0.05% (W/V) stirs, behind the standing adsorption 10min, filtering decarbonization; Add to the full amount of water for injection 95%, stir, regulate pH to 3.0 with the 0.1mol/L hydrochloric acid soln, benefit adds to the full amount of water for injection, and stirs; Its proterties of sampling and measuring, pH value, content and bacterial endotoxin, qualified rear smart filter, inflated with nitrogen, can, sealing by fusing 121 ℃ of moist heat sterilizations 12 minutes, and get final product.
Embodiment 10
Prescription feeds intake:
| Dolasetron mesilate (embodiment 1) | 12.5g |
| N.F,USP MANNITOL | 38.2g |
| Water for injection | Add to 1000ml |
Take by weighing the N.F,USP MANNITOL of recipe quantity, after dissolving fully with the water for injection of the recipe quantity 70% that is chilled to room temperature, the dolasetron mesilate stirring and dissolving (dense joining) that adds recipe quantity, the medicinal carbon that adds dense part long-pending 0.05% (W/V) stirs, behind the standing adsorption 10min, filtering decarbonization; Add to the full amount of water for injection 95%, stir, regulate pH to 3.5 with the 0.1mol/L hydrochloric acid soln, benefit adds to the full amount of water for injection, and stirs; Its proterties of sampling and measuring, pH value, content and bacterial endotoxin, qualified rear smart filter, inflated with nitrogen, can, sealing by fusing 121 ℃ of moist heat sterilizations 12 minutes, and get final product.
Embodiment 11
Prescription feeds intake:
| Dolasetron mesilate (embodiment 1) | 12.5g |
| N.F,USP MANNITOL | 38.2g |
| Water for injection | Add to 1000ml |
Take by weighing the N.F,USP MANNITOL of recipe quantity, after dissolving fully with the water for injection of the recipe quantity 70% that is chilled to room temperature, the dolasetron mesilate stirring and dissolving (dense joining) that adds recipe quantity, the medicinal carbon that adds dense part long-pending 0.05% (W/V) stirs, behind the standing adsorption 5min, filtering decarbonization; Add to the full amount of water for injection 95%, stir, regulate pH to 4.0 with the 0.1mol/L hydrochloric acid soln, benefit adds to the full amount of water for injection, and stirs; Its proterties of sampling and measuring, pH value, content and bacterial endotoxin, qualified rear smart filter, inflated with nitrogen, can, sealing by fusing 121 ℃ of moist heat sterilizations 12 minutes, and get final product.
Embodiment 12
Prescription feeds intake:
| Dolasetron mesilate (embodiment 1) | 12.5g |
| N.F,USP MANNITOL | 38.2g |
| Water for injection | Add to 1000ml |
Take by weighing the N.F,USP MANNITOL of recipe quantity, after dissolving fully with the water for injection of the recipe quantity 70% that is chilled to room temperature, the dolasetron mesilate stirring and dissolving (dense joining) that adds recipe quantity, the medicinal carbon that adds dense part long-pending 0.05% (W/V) stirs, behind the standing adsorption 15min, filtering decarbonization; Add to the full amount of water for injection 95%, stir, regulate pH to 4.5 with the 0.1mol/L hydrochloric acid soln, benefit adds to the full amount of water for injection, and stirs; Its proterties of sampling and measuring, pH value, content and bacterial endotoxin, qualified rear smart filter, inflated with nitrogen, can, sealing by fusing 121 ℃ of moist heat sterilizations 12 minutes, and get final product.
Experimental example: the application in the nausea and vomiting of the present invention after prevention and treatment chemotherapy
At random clinical study, enter at random altogether group 20 examples, patient's (can accept the Incidence of Inpatients with Malignant Tumors of chemotherapy) at random cross-assignment to dolasetron mesilate injection liquid group (embodiment 2), nausea and vomiting after the prevention of front 30 minutes intravenous injections of chemotherapy and treatment chemotherapy.The result shows that the efficient test group of acute vomiting after the chemotherapy (in 24 hours) is 90.00%.
Claims (8)
1. dolasetron mesilate compound is characterized in that in its X-ray powder diffraction 18.7444,21.1035, and 24.0029 have characteristic peak.
2. dolasetron mesilate compound according to claim 1 is characterized in that in its X-ray powder diffraction 13.7091,14.6752,17.3321,22.6352, and 27.3334,28.4501 and 29.3092 have characteristic peak.
3. dolasetron mesilate compound according to claim 2 is characterized in that and accompanying drawing 1 similar collection of illustrative plates.
4. arbitrary described dolasetron mesilate compound is characterized in that and accompanying drawing 2 similar collection of illustrative plates according to claim 1-3.
5. a pharmaceutical composition is characterized in that containing the described compound of effective dose claim 1-4 and the acceptable auxiliary material of pharmacy.
6. described pharmaceutical composition according to claim 5 is characterized in that described auxiliary material selects one or more in N.F,USP MANNITOL, Xylitol, sorbyl alcohol, hydrochloric acid, sulfuric acid, phosphoric acid, Citric Acid, acetic acid, toxilic acid and the lactic acid.
7. the arbitrary described dolasetron mesilate compound of claim 1-4 application in the nausea and vomiting after preparing treatment chemotherapy of tumors and gynaecology, surgical operation.
8. claim 5 or the 6 described pharmaceutical compositions application in the nausea and vomiting medicine after preparing treatment chemotherapy of tumors and gynaecology, surgical operation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2013102514927A CN103360392A (en) | 2013-06-21 | 2013-06-21 | Dolasetron mesylate compound |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2013102514927A CN103360392A (en) | 2013-06-21 | 2013-06-21 | Dolasetron mesylate compound |
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| CN103360392A true CN103360392A (en) | 2013-10-23 |
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| CN2013102514927A Pending CN103360392A (en) | 2013-06-21 | 2013-06-21 | Dolasetron mesylate compound |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109453112A (en) * | 2018-12-10 | 2019-03-12 | 南京恩泰医药科技有限公司 | A kind of selective serotonin 3(5-HT3) receptor antagonist and preparation method |
| CN111072651A (en) * | 2019-12-24 | 2020-04-28 | 四川海思科制药有限公司 | Dolasetron oxide and preparation method and application thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007072506A2 (en) * | 2005-12-23 | 2007-06-28 | Usv Limited | Polymorphic forms of dolasetron mesylate and processes thereof |
| WO2007081909A2 (en) * | 2006-01-05 | 2007-07-19 | Teva Gyogyszergyar Zartkoruen Mukodo | Forms of dolasetron mesylate and processes for their preparation |
-
2013
- 2013-06-21 CN CN2013102514927A patent/CN103360392A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007072506A2 (en) * | 2005-12-23 | 2007-06-28 | Usv Limited | Polymorphic forms of dolasetron mesylate and processes thereof |
| WO2007081909A2 (en) * | 2006-01-05 | 2007-07-19 | Teva Gyogyszergyar Zartkoruen Mukodo | Forms of dolasetron mesylate and processes for their preparation |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109453112A (en) * | 2018-12-10 | 2019-03-12 | 南京恩泰医药科技有限公司 | A kind of selective serotonin 3(5-HT3) receptor antagonist and preparation method |
| CN111072651A (en) * | 2019-12-24 | 2020-04-28 | 四川海思科制药有限公司 | Dolasetron oxide and preparation method and application thereof |
| CN111072651B (en) * | 2019-12-24 | 2022-10-14 | 四川海思科制药有限公司 | Dolasetron oxide and preparation method and application thereof |
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Application publication date: 20131023 |