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1. 发明专利

AU2009335943A1 Lower dosage strength imiquimod formulations and short dosing regimens for treating actinic keratosis 未知
公开(公告)号：AU2009335943A1
公开(公告)日：2013-10-24
申请号：AU2009335943
申请日：2009-12-11
申请人： GRACEWAY PHARMACEUTICALS LLC , NORDSIEK MICHAEL T
发明人： NORDSIEK MICHAEL T , LEVY SHARON F , LEE JAMES H , KULP JAMES H , BALAJI KODUMUDI S , MENG TZE-CHIANG , WU JASON J , BAHM VALYN S , BABILON ROBERT
IPC分类号： A01N43/42 , A61K31/44
摘要： Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1

2. 发明申请

WO2001091726A1 ACNE-TREATING COMPOSITION 审中-公开
标题翻译： ACNE-处理组合物
公开(公告)号：WO2001091726A1
公开(公告)日：2001-12-06
申请号：PCT/US2001/018033
申请日：2001-06-01
申请人： DERMIK INTERNATIONAL HOLDING INC. , MANETTA, Vincent, E. , MAHONEY, Linda, M. , NORDSIEK, Michael, T. , BALAJI, Kodumudi, S. , DORRELL, Jay
发明人： MANETTA, Vincent, E. , MAHONEY, Linda, M. , NORDSIEK, Michael, T. , BALAJI, Kodumudi, S. , DORRELL, Jay
IPC分类号： A61K9/06
CPC分类号： A61K8/042 , A61K8/38 , A61K8/602 , A61K8/731 , A61K9/06 , A61K2800/5422 , A61K2800/88 , A61Q19/00
摘要： A package comprising components which, upon being mixed, are capable of forming a pharmaceutical composition that is effective in treating acne, the composition tending to degrade prematurely, one of the components comprising an oxidizing agent and another of the components comprising an antibiotic which is effective against acne-associated bacterial species, the components separated one from the other in the package, one component having a viscosity within about 50 % of the viscosity of the other component. In addition, a package comprising: (A) components which, upon being mixed, are capable of forming a pharmaceutical composition that is effective in treating acne, one of the components comprising a benzoyl peroxide gel and another of the components comprising a gel of erythromycin and hydroxypropylcellulose; and (B) containers for holding the components in the package separated one from the other; the components having viscosities such that, upon the application of a uniform forces to the components, substantially equal volumes of the components are capable of being dispensed simultaneously from the containers.
摘要翻译：一种包含组分的组合物，其在混合时能够形成有效治疗痤疮的药物组合物，所述组合物倾向于过早降解，所述组合物中的一种包含氧化剂和另一种包含有效的抗生素的组分针对与痤疮相关的细菌种类，组分在包装中彼此分离，一种组分的粘度在其他组分的粘度的约50％以内。另外，一种包装，其包含：（A）组分，其在混合后能够形成有效治疗痤疮的药物组合物，其中一种组分包含过氧化苯甲酰凝胶，另一种组分包含红霉素凝胶和羟丙基纤维素; 和（B）用于保持包装中的组分彼此分离的容器; 所述组分具有粘度，使得在对组分施加均匀的力时，基本相等体积的组分能够从容器同时分配。

3. 发明申请

WO2013003646A1 HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS THEIR USE TO TREAT BACTERIAL VAGINOSIS 审中-公开
标题翻译：高剂量MUCOADHESIVE METRONIDAZOLE基于水性的凝胶制剂，用于治疗细菌性VAGINOSIS
公开(公告)号：WO2013003646A1
公开(公告)日：2013-01-03
申请号：PCT/US2012/044738
申请日：2012-06-28
申请人： MEDICIS PHARMACEUTICAL CORPORATION , NORDSIEK, Michael, T. , BALAJI, Kodumudi, S.
发明人： NORDSIEK, Michael, T. , BALAJI, Kodumudi, S.
IPC分类号： A01N43/50
CPC分类号： A61K31/4168 , A61K9/0034 , A61K9/06 , A61K31/4164 , A61K47/10 , A61K47/14 , A61K47/32
摘要： The present disclosure provides mucoadhesive aqueous-based gel formulations of metronidazole useful for a variety of purposes, including intravaginal application as a therapeutic approach towards the treatment of individuals suffering from and/or diagnosed with bacterial vaginosis.
摘要翻译：本公开提供了用于各种目的的甲硝唑的粘膜粘附性水基凝胶制剂，包括阴道内施用作为治疗患有和/或诊断为细菌性阴道炎的个体的治疗方法。

4. 发明申请

WO2010080345A1 LOWER DOSAGE STRENGTH IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING ACTINIC KERATOSIS 审中-公开
标题翻译：较低剂量强度液体制剂和短期剂量治疗药物治疗方案
公开(公告)号：WO2010080345A1
公开(公告)日：2010-07-15
申请号：PCT/US2009/067759
申请日：2009-12-11
申请人： GRACEWAY PHARMACEUTICALS, LLC , NORDSIEK, Michael, T. , LEVY, Sharon, F. , LEE, James, H. , KULP, James, H. , BALAJI, Kodumudi, S. , MENG, Tze-Chiang , WU, Jason, J. , BAHM, Valyn, S. , BABILON, Robert
发明人： NORDSIEK, Michael, T. , LEVY, Sharon, F. , LEE, James, H. , KULP, James, H. , BALAJI, Kodumudi, S. , MENG, Tze-Chiang , WU, Jason, J. , BAHM, Valyn, S. , BABILON, Robert
IPC分类号： A01N43/42 , A61K31/44
CPC分类号： A61K31/4745 , A61K9/0014 , A61K9/06 , A61K9/7061 , A61K31/437 , A61K31/47 , A61K47/10 , A61K47/12 , A61K47/14
摘要： Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1 H -imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylρropyl)- 1 H -imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat actinic keratosis with short durations of therapy, than currently prescribed for the commercially available Aldara ® 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration ("FDA"), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration ("FDA") for Aldara ® 5% imiquimod cream to treat actinic keratosis are also disclosed and described.
摘要翻译：用于局部或透皮递送1-异丁基-1H-咪唑并[4,5-c] - 喹啉-4-胺或1-（2-甲基羰基）-1H-咪唑并[4,5 -c]喹啉-4-胺，即咪喹莫特，用于治疗短时间疗法的光化性角化病，比目前为市售的5％咪喹莫特乳膏所规定的，如美国食品和药物管理局（FDA）批准 “），被公开和描述。更具体地说，低剂量强度咪喹莫特制剂以比目前美国食品和药物管理局（FDA）批准的给药方案递送有效剂量的咪喹莫特用于治疗光化性角化病，具有可接受的安全性和对患者使用而言更方便的给药方案还公开和描述了用于Aldara 5％咪喹莫特乳膏治疗光化性角化病的“FDA”）。

5. 发明申请

WO2011163617A1 COMBINATION THERAPY WITH CRYOSURGERY AND LOW DOSAGE STRENGTH IMIQUIMOD TO TREAT ACTINIC KERATOSIS 审中-公开
标题翻译：结合治疗与低剂量强度IMIQUIMOD治疗ACINIC KERATOSIS
公开(公告)号：WO2011163617A1
公开(公告)日：2011-12-29
申请号：PCT/US2011/041876
申请日：2011-06-24
申请人： GRACEWAY PHARMACEUTICALS, LLC , NORDSIEK, Michael, T. , LEVY, Sharon, F. , LEE, James, Hurn-joung , KULP, James, H. , MENG, Tze-chiang , WU, Jason, J. , BABILON, Robert , BALAJI, Kodumudi, S. , BAHM, Valyn, S.
发明人： NORDSIEK, Michael, T. , LEVY, Sharon, F. , LEE, James, Hurn-joung , KULP, James, H. , MENG, Tze-chiang , WU, Jason, J. , BABILON, Robert , BALAJI, Kodumudi, S. , BAHM, Valyn, S.
IPC分类号： A01N43/42 , A61K31/44
CPC分类号： A61B18/02 , A61K9/0014 , A61K9/06 , A61K9/1075 , A61K31/437 , A61K33/00 , A61K47/10 , A61K47/26 , A61K2300/00
摘要： The present invention is directed to the use of complementary or combination lesion-directed therapy, such as cryosurgery, and field-directed therapy, such as low dose imiquimod topical therapy with short durations, in combination to treat actinic keratosis ("AK"). In carrying out the present invention, the lesion-directed and field-directed therapies may be applied sequentially or concomitantly, in accordance with the present invention. The novel complementary or combination AK therapy contemplated by the present invention: (1) significantly improves clearance of cryosurgery-treated Aks; (2) treats subclinical AK lesions; (3) treats those visible AK lesions in excess of that cryosurgery can actually treat in a single treatment due to, e.g., patient tolerance, provider treatment limits and/or cryosurgery cost to the patient; and (4) enhances sustained clearance overall, as compared to mono AK lesion- directed therapy.
摘要翻译：本发明涉及使用互补或组合的病变导向疗法，例如冷冻手术和局部定向治疗，例如具有短持续时间的低剂量咪喹莫特局部治疗，以组合治疗光化性角化病（“AK”）。在实施本发明时，根据本发明可以依次或伴随地应用病变导向和场导向疗法。本发明考虑的新型互补或组合AK治疗：（1）显着改善冷冻治疗的Aks的清除率; （2）治疗亚临床AK病变; （3）由于例如患者耐受性，提供者治疗限度和/或对患者的冷冻手术费用，治疗超过该冷冻手术的那些可见的AK病变可以在单次治疗中实际治疗; 和（4）与单AK病变导向治疗相比，总体上增强了持续清除率。

6. 发明申请

WO0191726A9 ACNE-TREATING COMPOSITION 审中-公开
标题翻译： ACNE-处理组合物
公开(公告)号：WO0191726A9
公开(公告)日：2002-08-15
申请号：PCT/US0118033
申请日：2001-06-01
申请人： DERMIK INTERNAT HOLDING INC , MANETTA VINCENT E , MAHONEY LINDA M , NORDSIEK MICHAEL T , BALAJI KODUMUDI S , DORRELL JAY
发明人： MANETTA VINCENT E , MAHONEY LINDA M , NORDSIEK MICHAEL T , BALAJI KODUMUDI S , DORRELL JAY
IPC分类号： A61K8/02 , A61K8/04 , A61K8/38 , A61K8/60 , A61K8/73 , A61K9/06 , A61Q19/00 , A61K7/48
CPC分类号： A61K8/042 , A61K8/38 , A61K8/602 , A61K8/731 , A61K9/06 , A61K2800/5422 , A61K2800/88 , A61Q19/00
摘要： A package comprising components which, upon being mixed, are capable of forming a pharmaceutical composition that is effective in treating acne, the composition tending to degrade prematurely, one of the components comprising an oxidizing agent and another of the components comprising an antibiotic which is effective against acne-associated bacterial species, the components separated one from the other in the package, one component having a viscosity within about 50 % of the viscosity of the other component. In addition, a package comprising: (A) components which, upon being mixed, are capable of forming a pharmaceutical composition that is effective in treating acne, one of the components comprising a benzoyl peroxide gel and another of the components comprising a gel of erythromycin and hydroxypropylcellulose; and (B) containers for holding the components in the package separated one from the other; the components having viscosities such that, upon the application of a uniform forces to the components, substantially equal volumes of the components are capable of being dispensed simultaneously from the containers.
摘要翻译：一种包含组分的包装，其在混合时能够形成有效治疗痤疮的药物组合物，所述组合物倾向于过早降解，所述组合物中的一种包含氧化剂和另一种包含有效的抗生素的组分针对与痤疮相关的细菌种类，组分在包装中彼此分离，一种组分的粘度在其他组分的粘度的约50％以内。另外，一种包装，其包含：（A）组分，其在混合后能够形成有效治疗痤疮的药物组合物，其中一种组分包含过氧化苯甲酰凝胶，另一种组分包含红霉素凝胶和羟丙基纤维素; 和（B）用于保持包装中的组分彼此分离的容器; 所述组分具有粘度，使得在对组分施加均匀的力时，基本相等体积的组分能够从容器同时分配。

7. 发明申请

WO2011008324A1 LOWER DOSAGE STRENGTH IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING GENITAL AND PERIANAL WARTS 审中-公开
标题翻译：较低剂量强度液体制剂和短期剂量方案用于治疗一般和周期性的战争
公开(公告)号：WO2011008324A1
公开(公告)日：2011-01-20
申请号：PCT/US2010/033245
申请日：2010-04-30
申请人： GRACEWAY PHARMACEUTICALS, LLC , NORDSIEK, Michael T. , LEVY, Sharon F. , LEE, James H. , KULP, James H. , BALAJI, Kodumudi S. , MENG, Tze-Chiang , WU, Jason J. , BAHM, Valyn S. , BABILON, Robert
发明人： NORDSIEK, Michael T. , LEVY, Sharon F. , LEE, James H. , KULP, James H. , BALAJI, Kodumudi S. , MENG, Tze-Chiang , WU, Jason J. , BAHM, Valyn S. , BABILON, Robert
IPC分类号： A01N43/42 , A61K31/44
CPC分类号： A61K31/4745 , A61K9/0014 , A61K9/06 , A61K31/44 , A61K47/10 , A61K47/12
摘要： Pharmaceutical formulations and methods for the topical or transdermal delivery of 1 isobuty 1-1 H-imidazo [4, 5 -c] -quinolin-4-amine or 1 -(2-methylpropyl)- 1 H-imidazo [4,5 -c] quinolin-4-arnme, i.e., imiquimod, to treat genital/perianal warts with shorter durations of therapy than currently prescribed for the commercially available Aldara ® 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration ("FDA"), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating genital/perianal warts with an acceptable safety profile and dosing regimens that are shorter and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration ("FDA") for Aldara ® 5% imiquimod cream to treat genital/perianal warts are also disclosed and described.
摘要翻译：用于局部或透皮递送1种异丁基-1H-咪唑并[4,5-C-] - 喹啉-4-胺或1-（2-甲基丙基）-1H-咪唑并[4,5-d] c]喹啉-4-胺，即咪喹莫特，用于治疗生殖器/肛门周围疣的时间短于目前为商业可用的5％咪喹莫特乳膏所规定的治疗时间，目前由美国食品和药物管理局（FDA）批准 “），被公开和描述。更具体地说，低剂量强度的咪喹莫特制剂，以递送有效剂量的咪喹莫特，用于治疗生殖器/肛周疣具有可接受的安全性和给药方案，其比目前由美国食品和药物批准的给药方案更短，更方便患者使用还公开和描述了用于治疗生殖器/肛周疣的Aldara 5％咪喹莫特乳膏的给药（“FDA”）。

8. 发明申请

WO9966937A9 ERYTHROMYCIN COMPOSITIONS 审中-公开
标题翻译：红霉素组合物
公开(公告)号：WO9966937A9
公开(公告)日：2000-03-30
申请号：PCT/US9914369
申请日：1999-06-24
申请人： DERMIK LAB INC , VERKH FAINA I , NORDSIEK MICHAEL T , FELD KENNETH M
发明人： VERKH FAINA I , NORDSIEK MICHAEL T , FELD KENNETH M
IPC分类号： A61K45/06 , A61K31/70
CPC分类号： A61K31/7048 , A61K31/19 , A61K31/70 , A61K45/06 , A61K31/327 , A61K2300/00
摘要： A homogenous and smooth erythromycin composition can be prepared when the erythromycin contains not less than about 2 % by weight of erythromycin B.
摘要翻译：当红霉素含有不少于约2重量％的红霉素B时，可以制备均匀且光滑的红霉素组合物。

9. 发明申请

WO2012019158A3 PUMP SYSTEMS AND METHODS FOR STORING AND DISPENSING A PLURALITY OF PRECISELY MEASURED UNIT-DOSES OF IMIQUIMOD CREAM 审中-公开
标题翻译：用于储存和分配多种经过精确测定的IMIQUIMOD CREAM单位剂量的泵系统和方法
公开(公告)号：WO2012019158A3
公开(公告)日：2012-05-10
申请号：PCT/US2011046847
申请日：2011-08-05
申请人： GRACEWAY PHARMACEUTICALS LLC , NORDSIEK MICHAEL T , BALAJI KODUMUDI S
发明人： NORDSIEK MICHAEL T , BALAJI KODUMUDI S
IPC分类号： A61K31/4745 , B67B5/00
CPC分类号： A61M35/003 , A61K9/0014 , A61K9/0031 , A61K9/0034 , A61K9/06 , A61K31/4745 , A61K47/10 , B05B11/0024 , B05B11/0037 , B05B11/0048 , B05B11/3001 , B05B11/3042 , B05B11/3047
摘要： The present invention is directed to airless storage and dispensing systems that include a pump or dispensing package pre-filled with a topical semi-solid imiquimod pharmaceutical formulation ("pump systems") and methods for storing and dispensing from the pump systems a plurality of precisely measured and uniform unit doses of a topical semi-solid imiquimod pharmaceutical formulation, and more particularly to pump systems, pre-filled with a topical imiquimod pharmaceutical cream and methods for delivering multiple precisely measured unit doses of a topical imiquimod pharmaceutical cream, and methods for using a controlled delivery pump system to store and dispense a plurality of consistent and precisely measured unit doses of a topical imiquimod pharmaceutical cream for use in topically treating a dermal and mucosalassociated condition, such as, external genital warts and/or perianal warts (EGWs), actinic keratosis or actinic keratoses (AK or AKs) and superficial basal cell carcinoma (sBCC).
摘要翻译：本发明涉及无空气存储和分配系统，其包括预先填充有局部半固体咪喹莫特药物制剂（“泵系统”）的泵或分配包装，以及用于从泵系统存储和分配多个精确的测量并且均匀单位剂量的局部用咪喹莫特药物制剂，更具体地涉及用局部用咪喹莫特药物乳膏预填充的泵系统和用于递送多个精确测量的单位剂量局部用咪喹莫特药用乳膏的方法，以及用于使用受控输送泵系统来储存和分配局部治疗真皮和粘膜相关病症（例如外生殖器疣和/或肛周疣（EGW））的局部用咪喹莫特药物乳膏的多个一致且精确测量的单位剂量，，光化性角化病或光化性角化病（AK或AK）和浅表基底细胞癌（SBCC）。

10. 发明申请

WO2012019158A2 PUMP SYSTEMS AND METHODS FOR STORING AND DISPENSING A PLURALITY OF PRECISELY MEASURED UNIT-DOSES OF IMIQUIMOD CREAM 审中-公开
标题翻译：用于储存和分配多种精确测量的IMIQUIMOD CREAM单位的泵系统和方法
公开(公告)号：WO2012019158A2
公开(公告)日：2012-02-09
申请号：PCT/US2011/046847
申请日：2011-08-05
申请人： GRACEWAY PHARMACEUTICALS, LLC , NORDSIEK, Michael, T. , BALAJI, Kodumudi, S.
发明人： NORDSIEK, Michael, T. , BALAJI, Kodumudi, S.
IPC分类号： A61M35/00
CPC分类号： A61M35/003 , A61K9/0014 , A61K9/0031 , A61K9/0034 , A61K9/06 , A61K31/4745 , A61K47/10 , B05B11/0024 , B05B11/0037 , B05B11/0048 , B05B11/3001 , B05B11/3042 , B05B11/3047
摘要： The present invention is directed to airless storage and dispensing systems that include a pump or dispensing package pre-filled with a topical semi-solid imiquimod pharmaceutical formulation ("pump systems") and methods for storing and dispensing from the pump systems a plurality of precisely measured and uniform unit doses of a topical semi-solid imiquimod pharmaceutical formulation, and more particularly to pump systems, pre-filled with a topical imiquimod pharmaceutical cream and methods for delivering multiple precisely measured unit doses of a topical imiquimod pharmaceutical cream, and methods for using a controlled delivery pump system to store and dispense a plurality of consistent and precisely measured unit doses of a topical imiquimod pharmaceutical cream for use in topically treating a dermal and mucosalassociated condition, such as, external genital warts and/or perianal warts (EGWs), actinic keratosis or actinic keratoses (AK or AKs) and superficial basal cell carcinoma (sBCC).
摘要翻译：本发明涉及无空气储存和分配系统，其包括预先填充有局部半固体咪喹莫特药物制剂（“泵系统”）的泵或分配包装以及用于从泵系统存储和分配多个精确的测量和均匀单位剂量的局部半固体咪喹莫特药物制剂，更具体地涉及预先填充有局部咪喹莫特药物霜剂的泵系统和用于递送多个精确测量的单位剂量的局部咪喹莫特药物霜剂的方法，以及用于使用受控递送泵系统来存储和分配多个一致且精确测量的单位剂量的局部咪喹莫特药物霜，用于局部治疗皮肤和粘膜相关病症，例如外部生殖器疣和/或肛门周围疣（EGW），光化性角化病或光化性角化病（AK或AK）和浅表性基底细胞癌（SBCC）。

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