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1. 发明授权

US6136784A Amylin agonist pharmaceutical compositions containing insulin 失效
标题翻译：胰岛淀粉样多肽激动剂含有胰岛素的药物组合物
公开(公告)号：US6136784A
公开(公告)日：2000-10-24
申请号：US005240
申请日：1998-01-09
申请人： James L'Italien , Shankar Musunuri , Kale Ruby , Orville Kolterman
发明人： James L'Italien , Shankar Musunuri , Kale Ruby , Orville Kolterman
IPC分类号： A61K38/22 , A61K38/28 , A61K38/00
CPC分类号： A61K38/22 , A61K38/28 , Y10S514/866
摘要： The present invention is concerned with a pharmaceutical formulation in a container, for example, a vial, prefilled cartridge, prefilled syringe or disposable pen, comprising approximately 0.01 to about 0.5% (w/v) amylin agonist, preferably pramlintide, in an aqueous system along with approximately 0.02 to about 0.5% (w/v) of an acetate, phosphate, citrate, or glutamate buffer to a pH of the final composition of approximately 3.0 to about 6.0 as well as approximately 1.0 to 10% (w/v) of a carbohydrate or polyhydric alcohol tonicifier; and, optionally, approximately 0.005 to 1.0% (w/v) of a preservative selected from the group consisting of m-cresol, benzyl alcohol, parabens and phenol. These formulations maintain stability upon storage under refrigerated or room temperature conditions. Such formulations can be further combined with insulin in the same syringe for administration to a patient.
摘要翻译：本发明涉及容器中的药物制剂，例如小瓶，预填充的药筒，预充式注射器或一次性笔，其包含在水系统中约0.01至约0.5％（w / v）的胰岛淀粉样多肽激动剂，优选普兰林肽以及约0.02至约0.5％（w / v）的乙酸盐，磷酸盐，柠檬酸盐或谷氨酸盐缓冲液至最终组合物的pH为约3.0至约6.0，以及约1.0至10％（w / v）的碳水化合物或多元醇增稠剂; 和任选的约0.005至1.0％（w / v）的选自间甲酚，苯甲醇，对羟基苯甲酸酯和苯酚的防腐剂。这些制剂在冷冻或室温条件下保存时保持稳定性。这样的制剂可以在相同的注射器中进一步与胰岛素组合以给予患者。

2. 发明申请

US20080081366A1 Polynucleotide composition, method of preparation, and use thereof 审中-公开
标题翻译：多核苷酸组合物，制备方法及其用途
公开(公告)号：US20080081366A1
公开(公告)日：2008-04-03
申请号：US11895481
申请日：2007-08-24
申请人： Shankar Musunuri , Patrick DeLuca
发明人： Shankar Musunuri , Patrick DeLuca
IPC分类号： C12N15/00
CPC分类号： C12N15/1003 , A61K48/00
摘要： A lyophilized polynucleotide composition contains at least one polynucleotide and at least one cryoprotectant, wherein the ratio of the polynucleotide to cryoprotectant is from about 0.001 to about 1.0 part by weight polynucleotide per 1.0 part by weight of the cryoprotectant. This composition also contains from about 0.5 weight percent to about (6) weight percent water, based on the total weight of the final lyophilized polynucleotide composition. The polynucleotide composition of this invention is characterized by enhanced stability, in that it retains at least 90% supercoil over a time period of at least (10) days at a temperature of about 37° C. The lyophilized polynucleotide composition also has improved solubility. An improved process for lyophilization of polynucleotides employs a specific primary drying cycle, that results in the above-described stable, lyophilized polynucleotide composition.
摘要翻译：冻干的多核苷酸组合物含有至少一种多核苷酸和至少一种冷冻保护剂，其中多核苷酸与冷冻保护剂的比例为每1.0重量份冷冻保护剂约0.001至约1.0重量份的多核苷酸。基于最终冻干的多核苷酸组合物的总重量，该组合物还含有约0.5重量％至约（6）重量百分比的水。本发明的多核苷酸组合物的特征在于增强的稳定性，因为其在约37℃的温度下在至少（10）天的时间内保留至少90％的超螺旋。冻干的多核苷酸组合物也具有改善的溶解度。用于冻干多核苷酸的改进方法采用特定的初级干燥循环，其导致上述稳定的冻干多核苷酸组合物。

3. 发明授权

US06482804B1 Compositions and methods for delivery of genetic material 失效
标题翻译：用于遗传物质传递的组合物和方法
公开(公告)号：US06482804B1
公开(公告)日：2002-11-19
申请号：US09530315
申请日：2000-04-27
申请人： Shankar Musunuri , Chandrasekhar Satishchandran
发明人： Shankar Musunuri , Chandrasekhar Satishchandran
IPC分类号： H61K4800
CPC分类号： C12N15/87 , A61K39/12 , A61K39/245 , A61K48/00 , A61K2039/53 , A61K2039/545 , A61K2039/55505 , A61K2039/57 , C12N2710/16634 , Y10S977/80 , Y10S977/916
摘要： A soluble ionic complex is formed by an aqueous mixture of a benzylammonium group-containing surfactant and a polynucleic acid sequence. When the mixture forms a vesicular complex, the sequence is packaged therein. This composition is useful in pharmaceutical compositions and in methods of delivering the polynucleic acid sequence (which preferably encodes a protein or peptide) to a cell for expression. Such methods are useful in therapy, as vaccines and as gene therapy agents.
摘要翻译：可溶性离子络合物由含苄基铵基的表面活性剂和多核酸序列的水性混合物形成。当混合物形成囊状复合物时，将序列包装在其中。该组合物可用于药物组合物和将多核酸序列（其优选编码蛋白质或肽）递送至用于表达的细胞的方法中。这些方法可用于治疗，疫苗和基因治疗剂。

4. 发明授权

US07276359B1 Polynucleotide composition, method of preparation, and use thereof 失效
标题翻译：多核苷酸组合物，制备方法及其用途
公开(公告)号：US07276359B1
公开(公告)日：2007-10-02
申请号：US09622235
申请日：1999-03-12
申请人： Shankar Musunuri , Patrick P. DeLuca
发明人： Shankar Musunuri , Patrick P. DeLuca
IPC分类号： C12N15/64 , A61K31/70
CPC分类号： C12N15/10
摘要： A lyophilized polynucleotide composition contains at least one polynucleotide and at least one cryoprotectant, wherein the ratio of the polynucleotide to cryoprotectant is from about 0.001 to about 1.0 part by weight polynucleotide per 1.0 part by weight of the cryoprotectant. This composition also contains from about 0.5 weight percent to about (6) weight percent water, based on the total weight of the final lyophilized polynucleotide composition. The polynucleotide composition of this invention is characterized by enhanced stability, in that it retains at least 90% supercoil over a time period of at least (10) days at a temperature of about 37° C. The lyophilized polynucleotide composition also has improved solubility. An improved process for lyophilization of polynucleotides employs a specific primary drying cycle, that results in the above-described stable, lyophilized polynucleotide composition.
摘要翻译：冻干的多核苷酸组合物含有至少一种多核苷酸和至少一种冷冻保护剂，其中多核苷酸与冷冻保护剂的比例为每1.0重量份冷冻保护剂约0.001至约1.0重量份的多核苷酸。基于最终冻干的多核苷酸组合物的总重量，该组合物还含有约0.5重量％至约（6）重量百分比的水。本发明的多核苷酸组合物的特征在于增强的稳定性，因为其在约37℃的温度下在至少（10）天的时间内保留至少90％的超螺旋。冻干的多核苷酸组合物也具有改善的溶解度。用于冻干多核苷酸的改进方法采用特定的初级干燥循环，其导致上述稳定的冻干多核苷酸组合物。

5. 发明授权

US06410511B1 Formulations for amylin agonist peptides 失效
公开(公告)号：US06410511B1
公开(公告)日：2002-06-25
申请号：US09005262
申请日：1998-01-09
申请人： James L'Italien , Shankar Musunuri , Kale Ruby
发明人： James L'Italien , Shankar Musunuri , Kale Ruby
IPC分类号： A61K3800
摘要： The present invention is concerned with a pharmaceutical formulation in a container, for example, a vial, prefilled cartridge, prefilled syringe or disposable pen, comprising approximately 0.01 to about 0.5% (w/v) amylin agonist, preferably pramlintide, in an aqueous system along with approximately 0.02 to about 0.5% (w/v) of an acetate, phosphate, citrate, or glutamate buffer to a pH of the final composition of approximately 3.0 to about 6.0 as well as approximately 1.0 to 10% (w/v) of a carbohydrate or polyhydric alcohol tonicifier; and, optionally, approximately 0.005 to 1.0% (w/v) of a preservative selected from the group consisting of m-cresol, benzyl alcohol, parabens and phenol. These formulations maintain stability upon storage under refrigerated or room temperature conditions. Such formulations can be further combined with insulin in the same syringe for administration to a patient.

6. 发明授权

US5451409A Sustained release matrix system using hydroxyethyl cellulose and hydroxypropyl cellulose polymer blends 失效
标题翻译：使用羟乙基纤维素和羟丙基纤维素聚合物共混物的缓释基质体系
公开(公告)号：US5451409A
公开(公告)日：1995-09-19
申请号：US156223
申请日：1993-11-22
申请人： William F. Rencher , Suresh Babu , Shankar Musunuri , Christopher H. Day , James Schwing
发明人： William F. Rencher , Suresh Babu , Shankar Musunuri , Christopher H. Day , James Schwing
IPC分类号： A61K9/20 , A61K9/22 , A61K9/24
CPC分类号： A61K9/209 , A61K9/2054 , Y10S514/963 , Y10S514/964 , Y10S514/965
摘要： The present invention is directed to a novel sustained release matrix and oral dosage form comprising a homogeneous matrix formed from a wet granulation containing an effective amount of a medicament and a polymer blend of hydroxypropyl cellulose and hydroxyethyl cellulose. The present invention also discloses a novel process for making a sustained release oral dosage form comprising wet granulating a medicament with a polymer blend of hydroxypropyl cellulose and hydroxyethyl cellulose to form a homogeneous matrix, wherein the polymer blend is provided in an amount effective to control the release of said medicament, then forming the homogenous matrix into a solid oral dosage form.
摘要翻译：本发明涉及一种新型的缓释基质和口服剂型，其包含由含有有效量的药物和羟丙基纤维素与羟乙基纤维素的聚合物共混物的湿法制粒形成的均匀基质。本发明还公开了一种制备持续释放口服剂型的新方法，其包括用羟丙基纤维素和羟乙基纤维素的聚合物共混物湿法造粒药物以形成均匀的基质，其中聚合物共混物以有效控制释放所述药物，然后将均匀基质形成固体口服剂型。

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