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Nanoparticle comprising rapamycin and albumin as anticancer agent

a technology of nanoparticles and tumors, which is applied in the direction of biocide, drug compositions, therapy, etc., can solve the problems of inaccessibility to surgeons, inability to treat tumors located in other areas, and inability to respond to significant numbers of tumors to drugs and/or radiation therapy, etc., to achieve the effect of preventing or retarding the development of tumors

Inactive Publication Date: 2013-10-24
DESAI NEIL P +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The nanoparticle formulation of rapamycin demonstrates increased specificity and solubility, allowing for higher doses with reduced toxicity, improved tumor penetration, and enhanced antitumor activity, potentially overcoming the limitations of traditional cancer therapies by inhibiting tumor growth and delaying disease progression.

Problems solved by technology

The failure of a significant number of tumors to respond to drug and / or radiation therapy is a serious problem in the treatment of cancer.
Surgery generally is only effective for treating the earlier stages of cancer.
While surgery is sometimes effective in removing tumors located at certain sites, for example, in the breast, colon, and skin, it cannot be used in the treatment of tumors located in other areas, inaccessible to surgeons, nor in the treatment of disseminated neoplastic conditions such as leukemia.
For more than 50% of cancer individuals, by the time they are diagnosed they are no longer candidates for effective surgical treatment.
Other therapies are also often ineffective.
Radiation therapy is only effective for individuals who present with clinically localized disease at early and middle stages of cancer, and is not effective for the late stages of cancer with metastasis.
However, it is difficult (if not impossible) to selectively administer therapeutic radiation to the abnormal tissue.
Thus, normal tissue proximate to the abnormal tissue is also exposed to potentially damaging doses of radiation throughout the course of treatment.
Because of this, radiotherapy techniques have an inherently narrow therapeutic index which results in the inadequate treatment of most tumors.
Even the best radiotherapeutic techniques may result in incomplete tumor reduction, tumor recurrence, increased tumor burden, and induction of radiation resistant tumors.
Chemotherapy can be effective, but there are severe side effects, e.g., vomiting, low white blood cells, loss of hair, loss of weight and other toxic effects.
Because of the extremely toxic side effects, many cancer individuals cannot successfully finish a complete chemotherapy regime.
Chemotherapy-induced side effects significantly impact the quality of life of the individual and may dramatically influence individual compliance with treatment.
Additionally, adverse side effects associated with chemotherapeutic agents are generally the major dose-limiting toxicity in the administration of these drugs.
Many of these chemotherapy-induced side effects if severe may lead to hospitalization, or require treatment with analgesics for the treatment of pain.
Some cancer individuals die from the chemotherapy due to poor tolerance to the chemotherapy.
The extreme side effects of anticancer drugs are caused by the poor target specificity of such drugs.
The poor target specificity that causes side effects also decreases the efficacy of chemotherapy because only a fraction of the drugs is correctly targeted.
The efficacy of chemotherapy is further decreased by poor retention of the anti-cancer drugs within the target tumors.
Another problem associated with chemotherapy is the development of drug resistance.

Method used

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  • Nanoparticle comprising rapamycin and albumin as anticancer agent
  • Nanoparticle comprising rapamycin and albumin as anticancer agent
  • Nanoparticle comprising rapamycin and albumin as anticancer agent

Examples

Experimental program
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example 1

Exemplary Methods for the Formation of Nanoparticle Compositions with Rapamycin and Albumin

example 1-a

[0260]This example demonstrates the preparation of a pharmaceutical composition comprising rapamycin and albumin in which the rapamycin concentration was 8 mg / mL in the emulsion and the formulation was made on a 300 mL scale. Rapamycin (2400 mg) was dissolved in 12 mL of chloroform / t-butanol. The solution was then added into 288 mL of a human serum albumin solution (3% w / v). The mixture was homogenized for 5 minutes at 10,000 rpm (Vitris homogenizer model Tempest I.Q.) in order to form a crude emulsion, and then transferred into a high pressure homogenizer. The emulsification was performed at 20,000 psi while recycling the emulsion. The resulting system was transferred into a Rotavap, and the solvent was rapidly removed at 40° C. at reduced pressure (25 mm of Hg). The resulting dispersion was translucent. At this stage, human serum albumin solution was added to the dispersion to adjust the human serum albumin to rapamycin ratio. The dispersion was serially filtered through multiple ...

example 1-b

[0261]This example demonstrates the preparation of a pharmaceutical composition comprising rapamycin and albumin in which the rapamycin concentration was 8.3 mg / mL in the emulsion and the formulation was made on a 200 mL scale. Rapamycin (1660 mg) was dissolved in 8.5 mL of chloroform / ethanol. The solution was then added into 191.5 mL of a human serum albumin solution (6% w / v). The mixture was homogenized for 5 minutes at 10,000 rpm (Vitris homogenizer model Tempest I.Q.) in order to form a crude emulsion, and then transferred into a high pressure homogenizer. The emulsification was performed at 20,000 psi while recycling the emulsion. The resulting system was transferred into a Rotavap, and the solvent was rapidly removed at 40° C. at reduced pressure (25 mm of Hg). The dispersion was serially filtered. The size of the 0.22 μm filtered formulation was 85 nm (Zav, Malvern Zetasizer). The dispersion was further lyophilized (FTS Systems, Dura-Dry μP, Stone Ridge, New York) for 60 hour...

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Abstract

The present invention features methods for treating, stabilizing, preventing, and / or delaying cancer by administering nanoparticles that comprise rapamycin or a derivative thereof. The invention also provides compositions (e.g., unit dosage forms) comprising nanoparticles that comprise a carrier protein and rapamycin or a derivative thereof. The invention further provides combination therapy methods of treating cancer comprising administering to an individual an effective amount of nanoparticles that comprise rapamycin or a derivative thereof and a second therapy.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority benefit to provisional application Ser. No. 60 / 905,669, filed Mar. 7, 2007, provisional application Ser. No. 60 / 905,734, filed Mar. 7, 2007, provisional application Ser. No. 60 / 905,662, filed Mar. 7, 2007, provisional application Ser. No. 60 / 905,735, filed Mar. 7, 2007, provisional application Ser. No. 60 / 905,672, filed Mar. 7, 2007, provisional application Ser. No. 60 / 905,787, filed Mar. 7, 2007, provisional application Ser. No. 60 / 905,663, filed Mar. 7, 2007, provisional application Ser. No. 60 / 905,767, filed Mar. 7, 2007, provisional application Ser. No. 60 / 905,750, filed Mar. 7, 2007, provisional application Ser. No. 60 / 923,248, filed Apr. 13, 2007, and provisional application Ser. No. 60 / 923,456, filed Apr. 13, 2007, the entire disclosures of each of which are hereby incorporated by reference.TECHNICAL FIELD[0002]This application relates to methods and compositions for treating, stabilizing, preventin...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/436A61K45/06A61N7/00A61K31/517A61N5/10A61K47/42A61K31/675
CPCA61K31/436A61K47/42A61K45/06A61K31/675A61K31/517A61N5/10A61N7/00A61K9/0019A61K9/19A61K31/337A61K31/7068A61P35/00A61K9/5169A61K31/704A61K2300/00A61K31/685A61K9/51
Inventor DESAI, NEIL P.SOON-SHIONG, PATRICKTRIEU, VUONG
Owner DESAI NEIL P
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