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Compositions for treating tumor diseases

A composition and disease technology, applied in the field of compositions for the treatment of tumor diseases, can solve the problems of less serious hematological toxicity and the like

Active Publication Date: 2012-02-15
斯蒂廷海特盖格荷兰协会 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, hematological toxicity appears to be less severe after intravenous administration [77]

Method used

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  • Compositions for treating tumor diseases
  • Compositions for treating tumor diseases
  • Compositions for treating tumor diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0134] A 100 mg ritonavir dose was combined with a 100 mg docetaxel dose and administered orally to 22 patients simultaneously. with intravenous docetaxel (100mg) In comparison, dosing was administered as a 1-hour intravenous infusion (standard method) (without ritonavir).

[0135] Oral ritonavir: 1 capsule contains 100 mg ritonavir . Oral docetaxel dose: 100mg. A commercially available intravenous docetaxel formulation ( 2ml=80mg docetaxel; excipient polysorbate 80) is diluted with ethanol 95%: water (13:87), provides 10mg / ml docetaxel solution, let patient drink together with 100ml tap water (10ml 10mg / ml solution).

[0136] The obtained pharmacodynamic data are as follows:

[0137] Without ritonavir, the AUC of docetaxel administered orally is 0.29±0.26(mg.h / L)

[0138] With ritonavir, the AUC of docetaxel administered orally was 2.4±1.5(mg.h / L)

[0139] Without ritonavir, AUC of intravenous docetaxel 1.9±0.4(mg.h / L)

[0140] The results indicated a dual effect ...

Embodiment 2

[0144] Oral combination of docetaxel and ritonavir for the treatment of solid malignancies.

[0145] Patients are randomized into two treatment groups, X and Y. Group X, in the first week, received 100 mg ritonavir, 60 minutes later, received 100 mg oral docetaxel, and in the second week, these patients received both 100 mg ritonavir and 100 mg oral docetaxel. Patients in group Y received 100 mg ritonavir and 100 mg oral docetaxel concurrently during the first week, and 100 mg ritonavir followed 60 minutes later by 100 mg oral docetaxel during the second week. 15 days after the start of oral administration, both X and Y groups received 100 mg of intravenous docetaxel without ritonavir ( Standard method; 1 hour perfusion).

[0146] Oral docetaxel dose: 100mg. A commercially available intravenous docetaxel formulation ( 2ml=80mg docetaxel; excipient polysorbate 80) is diluted with ethanol 95%: water (13:87), provides 10mg / ml docetaxel solution, let patient drink together w...

Embodiment 3

[0181] Oral formulation of embodiment 3-paclitaxel

[0182] 3.1: Solid Dispersions Compared to Physical Mixtures

[0183] In this experiment, the solubility and dissolution rate of a composition comprising a solid dispersion of paclitaxel and PVP-K17 mixed with SDS was compared to a physical mixture of anhydrous paclitaxel, PVP-K17 and SDS.

[0184] Paclitaxel solid dispersion in PVP-K 17 5 mg capsules

[0185] A 20% solid dispersion of paclitaxel in PVP-K17 was prepared by dissolving 100 mg of paclitaxel in 10 mL of t-butanol and 400 mg of PVP-K17 in 6.67 mL of water. With continuous stirring, the paclitaxel / tert-butanol solution was added to the PVP-K17 / water solution. The final mixture was transferred to an 8 mL vial with a maximum fill level of 2 mL. The tert-butanol and water were subsequently removed by lyophilization (see Table 3 for conditions). 25 mg paclitaxel 20% / PVP-K17 solid dispersion (=5 mg paclitaxel) was mixed with 125 mg lactose, 30 mg sodium lauryl sulfa...

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Abstract

The present invention includes pharmaceutical compositions and methods for treating neoplastic diseases comprising co-administering a taxane (eg, docetaxel) with a CYP3A4 inhibitor (eg, ritonavir). The present invention also includes a method of treating a neoplastic disease comprising the simultaneous or separate administration of a taxane and a CYP3A4 inhibitor. Additionally, the present invention includes kits for practicing the methods. The present invention also includes solid pharmaceutical taxane compositions for oral administration comprising a substantially amorphous taxane, a carrier and a surfactant.

Description

technical field [0001] The present invention relates to pharmaceutical compositions. More particularly, but not exclusively, the present invention relates to compositions and methods for the treatment of neoplastic diseases. Background technique [0002] Drugs administered in oral form offer various advantages. The availability of oral anticancer drugs is important when long-term treatment is necessary to be most effective, for example, 5-fluorouracil (5-FU) prodrugs (such as capecitabine) and interference with signal transduction pathways or blood vessels Drugs that generate processes [I]. In addition, oral medications can be administered as an outpatient or at home, improving convenience and quality of life for patients, and potentially reducing costs due to fewer hospital visits [2]. Therefore, it is advantageous to attempt to administer anticancer drugs orally. [0003] In general, oral administration of drugs is convenient and practical. Unfortunately, the oral bio...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K9/19A61K9/48A61K31/337A61K31/426A61K45/06A61P35/00
Inventor J·H·贝内恩J·H·M·舍伦斯J·默斯B·努伊耶恩
Owner 斯蒂廷海特盖格荷兰协会
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