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Methods and compositions for producing anti-androgenic effects

A technology of bicalutamide and composition, which can be applied in the directions of drug combination, medical preparations containing active ingredients, antitumor drugs, etc., can solve problems such as incomplete absorption, and achieve the effect of reducing the frequency of dose administration

Inactive Publication Date: 2009-07-08
PANACEA BIOTEC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the inclusion of such doses can lead to incomplete absorption, resulting in suboptimal drug levels in plasma

Method used

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  • Methods and compositions for producing anti-androgenic effects
  • Methods and compositions for producing anti-androgenic effects
  • Methods and compositions for producing anti-androgenic effects

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Table 3: Formulations (core tablets)

[0074] serial number

Element

quantity

quantity

(mg / tablet) 1 bicalutamide 250.00 2 lactose monohydrate 188.00 3 Sodium starch glycolate 35.00 4 polyvinylpyrrolidone 7.50 5 pure water Appropriate amount 6 Sodium starch glycolate 17.50 7 Magnesium stearate 2.00

[0075] Table 4: Formulations (Subcoat Compositions)

[0076] serial number

Element

quantity

(g / kg) 1 Hypromellose 50.00 2 Polyethylene glycol (PEG 6000) 7.50 3 Methanol 628.30 4 Dichloromethane 314.20

[0077] Table 5: Formulation (enteric coating composition)

[0078] serial number

Element

quantity

(g / kg) 1

Methacrylic acid copolymer

(methacrylic acid-methyl methacrylate copolymer (1:2)) 53.85

2

Methacrylic acid copolymer

(methacrylic acid-methyl methacrylate cop...

Embodiment 2

[0084] Table 6: Formulations (core tablets)

[0085] serial number

[0086] Table 7: Formulations (Subcoat Compositions)

[0087] serial number

[0088] Table 8: Formulations (Enteric Coating Compositions)

[0089] serial number

[0090] Carry out according to the same method of Example 1. Tablets corresponding to a total dose of 250 mg of bicalutamide (ie, five coated tablets) were filled into empty hard gelatin capsules.

Embodiment 3

[0092] Table 9: Formulations (core tablets)

[0093] serial number

[0094] Table 10: Formulations (Subcoat Compositions)

[0095] serial number

[0096] Table 11: Formulations (Enteric Coating Compositions)

[0097] serial number

[0098] Carry out according to the same method of Example 1. Three uncoated tablets corresponding to a total dose of 150 mg and two coated tablets corresponding to a total dose of 100 mg are filled into hard gelatin capsules. Dissolution studies were performed on the compositions using the pH shift method using buffers with 1% sodium lauryl sulfate (SLS) at pH 1.2, 4.5 and 6.8. The study was performed in USPapparatus type I. The dissolution profile obtained was figure 2 shown.

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Abstract

The present invention relates to a preparation for oral use, which contains bicalutamide and has a modified release mode. The composition is suitable for adopting a dosage regimen which is three times a week, twice a week and once a week, and the composition is used for producing an anti-androgenic effect.

Description

technical field [0001] The present invention belongs to the field of pharmacy. The present invention relates to methods and compositions of bicalutamide, a non-steroidal antiandrogen compound. Background technique [0002] Androgens are natural or synthetic compounds, usually steroid hormones, which stimulate and control the development and maintenance of male characteristics by binding to androgen receptors. As anabolic hormones, they are known to promote the growth of certain tissues such as the prostate and other surrounding tissues, including primary or metastatic prostate tumor cells. Androgens such as testosterone and dihydrotestosterone exert their effects on cellular function by binding to androgen receptors. The high response rate to first-line "androgen deprivation therapy" and the presence of androgen receptors in primary and metastatic prostate tumor cells support the notion that the receptor is an important mediator of prostate cancer development and growth. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/277A61K31/10A61K31/167
CPCA61K9/2886A61K31/10A61K9/2846A61K31/167A61K9/2018A61P35/00A61P5/26A61P5/28A61K31/277
Inventor 阿马尔吉特·辛格塞尔伯吉特·辛格沙瓦南德·珀思利
Owner PANACEA BIOTEC
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