Medicine and spryceltm composition tablet for treating leukemia

A dasatinib and composition technology, applied in the field of dasatinib composition tablets for the treatment of blood cancer, can solve the problems of low bioavailability of preparations, poor solubility of dasatinib, etc., and achieve water and impurity content Low, good water solubility, convenient preparation

Inactive Publication Date: 2015-11-04
QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patented method allows for making certain forms (called “dasanitab”) other than those previously known but without being able to achieve this precise controlled process. It also shows how these novel structures have excellent characteristics such as high water solvability or less likely absorbing moistures compared to existing molecules like Dasatinib itself. These improvements make them easier to prepare on large scales while still maintaining their effectiveness at deliverable dosages over longer periods of storage.

Problems solved by technology

This patented technical problem addressed in this patents relates to finding better ways to make certain types of active ingredients like dasatinabitmeilceptive against Chron'blastic Leukaemias ( CBLS). Different molecular structures may lead to differences in their physicochemistry, solvabilities, etc., making them difficult to handle safely over prolonged storage times while maintaining consistency during use. Additionally, due to lack of suitable techniques for producing pure and usable saltforms of such APIs, they could potentially harm patients receiving therapy if taken improving dosage accuracy.

Method used

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  • Medicine and spryceltm composition tablet for treating leukemia
  • Medicine and spryceltm composition tablet for treating leukemia
  • Medicine and spryceltm composition tablet for treating leukemia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1: Preparation of dasatinib crystals

[0027] (1) Add the crude product of dasatinib to the mixed solution of dimethyl sulfoxide and carbon tetrachloride whose volume is 8 times the weight of dasatinib, and the volume ratio of dimethyl sulfoxide and carbon tetrachloride is 6 : 1, be warming up to 35 ℃, stir until completely dissolving;

[0028] (2) Under a sound field with a frequency of 20KHz and an output power of 55W, add a mixed solution of acetonitrile and water whose volume is 11 times the weight of dasatinib while stirring. The volume ratio of acetonitrile to water is 1:1, and the stirring speed It is 70 rev / min, and the adding speed is 45 ml / min;

[0029] (3) After adding the mixed solution of acetonitrile and water, under a sound field with a frequency of 25KHz and an output power of 40W, cool down to -5°C at 15°C / hour, grow crystals for 3 hours, wash, and dry in vacuum to obtain Dasa tinib compound.

[0030] The X-ray powder diffraction pattern ob...

Embodiment 2

[0031] Example 2: Preparation of Dasatinib Tablets:

[0032] Prescription: in parts by weight as shown in Table 1

[0033] Table 1 Dasatinib composition prescription

[0034]

[0035] Preparation:

[0036] (1) Processing of raw and auxiliary materials: use a vibrating sieve machine to sieve the raw material dasatinib to 80 meshes;

[0037] (2) Weighing: Weighing according to the process prescription;

[0038] (3) Total mixing: place dasatinib, polyvinyl butyral, calcium sulfate, lactose F100, and microcrystalline cellulose 102 in the three-dimensional motion mixer, set the motor operating frequency to 200r / min, and start the mixer to mix for 15 minutes, after the mixing is completed, magnesium stearate is added, the operating frequency of the motor is set to 200r / min, and the mixer is started to mix for 5 minutes;

[0039] (4) Tablet pressing: choose a high-speed tablet press to press the tablet, adjust the pressure so that the tablet can be formed and the hardness is...

Embodiment 3

[0041] Example 3: Preparation of Dasatinib Tablets:

[0042] Prescription: in parts by weight as shown in Table 2

[0043] Table 2 Dasatinib composition prescription

[0044]

[0045] Preparation:

[0046] (1) Processing of raw and auxiliary materials: use a vibrating sieve machine to sieve the raw material dasatinib to 80 meshes;

[0047] (2) Weighing: Weighing according to the process prescription;

[0048] (3) Total mixing: place dasatinib, polyvinyl butyral, calcium sulfate, lactose F100, and microcrystalline cellulose 102 in the three-dimensional motion mixer, set the motor operating frequency to 200r / min, and start the mixer to mix for 15 minutes, after the mixing is completed, magnesium stearate is added, the operating frequency of the motor is set to 200r / min, and the mixer is started to mix for 5 minutes;

[0049] (4) Tablet pressing: choose a high-speed tablet press to press the tablet, adjust the pressure so that the tablet can be formed and the hardness is...

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Abstract

The invention discloses a medicine and spryceltm composition tablet for treating leukemia and belongs to the technical field of medicines. The medicine and spryceltm composition tablet consists of spryceltm, polyvinyl butyral, calcium sulfate, lactose F100, microcrystalline cellulose 102 and magnesium stearate, wherein spryceltm is a novel crystal compound of which the X-ray powder diffraction pattern obtained through Cu-K alpha ray measurement, and is different from dasatinib reported in the prior art; tests show that the compound adopting the novel crystal structure is good in water solubility, low in probability of moisture absorption and moisture and impurity content and excellent in stability, so that convenience is brought for agent preparation. Compared with the prior art, the medicine and spryceltm composition tablet prepared from the novel crystal compound (spryceltm) is high in dissolution rate and stability and low in moisture and impurity content, and has the advantage that the safety of clinical application is improved.

Description

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Claims

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Application Information

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Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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