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Crystalline forms of ferric maltol

A technology of ferric maltol and crystallization, which is applied in the field of new polymorphs of compounds, can solve problems such as no identification or research of polymorphs

Active Publication Date: 2017-08-01
SHIELD TX (UK) LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Ferric maltol has been known for about 100 years, but no polymorphs were identified or studied prior to the present invention

Method used

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  • Crystalline forms of ferric maltol
  • Crystalline forms of ferric maltol
  • Crystalline forms of ferric maltol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0190] Example 1: Type I

[0191] Combine 9.04 kg of ferric citrate with 29 liters of purified water. Separately, 12.2 kg of maltol were combined with 15.2 liters of sodium hydroxide solution (20% w / w). Put ferric citrate and sodium hydroxide into a container, add 4 liters of water, and then stir at 20°C to 25°C. Then add seed crystals. The seed crystals are 65 g of iron maltol polymorph in 12 liters of water. The seed crystal was prepared by the same method as that described in Example 1, but the seed crystal was not used. Add seed crystals to the container to help consistent crystallization / precipitation. The mixture was kept in the form of a suspension in a container to allow crystal growth, then filtered and washed three times, using 13 liters of water each time. The resulting solid was dried below 80°C and yielded 13.25 kg of dry maltol iron.

[0192] The ferric maltol in Example 1 was produced on a scale of 12 kg to 15 kg in different batches. Analysis of the ferrous ...

Embodiment 1a

[0194] Production of iron maltol via recrystallization with and without type II inoculation

[0195] Ferric citrate (15g, 6.12×10 -2 mol) was dissolved in water (60 ml) and heated under reflux with stirring to aid dissolution. The solution was then cooled to room temperature. In a separate reaction vessel, maltol (19.17g, 0.152mol) was placed in 6M sodium hydroxide (27ml) at room temperature with stirring until the solid was completely dissolved. Then the solution is finely filtered.

[0196] The ferric citrate solution was added to the sodium maltolate solution under stirring at room temperature. The formation of a precipitate was observed after about 15 minutes. The mixture was sampled after stirring for 2 hours and 4 hours. XRPD analysis shows that the solid is comparable to type I. The slurry was then stirred overnight. The mixture was filtered under suction and most of the solids were dried in a vacuum oven (45°C). A small portion of the solid (3 g) was taken out and dr...

Embodiment 2

[0200] Example 2: Type II

[0201] The general method as described in Example 1 was used to produce the ferric maltol in Example 2, but the ferric maltol was produced in larger batches of 24 kg to 33 kg.

[0202] Analysis of the produced iron maltol showed that the% w / w of iron present was about 12.7% w / w and the% w / w of maltol present was about 88% w / w to 88.6% w / w.

[0203] The XRPD diagram of the type II polymorph obtained from Example 1a is shown in Figure 5 in.

[0204] Analysis of the produced iron maltol showed that in different batches, the% w / w of iron present was about 12.7% w / w to 12.9% w / w and the% w / w of maltol present was about 86.7% w / w to 87.1% w / w. However, the iron maltol seed crystals used in Example 2 are the seed crystals of the type I and type II polymorphs.

[0205] The precipitated ferric maltol was also kept in the wet slurry for a longer time than in Example 1.

[0206] The XRPD diagram of the type II polymorph obtained from Example 1a is shown in Figure 5 ...

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Abstract

There is provided polymorphs of ferric maltol. Such forms may be useful in the treatment of iron deficiency with or without anaemia, such as iron deficiency anaemia.

Description

Technical field [0001] The present invention relates to new polymorphs of compounds, pharmaceutical compositions containing them, and methods for obtaining them. Background technique [0002] Sufficient iron supply to the body is a basic requirement for tissue growth and maintenance of good health in both humans and animals. In addition, in certain pathological states where there is hidden blood loss or uneven iron distribution in the body, there may be a low iron storage state in the body, which leads to iron deficiency and accompanying chronic anemia. This is seen in inflammatory diseases of the gastrointestinal tract, such as gastric ulcer and peptic ulcer, reflux esophagitis, ulcerative colitis, and Crohn's disease. [0003] Anemia can also occur after surgery that causes severe blood loss and can be associated with gastrointestinal infections, such as those caused by Helicobacter pylori. [0004] Iron maltol contains a complex of trivalent iron and three maltol anions and has ...

Claims

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Application Information

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IPC IPC(8): C07D309/40A61K31/351A61P7/06
CPCC07D309/40C07B2200/13A61P3/02A61P3/12A61P7/06A61K31/351C07F15/025
Inventor D·P·蔡尔兹
Owner SHIELD TX (UK) LTD
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