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Manufacture Process

a technology of manufacture process and process, applied in the field of manufacture process, can solve the problems of increasing morbidity and mortality, reducing vitamin d production, increasing incidence, etc., and achieve the effect of reducing the phosphate binding capacity

Inactive Publication Date: 2012-05-24
NOVARTIS TIERUNDHEIT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention provides a new phosphate adsorbent containing iron(III) oxide-hydroxide with higher phosphate binding capacity than existing adsorbents. The adsorbent has a unique structure formed by polynuclear iron(III) oxide hydroxides, insoluble carbohydrates, and soluble carbohydrates. The soluble carbohydrates stabilize the polynuclear iron(III) oxide hydroxides. The adsorbent can be used in pharmaceutical compositions and has a high phosphate binding capacity. The invention also provides a manufacturing process for the adsorbent and a method for preparing oxide-hydroxide of iron(III) with gamma-configuration."

Problems solved by technology

Hyperphosphatemia is associated with significant increase in morbidity and mortality, and may induce severe complications, such as hypocalcemia, decreasing of vitamin D production, metastatic calcification.
Hyperphosphatemia is also contributing to the increased incidence of cardiovascular disease among dialysis-dependent patients, and can result in bone pathology.
In many cases, restricting intake of dietary phosphorus is not sufficient to reduce serum phosphate levels into the normal range, and oral phosphate binders need to be taken.
But there are concerns regarding their long-term safety.
The traditional aluminium-based phosphate binders have the drawback of side effects due to aluminium absorption (osteomalacia, encephalopathy, microcytic anaemia).
Since this product is soluble its long term administration may induce an increase of the concentration of iron in gastrointestinal tract, which may be safety issue as mentioned hereinabove.
The phosphate binding capacity of the known phosphate adsorbents containing oxide hydroxides is limited.
Furthermore, the processes described to manufacture such compounds are not suitable for preparing larger amounts of compounds.
The possible release of iron under physiological conditions from any iron containing drugs or compounds, in particular in case of the phosphate adsorbent described in U.S. Pat. No. 6,174,442, may be a safety issue, since excess iron is toxic to body organs.
A too high release of iron can particularly problematic in case of patients suffering from haemochromatosis.
The glucose derivative is probably acting by preventing the phosphate adsorbent from being overdried during its purification, as overdrying would lead to a loss of the phosphate binding capacity.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Preparation of Iron(III)-Based Phosphate Adsorbent

[0238]To a mixture of 41 kg potato starch, 118 kg sodium carbonate and 480 kg water a solution of 148 kg iron(III) chloride hexahydrate dissolved in 588 kg water is added over 30 minutes time span at a temperature of 20-35° C. The resulting brown suspension is stirred for at least 60 minutes at 25° C. then filtered and washed three times with 968 kg water each using a decanter centrifuge. Subsequent 160 kg water, 41 kg sucrose and 129 kg ethanol are added and the mixture is stirred for at least 60 minutes. 172 kg of the final product are isolated as a reddish brown powder, obtained by spray drying using a NIRO SD42 with appropriate spray drying parameters or with an atomization pressure of 1.2 bar, an outlet temperature of 65° C. and an Inlet temperature of 140° C.

[0239]The product may be filled without any other processing directly into sachets or stick packs.

example 2

Preparation of Iron(III)-Based Phosphate Adsorbent

[0240]An aqueous solution of 21.1 g sodium carbonate dissolved in 105 g water (solution A) and an aqueous solution of 26.5 g iron(III) chloride hexahydrate dissolved in 55 g water (solution B) are prepared. Solution A (4.2 g / min) and B (2.7 g / min) are dosed to a suspension of 7.36 g potato starch in 40 g water over a time span of 30 minutes by continuous mixing of solution A and B and subsequent addition to the potato starch suspension. The resulting brown-reddish suspension is stirred for at least one hour at 25° C., filtered and washed three times with 173.6 g water each. To the resulting reddish brown solids 14.6 g water, 7.36 g sucrose and 24.2 g ethanol are added and the mixture is stirred for 60 minutes. 18.4 g of the final product are obtained by fluidized spray drying using appropriate FSD conditions.

example 3

Phosphate Binding Capacity of the Material Described in Example 1 or Example 2 Determined by Ion Chromatography / Conductivity Detection

[0241]Separation mechanism used is ion exchange.

[0242]Reagents: Highly pure water (e.g. from Milli-Q-System (Millipore)); Sodium hydroxide (50% (m / m) solution, carbonate free, e.g. Merck 1.58793); 0.1 N Hydrochloric acid (HCl); Hydrochloric acid 37%; Sodium hydrogen phosphate (Na2HPO4).

[0243]Equipment: Ion chromatograph with gradient pump; Anion exchange column (e.g. Dionex IonPac AS11-HC Length 250 mm, internal diameter 4 mm; or equivalent); Self regenerating anion suppressor (e.g. Dionex ASRS-ULTRA II 4 mm, anion suppressor system), PVDF Filter (e.g. Infochroma: 8817E-PV-4 ECO HPLC-Filter PVDF 0.45 μm).

[0244]Chromatographic Conditions

[0245]Gradient elution using degassed water as eluent 1 and 80 mM sodium hydroxide in water as eluent 2.

Gradient programTimeOH− [mM]% E1% E2Remark 01680 20Run start1080 01001480 010014.11680 2016.01680 20Run end18.01680...

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Abstract

The present invention relates to a new iron containing phosphate adsorbent and its use e.g. for treating hyperphosphataemia.

Description

[0001]This application is a continuation of U.S. application Ser. No. 12 / 001,132, filed Dec. 10, 2007, which claims benefit from European Application No. 06126122.8, filed Dec. 14, 2006 and European application No. 06126101.2, filed Dec. 14, 2006, which in their entirety are herein incorporated by reference.[0002]The present invention relates to new iron containing phosphate adsorbent, process for its production, uses thereof and pharmaceutical compositions containing it.BACKGROUND OF THE INVENTION[0003]Phosphorus is critical for bone mineralization, cellular structure, genetic coding, and energy metabolism. Many organic and inorganic forms exist. Phosphorus is present in nearly all foods, and GI absorption of dietary forms is very efficient. Phosphorus homeostasis normally is maintained through several mechanisms (renal excretion, cellular release, hormonal control, etc). When the phosphorus load (from GI absorption, exogenous administration, or cellular release) exceeds renal excr...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): B29B9/12
CPCC01G49/0018B01J20/2803B01J20/223C01G49/02A61P13/12A61P19/00A61P19/08A61P3/02A61P3/12A61P3/14A61P31/14A61P43/00A61P5/18A61P7/00A61P7/08A61P9/00A61K33/26B01J20/06C07F15/02C01G49/00
Inventor AMBUHL, MICHAELGESSIER-VIAL, CORINEHARTMANN, CHRISTAKAUFMANN, DANIELKUSTERS, ERNSTMEIER, ULRICHMEYERSEKKAT, NABILA
Owner NOVARTIS TIERUNDHEIT
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