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Ferric organic compounds, uses thereof and methods of making same

A pharmaceutical-grade compound technology, applied in the field of pharmaceutical-grade iron-organic compounds

Inactive Publication Date: 2008-08-27
GLOBOASIA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, no commercial scale manufacturing process with quality control / analytical measures to ensure and / or verify compliance of pharmaceutical grade ferric citrate or ferric organic compounds with established standards or specifications has been previously disclosed

Method used

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  • Ferric organic compounds, uses thereof and methods of making same
  • Ferric organic compounds, uses thereof and methods of making same
  • Ferric organic compounds, uses thereof and methods of making same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0138] Example 1. General method for the synthesis of pharmaceutical grade ferric citrate

[0139] With respect to Fig. 1, which shows the general method for synthesizing pharmaceutical grade ferric citrate according to the present invention, the flow chart shows the instrumentation of quality control measures at selected stages of the synthetic process to ensure that the final ferric citrate product complies with those shown in Table A or any established manufacturing release specification for pharmaceutical grade ferric citrate that is approved or suitable for human use. Other quality control measures or steps, apparent to those of ordinary skill in the art, can be used or incorporated into pharmaceutical grade synthesis processes to maintain the quality and purity of the final product and to increase the efficiency and yield of the synthesis process. See, eg, QC10 and QC11 in FIG. 1 .

[0140]Examples of quality control measures employed during synthesis include: (QC4) kee...

Embodiment 1A

[0142] Example 1A. General method for the synthesis of pharmaceutical grade iron organic compounds

[0143] With respect to Figure 10, which shows the general method for the synthesis of pharmaceutical grade ferric organic compounds according to the present invention, the flow diagram shows the implementation of quality control measures at selected stages of the synthetic process to ensure that the final ferric citrate product complies with the requirements for the approved Pharmaceutical-grade iron-organic compounds that are or are suitable for human use have established manufacturing release specifications. Other quality control measures or steps, apparent to those of ordinary skill in the art, can be used or incorporated into pharmaceutical grade synthesis processes to maintain the quality and purity of the final product and to increase the efficiency and yield of the synthesis process. See, eg, QC10A and QC11A in FIG. 10 .

[0144] Examples of quality control measures emp...

Embodiment 2

[0146] Example 2. Solubility properties of iron organic compounds according to the invention

[0147] Ferric organic compounds produced according to the method described above are more soluble over a wider range of pH levels than commercially available ferric organic compounds. The increased solubility of the inventive ferric organic compounds is believed to be a result of the uniquely large active surface area of ​​the inventive ferric organic compounds. For example, at pH 8.0, the intrinsic dissolution rate of ferric citrate of the present invention is 3.08 times greater than that of commercially available ferric citrate. See Table 1.

[0148] The intrinsic dissolution rate of commercially available ferric citrate was compared with that of the present invention. The intrinsic dissolution rate is specified as the dissolution rate of the pure substance under constant surface area conditions. The dissolution rate and bioavailability of a drug substance are influenced by its ...

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PUM

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Abstract

The present invention discloses a pharmaceutical-grade ferric organic compounds, including ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. A manufacturing and quality control process for making a pharmaceutical -grade ferric citrate that consistently complies with the established Manufacture Release Specification is also disclosed. The pharmaceutical-grade ferric organic compounds are suitable for treating disorders characterized by elevated serum phosphate levels.

Description

[0001] This application claims priority to U.S. Serial No. 60 / 709,511, filed Aug. 19, 2005, and U.S. Serial No. 11 / 206,981, filed Aug. 18, 2005, which was filed Feb. 18, 2004 , a continuation-in-part of PCT / US2004 / 004646, published September 2, 2004 under International Publication No. WO2004 / 074444, which claims U.S. Serial No. 60 / 447,690 filed February 19, 2003 and The benefit of US Serial No. 60 / 462,684, filed April 15, 2003, and the entire content and disclosure of the above application is incorporated by reference into this application. [0002] Throughout this application, various publications are referenced. The entire disclosures of these publications are hereby incorporated herein by reference into this application in order to more fully describe the state of the art to which this invention pertains. technical field [0003] The present invention relates to the preparation and application of pharmaceutical-grade iron organic compounds such as ferric citrate. Uses of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07F15/02A01N37/00
CPCA61K31/295C07C51/412C07C51/42A61P13/12A61P27/02A61P3/00A61P3/12A61P3/14A61P7/00A61P7/08A61P9/00C07C59/265C07F15/02
Inventor 占基思汤竣钧
Owner GLOBOASIA
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