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Composition therapy with iron compound and citrate compound

A technology of citrate and iron compounds, applied in the directions of drug combination, drug delivery, medical preparations containing active ingredients, etc., can solve the problems of unavoidable block, slow correction of microcytic anemia, etc.

Inactive Publication Date: 2018-11-23
罗克韦尔医疗公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Thus, parenteral iron treatment cannot avoid hepcidin-induced block in iron export and produces only slow partial correction of microcytic anemia

Method used

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  • Composition therapy with iron compound and citrate compound
  • Composition therapy with iron compound and citrate compound
  • Composition therapy with iron compound and citrate compound

Examples

Experimental program
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Effect test

example 1

[0048] In healthy male and female volunteers, with or without citrate compounds (ORACIT Shohl solution, CMC Pharma, Farmville, NC), stage 1, open labeling, Random sequence, single-dose studies to evaluate ferrous sulfate (FER-IN-SOL, Mead Johnson, Glenview, IL) or SFP (TRIFERIC, Rock The safety, pharmacokinetics and absolute bioavailability of iron from Weir Medical Technology Co., Ltd. A total of 14 healthy male and female subjects between the ages of 18 and 65 (including endpoints) participated in the study, and the subjects’ body mass index at the time of screening was ≤35kg / m 2 . At screening, subjects were required to use hemoglobin (male, ≥13g / dL; female, ≥12g / dL), mean red blood cell volume, reticulocyte count, and serum ferritin (male, 23 to 336ng / mL; female, 11 To 306ng / mL) is within the reference range of each gender; TSAT≥20%; and serum TIBC concentration≥250g / dL. The subject agreed to stop using all iron preparations 14 days before baseline.

[0049] The study incl...

example 2

[0087] To evaluate the safety, effectiveness, and safety of SFP (TRIFERIC, Rockwell Medical Technologies, Inc.) and citrate compounds (ORACIT Shohl solution, CMC Pharmaceuticals, Farmville, North Carolina) administered orally to patients with IRIDA Pharmacokinetic phase 2, open label, phase 3 study. A total of 28 participants were divided into 4 age groups (0 years old to 18 years old) stratified patients for the study. A schematic diagram of the study design is shown in Table 5.

[0088] table 5

[0089]

[0090] The patient should participate only when the patient has the following conditions: (1) history of congenital hypochromic microcytic anemia; (2) mean red blood cell volume (MCV) ≤75fL at screening; (3) serum transferrin saturation at screening Degree ≤ 15%; (4) History of no or incomplete response to oral iron treatment and intravenous iron administration; (5) History of hepcidin concentration relative to the range of iron deficiency anemia; (6) From CLIA certificatio...

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Abstract

Combination therapy comprising an iron compound, preferably soluble ferric pyrophosphate (SFP), in combination with a citrate compound is disclosed. Methods of using the combination therapy in the treatment of iron deficiency, with or without anemia, including iron-refractory iron deficiency anemia and other iron-sequestration syndromes, and pharmaceutical compositions and kits comprising SFP or another iron compound and a citrate compound are also disclosed.

Description

[0001] Cross references to related applications [0002] I hereby claim the rights of U.S. Provisional Patent Application No. 62 / 275,487 filed on January 6, 2017 and U.S. Provisional Patent Application No. 62 / 432,564 filed on December 9, 2016 under 35U.SC §119(e), Its disclosure is incorporated herein by reference. Technical field [0003] The present disclosure relates to a combination therapy comprising an iron compound and a citrate compound for the treatment of iron deficiency. Background technique [0004] Iron deficiency is the most common micronutrient deficiency in the world. In absolute iron deficiency, there is no iron storage and there is a decrease in iron throughout the body. In functional iron deficiency, iron stores exist, but the iron supply to plasma transferrin is insufficient, for example, due to the administration of erythropoiesis stimulants, which increase the iron requirement above the amount that can be mobilized from these stores. Iron is required for sev...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/194A61K33/26A61K9/12A61P7/06
CPCA61K9/0019A61K47/02A61K9/0095A61K31/194A61K33/26A61P7/06A61K2300/00
Inventor A.古普塔G.布里滕汉R.普拉特V.H.林
Owner 罗克韦尔医疗公司
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