US2017106091A1PendingUtilityA1

Method of Using Composition Comprising Mixed Metal Compounds and Xanthan Gum

41
Assignee: OPKO IRELAND GLOBAL HOLDINGS LTDPriority: Feb 4, 2010Filed: Dec 29, 2016Published: Apr 20, 2017
Est. expiryFeb 4, 2030(~3.5 yrs left)· nominal 20-yr term from priority
Inventors:Richard Jonathan ApplewhiteMaurice Sydney NewtonAlexis John Toft
A61P 3/06A61K 47/32A61K 47/36A61K 33/06A61K 47/38A61K 33/26A61K 33/30A61K 9/10A61K 41/17A61K 9/0053A61K 41/0019A61K 33/244A61K 33/24
41
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Claims

Abstract

The present invention provides a composition comprising (i) a mixed metal compound containing at least one trivalent metal selected from iron (III) and aluminium and at least one divalent metal selected from of magnesium, iron, zinc, calcium, lanthanum and cerium, (ii) xanthan gum (iii) at least one of (a) polyvinyl pyrrolidone (b) locust bean gum (c) methyl cellulose wherein the composition has been irradiated with ionising radiation in an amount of at least 4kGy.

Claims

exact text as granted — not AI-modified
1 .- 24 . (canceled) 
     
     
         25 . A method for binding phosphate comprising administering a composition comprising an aqueous suspension comprising:
 (i) an insoluble mixed metal compound capable of binding phosphate containing at least one trivalent metal selected from iron (III) and aluminium and at least one divalent metal selected from of magnesium, iron, zinc, calcium, lanthanum and cerium, wherein the component (i) is present in an amount up to 12% by weight, based on the total weight of the composition,   (ii) xanthan gum present in the composition in an amount of no greater than about 2% by weight, based on the total weight of the composition;   (iii) at least one of
 (a) polyvinyl pyrrolidone 
 (b) locust bean gum 
 (c) methyl cellulose 
   wherein the composition has been irradiated with ionising radiation in an amount of at least 4 kGy.   
     
     
         26 . The method according to  claim 25  where in the compound is of formula I
   M II   1-x M III   x (OH) 2 A n−   y   .m H 2 O  (I)
 
 wherein M II  is one or more bivalent metals and is at least Mg 2+ ; 
 M III  is one or more trivalent metals and is at least Fe 3+ ; 
 A n−  is one or more n-valent anions and is at least CO 3   2 ; 
 (Σyn)/x is from 0.5 to 1.5 
 0<x≦0.4, 
 0<y≦1 and 
 0<m≦10. 
 
     
     
         27 . The method according to  claim 25  wherein the compound has an aluminium content of less than 10000 ppm. 
     
     
         28 . The method according to  claim 25  wherein the composition has been irradiated with ionising radiation in an amount of at least 6 kGy. 
     
     
         29 . The method according to  claim 25  wherein the composition has been irradiated with ionising radiation in an amount of at least 8 kGy. 
     
     
         30 . The method according to  claim 25  wherein the composition has been irradiated with ionising radiation in an amount of at least 10 kGy. 
     
     
         31 . The method according to  claim 25  wherein component (iii) is present in an amount of no greater than 2 wt % based on weight of the composition. 
     
     
         32 . The method according to  claim 25  wherein the xanthan gum and component (iii) are present in a ratio of 2:1 to 1:2. 
     
     
         33 . The method according to  claim 25  wherein the xanthan gum and component (iii) are present in a ratio of approximately 1:1. 
     
     
         34 . The method according to  claim 25  wherein the composition comprises at least polyvinyl pyrrolidone. 
     
     
         35 . The method according to  claim 34  wherein the composition comprises (ii) xanthan gum and (iii) polyvinyl pyrrolidone, wherein the xanthan gum and polyvinyl pyrrolidone are present in a ratio of approximately 2:1. 
     
     
         36 . The method according to  claim 34  wherein the composition has been irradiated with ionising radiation in an amount of at least 8 kGy. 
     
     
         37 . The method according to  claim 25  wherein the composition comprises at least locust bean gum. 
     
     
         38 . The method according to  claim 37  wherein the composition comprises (ii) xanthan gum and (iii) locust bean gum, wherein the xanthan gum and locust bean gum are present in a ratio of approximately 1:1. 
     
     
         39 . The method according to  claim 37  wherein the composition has been irradiated with ionising radiation in an amount of at least 6 kGy. 
     
     
         40 . The method according to  claim 25  wherein the composition comprises at least methyl cellulose. 
     
     
         41 . The method according to  claim 40  wherein the composition comprises (ii) xanthan gum and (iii) methyl cellulose, wherein the xanthan gum and methyl cellulose are present in a ratio of approximately 1:1. 
     
     
         42 . The method according to  claim 40  wherein the composition has been irradiated with ionising radiation in an amount of at least 10 kGy. 
     
     
         43 . The method according to  claim 25  wherein the composition is a pharmaceutical composition and optionally further comprises (iv) one or more pharmaceutically acceptable adjuvants, excipients, diluents or carriers. 
     
     
         46 . The method according to  claim 25 , comprising administering the composition in amount effective for the treatment of hyperphosphataemia. 
     
     
         47 . A method of binding phosphate comprising administering a composition comprising an aqueous suspension comprising:
 (i) an insoluble mixed metal compound capable of binding phosphate containing at least one trivalent metal selected from iron (iii) and aluminum and at least one divalent metal selected from magnesium, iron, zinc, calcium, lanthanum, and cerium, wherein component (i) is present in the composition in an amount of about 8% to 12% by weight, based on the total weight of the composition,   (ii) xanthan gum, wherein component (ii) is present in the composition in an amount of no greater than about 2% by weight, based on the total weight of the composition, and   (iii) at least one of (a) polyvinyl pyrrolidone, (b) locust bean gum, and (c) methyl cellulose, wherein component (iii) is present in an amount no greater than about 2% by weight based on the total weight of the composition, wherein the composition has been irradiated with ionizing radiation in an amount of at least 4 kGy.   
     
     
         48 . A method for binding phosphate, comprising administering an aqueous suspension comprising:
 (i) an insoluble mixed metal compound capable of binding phosphate containing at least one trivalent metal selected from iron (III) and aluminium and at least one divalent metal selected from magnesium, iron, zinc, calcium, lanthanum and cerium,   (ii) xanthan gum;   (iii) at least one of
 (a) polyvinyl pyrrolidone 
 (b) locust bean gum 
 (c) methyl cellulose 
   wherein the xanthan gum and component (iii) are provided in a ratio of 2:1 to 1:2, the suspension has been irradiated with ionising radiation in an amount of at least 4 kGy, and the suspension has a yield stress of greater than about 2.6 Pa to about 19 Pa.   
     
     
         49 . The method of  claim 48 , wherein the xanthan gum is present in the suspension in an amount of no greater than about 2% by weight, based on the total weight of the suspension. 
     
     
         50 . The method of  claim 49 , wherein the mixed metal compound is present in the suspension in an amount up to about 12 wt %.

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