Modifier system for compositions containing layered double hydroxide

Abstract

The invention relates to a composition comprising: i) one or more LDH-active anion materials comprising an LDH matrix intercalated with one or more active anions, and ii) a modifier system comprising a) one or more surfactants, in combination with b) one or more compounds having the generic formula MA, where M comprises one or more positively charged ions and A comprises one or more negatively charged counter ions.

1 . A composition comprising: i) one or more LDH-active anion materials comprising an LDH matrix intercalated with one or more active anions, and ii) a modifier system comprising a) one or more surfactants, in combination with b) one or more compounds having the generic formula MA, where M comprises one or more positively charged ions and A comprises one or more negatively charged counter ions. 
     
     
         2 . A composition according to  claim 1  wherein the one or more surfactants are selected from anionic surfactants, zwitterionic (amphoteric) surfactants, cationic surfactants and non-ionic surfactants. 
     
     
         3 . A composition according to  claim 2  wherein the one or more surfactants are selected from sodium lauryl sulfate, lecithin and poloxamer. 
     
     
         4 . A composition according to  claim 1  wherein M comprises the one or more positively charged ions selected from one or more mono-, di-, or tri-valent metals. 
     
     
         5 . A composition according to  claim 4  wherein M comprises one or more metals selected from alkali metals, alkaline earth metals and transition metals. 
     
     
         6 . A composition according to  claim 1  wherein the one or more negatively charged counter ions, A, are selected from carbonate, hydrogen carbonate, sulfate, hydroxide, oxide, chloride, bromide, fluoride, nitrate, dihydrogen phosphate, hydrogen phosphate, phosphate, acetate, maleate, citrate, mesylate, tartrate, gluconate, formate, malate, oxylate, succinate, tosylate, fumarate, pamoate, furoate, propionate, saccharate and thiocyanate anions. 
     
     
         7 . A composition according to  claim 1  wherein the one or more active anions are derived from ibuprofen, naproxen, ketorolac, diclofenac, indomethacin and atorvastatin, either in salt and/or free acid form. 
     
     
         8 . A composition according to  claim 1  wherein the modifier system has a weight ratio of the LDH matrix:the one or more compounds having the generic formula MA: the one or more surfactants, of 2:0.1 to 4:0.1 to 4. 
     
     
         9 . A composition according to  claim 1  comprising 400 mg LDH-ibuprofen (contains 200 mg LDH), at least 100 mg sodium carbonate and 200 mg of one or more surfactants selected from sodium lauryl sulfate, poloxamer and lecithin. 
     
     
         10 . A method for 1) controlling the total amount of active anion released from the LDH matrix under acidic conditions designed to represent the conditions found in a fasted human stomach, and 2) controlling the amount of released active anion which is dissolved in the acidic medium, the method comprising the step of forming a composition comprising: i) one or more LDH-active anion materials comprising an LDH matrix intercalated with one or more active anions, and ii) a modifier system comprising a) one or more surfactants, in combination with b) one or more compounds having the generic formula MA, where M comprises one or more positively charged ions and A comprises one or more negatively charged counter ions, wherein the amount of released active anion which is dissolved in the acidic medium is controlled relative to both the amount which is dissolved when the one or more surfactants is used in the absence of the metal salt and the amount which is dissolved when the one or more metal salts is used in the absence of the one or more surfactants. 
     
     
         11 . A formulation comprising a composition containing i) one or more LDH-active anion materials, and ii) a modifier system comprising a) one or more surfactants, in combination with b) one or more compounds having the generic formula MA, where M comprises one or more positively charged ions and A comprises one or more negatively charged counter ions. 
     
     
         12 . A formulation according to  claim 11  in a form selected from dry granules, tablets, caplets, orally disintegrating tablets, orally disintegrating granules, lozenges, films, capsules, powders, effervescent formulations and buccal and sub-lingual formats.