US2015157649A1PendingUtilityA1

Long term sustained release pharmaceutical composition containing aqueous suspension of bisphosphonate

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Assignee: AMPHASTAR PHARMACEUTICALS INCPriority: Dec 21, 2006Filed: Feb 13, 2015Published: Jun 11, 2015
Est. expiryDec 21, 2026(~0.4 yrs left)· nominal 20-yr term from priority
Inventors:Jack Yongfeng ZhangMary Ziping LuoDingyuan FeiKevin XieJie Fei Ding
A61P 19/10A61P 19/08A61K 33/42A61K 9/0019A61K 31/663A61K 9/10
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Claims

Abstract

Pharmaceutical compositions for long-term sustained release of bisphosphonate drugs are provided. In one embodiment, the composition includes an aqueous suspension of a solid which includes a salt of a bisphosphonate drug and a salt of pentavalent phosphorus oxoacid. The compositions can be used to treat a variety of bone diseases, including osteoporosis.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of administering a bisphosphonate drug to a patient, the method comprising:
 preparing an aqueous suspension of an amorphous sosoloid, the amorphous sosoloid comprising a salt of a bisphosphonate drug and a salt of a pentavalent phosphorus oxoacid; and   intramuscularly injecting the aqueous suspension of the amorphous sosoloid into the patient.   
     
     
         2 . The method according to  claim 1 , wherein the aqueous suspension of the amorphous sosoloid is adapted to release the bisphosphonate drug into the patient over an extended period of time. 
     
     
         3 . The method according to  claim 2 , wherein the extended period of time comprises two months or longer. 
     
     
         4 . The method according to  claim 1 , wherein the amorphous sosoloid has a solubility in saline of less than 0.05% by weight as bisphosphonic acid. 
     
     
         5 . The method according to  claim 1 , wherein the bisphosphonate drug comprises a compound represented by (HO) 2 PO—R—OP(OH) 2 , wherein the chemical composition of the functional group R dictates the bisphosphonate drug as pamidronic acid, alendronic acid, ibandronic acid, risedronic acid, zoledronic acid or tiludronic acid. 
     
     
         6 . The method according to  claim 1 , wherein the intramuscularly injecting is performed no more than once every two months. 
     
     
         7 . A method of treating or preventing a bone disease in a patient, the method comprising intramuscularly injecting the patient with a pharmaceutical composition comprising an aqueous suspension of an amorphous sosoloid, the amorphous sosoloid comprising a calcium salt of a bisphosphonate drug and a calcium salt of a pentavalent phosphorus oxoacid. 
     
     
         8 . The method according to  claim 7 , wherein the bone disease is osteoporosis. 
     
     
         9 . The method according to  claim 7 , wherein the aqueous suspension of the amorphous sosoloid is adapted to release the bisphosphonate drug into the patient over an extended period of time. 
     
     
         10 . The method according to  claim 9 , wherein the extended period of time comprises two months or longer. 
     
     
         11 . The method according to  claim 7 , wherein the amorphous sosoloid has a solubility in saline of less than 0.05% by weight as bisphosphonic acid. 
     
     
         12 . The method according to  claim 7 , wherein the bisphosphonate drug comprises a compound represented by (HO) 2 PO—R—OP(OH) 2 , wherein the chemical composition of the functional group R dictates the bisphosphonate drug as pamidronic acid, alendronic acid, ibandronic acid, risedronic acid, zoledronic acid or tiludronic acid. 
     
     
         13 . The method according to  claim 7 , wherein the intramuscularly injecting is performed no more than once every two months. 
     
     
         14 . A method of treating or preventing a bone disease in a patient, the method comprising:
 preparing an aqueous suspension of an amorphous sosoloid, the amorphous sosoloid comprising a salt of a bisphosphonate drug and a salt of pentavalent phosphorus oxoacid; and   intramuscularly injecting the aqueous suspension of the solid into the patient.   
     
     
         15 . The method according to  claim 14 , wherein the bone disease is osteoporosis. 
     
     
         16 . The method according to  claim 14 , wherein the aqueous suspension of the solid is adapted to release the bisphosphonate drug into the patient over an extended period time. 
     
     
         17 . The method according to  claim 15 , wherein the extended period of time comprises two months or longer. 
     
     
         18 . The method according to  claim 14 , wherein the amorphous sosoloid has a solubility in saline of less than 0.05% by weight as bisphosphonic acid. 
     
     
         19 . The method according to  claim 14 , wherein the bisphosphonate drug comprises a compound represented by (HO) 2 PO—R—OP(OH) 2 , wherein the chemical composition of the functional group R dictates the bisphosphonate drug as pamidronic acid, alendronic acid, ibandronic acid, risedronic acid, zoledronic acid or tiludronic acid. 
     
     
         20 . The method according to  claim 14 , wherein the intramuscularly injecting is performed no more than once every two months.

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