LONG TERM SUSTAINED RELEASE PHARMACEUTICAL COMPOSITION CONTAINING AQUEOUS SUSPENSION OF BISPHOSPHONATE
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.
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.