Treatment approach by targeted delivery of bioactive molecules bio modulated ceramics

1 . A method of treating a subject in need thereof with one or more first pharmaceutically active compounds at a site of the subject, the method comprising the steps of:

i) administering to the site of the subject in need thereof a finely divided (particulate) material,

wherein the finely divided material comprises a first material and a second material,

wherein the first material comprises hydroxyapatite and consists of a mixture of micro-sized particles in a size range of about 10 μm, and nano-sized particles in a size range of about 40 nm to about 100 nm,

wherein the ratio of micro-sized particles and nano-sized particles in the first materials is 1:1,

wherein the second material is calcium sulphate hemi-hydrate and/or di-hydrate;

ii) allowing a period of time to pass in order to provide for a sufficient amount of the second material to be bioresorbed such that the first material is exposed to the body; and

iii) systemically administering the one or more first pharmaceutically active compounds after the period of time in (ii), such that the one or more first pharmaceutically active compounds bind to the first material at the site of the subject,

wherein the one or more first pharmaceutically active compounds is a bisphosphonate selected from the group consisting of zoledronic acid, etidronic acid, clodronic acid, tiludronic acid, pamidronic acid, neridronic acid, olpadronic acid, alendronic acid, ibandronic acid, risendronic acid and a salt thereof.

2 . The method according to claim 1 , wherein the calcium sulphate hemi-hydrate and/or di-hydrate is absorbed by the body of the subject within 6 weeks.

3 . The method according to claim 1 , wherein the second material is pre-loaded or soaked with one or more second pharmaceutically active compounds; wherein the one or more second pharmaceutically active compounds is selected from the group consisting of an antibiotic compound and a bisphosphonate.

4 . The method according to claim 3 , wherein the one or more second pharmaceutically active compounds display lower affinity for the first material than to the second material.

5 . The method according to claim 1 , wherein the one or more first pharmaceutically active compounds display lower affinity for the second material than to the first material.

6 . The method according to claim 1 , wherein a ratio between the first and the second material is in a range of 1% to 99.9%.

7 . The method according to claim 6 , wherein a ratio between the first and the second material is in a range of 40% to 60%.

8 . The method according to claim 1 , wherein the first material is additionally pre-loaded or soaked with one or more first pharmaceutically active compounds.

9 . The method according to claim 3 , wherein the one or more second pharmaceutically active compounds is an antibiotic selected from the group consisting of geldanamycin, herbimycin A, macbecin, natalamycin, streptovaricin, rifamycin, daptomycin, and derivatives thereof.

10 . The method according to claim 3 , wherein the one or more second pharmaceutically active compounds is a bisphosphonate selected from the group consisting of zoledronic acid, etidronic acid, clodronic acid, tiludronic acid, pamidronic acid, neridronic acid, olpadronic acid, alendronic acid, ibandronic acid, risendronic acid and a salt thereof.

11 . The method according to claim 10 , wherein the bisphosphonate is a salt including a radioactive compound selected from the group consisting of 99 Tc, 223 Ra, strontium, and samarium, or the bisphosphonate is a compound comprising 18 F.