High purity therapeutic bone agents
AssigneeIsoTherapeutics Group LLC
InventorsJaime Simon, R. Keith Frank, David A. Wilson
Life of this patent
Estimating the term…
Abstract
This invention relates to radioactive, bone-seeking, pharmaceutical methods, compositions and formulations that have a lower impurity profile, a longer shelf life, improved availability and are less expensive to prepare. The compositions of this invention can be conveniently prepared in a timely manner resulting in improved availability and delivery of the drugs to patients.
Claims18
A method for the treatment of a Patient comprising administration to the Patient having bone pain, one or more calcific tumors, or in need of a bone marrow suppressing procedure, a pharmaceutically-acceptable formulation of a chelate composition comprising a Clinically Relevant Dosage of the composition that is therapeutically effective, said composition either:
- a) has said formulation as a chelate composition consisting essentially of Sm-153 and DOTMP or a physiologically-acceptable salt thereof or
- b) has said formulation comprising a kit containing as two separate components, the DOTMP chelant and the Sm-153 isotope, which components are mixed to form the chelate composition at the appropriate time prior to use,
- wherein the Sm-153 isotope possesses an extended Expiration Date of greater than or equal to about 5 days, and wherein the Sm-153 dosage is at least 35 mCi.
(canceled)
(canceled)
A pharmaceutically-acceptable chelate composition comprising a Clinically Relevant Dosage of the composition that is therapeutically effective and pharmaceutically-acceptable, Sm-153 isotope used in the said chelate composition possessing an extended Expiration Date of greater than or equal to about 5 days and said chelate consisting essentially of Sm-153 and DOTMP or a physiologically-acceptable salt thereof, wherein the Sm-153 dosage is at least 35 mCi.
A pharmaceutical formulation comprising a chelate composition comprising a Clinically Relevant Dosage of the composition that is therapeutically effective and pharmaceutically-acceptable, Sm-153 used in the said chelate composition possessing an extended Expiration Date of greater than or equal to about 5 days and said chelate consisting essentially of Sm-153 and DOTMP or a physiologically-acceptable salt thereof, wherein the Sm-153 dosage is at least 35 mCi, and a pharmaceutically-acceptable carrier.
(canceled)
A process for preparing a pharmaceutically-acceptable formulation of a radioactive chelate composition comprising the steps of:
- a) irradiating Sm-152 in a lower flux portion of the nuclear reactor to form low specific activity Sm-153, wherein the isotope composition after the irradiation contains mainly Sm-152 and Sm-153 with reduced trace impurity of Eu-154, thereby providing an extended Expiration Date greater than or equal to about 5 days;
- b) taking the prepared isotope mixture from step a) and either using it in step c) or allowing it to decay and then using it in step c) which decay further lowers the specific activity of the Sm-153 formed in step a) while maintaining less than the FDA allowable maximum amount of Eu-154;
- and
- c) reacting DOTMP or a physiologically-acceptable salt thereof as the chelant with the Sm-153 isotope mixture from step b) in an aqueous solvent to form the radioactive chelate composition that is pharmaceutically-acceptable.
Dependencies are inferred from the claim text.