US 12,268,758 B2
DOTMP kit formulations for radioisotopes
R. Keith Frank, Lake Jackson, TX (US); Jaime Simon, Angleton, TX (US); and Kelli R. Jay, Brazoria, TX (US)
Assigned to IGL Pharma Inc., Angelton, TX (US)
Filed by IGL Pharma Inc., Angleton, TX (US)
Filed on May 21, 2022, as Appl. No. 17/750,333.
Application 17/750,333 is a division of application No. 16/866,001, filed on May 4, 2020, granted, now 11,369,700.
Application 16/866,001 is a continuation in part of application No. 15/821,974, abandoned, previously published as PCT/US2016/033900, filed on May 24, 2016.
Claims priority of provisional application 62/166,051, filed on May 25, 2015.
Prior Publication US 2022/0273828 A1, Sep. 1, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 51/04 (2006.01); A61K 9/19 (2006.01); A61K 47/02 (2006.01); A61P 35/00 (2006.01)
CPC A61K 51/0482 (2013.01) [A61K 9/19 (2013.01); A61K 47/02 (2013.01); A61P 35/00 (2018.01)] 10 Claims
 
1. A pharmaceutically-acceptable kit formulation for the preparation of a radioactive bone-seeking drug comprising at least three components, having a two part buffering system, including instructions for its use, for preparing a pharmaceutically-acceptable drug formulation of a radioisotope-DOTMP chelate, wherein the kit components are:
vial 1: lyophilized DOTMP, carbonate and an empirically determined amount of NaOH or KOH; which becomes a carbonate buffer after the addition of acid from vial 3;
vial 2: a calcium solution in a pharmaceutically-acceptable aqueous solvent; and
vial 3: a phosphate buffer in a pharmaceutically-acceptable aqueous solvent at a pH of about 7, optionally with pharmaceutically-acceptable preservatives, diluents, and excipients;
provided that the amount of each component of the above three vials is determined by the low dose or high dose kit desired to be administered to a patient;
provided that when the kit is constituted to form the drug at the time of use, a radioisotope selected from the group consisting of Sm-153, Gd-159, Ho-166, Lu-177, and Y-90 in HCl or HNO3 is added to vial 1 to achieve a pH of 9-10 and then adding vial 2 to form the drug.