US 2025/0144256 A1 · Albumin Conjugates and Process for Preparation thereof

Abstract

The embodiments of the present invention disclose a conjugate compound of formula X-J-MAA, wherein X is a diagnostic or therapeutic radioisotope; J is an optional chelating agent; and MAA is macroaggregated albumin particles. The invention also discloses sterile and stable ready to use or reconstituted radiopharmaceutical composition of X-J-MAA and manufacturing process thereof, preferably the invention relates to radiopharmaceutical compositions of 99mTc. The prepared radiopharmaceutical compositions exhibit desirable technical attributes like stability, radiochemical purity, less impurities, pH, better bio-distribution and desirable average particle size for further administration to patients for therapeutic and diagnostic use.

Claims26

Dependent claims

A sterile, non-pyrogenic, lyophilised pharmaceutical composition, comprising:

i) macroaggregated albumin;
ii) a reducing agent;
iii) human serum albumin;
and
iv) an isotonicity agent;
wherein the macroaggregated albumin is stannous incorporated macroaggregated albumin and wherein the average particle size of the macroaggregated albumin particles is 20 μm to 35 μm when measured by optical microscopy and/or automated microscopy and image analysis.

3 more elements

A reconstituted radiopharmaceutical composition, comprising:

(i) a first component comprising an aqueous solution of 99mTc pertechnetate and
(ii) a second component comprising a lyophilised pharmaceutical composition comprising:
a) macroaggregated albumin,
b) a reducing agent,
c) human serum albumin, and
d) an isotonicity agent,
wherein the macroaggregated albumin is stannated macroaggregated albumin having a particle density in the range of 300,000-700,000 particles in a unit dose and wherein the average particle size of the macroaggregated albumin particles is 25-35 μm, at least 95% of the macroaggregated albumin particles are between 10-70 μm, not more than 3% of the macroaggregated albumin particles are below 10 μm and none of the macroaggregated albumin particles are above 100 μm, when measured by optical microscopy and/or automated microscopy and image analysis;
and wherein it comprises not more than 3% soluble and dispersed radiochemical impurities.

5 more elements

Dependencies are inferred from the claim text.

Facts

Application

18/940,433Filed 7 Nov 2024

Priority

8 Nov 2023

Published

8 May 2025

Term ends

Not estimatedThe source records don’t support an estimate.

Classification25 codes

A61K 51/1241
Characterised by a special physical form, e.g. emulsion, microcapsules, liposomes , characterized by a special physical form, e.g. emulsions,…:…
A61K 9/0019
Galenical forms characterised by the site of application: injectable compositions; Intramuscular, intravenous, arterial, subcutaneous…
A61K 9/19
Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles: lyophilised , i.e.…
A61K 31/175
Having the group >N—C—N< or >N—C—N<, e.g. urea, thiourea, carmustine: having the group [IMAGE cpc-sch-A61K-0950.gif] , >N—C—N=N— or[IMAGE…

Albumin Conjugates and Process for Preparation thereof

Life of this patent

Albumin Conjugates and Process for Preparation thereof

Life of this patent

Abstract

Claims26