PATENT CLAIM ANALYSIS

Application Number: 16175239
Application Type: Utility
Filing Date: 2018-10
Publication Date: 2020-01
Patent Classification: ["424", "001690"]

Abstract:
The present invention relates to radionuclide complex solutions of high concentration and of high chemical stability, that allows their use as drug product for diagnostic and/or therapeutic purposes. The stability of the drug product is achieved by at least one stabilizer against radiolytic degradation. The use of two stabilizers introduced during the manufacturing process at different stages was found to be of particular advantage.

Claim (Index 1):
A pharmaceutical aqueous solution comprising:\n (a) a complex formed by\n (ai) the radionuclide  177 Lu (Lutetium-177), and \n (aii) a somatostatin receptor binding peptide linked to the chelating agent DOTA; and \n (b) at least two different stabilizers against radiolytic degradation comprising\n (bi) gentisic acid or a salt thereof; and \n (bii) ascorbic acid or a salt thereof; \n wherein\n said radionuclide is present in a concentration that it provides a volumetric radioactivity of from 250 to 500 MBq/mL; \n said stabilizers are present in a total concentration of from 1.0 to 5.0 mg/mL; and \n the pharmaceutical aqueous solution is substantially free of ethanol, and the radiochemical purity (determined by HPLC) of the solution is maintained at \u226595% for at least 72 h when stored at 25\u00b0 C.

Metadata:
- Claim Count in Document: 68.0
- Percentile: 97.0
- Lexical Diversity: 1.30769
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: True
- Related Applications: ['16175261', '10513586', '11486338', '13264276', '15133623']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7141326698643324
- 35 USC 102 Novelty (BERT): 0.6149345905360082
- Combined Prediction Score: 0.7042128619315
- Mean Citation Score: 276.49370600000003
- Max Citation Score: 574.55035
- Similarity Product: 497.3381400138469

Labels:
- Claim Label 101: 1
- Claim Label 102: 1
- Claim Label 103: 0
- Claim Label 112: 1
- Combined Label: 1
- Label 101 Adjusted: 1

Dataset: test