PATENT CLAIM ANALYSIS

Application Number: 16075745
Application Type: Utility
Filing Date: 2018-08
Publication Date: 2019-01
Patent Classification: ["514", "622000"]

Abstract:
A process for minimizing formation of a highest degradation product during moist heat sterilization of a drug solution of an oxidation susceptible active pharmaceutical ingredient (API) is provided, wherein the water is not deoxygenated and a nitrogen blanket is not used during formulation, or the formulation is stored in ambient conditions in the polymer bag and autoclaved. The highest degradation product in the parenteral drug product is less than 0.1% by weight of a labeled amount of the oxidation susceptible API in the parenteral drug product.

Claim (Index 1):
A process of manufacturing a pharmaceutically acceptable product comprising of an oxidation susceptible active pharmaceutical ingredient (API) which can be moist heat sterilized in a moist heat sterilizable container, said process comprising sterilizing a drug solution comprising an oxidation-susceptible API dissolved in water, said drug solution being contained in a moist heat sterilizable container, said moist heat sterilization being performed at an air overpressure between about 0.2 bar to about 1.2 bar, to obtain a parenteral drug product with a degradation of less than 0.1% by weight of a labeled amount of said oxidation susceptible API, wherein said moist heat sterilizable container is a flexible infusion bag made of a plastic material, and wherein the water is not deoxygenated and a nitrogen blanket is not used during formulation, or the formulation is stored in ambient conditions in the polymer bag before autoclaving.

Metadata:
- Claim Count in Document: 1.0
- Percentile: 96.0
- Lexical Diversity: 1.63158
- Patent Class: 514.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['13973003', '15638901', '10570339', '15616157', '15883798']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7061891230923758
- 35 USC 102 Novelty (BERT): 0.4990689186145604
- Combined Prediction Score: 0.6854771026445943
- Mean Citation Score: 190.124252
- Max Citation Score: 208.52908
- Similarity Product: 144.96536989275216

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