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 20):
A process for preparing a stable, ready to use parenteral drug product by minimizing formation of a highest degradation product during moist heat sterilization of a drug solution comprising an oxidation susceptible active pharmaceutical ingredient (API), said process comprising:\n a. providing a moist heat sterilizable container made of a flexible material; b. filling an oxidation susceptible drug solution in said manufactured moist heat sterilizable container; and c. sterilizing said oxidation susceptible drug solution filled in said manufactured moist heat sterilizable container in an autoclave at an air overpressure between about 0.2 bar to about 1.2 bar to prepare said stable, ready to use parenteral drug product, wherein a highest degradation product in said stable, ready to use parenteral drug product is less than 0.1% by weight of a labeled amount of said oxidation susceptible API; wherein the solution is not deoxygenated and a nitrogen blanket is not used during formulation, or the formulation is stored in ambient conditions in the polymer bag.

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): 0.7061506519135451
- 35 USC 102 Novelty (BERT): 0.4992562992904881
- Combined Prediction Score: 0.6854612166512394
- Mean Citation Score: 190.124252
- Max Citation Score: 208.52908
- Similarity Product: 144.65757066449405

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

Dataset: test