PATENT CLAIM ANALYSIS

Application Number: 15770138
Application Type: Utility
Filing Date: 2018-04
Publication Date: 2018-11
Patent Classification: ["514", "394000"]

Abstract:
The invention provides a pharmaceutical composition for injection comprising a NL-101 type compound and a preparation method thereof. The composition uses the NL-101 type compound as an active pharmaceutical ingredient, and the stability of the NL-101 type compound is improved by adding a chloride-containing stabilizing agent or using a co-solvent containing hydrochloric acid, so that the formulation can be stably produced and meet the requirements for clinical safe use.

Claim (Index 12):
A method for preparing a pharmaceutical composition according to  claim 11 , characterized in comprising the steps of:\n A. the lyophilizing protectant is weighed and dissolved in a suitable amount of water for injection to give solution 1; B. the compound of formula (I) (preferably compound of formula (II), most preferably NL-101) or a pharmaceutically acceptable salt thereof is weighed and dissolved with a co-solvent to give a concentrated solution which is then added to the solution 1, the pH controlling agent is used to adjust the pH, and finally the volume is adjusted with water for injection to obtain diluted solution; C. the diluted solution is filtrated, sterilized and filled in, half-stoppered, and put into a lyophilizer; D. following lyophilization, taken out of the lyophilizer, fully stoppered and capped to give the pharmaceutical composition; preferably, in step A, the lyophilizing protectant and stabilizing agent are weighed and dissolved in a suitable amount of water for injection to give solution 1; preferably, the co-solvent is firstly formulated with water for injection as a solution of co-solvent; further preferably, the volume percent concentration of hydrochloric acid in the solution of the co-solvent is 30-70%, still further preferably 40-60%, still further preferably 50%; further preferably, the volume percent concentration of acetic acid or citric acid in the solution of the co-solvent is 30-100%, further preferably 40-80%, still further preferably 40-60%, and still further preferably 50%.

Metadata:
- Claim Count in Document: 20.0
- Percentile: 91.0
- Lexical Diversity: 1.43137
- Patent Class: 514.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: True
- Related Applications: ['14345562', '13746999', '12762025', '14538464', '14030692']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7518270523761299
- 35 USC 102 Novelty (BERT): 0.5005639681921475
- Combined Prediction Score: 0.7267007439577318
- Mean Citation Score: 226.71752
- Max Citation Score: 266.564
- Similarity Product: 206.7592926931381

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

Dataset: test