PATENT CLAIM ANALYSIS

Application Number: 16420581
Application Type: Utility
Filing Date: 2019-05
Publication Date: 2019-09
Patent Classification: ["514", "049000"]

Abstract:
The present invention provides an oral self micro-emulsifying pharmaceutical composition of a hydrophilic drug or a pharmaceutically acceptable salt thereof which, in addition to the hydrophilic drug, one or more solvents for solving the hydrophilic drug to form a drug-solvent solution and a surfactant system, further comprises one or more hydrophilic carrier which are compatible with said drug-solvent solution and the surfactant system. The oral self micro-emulsifying pharmaceutical composition of the invention exhibits comparative bioavailability to that of the hydrophilic drug through injection and is stable during storage. A method for preparing the oral self micro-emulsifying pharmaceutical composition is also provided.

Claim (Index 15):
The oral self micro-emulsifying pharmaceutical composition of  claim 1 , which is selected from the group consisting of:\n (i) a formulation comprising gemcitabine HCl in an amount of 2.00% (w/w), water in an amount of 20.00% (w/w); glycerol in an amount of 2.10% (w/w); PEG 400 in an amount of 30.20% (w/w); Tween 80 in an amount of 32.30% (w/w) and Labrafil in an amount of 13.40% (w/w), wherein the % (w/w) values are based on the total weight of the pharmaceutical composition; (ii) a formulation comprising gemcitabine HCl in an amount of 2.00% (w/w); water in an amount of 20.00% (w/w); propylene glycol in an amount of 2.10% (w/w) and PEG 400 in an amount of 30.20% (w/w); Tween 80 in an amount of 32.30% and Labrafil in an amount of 13.40% (w/w), wherein the % (w/w) values are based on the total weight of the pharmaceutical composition; (iii) a formulation comprising gemcitabine HCl in an amount of 1.98% (w/w); water in an amount of 19.8% (w/w); glycerol in an amount of 2.08% (w/w); PEG 400 in an amount of 29.90% (w/w); D-\u03b1-tocopheryl polyethylene glycol 1000 succinate (TPGS) in an amount of 0.99% (w/w); Tween 80 in an amount of 31.94%; and Labrafil in an amount of 13.31% (w/w), wherein the % (w/w) values are based on the total weight of the pharmaceutical composition; (iv) a formulation comprising gemcitabine HCl in an amount of 2.00% (w/w), water in an amount of 18.03% (w/w); 4.0 N NaOH in an amount of 1.97% (w/w); glycerol in an amount of 2.10% (w/w); PEG 400 in an amount of 30.20% (w/w); Tween 80 in an amount of 32.30% (w/w) and Labrafil in an amount of 13.40% (w/w), wherein the % (w/w) values are based on the total weight of the pharmaceutical composition; (v) a formulation comprising gemcitabine HCl in an amount of 1.98% (w/w); water in an amount of 17.85% (w/w); 4.0 N NaOH in an amount of 1.95% (w/w); propylene glycerol in an amount of 2.08% (w/w); PEG 400 in an amount of 29.90% (w/w); D-\u03b1-tocopheryl polyethylene glycol 1000 succinate (TPGS) in an amount of 0.99% (w/w); Tween 80 in an amount of 31.94%; and Labrafil in an amount of 13.31% (w/w), wherein the % (w/w) values are based on the total weight of the pharmaceutical composition; (vi) a formulation comprising gemcitabine HCl in an amount of 2.00% (w/w), water in an amount of 18.26% (w/w); 4.0 N NaOH in an amount of 1.74% (w/w); glycerol in an amount of 2.10% (w/w); PEG 400 in an amount of 30.20% (w/w); Tween 80 in an amount of 32.30% (w/w) and Labrafil in an amount of 13.40% (w/w), wherein the % (w/w) values are based on the total weight of the pharmaceutical composition; (vii) a formulation comprising gemcitabine HCl in an amount of 2.00% (w/w), water in an amount of 14.40% (w/w); 4.0 N NaOH in an amount of 5.60% (w/w); glycerol in an amount of 2.10% (w/w); PEG 400 in an amount of 30.20% (w/w); Tween 80 in an amount of 32.30% (w/w) and Labrafil in an amount of 13.40% (w/w), wherein the % (w/w) values are based on the total weight of the pharmaceutical composition; and (viii) a formulation comprising gemcitabine HCl in an amount of 2.00% (w/w), water in an amount of 14.30% (w/w); 4.0 N NaOH in an amount of 5.70% (w/w); glycerol in an amount of 2.10% (w/w); PEG 400 in an amount of 30.20% (w/w); Tween 80 in an amount of 32.30% (w/w) and Labrafil in an amount of 13.40% (w/w), wherein the % (w/w) values are based on the total weight of the pharmaceutical composition.

Metadata:
- Claim Count in Document: 5.0
- Percentile: 100.0
- Lexical Diversity: 1.81356
- Patent Class: 514.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['12876292', '12680335', '10585298', '09281430', '12674048']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7917828174756117
- 35 USC 102 Novelty (BERT): 0.4964186668861683
- Combined Prediction Score: 0.7622464024166674
- Mean Citation Score: 236.517702
- Max Citation Score: 245.00243
- Similarity Product: 175.7719754351437

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