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 1):
An oral self micro-emulsifying pharmaceutical composition, which comprises:\n (a) a therapeutically effective amount of a hydrophilic drug or its pharmaceutically acceptable salt, wherein the hydrophilic drug is selected from the group consisting of albuterol, bendamustine, captopril, carboplatin, ciprofloxacin, gemcitabine, ibandronate, lamivudine, niacin, oxycodone, ranitidine, and sumatriptan; (b) one or more solvents selected from the group consisting of water, ethanol, polyethylene glycol (PEG), isopropanol (IPA), 1,2-propanediol (propylene glycol), glycerol, acetic acid, and any combinations thereof; (c) a surfactant system comprising one or more surfactants selected from the group consisting of polysorbate, poloxamers, oleoyl polyoxylglycerides, linoleoyl polyoxylglycerides, caprylocaproyl polyoxylglycerides, polyoxyethylene castor oil derivatives, polyoxyethylene alkyl ethers, sorbitan fatty acid esters, glyceryl monooleate, glyceryl monolinoleate, medium-chain triglycerides (MCT), polyglyceryl oleate, lauroyl polyoxylglyceride, stearoyl polyoxylglycerides, propylene glycol dicaprylocaprate, propylene glycol laurate, propylene glycol monolaurate, propylene glycol caprylate and propylene glycol monocaprylate, and combinations thereof, said surfactant system exhibiting a hydrophilic-lipophilic balance (HLB) value ranging from about 8 to about 17; and (d) one or more hydrophilic carriers selected from the group consisting of polysorbate, ethanol, polyethylene glycol (PEG), glycerol, 1,2-propanediol (propylene glycol), propylene carbonate (PC), diethylene glycol monoethyl ether, and combinations thereof; wherein component (a) is present in an amount of 0.20% to 15% (w/w), component (b) is present in an amount of 2.5% to 60% (w/w), component (c) is present in an amount of 20% to 75% (w/w), and component (d) is present in an amount of 2.0% to 60% (w/w), based on the total weight of the pharmaceutical composition, and wherein components (a), (b), (c) and (d) are mixed to form a self-emulsifying formulation for oral administration.

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): 0.7921421510096887
- 35 USC 102 Novelty (BERT): 0.493994590187995
- Combined Prediction Score: 0.7623273949275193
- Mean Citation Score: 236.517702
- Max Citation Score: 245.00243
- Similarity Product: 181.79620927931543

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