PATENT CLAIM ANALYSIS

Application Number: 15904086
Application Type: Utility
Filing Date: 2018-02
Publication Date: 2018-12
Patent Classification: ["424", "489000"]

Abstract:
A quetiapine fumarate composition for oral administration is provided comprising a pharmaceutically acceptable salt or solvate of quetiapine existing as a suspension in an aqueous carrier agent. The inventive liquid formulation demonstrates high bioavailability consistent with approved dosage forms, low agglomeration, reduced content of excipients commonly used in solid oral dosage forms and extended shelf life stability. Also provided is a method of manufacturing a liquid quetiapine suspension composition for oral administration and methods of administering therapeutically effective dosages of an oral liquid quetiapine suspension composition to patients in need thereof.

Claim (Index 15):
A process for the manufacture of a pharmaceutical composition comprising a pharmaceutically effective amount of quetiapine fumarate particles dispersed in suspension comprising:\n adding purified water to a main vessel, adding citric acid monohydrate to the main vessel and mixing until dissolved using a high-shear mixer, adding disodium hydrogen phosphate dihydrate to the main vessel and mixing until dissolved using a high-shear mixer, adding sucralose to the main vessel and mixing until dissolved using a high-shear mixer, adding the simethicone emulsion to the main vessel and mixing until dispersed using a high-shear mixer, adding quetiapine fumarate to the main vessel and mixing using a high-shear mixer until a homogeneous suspension is produced, to a separate stage vessel adding propylene glycol, to the separate stage vessel adding methyl hydroxybenzoate, to the separate stage vessel adding propyl hydroxybenzoate and mixing using a high-shear mixer until dissolved, to the preservative solution in the separate stage vessel adding xanthan gum and mixing until homogenous using a propeller mixer, adding the preservative solution/xanthan gum slurry in the separate stage vessel to the main vessel and mixing using a high-shear mixer until a uniformly thickened suspension is produced, adding the lemon flavour to the main vessel and mixing with a high-shear mixer until dispersed, checking the pH of the solution (target pH is 5.50), wherein if the pH is outside the range of 5.2-5.8 adjusting the pH until it within this range by using either 10% w/v citric acid monohydrate solution to lower pH or a 10% w/v disodium hydrogen phosphate dihydrate solution to increase the pH, adding purified water to final volume and mixing until dispersed using a high-shear mixer, filling 152\u00b12 ml of finished product into 180 ml amber glass bottles and closing with child resistant closures.

Metadata:
- Claim Count in Document: 14.0
- Percentile: 88.0
- Lexical Diversity: 1.5
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['15627087', '13518981', '14216342', '13581496', '14525836']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.678263464547097
- 35 USC 102 Novelty (BERT): 0.5728206858457258
- Combined Prediction Score: 0.6677191866769598
- Mean Citation Score: 286.621392
- Max Citation Score: 533.6253
- Similarity Product: 322.3334577385068

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