PATENT CLAIM ANALYSIS

Application Number: 16025487
Application Type: Utility
Filing Date: 2018-07
Publication Date: 2018-11
Patent Classification: ["424", "495000"]

Abstract:
Controlled release dosage forms are described herein. The controlled release formulations described herein provide prolonged delivery of high dose drugs that are highly water soluble and highly hygroscopic. In specific embodiments, controlled release dosage forms for delivery of a drug selected from GHB and pharmaceutically acceptable salts, hydrates, tautomers, solvates and complexes of GHB. The controlled release dosage forms described herein may incorporate both controlled release and immediate release formulations in a single unit dosage form.

Claim (Index 109):
A formulation comprising immediate release and controlled release portions, each comprising gamma-hydroxybutyrate or a pharmaceutically acceptable salt thereof, wherein:\n a. the controlled release portion comprises a controlled release coating comprising one or more methacrylic acid-methyl methacrylate co-polymers; b. the immediate release portion comprises one or more film-formers; c. the controlled release portion releases greater than about 40% of its gamma-hydroxybutyrate over about 4 to about 6 hours when tested in a dissolution apparatus 2 in deionized water at a temperature of 37\u00b0 C. and a paddle speed of 50 rpm; d. the formulation releases at least about 30% of its gamma-hydroxybutyrate by one hour when tested in a dissolution apparatus 2 in deionized water at a temperature of 37\u00b0 C. and a paddle speed of 50 rpm; and e. the formulation releases greater than about 90% of its gamma-hydroxybutyrate by 8 hours when tested in a dissolution apparatus 2 when tested in a dissolution apparatus 2 in deionized water at a temperature of 37\u00b0 C. and a paddle speed of 50 rpm.

Metadata:
- Claim Count in Document: 39.0
- Percentile: 95.0
- Lexical Diversity: 1.71429
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['15655924', '14295098', '12264709', '15385447', '12773599']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.734125272500709
- 35 USC 102 Novelty (BERT): 0.5318608385900678
- Combined Prediction Score: 0.713898829109645
- Mean Citation Score: 309.10608600000006
- Max Citation Score: 370.71924
- Similarity Product: 271.2928332753396

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

Dataset: test