PATENT CLAIM ANALYSIS

Application Number: 16049390
Application Type: Utility
Filing Date: 2018-07
Publication Date: 2018-11
Patent Classification: ["424", "464000"]

Abstract:
The invention pertains to a method of relieving pain by administering a controlled release pharmaceutical tablet containing oxymorphone which produces a mean minimum blood plasma level 12 to 24 hours after dosing, as well as the tablet producing the sustained pain relief.

Claim (Index 11):
A solid oral controlled release dosage form, comprising:\n (a) about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof as the sole active ingredient; and (b) a controlled release matrix, comprising:\n (i) about 10% to about 75% (by total weight of the controlled release matrix) of a gelling agent which forms a gel upon exposure to gastrointestinal fluid wherein the agent is selected from the group consisting of hydroxyalkyl cellulose, carboxyalkyl cellulose, hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), hydroxypropylmethyl cellulose (HPMC), carboxy methylcellulose (CMC), a polymer of acrylic acid, a copolymer of acrylic acid, methacrylic acid, methyl acrylate, methyl methacrylate, xanthan gum, tragacanth, acacia, karaya, alginate, agar, guar, hydroxypropyl guar, carrageenan, locust bean gum, a protein-derived material and mixtures of any of the foregoing; and \n (ii) a filler; \n wherein upon placement of the dosage form in an in vitro release rate test, about 27% to about 33%, by weight, of the oxymorphone or salt thereof is released from the dosage form at about 1 hour in the test, about 40% to about 48%, by weight, of the oxymorphone or salt thereof is released from the dosage form at about 2 hours in the test, about 50% to about 59%, by weight, of the oxymorphone or salt thereof is released from the dosage form at about 3 hours in the test, and about 58% to about 67%, by weight, of the oxymorphone or salt thereof is released from the dosage form at about 4 hours in the test; wherein upon oral administration of the dosage form to a human subject in need of an analgesic effect, the blood plasma concentration of oxymorphone comprises a first peak at about 3 hours after administration and a second peak at about 6-7 hours after administration; and wherein upon oral administration of the dosage form to the subject:\n (i) the dosage form provides detectable blood plasma levels of 6-OH oxymorphone and oxymorphone; \n (ii) the blood plasma levels of 6-OH oxymorphone and oxymorphone peak within about 1 hour to about 8 hours after administration; \n (iii) the blood plasma levels of 6-OH oxymorphone and oxymorphone exhibit a ratio of area under the curve (AUC (0 to inf) ) of blood plasma level versus time for 6-OH oxymorphone compared to oxymorphone in a range of about 0.5 to about 1.5; and \n (iv) the duration of the analgesic effect is through at least about 12 hours after administration.

Metadata:
- Claim Count in Document: 50.0
- Percentile: 95.0
- Lexical Diversity: 1.18919
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['11427438', '10190192', '11680432', '12716973', '14336753']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7741296163704752
- 35 USC 102 Novelty (BERT): 0.5940701588899863
- Combined Prediction Score: 0.7561236706224264
- Mean Citation Score: 463.99081000000007
- Max Citation Score: 525.475
- Similarity Product: 442.75789963006974

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