PATENT CLAIM ANALYSIS

Application Number: 15889893
Application Type: Utility
Filing Date: 2018-02
Publication Date: 2018-06
Patent Classification: ["514", "254040"]

Abstract:
A preparation for oral administration comprising: a pregelatinized starch comprising N-[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-(2R,3R)-2,3-tetramethylene-butyl]-(1′R,2′S,3′R,4′S)-2,3-bicyclo[2,2,1]-heptanedicarboxyimide hydrochloride (lurasidone) represented by the formula (1) as an active ingredient; a water-soluble excipient; and a water-soluble polymeric binder, the preparation exhibiting an invariant level of elution behavior even when the content of its active ingredient is varied.

Claim (Index 19):
A tablet for oral administration, comprising:\n granules comprising:\n from 20 mg to 120 mg of N-[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-(2R,3R)-2,3-tetramethylene-butyl]-(1\u2032R,2\u2032S,3\u2032R,4\u2032S)-2,3-bicyclo[2,2,1]heptane-dicarboxyimide hydrochloride (lurasidone) as an active ingredient; \n a pregelatinized starch; \n a water-soluble excipient; and \n a water-soluble polymer binder, \n wherein the tablet includes lurasidone at a content ration of 20 to 45% (wt/wt); wherein the tablet has a dissolution rate of 80% or more at 30 minutes as measured according to Japanese Pharmacopoeia, Dissolution test, Method 2, where the tablet is subjected to the dissolution test using paddle rotation at a rotation rate of 50 rpm in 900 mL of a diluted McIlvaine buffer having a pH of 3.8 to 4.0; wherein the tablet has a similar dissolution profile to a second tablet comprising from 20 mg to 120 mg of lurasidone, wherein similarity of the dissolution profiles is exhibited by the tablet and a second tablet having a similarity factor f2 value of 50 or more, wherein the tablet and the second tablet are prepared according to the same method, and comprise the same ratio of lurasidone, pregelatinized starch, water-soluble excipient, and water-soluble polymer binder, and the second tablet has a different lurasidone content than the tablet.

Metadata:
- Claim Count in Document: 79.0
- Percentile: 88.0
- Lexical Diversity: 1.46429
- Patent Class: 514.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: True
- Related Applications: ['14733204', '11919678', '14512189', '14183283', '10381036']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.8239866852158965
- 35 USC 102 Novelty (BERT): 0.6386807179800557
- Combined Prediction Score: 0.8054560884923124
- Mean Citation Score: 535.981714
- Max Citation Score: 597.18396
- Similarity Product: 589.5349994108034

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

Dataset: test