PATENT CLAIM ANALYSIS

Application Number: 16120900
Application Type: Utility
Filing Date: 2018-09
Publication Date: 2019-02
Patent Classification: ["424", "452000"]

Abstract:
There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.

Claim (Index 1):
An oral solid pharmaceutical composition comprising a plurality of coated beads,\n wherein each coated bead comprises: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of methylphenidate hydrochloride; (c) an inner controlled release coating coated over the first layer and an outer delayed release coating coated over the inner controlled release coating; and (d) an immediate release layer comprising a second amount of methylphenidate hydrochloride, coated over the outer delayed release coating, the immediate release layer providing immediate release of the second amount of methylphenidate hydrochloride; wherein the plurality of coated beads comprise 25, 30, 35, 45, 55, 75, 85, or 100 mg methylphenidate hydrochloride and wherein the plurality of coated beads have the following in vitro methylphenidate dissolution profile: Time (hours) Methylphenidate (% dissolved) 1 NLT 15% 4 18-38% 8 35-55% 12\u2002 68-98\u2009\u2009\u2009 16\u2002 NLT 68\u2009\u2009\u2009 when tested according to the USP paddle method, 100 rpm, at 37 \u00b0 C.; (i) starting with 900 ml simulated gastric fluid for 2 hours, (ii) followed by 900 ml phosphate buffer pH 6.0 for 4 hours, and (iii) for the 7th hour onwards, 900mL of phosphate buffer pH 7.4; USP <711> Acceptance Table 2; and wherein the oral solid pharmaceutical composition provides, in a fed state, an in vivo methylphenidate T max0-4  of about 3 hours and a methylphenidate T max8-16  of about 13.5 hours.

Metadata:
- Claim Count in Document: 77.0
- Percentile: 97.0
- Lexical Diversity: 2.46154
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: True
- Related Applications: ['14928276', '15958413', '16120999', '15343377', '15069734']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7448627716980647
- 35 USC 102 Novelty (BERT): 0.5995645254594142
- Combined Prediction Score: 0.7303329470741996
- Mean Citation Score: 415.390078
- Max Citation Score: 512.76935
- Similarity Product: 474.6448268671692

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