PATENT CLAIM ANALYSIS

Application Number: 16025719
Application Type: Utility
Filing Date: 2018-07
Publication Date: 2019-05
Patent Classification: ["424", "464000"]

Abstract:
An orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg is disclosed. The dosage unit comprises (a) 0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and (b) 75-99.9 wt. % of one or more pharmaceutically acceptable excipients. The solid dosage unit comprises at least 100 μg of the estetrol component and can be obtained by a process that comprises compressing a dry blend of estetrol particles and one or more pharmaceutically acceptable excipients into a solid dosage unit. The solid dosage unit is easy to manufacture and suited for sublingual, buccal or sublabial administration.

Claim (Index 17):
A process of preparing an estetrol orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, the dosage unit comprising:\n (a) 0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters, and combinations thereof; and (b) 75-99.9 wt. % of one or more pharmaceutically acceptable excipients; wherein the solid dosage unit contains at least 100 \u03bcg of the estetrol component and disintegrates within less than 5 minutes when subjected to disintegration testing in accordance with USP <701> (\u201cDisintegration\u201d) using water as the disintegration medium, the process comprising: (i) providing estetrol particles having a volume median diameter between 2 \u03bcm to 50 \u03bcm and containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; (ii) mixing 1 part by weight of the estetrol particles with 2-1,000 parts by weight of one or more pharmaceutically acceptable excipients to obtain a dry blend; and (iii) compressing the dry blend into a solid dosage unit.

Metadata:
- Claim Count in Document: 50.0
- Percentile: 95.0
- Lexical Diversity: 1.82857
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: True
- Related Applications: ['15852187', '15516127', '10495707', '15516078', '12441342']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.709954863295417
- 35 USC 102 Novelty (BERT): 0.5525329396832686
- Combined Prediction Score: 0.6942126709342022
- Mean Citation Score: 268.660974
- Max Citation Score: 428.9787
- Similarity Product: 313.16785740258695

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