Uncoated Ebselen Tablets for Faster Oral Cmax Delivery

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Solution Overview

Problem

Existing oral ebselen formulations fail to achieve an enhanced maximum blood plasma concentration (Cmax) within a short timeframe, limiting their therapeutic efficacy in treating conditions such as sensorineural hearing loss and ototoxicity.

Innovation Solution

A pharmaceutical composition comprising 40-60% w/w ebselen, 20-40% w/w filler, 2-9% disintegrant, 0.1-1% lubricant, and 0.1-1% glidant, formulated for oral administration, particularly in uncoated pressed tablets, to enhance Cmax within 4 hours or less.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If conventional oral ebselen formulations are used, then the formulation is simple to manufacture, but the maximum blood plasma concentration (Cmax) is not enhanced within a short timeframe

Engineering Contradiction:

Improvetime to achieve CmaxVSAvoidformulation complexity

Core Design Contradiction:

SpeedVSEase of manufacture

Solution Approach 1:

The patent changes the physical and chemical parameters of the formulation by using uncoated pressed tablets with specific excipient combinations and ratios, altering the dissolution characteristics to achieve faster Cmax without complex manufacturing processes

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent uses composite materials by combining ebselen with specific excipients (fillers, disintegrants, lubricants, glidants) in optimized ratios to create a formulation that enhances dissolution rate and Cmax achievement within 4 hours

Inventive Principle:

Principle #40Composite materials

2Reliability

If the ebselen dosage is increased to improve therapeutic efficacy, then the treatment effectiveness improves, but the formulation complexity increases

Engineering Contradiction:

Improvetherapeutic efficacyVSAvoidformulation complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent optimizes the concentration parameter of ebselen within the tablet formulation (40-60% w/w) to achieve effective therapeutic doses while maintaining formulation simplicity through direct compression technology

Inventive Principle:

Principle #35Parameter changes

3Speed

If a coated tablet formulation is used, then the drug release can be controlled, but the dissolution rate and Cmax achievement are reduced

Engineering Contradiction:

Improvedissolution rateVSAvoidmanufacturing process simplicity

Core Design Contradiction:

SpeedVSEase of manufacture

Solution Approach 1:

The patent removes the coating layer from the tablet formulation, using uncoated pressed tablets to eliminate the barrier that slows drug release, thereby achieving faster dissolution and Cmax without significantly complicating the manufacturing process

Inventive Principle:

Principle #2Taking out (Extraction)

Data Source

PatentUS20260069569A1Ebselen containing oral dosage forms

Publication Date: 2026.03.12 SOUND PHARMACEUTICALS INC

AI summary

The present disclosure provides a pharmaceutical composition comprising ebselen, wherein the composition is formulated for oral administration. Also provided are pharmaceutical dosage forms including the same. In some embodiments, the dosage form is a solid dosage form, such as a tablet (e.g., an uncoated pressed tablet). Also provided are methods of delivering the subject ebselen pharmaceutical dosage forms to a subject to achieve an enhanced maximum blood plasma concentration (Cmax) with respect to a control ebselen formulation, and a maximum blood plasma concentration (Cmax) for ebselen within 4 hours or less of administration.