Liquid Oncology Dosage Form for Flexible Pediatric Dosing

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Solution Overview

Problem

Current dosage forms for oncological active ingredients, such as capecitabine, raloxifene, and letrozole, do not allow for flexible dosing, particularly for pediatric and geriatric patients, as they are often fixed in solid forms that may not accommodate individual needs, and there is a need for formulations that can be easily titrated and administered in liquid forms.

Innovation Solution

Development of liquid oral solutions, suspensions, and granules containing oncological active ingredients, including capecitabine, raloxifene, and letrozole, with specific compositions that include preservatives, buffers, sweeteners, solvents, flavorings, and chelating agents, allowing for flexible dosing and improved administration methods.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If solid dosage forms are used for oncological active ingredients, then manufacturing and storage are simplified, but flexible dosing and titration capability are lost

Engineering Contradiction:
Improvedosage form manufacturingVSAvoiddosing flexibility
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The patent transforms the dosage form from solid to liquid state, fundamentally changing the physical parameter of the formulation. This enables flexible dosing by allowing the liquid to be divided into variable volumes, while maintaining manufacturing simplicity through established liquid formulation techniques and apheresis-based production methods.

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If liquid oral solutions are developed for flexible dosing, then dosing flexibility is improved, but formulation complexity increases

Engineering Contradiction:
Improvedosing flexibilityVSAvoidformulation complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent extracts the active pharmaceutical ingredient from its traditional solid dosage form and dissolves it in appropriate liquid vehicles. This separation allows the active ingredient to be delivered in a flexible liquid medium while using standard excipients and formulation techniques, thereby achieving dosing flexibility without excessive complexity.

Inventive Principle:
Principle #2Taking out (Extraction)

3Stability of the object's composition

If solid dosage forms are used, then formulation stability is maintained, but ease of administration and patient compliance deteriorate

Engineering Contradiction:
Improveformulation stabilityVSAvoidadministration ease
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The patent changes the physical state parameter from solid to liquid, which inherently improves ease of administration by eliminating the need for crushing, splitting, or swallowing large tablets. The liquid formulation can be easily measured, administered, and adjusted for different patient needs while maintaining stability through controlled formulation conditions.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS20240398763A1Oral dosage form containing oncological active ingredient
Publication Date: 2024.12.05 OWP PHARMACEUTICALS INC
  • US20240398763A1 patent drawing
  • US20240398763A1 patent drawing
  • US20240398763A1 patent drawing

AI summary

The present invention provides for a dosage form (e.g., liquid oral solution, liquid oral suspension, solid oral bead, granules, etc.) that contains one or more oncological active ingredients, methods of administering the same, and methods of manufacturing the same.