Pioglitazone Coated Preparation Dissolution

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Solution Overview

Problem

Existing pharmaceutical preparations containing pioglitazone hydrochloride often face challenges with preservation stability and dissolution properties, particularly in releasing the active ingredient effectively within a short timeframe.

Innovation Solution

A production method involving coating pioglitazone hydrochloride with an aqueous dispersion using a coating material of low viscosity, such as hydroxypropyl cellulose or polyvinyl alcohol-polyethylene glycol graft copolymer, to enhance dissolution properties, ensuring at least 50% release within 15 minutes in dissolution tests.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional coating materials with high viscosity are used, then the coating process is easier to handle, but the dissolution property of pioglitazone hydrochloride deteriorates

Engineering Contradiction:
Improvecoating process handleabilityVSAvoiddissolution property
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The patent applies parameter changes by selecting coating materials with specifically controlled low viscosity (≤35 mPa·s at 20°C in 5% aqueous solution) to resolve the contradiction between ease of operation and dissolution property. This parameter specification enables both manageable coating processes and superior dissolution characteristics (≥50% release within 15 minutes).

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite materials by combining pioglitazone hydrochloride with specific low-viscosity coating materials (hydroxypropyl cellulose SL/SSL or polyvinyl alcohol-polyethylene glycol graft copolymer) to create a coated preparation that achieves both operational feasibility and enhanced dissolution performance.

Inventive Principle:
Principle #40Composite materials

2Manufacturing precision

If coating material viscosity is reduced to improve dissolution, then the coating process becomes more difficult to control

Engineering Contradiction:
Improvedissolution propertyVSAvoidcoating process control
Core Design Contradiction:
Manufacturing precisionVSEase of operation

Solution Approach 1:

The patent resolves this contradiction by establishing a specific viscosity parameter range (≤35 mPa·s at 20°C for 5% aqueous solution) that balances dissolution performance with coating process controllability, demonstrating that precise parameter control can simultaneously achieve both goals.

Inventive Principle:
Principle #35Parameter changes

3Manufacturing precision

If conventional formulations are used, then preservation stability is compromised, but modifying the formulation improves dissolution properties

Engineering Contradiction:
Improvedissolution propertyVSAvoidpreservation stability
Core Design Contradiction:
Manufacturing precisionVSStability of the object's composition

Solution Approach 1:

The patent applies composite materials by formulating pioglitazone hydrochloride with specific low-viscosity coating materials (hydroxypropyl cellulose SL/SSL or polyvinyl alcohol-polyethylene glycol graft copolymer) to simultaneously achieve superior dissolution properties (≥50% release within 15 minutes) and improved preservation stability.

Inventive Principle:
Principle #40Composite materials

Data Source

PatentUS7976853B2Process for producing coated preparation
Publication Date: 2011.07.12 TAKEDA PHARMA CO LTD

AI summary

The present invention provides a production method of a preparation coated with pioglitazone hydrochloride, which is useful as a therapeutic agent for diabetes and the like, and which is superior in the characteristics of the preparation such as dissolution property of pioglitazone hydrochloride.