Pharmaceutical composition having improved bioavailability of pranlukast, and preparation method therefor

A pharmaceutical composition with pranoxetine, water-soluble polymer, and silica-based glidant, prepared via a solvent-free method, addresses bioavailability challenges, achieving equivalent efficacy at lower doses and reducing side effects.

HK40134822APending Publication Date: 2026-07-10DASHAN PHARMACEUTICAL CO LTD

Patent Information

Authority / Receiving Office
HK · HK
Patent Type
Applications
Current Assignee / Owner
DASHAN PHARMACEUTICAL CO LTD
Filing Date
2026-05-27
Publication Date
2026-07-10

AI Technical Summary

Technical Problem

Existing methods for improving the bioavailability of pranoxetine, a poorly soluble drug, face challenges such as high manufacturing costs, complex equipment requirements, environmental pollution risks, and side effects from high-dose administration, necessitating a novel formulation and preparation method.

Method used

A pharmaceutical composition comprising 15 to 25 parts by weight of pranoxetine, 0.1 to 10 parts by weight of a water-soluble polymer, and 0.1 to 5 parts by weight of a silica-based glidant, prepared through a method involving mixing with a diluent and disintegrant, followed by kneading with a water-soluble polymer and solubilizer in water and ethanol, respectively, without using organic solvents.

Benefits of technology

The composition enhances solubility and bioavailability, allowing a reduced dosage of pranoxetine to 50 mg per tablet, equivalent to or better than commercially available formulations, improving patient compliance and reducing side effects.

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Abstract

The present invention relates to a pharmaceutical composition for improving the bioavailability of pranlukast and a method for preparing the same, and more particularly, to a pharmaceutical composition for improving the bioavailability of pranlukast, which comprises 0.1 to 10 parts by weight of a water-soluble polymer and 0.1 to 5 parts by weight of a flow aid such as silicon dioxide, relative to 15 to 25 parts by weight of pranlukast, so that the composition of the present invention exhibits bioequivalent or even superior pharmacokinetic characteristics to a commercially available preparation even when the content of pranlukast is reduced to 50 mg or less per tablet (1 tablet per time, twice a day), thereby improving the medication compliance of patients and reducing side effects caused by the intake of an excessive amount of pranlukast, and a method for preparing the same.
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