Delving into the Latest Updates on Levodropropizine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Levodroproizine, Levodropropizine Buccal

+ [11]

Target-

Mechanism

Neuropeptides modulators(Neuropeptides modulators)

Therapeutic Areas

Respiratory Diseases

Active Indication

Cough

Inactive Indication

BronchitisRefractory chronic cough

Originator Organization

Dompe Farmaceutici SpA

Active Organization

Shenzhen Neptunus Pharmaceutical Co. Ltd.Dompe Farmaceutici SpA

Inactive Organization

Hyundai Pharmaceutical Co., Ltd.Azienda Ospedaliero-Universitaria Careggi

Drug Highest PhaseApproved

First Approval Date

IT (01 Jan 1988),

Cough

Regulation-

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Structure

Molecular FormulaC13H20N2O2

InChIKeyPTVWPYVOOKLBCG-ZDUSSCGKSA-N

CAS Registry99291-25-5

The goal of this monocentric double blinded cross over trial is to evaluate safety and tolerability of inhaled furosemide in patients with pulmonary diseases and dyspnea.
The main question[s] it aims to answer are:
is inhaled furosemide safe and well tolerated?
is inhaled furosemide capable of dyspnea suppression and is there any additive effect of levodropropizine
Participants will be given:
inhaled furosemide or placebo in double blinded cross over manner. Dyspnea severity and vital functions will be measured, adverse reactions monitored
all participants will receive levodropropizine open label. Dyspnea severity and vital functions will be measured, adverse reactions monitored

Start Date27 Feb 2024

Sponsor / Collaborator

University Hospital Hradec Kralove

[+1]

NCT03489837 / CompletedPhase 3

A Randomized, Double-blind, Multicenter, Active-controlled Phase III Study to Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis

A randomized, double-blind, multicenter, active-controlled phase III study to evaluate the efficacy and safety of Levotuss CR tab. in comparison with Levotuss syrup in patients with cough due to acute or chronic bronchitis

Start Date01 Jan 2017

Sponsor / Collaborator

Hyundai Pharmaceutical Co., Ltd.

100 Clinical Results associated with Levodropropizine

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100 Translational Medicine associated with Levodropropizine

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100 Patents (Medical) associated with Levodropropizine

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68

Literatures (Medical) associated with Levodropropizine

01 Jun 2024·Naunyn-Schmiedeberg's Archives of Pharmacology

Population pharmacokinetic modeling of levodropropizine: extended application to comparative analysis between commercial formulations and exploration of pharmacokinetic effects of diet

Article

Author: Jang, Ji-Hun ; Jeong, Seung-Hyun ; Lee, Yong-Bok

Levodropropizine, a nonopioid antitussive agent, is being increasingly used in clinical practice with the development of several formulations for symptomatic relief of acute and chronic bronchitis. However, scientific and quantitative population pharmacokinetic analyses of levodropropizine are lacking. Moreover, no integrated quantitative comparison has been performed between formulations. This study quantitatively evaluated and predicted pharmacokinetic properties of formulations through population pharmacokinetic model-based comparisons of commercially available formulations. Plasma concentration profile results from bioequivalence studies of 60-mg immediate release (IR) levodropropizine tablets in 40 healthy Korean males were used as population pharmacokinetic modeling data. For interindividual variability in levodropropizine pharmacokinetics, body surface area was identified as an effective covariate that was positively correlated with peripheral compartment distribution volume. Population pharmacokinetic model for IR tablets well-described the levodropropizine syrup and capsule datasets, suggesting no significant differences in pharmacokinetics among IR tablets, syrups, and capsules of levodropropizine. In contrast, pharmacokinetic profiles differed between 90-mg controlled release (CR) and IR levodropropizine tablets; however, separate parameter estimation was possible by applying the same model structure. In terms of pharmacokinetics, twice-daily regimen of 90-mg CR tablets was equivalent to thrice-daily regimen of 60-mg IR tablets. However, at steady-state, interindividual plasma concentration variability within population was reduced by approximately 36.71-83.18%. For levodropropizine CR tablets, a high-fat diet significantly delayed gastrointestinal absorption but maintained overall plasma exposure equivalent. This study provides useful quantitative judgment data for precision medicine of levodropropizine and can be helpful in predicting the pharmacokinetics of levodropropizine based on commercialized formulation switching.

01 May 2024·Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Green and inventive fluorescence approach for levodropropizine determination in human plasma

Article

Author: Omar, Mahmoud A ; Mostafa, Islam M ; Mohamed, Abobakr A ; Almaghrabi, Mohammed ; Ahmed Elsayed, Mohamed

A green, rapid and sensitive fluorimetric method to quantify levodropropizine (LVP) in human plasma was exploited for the first time. The proposed method adopts LVP's intrinsic fluorescence in distilled water at a detecting emission of 345 nm following excitation at 240 nm. LVP displayed linearity across concentrations ranging from 50 to 1000 ng mL^-1, with a detection limit of 0.77 ng mL^-1 and a quantification limit of 2.33 ng mL^-1. Thorough validation confirmed its reliability, successfully determining LVP in tablets with an average recovery of 98.64 ± 1.07 %. Furthermore, the method's applicability extended to estimate the studied drug in spiked human plasma with excellent obtained percentage recoveries (98.68 ± 1.28-100.14 ± 1.23).

01 Mar 2024·Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Eco-friendly novel deconvoluted synchronous spectrofluorimetric approach for the determination of favipiravir, levodropropizine and moxifloxacin hydrochloride as an effective therapeutic combination for COVID-19; application in laboratory prepared mixtures and spiked human plasma

Article

Author: El-Shanawani, Abdalla A ; Madbouly, Eman A ; Abdelkhalek, Ahmed S ; El-Adl, Sobhy M

In this work, a green, fast, and simple synchronous spectrofluorimetric approach has been developed to simultaneously determine favipiravir, levodropropizine, and moxifloxacin hydrochloride as co-administered medications for COVID-19 treatment in pure form and spiked human plasma. The synchronous fluorescence spectroscopy technique to analyze the studied drugs at Δλ = 110 nm enabled the determination of levodropropizine at 360 nm. Then, applying Fourier Self-Deconvolution to each spectra to measure favipiravir and moxifloxacin hydrochloride at peak amplitudes of 431 nm and 479 nm, respectively, without any interference. Favipiravir, levodropropizine, and moxifloxacin hydrochloride could be sensitively determined using the described approach over concentration ranges of 20-300 ng/mL, 10-600 ng/mL, and 50-500 ng/mL, respectively. The method's validation was carried out effectively in accordance with guidelines recommended by the ICH. Finally, the Eco-scale and Green Analytical Procedure Index (GAPI) techniques have been used to evaluate the greenness of the proposed method.

100 Deals associated with Levodropropizine

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Levodropropizine	R05DB27	DB12472

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cough	IT	Dompe Farmaceutici SpA	01 Jan 1988

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bronchitis	Preclinical	KR	Hyundai Pharmaceutical Co., Ltd.	01 Jan 2017
Cough	Preclinical	KR	Hyundai Pharmaceutical Co., Ltd.	01 Jan 2017
Refractory chronic cough	Preclinical	IT	Azienda Ospedaliero-Universitaria Careggi	12 Feb 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03837938 (LDP0114, CTgov)	Phase 3	Dry cough \| Acute upper respiratory infection	184	Levopront® syrup 30 mg/5 ml (Levopront® Syrup 30 mg/5 ml)	eerifwugkm(rrmtlrkkgb) = ougrosmyyo pyjfzpclfi (otlqyebxbq, kizwpjqtga - qdnnprwcjh) View more	-	15 Apr 2024
				Libexin® (Libexin® 100 mg Tablets)	eerifwugkm(rrmtlrkkgb) = xhtusjalqq pyjfzpclfi (otlqyebxbq, xlowprmdda - wqspsjrcom) View more