4.3 Article

A new method for investigating bioequivalence of inhaled formulations: A pilot study on salbutamol

相关参考文献

注意:仅列出部分参考文献,下载原文获取全部文献信息。
Article Pharmacology & Pharmacy

Applications of Exhaled Breath Condensate Analysis for Drug Monitoring and Bioequivalence Study of Inhaled Drugs

Nastaran Hashemzadeh et al.

JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES (2023)

Review Respiratory System

Fine Particle Fraction: The Good and the Bad

Stephen P. Newman

Summary: Fine particle fraction (FPF) refers to the fraction or percentage of drug mass in an aerosol cloud that can enter the lungs and have a clinical effect. There is no universally agreed upon definition of FPF in terms of aerodynamic particle size range. FPF, measured using cascade impactors, is primarily a measure of aerosol quality and is not intended to predict in vivo behavior. However, FPF can broadly predict lung deposition of drug from an inhaler device, although it may overestimate whole lung deposition and not accurately predict relative lung depositions for different inhaler types. The relationship between FPF, drug pharmacokinetics, and clinical response is not fully understood, and further studies are needed to investigate these relationships.

JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY (2022)

Review Pharmacology & Pharmacy

In vitro-in vivo correlation of cascade impactor data for orally inhaled pharmaceutical aerosols

Michael Yee Tak Chow et al.

Summary: In vitro - in vivo correlation refers to the predictive relationship between in vitro and in vivo data, particularly in the context of orally inhaled pharmaceutical aerosols. Correlating impactor data to lung deposition is a recent research area that can potentially optimize drug development efficiency.

ADVANCED DRUG DELIVERY REVIEWS (2021)

Article Pharmacology & Pharmacy

The Global Bioequivalence Harmonisation Initiative (GBHI): Report of EUFEPS/AAPS fourth conference

H. H. Blume et al.

Summary: This report summarizes the 4th International Conference on Global Bioequivalence Harmonisation Initiative (GBHI), which aims to promote global harmonisation of bioequivalence in drug development. The conference provided a platform for discussing BE-related topics and presented cutting-edge insights into the field.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

Article Pharmacology & Pharmacy

Concentration profile of tobramycin in exhaled breath condensate after inhalation of a single dose: A pilot study

Maryam Khoubnasabjafari et al.

Summary: Exhaled breath condensate (EBC) is a noninvasive alternative for obtaining respiratory samples to study drug concentration in the airways, with this study exploring the feasibility of measuring tobramycin concentration using a synthesized nanoprobe. Tobramycin was detectable in EBC 4 hours post inhalation, with a limit of detection of 0.5 ng/mL, demonstrating the possibility of investigating the bioequivalency of inhaled formulations of tobramycin employing EBC samples. Mean C-max and AUC(last) values were 31.5 (6.8) ng/mL and 53.2 (25.5) ng.h/mL, respectively.

JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY (2021)

Article Pharmacology & Pharmacy

Performance of Multiple-Batch Approaches to Pharmacokinetic Bioequivalence Testing for Orally Inhaled Drug Products with Batch-to-Batch Variability

Elise Burmeister Getz et al.

Summary: The article discusses four multiple-batch PK BE approaches to improve reliability of outcomes without increasing the number of clinical study participants, with three approaches following the single-batch PK BE convention and providing higher power to correctly identify true bioequivalence. False equivalence error was controlled better with multiple batches, and the Random Batch Effect approach restored type 1 error to the expected level.

AAPS PHARMSCITECH (2021)

Review Pharmacology & Pharmacy

Bioequivalence assessment of pharmaceutical aerosol products through IVIVC

Dennis Sandell

Summary: Many pharmaceutical developers of generic orally inhaled products are struggling to demonstrate pharmacokinetic bioequivalence to the originator product due to the lack of reliable in vitro-in vivo correlation. This paper identifies issues in this area and proposes methods to improve data used for developing an IVIVC, as well as an IVIVC-free approach for formulating a product that matches the originator's pharmacokinetic performance.

ADVANCED DRUG DELIVERY REVIEWS (2021)

Article Pharmacology & Pharmacy

Lung pharmacokinetics of inhaled and systemic drugs: A clinical evaluation

Muhammad Waqas Sadiq et al.

Summary: This study evaluated the lung pharmacokinetics of commonly prescribed drugs by sampling different lung compartments after inhalation and oral administration. The results showed that inhalation of salbutamol resulted in significantly higher lung concentrations compared to plasma, with salmeterol and fluticasone showing even higher concentration ratios. The study concluded that combining data from multiple individuals and techniques sampling different lung compartments enabled the generation of pharmacokinetic profiles for evaluating lung targeting after inhaled and oral drug delivery.

BRITISH JOURNAL OF PHARMACOLOGY (2021)

Review Pharmacology & Pharmacy

In vitro-in vivo correlations (IVIVCs) of deposition for drugs given by oral inhalation

Stephen P. Newman et al.

ADVANCED DRUG DELIVERY REVIEWS (2020)

Review Respiratory System

Deposition Mechanisms

Chantal Darquenne

JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY (2020)

Article Pharmacology & Pharmacy

Dry powder inhaler aerosol deposition in a model of tracheobronchial airways: Validating CFD predictions with in vitro data

Kaveh Ahookhosh et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2020)

Review Pharmacology & Pharmacy

Addressing the Regulatory and Scientific Challenges with Generic Orally Inhaled Drug Products

Bryan Newman et al.

PHARMACEUTICAL MEDICINE (2020)

Article Pharmacology & Pharmacy

Variability in oropharyngeal airflow and aerosol deposition due to changing tongue positions

Jinxiang Xi et al.

JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY (2019)

Article Pharmacology & Pharmacy

A new hypothesis to investigate bioequivalence of pharmaceutical inhalation products

Maryam Khoubnasabjafari et al.

DARU-JOURNAL OF PHARMACEUTICAL SCIENCES (2019)

Article Pharmacology & Pharmacy

Considerations in establishing bioequivalence of inhaled compounds

Irvin Mayers et al.

EXPERT OPINION ON DRUG DELIVERY (2018)

Article Chemistry, Medicinal

The effect of different coating materials on the prevention of powder bounce in the next generation impactor

Shadi Farshbaf Khalili et al.

RESEARCH IN PHARMACEUTICAL SCIENCES (2018)

Article Pharmacology & Pharmacy

An In Vitro Aerosolization Efficiency Comparison of Generic and Branded Salbutamol Metered Dose Inhalers

Sara Rahimkhani et al.

PHARMACEUTICAL SCIENCES (2017)

Article Chemistry, Medicinal

Pharmacokinetic properties and bioequivalence of orally inhaled salbutamol in healthy Chinese volunteers

Bo Jiang et al.

DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY (2016)

Article Respiratory System

In Vitro Tests for Aerosol Deposition II: IVIVCs for Different Dry Powder Inhalers in Normal Adults

Renishkumar Delvadia et al.

JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY (2013)

Article Respiratory System

ProAir® HFA Delivers Warmer, Lower-Impact, Longer-Duration Plumes Containing Higher Fine Particle Dose Than Ventolin® HFA

Jacquelyn Cruz McCabe et al.

JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY (2012)

Review Biochemical Research Methods

Exhaled breath condensate: lessons learned from veterinary medicine

Petra Reinhold et al.

JOURNAL OF BREATH RESEARCH (2010)

Article Physiology

Mass spectrometric analysis of biomarkers and dilution markers in exhaled breath condensate reveals elevated purines in asthma and cystic fibrosis

Charles R. Esther et al.

AMERICAN JOURNAL OF PHYSIOLOGY-LUNG CELLULAR AND MOLECULAR PHYSIOLOGY (2009)

Article Chemistry, Analytical

Airway Monitoring by Collection and Mass Spectrometric Analysis of Exhaled Particles

Ann-Charlotte Almstrand et al.

ANALYTICAL CHEMISTRY (2009)

Article Respiratory System

In vitro/in vivo comparisons in pulmonary drug delivery

Stephen P. Newman et al.

JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY (2008)

Article Public, Environmental & Occupational Health

Degree of throat deposition can explain the variability in lung deposition of inhaled drugs

Lars Borgstrom et al.

JOURNAL OF AEROSOL MEDICINE-DEPOSITION CLEARANCE AND EFFECTS IN THE LUNG (2006)

Article Pharmacology & Pharmacy

An investigation into the predictive value of cascade impactor results for side effects of inhaled salbutamol

M Weda et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2004)

Article Critical Care Medicine

A simple method for estimating respiratory solute dilution in exhaled breath condensates

RM Effros et al.

AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE (2003)

Review Pharmacology & Pharmacy

Inhalation therapy: technological milestones in asthma treatment

R Dalby et al.

ADVANCED DRUG DELIVERY REVIEWS (2003)

Review Pharmacology & Pharmacy

Pulmonary drug delivery. Part I: Physiological factors affecting therapeutic effectiveness of aerosolized medications

NR Labiris et al.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2003)

Article Pharmacology & Pharmacy

Equivalence testing of salbutamol dry powder inhalers: in vitro impaction results versus in vivo efficacy

M Weda et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2002)

Article Public, Environmental & Occupational Health

An investigation of in vitro/in vivo correlations for salbutamol nebulized by eight systems

VL Silkstone et al.

JOURNAL OF AEROSOL MEDICINE-DEPOSITION CLEARANCE AND EFFECTS IN THE LUNG (2002)

Article Critical Care Medicine

Dilution of respiratory solutes in exhaled condensates

RM Effros et al.

AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE (2002)

Article Public, Environmental & Occupational Health

Respiratory deposition patterns of salbutamol pMDI with CFC and HFA-134a formulations in a human airway replica

YS Cheng et al.

JOURNAL OF AEROSOL MEDICINE-DEPOSITION CLEARANCE AND EFFECTS IN THE LUNG (2001)

Article Pharmacology & Pharmacy

Human lung deposition data: the bridge between in vitro and clinical evaluations for inhaled drug products?

SP Newman et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2000)