4.7 Article

Assessing the performance of two dry powder inhalers in preschool children using an idealized pediatric upper airway model

期刊

INTERNATIONAL JOURNAL OF PHARMACEUTICS
卷 444, 期 1-2, 页码 169-174

出版社

ELSEVIER
DOI: 10.1016/j.ijpharm.2013.01.007

关键词

Pediatric upper airway model; Idealized throat model; Children; Dry powder inhaler; Easyhaler; Novolizer

资金

  1. Boehringer Ingelheim Pharma GmbH Co.

向作者/读者索取更多资源

High prevalence of pulmonary diseases in childhood requires inhalable medication even for young children. Little is known about the efficiency of aerosol therapy especially in preschool children. One factor which limits the lung dose is the upper airway geometry. Based on clinical data a recently developed idealized pediatric upper airway model (children 4-5 years) was used to investigate the performance of two dry powder inhalers (Easyhaler and Novolizer). In vitro investigations were first examined using steady flow rates and an inhalation volume of 1 L. Chosen flow rates were 28, 41 and 60 L/min (Easyhaler) and 45, 60 and 75 L/min (Novolizer). Afterwards inhalation profiles simulated by an electronic lung were included. The investigations showed high amounts of drug particles (up to 80%) which were deposited in the upper airway model. The pulmonary deposition in vitro using the Easyhaler was about 28% (28-60 L/min) and 22% (inhalation profile). Using the Novolizer in vitro pulmonary doses of 8-12% (45-75 L/min) and about 5% (inhalation profile) were observed. The idealized model shows good performance reproducibility of dry powder inhalers. We have shown that age-dependent models might be appropriate tools for formulation and device development in pediatric age groups. (C) 2013 Elsevier B. V. All rights reserved.

作者

我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。

评论

主要评分

4.7
评分不足

次要评分

新颖性
-
重要性
-
科学严谨性
-
评价这篇论文

推荐

Article Pharmacology & Pharmacy

Investigation of hydroxypropyl-β-cyclodextrin inclusion complexation of two poorly soluble model drugs and their taste-sensation - Effect of electrolytes, freeze-drying and incorporation into oral film formulations

Julia F. Alopaeus, Anja Goebel, Joerg Breitkreutz, Sverre Arne Sande, Ingunn Tho

Summary: The study aimed to enhance the solubility of two lipophilic model drugs by forming inclusion complexes with hydroxypropyl-beta-cyclodextrin while hindering taste sensation. The inclusion complexes showed improved taste perception compared to plain drugs, indicating successful tastemasking.

JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY (2021)

Article Pharmacology & Pharmacy

Fundamental Investigations into Metoprolol Tartrate Deposition on Orodispersible Films by Inkjet Printing for Individualised Drug Dosing

Olga Kiefer, Bjoern Fischer, Joerg Breitkreutz

Summary: Individualized medicine is gaining attention in pharmaceutical research, requiring new concepts and manufacturing technologies. The combination of orodispersible films and inkjet printing technology provides precise and acceptable doses of MPT for pediatric use. Uniform dosages can be achieved, but considerations are needed for implementation of inkjet printing in pharmaceutical production due to nozzle aging affecting printed quantity.

PHARMACEUTICS (2021)

Article Pharmacology & Pharmacy

Precipitation from amorphous solid dispersions in biorelevant dissolution testing: The polymorphism of regorafenib

Martin Mueller, Florian Platten, Martin Dulle, Bjorn Fischer, Werner Hoheisel, Peter Serno, Stefan Egelhaaf, Joerg Breitkreutz

Summary: The precipitation process and physicochemical properties of precipitates formed by regorafenib in amorphous solid dispersions were investigated. Different crystalline and amorphous precipitates were identified, and the controlled formation of defined amorphous structures in-vivo could be a promising future drug formulation strategy.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2021)

Article Pharmacology & Pharmacy

Concept of Orodispersible or Mucoadhesive Tandem Films and Their Pharmaceutical Realization

Anja Goebel, Joerg Breitkreutz

Summary: This paper presents a modification of the solvent casting technique to divide oral films into multiple compartments, aiming to improve handling properties, safety of application, drug release kinetics, and long-term stability. Feasibility studies showed that combination of different film-forming polymers can achieve these objectives.

PHARMACEUTICS (2022)

Article Pharmacology & Pharmacy

Precise Dosing of Pramipexole for Low-Dosed Filament Production by Hot Melt Extrusion Applying Various Feeding Methods

Rebecca Chamberlain, Hellen Windolf, Simon Geissler, Julian Quodbach, Joerg Breitkreutz

Summary: The aim of this research was to produce low-dosed filaments via hot-melt extrusion (HME) with a model drug for Parkinson's disease treatment. It was found that deviation from target drug concentration occurred due to degradation products in certain formulations. Material temperature and the formation of anhydrous drug in the extruded filaments should be considered for the calculation of recovered API. The study showed that equilibrium condition for drug content was reached relatively late in the process, and the calculated RSD by Stange-Poole equation can be used to evaluate the deviations of drug content in equilibrium conditions.

PHARMACEUTICS (2022)

Article Pharmacology & Pharmacy

Embedding a Sensitive Liquid-Core Waveguide UV Detector into an HPLC-UV System for Simultaneous Quantification of Differently Dosed Active Ingredients during Drug Release

Rebecca Chamberlain, Hellen Windolf, Bjoern B. Burckhardt, Joerg Breitkreutz, Bjoern Fischer

Summary: Individual dosing of pharmaceutics and personalized medicine have become important for therapeutic safety, including dose adjustments, biorelevant drug release, and combination of multiple active substances. This requires both innovative drug products and new analytical methods for drug development and quality control. The liquid-core waveguide UV absorbance flow cell detector coupled to an existing HPLC-UV system allows for simultaneous determination of different active ingredients and wide concentration ranges, increasing sensitivity and reducing analysis time.

PHARMACEUTICS (2022)

Article Pharmacology & Pharmacy

Pharmaceutical Development of Film-Coated Mini-Tablets with Losartan Potassium for Epidermolysis Bullosa

Valentinee Elezaj, Ard Lura, Luis Canha, Joerg Breitkreutz

Summary: Epidermolysis bullosa is a skin fragility disorder that can be treated with mini-tablets containing losartan potassium. The development process faced several challenges, but successful formulation of the mini-tablets was achieved through dry granulation and appropriate coating, meeting pharmacopoeial requirements and demonstrating promising stability.

PHARMACEUTICS (2022)

Article Pharmacology & Pharmacy

3D Printed Mini-Floating-Polypill for Parkinson's Disease: Combination of Levodopa, Benserazide, and Pramipexole in Various Dosing for Personalized Therapy

Hellen Windolf, Rebecca Chamberlain, Joerg Breitkreutz, Julian Quodbach

Summary: Treating Parkinson's disease is challenging, and personalized therapy is crucial due to specific requirements of drug therapy. This study utilized 3D printing to create personalized medication, including both rapid and prolonged drug release formulations, to meet the varying drug release needs. This provides a more personalized and effective treatment option for patients with Parkinson's disease.

PHARMACEUTICS (2022)

Article Pharmacology & Pharmacy

Enalapril and Enalaprilat Pharmacokinetics in Children with Heart Failure Due to Dilated Cardiomyopathy and Congestive Heart Failure after Administration of an Orodispersible Enalapril Minitablet (LENA-Studies)

Stephanie Laeer, Willi Cawello, Bjoern B. Burckhardt, Laszlo Ablonczy, Milica Bajcetic, Johannes M. P. J. Breur, Michiel Dalinghaus, Christoph Male, Saskia N. de Wildt, Joerg Breitkreutz, Muhammed Faisal, Anne Keatley-Clarke, Ingrid Klingmann, Florian B. Lagler

Summary: This study investigated the pharmacokinetics of enalapril in pediatric heart failure patients using a novel oral disintegrating tablet formulation, finding the rate and extent of enalapril and its active metabolite, and supporting the tolerability and safety of the appropriate dosing schedule.

PHARMACEUTICS (2022)

Article Pharmacology & Pharmacy

Implementation of a New Electronic Liquid Dispensing System for Individualized Compounding of Hard Capsules

Bakul Sarker, Mariele Fligge, Tanja Knaab, Joerg Breitkreutz

Summary: A novel electronic liquid dispensing system (ELDS) was investigated for producing individualized dose strengths of hard capsules. The ELDS showed good dosing accuracy and content uniformity compared to manual preparation, with almost no drug loss.

PHARMACEUTICS (2022)

Article Pharmacology & Pharmacy

Hot-Melt Extrusion of the Thermo-Sensitive Peptidomimetic Drug Enalapril Maleate

Lena Hoffmann, Joerg Breitkreutz, Julian Quodbach

Summary: The aim of this research was to produce extrudates for the treatment of hypertension and heart failure and investigate the degradation of the drug enalapril maleate during hot-melt extrusion (HME). The study found that the use of specific polymer formulations prevented thermal degradation and maintained high dissolution. These findings have important implications for developing similar drug formulations.

PHARMACEUTICS (2022)

Article Pharmacology & Pharmacy

Nano-Dry-Melting: A Novel Technology for Manufacturing of Pharmaceutical Amorphous Solid Dispersions

Malin Hermeling, Christoph Nueboldt, Roman Heumann, Werner Hoheisel, Joerg Breitkreutz

Summary: Amorphous solid dispersions (ASD) are a prominent formulation approach for poorly soluble drugs. This study introduces a novel process technology called Nano-Dry-Melting (NDM) as an alternative option for ASD manufacturing. Feasibility studies and proof-of-concept experiments demonstrate the successful production of amorphous samples with NDM, even for drug candidates that cannot be processed by conventional methods.

PHARMACEUTICS (2022)

Article Pharmacology & Pharmacy

Personalized dermal patches - Inkjet printing of prednisolone nanosuspensions for individualized treatment of skin diseases

Mariele Fligge, Ilse Letofsky-Papst, Miriam Baeumers, Andreas Zimmer, Joerg Breitkreutz

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2023)

Article Pharmacology & Pharmacy

Fused Deposition Modeling (FDM) 3D Printing of the Thermo-Sensitive Peptidomimetic Drug Enalapril Maleate

Lena Hoffmann, Joerg Breitkreutz, Julian Quodbach

Summary: In this study, 3D printed tablets containing enalapril maleate were produced using Fused deposition modeling (FDM) technology, and two different formulations were prepared to investigate drug degradation during the printing process. Despite attempts to prevent degradation using various methods, it was not completely successful, but significant differences in degradation levels were observed between formulations with different polymers.

PHARMACEUTICS (2022)

Article Pharmacology & Pharmacy

Technical evaluation of precisely manufacturing customized microneedle array patches via inkjet drug printing

Lukas C. Lammerding, Joerg Breitkreutz

Summary: The study investigated the use of inkjet printing as a manufacturing technology for dissolvable microneedle array patches. It was found that using printing method could precisely control the dosage and reduce drug waste. This study demonstrated the potential of inkjet printing technology in the manufacturing of personalized microneedle array patches.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2023)

Article Pharmacology & Pharmacy

3D human foreskin model for testing topical formulations of sildenafil citrate

Greta Camilla Magnano, Marika Quadri, Elisabetta Palazzo, Roberta Lotti, Francesca Loschi, Stefano Dall'Acqua, Michela Abrami, Francesca Larese Filon, Alessandra Marconi, Dritan Hasa

Summary: This study aimed to investigate the loading of sildenafil citrate in three commercial transdermal vehicles using 3D full-thickness skin equivalent and compare the results with permeability experiments using porcine skin. The results showed that the results obtained using the 3D skin equivalent were comparable to those obtained using porcine skin, suggesting that the 3D skin model can be a valid alternative for ex-vivo skin absorption experiments.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2024)

Article Pharmacology & Pharmacy

Large volume subcutaneous delivery using multi-orifice jet injection

James W. Mckeage, Andrew Z. H. Tan, Andrew J. Taberner

Summary: Needle-free jet injection is a promising alternative drug delivery technique that offers rapid, non-invasive, and large-volume injections. The study presents a prototype multi-orifice nozzle and a computational fluid dynamic model to demonstrate the feasibility and effectiveness of this technology.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2024)