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Anna Płoszczuk, Miroslava Bosheva, Kay Spooner, Tammy McIver, Sanjeeva Dissanayake
BACKGROUND: The efficacy and safety of fluticasone propionate/formoterol fumarate pressurized metered-dose inhaler (pMDI) (fluticasone/formoterol; Flutiform® ; 100/10 µg b.i.d.) was compared with fluticasone propionate (Flixotide® Evohaler® pMDI; 100 µg b.i.d.) and fluticasone/salmeterol (Seretide® Evohaler® pMDI; 100/50 µg b.i.d.) in a pediatric asthma population (EudraCT number: 2010-024635-16). METHODS: A double-blind, double-dummy, parallel group, multicenter study...
January 2018: Therapeutic Advances in Respiratory Disease
Claire A Cox, Ilse M Boudewijn, Sebastiaan J Vroegop, Siebrig Schokker, Anne J Lexmond, Henderik W Frijlink, Paul Hagedoorn, Judith M Vonk, Martijn P Farenhorst, Nick H T Ten Hacken, Huib A M Kerstjens, Dirkje S Postma, Maarten van den Berge
BACKGROUND: Smoking is as prevalent in asthmatics as in the general population. Asthmatic smokers benefit less from inhaled corticosteroids (ICS) than non-smoking asthmatics, possibly due to more smoking-induced small airways disease. Thus targeting small airways may be important in treating asthmatic (ex-)smokers. We hypothesized that extrafine particle ICS improve small airways function more than non-extrafine particle ICS in asthmatic (ex-)smokers. METHODS: We performed an open-label, randomized, three-way cross-over study comparing extrafine beclomethasone (HFA-QVAR) to non-extrafine beclomethasone (HFA-Clenil) and fluticasone (HFA-Flixotide) in 22 smokers and 21 ex-smokers with asthma (?5 packyears)...
September 2017: Respiratory Medicine
Hui Wang, Pallavi Bhambri, James Ivey, Reinhard Vehring
A new low-flow-rate (0.5L/min) single-nozzle impactor for the concentration of dilute aerosol particles with selected pharmaceutical applications is described in this paper. The impactor can be configured up to 11 stages with a wide range of cutoff diameters from 0.6μm to 21.1μm, enabling convenient sampling of inhalable drug particles from inhalation devices and drug production processes. Its unique single-nozzle design and removable impaction plate allow direct sample transfer for subsequent compositional, morphological, solid-state, and other analysis...
November 25, 2017: International Journal of Pharmaceutics
Wantida Chuenjit, Vorapan Engchuan, Araya Yuenyongviwat, Pasuree Sangsupawanich
Background: The metered-dose inhalers (MDIs) currently available for inhaled corticosteroid delivery do not offer an integrated dose counter; therefore, it is difficult to evaluate adherence of patients. The present authors developed a linear regression equation using canister weight to calculate the number of doses actuated from the MDIs. This study aimed to assess medical adherence after the integration of regular weighing of the canisters into the routine service.  Methods: A cohort study was carried out between May 2013 and April 2014...
2017: F1000Research
Ole D Wolthers, Ainslee Moore, Sabine Mersmann, Sanjeeva Dissanayake
BACKGROUND: Fluticasone propionate/formoterol (FP/FORM) is a pressurized metered-dose inhaler (pMDI; Flutiform(®)) approved for use in adolescents and adults and under development for pediatric use. OBJECTIVE: To compare short-term growth in asthmatic children treated with FP/FORM, FP pMDI with valved holding chamber, and beclomethasone dipropionate (BDP) in a breath-actuated device. METHODS: Children with persistent asthma (n = 48; 5 to <12 years) participated in an assessor-blinded, randomized, three-way crossover trial with run in, wash out, and active treatment periods, each of 2 weeks duration...
October 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Hui Wang, David Barona, Sulayman Oladepo, Lisa Williams, Susan Hoe, David Lechuga-Ballesteros, Reinhard Vehring
A new macro-Raman system equipped with a motorized translational sample stage and low-frequency shift capabilities was developed for bulk composition and homogeneity analysis of multi-component pharmaceutical powders. Different sampling methods including single spot and scanning measurement were compared. It was found that increasing sample volumes significantly improved the precision of quantitative composition analysis, especially for poorly mixed powders. The multi-pass cavity of the macro-Raman system increased effective sample volumes by 20 times from the sample volume defined by the collection optics, i...
July 15, 2017: Journal of Pharmaceutical and Biomedical Analysis
Wei-Ping Lan, Jing Wang, Chuan-Lin Dai, Jia-Hua Pan
OBJECTIVE: To investigate the efficacy of fluticasone propionate aerosol (flixotide) versus budesonide suspension in the treatment of recurrent wheezing caused by bronchiolitis. METHODS: A total of 214 infants with newly diagnosed bronchiolitis were randomly divided into flixotide treatment (106 infants) and budesonide treatment groups (108 infants), and were given aerosol inhalation of flixotide or budesonide for 3 months after achieving remission of clinical symptoms...
April 2016: Zhongguo Dang Dai Er Ke za Zhi, Chinese Journal of Contemporary Pediatrics
Li Nien Michelle Tan, Supriya Srivastava, Ming Teh, Seng Hock Quak, Marion M Aw
INTRODUCTION: We aimed to determine the prevalence and clinical manifestations of eosinophilic oesophagitis (EoE) in children who presented to a tertiary care hospital in Singapore. METHODS: We conducted a retrospective review of all oesophageal biopsies taken during oesophagogastroduodenoscopy (OGD) from March 2010 to December 2011. The patients' demographics and clinical characteristics were collected. Biopsies were reviewed by a single pathologist who was blinded to the original reports, using the current consensus criteria for the histological diagnosis of EoE...
April 2017: Singapore Medical Journal
Hui Wang, Lisa Williams, Susan Hoe, David Lechuga-Ballesteros, Reinhard Vehring
Quantitative macro-Raman spectroscopy was applied to the analysis of the bulk composition of pharmaceutical drug powders. Powders were extracted from seven commercial lactose-carrier-based dry-powder inhalers: Flixotide 50, 100, 250, and 500 μg/dose (four concentrations of fluticasone propionate) and Seretide 100, 250, and 500 μg/dose (three concentrations of fluticasone propionate, each with 50 μg/dose salmeterol xinafoate ). Also, a carrier-free pressurized metered-dose inhaler of the same combination product, Seretide 50 (50 μg fluticasone propionate and 25 μg salmeterol xinafoate per dose) was tested...
July 2015: Applied Spectroscopy
Jagdeep Shur, Bhawana Saluja, Sau Lee, James Tibbatts, Robert Price
The focus of this investigation was to understand the design space to achieve comparable in vitro performance of two multi-unit dose dry powder inhalers (DPIs)—Flixotide® Accuhaler® (reference product) and MultiHaler® (test product). Flow field, pressure drop and particle trajectories within the test and reference DPI devices were modelled via computational fluid dynamics (CFD). Micronized fluticasone propionate (FP) was characterized to determine particle size distribution (PSD), specific surface area (SSA) and surface interfacial properties using cohesive-adhesive balance (CAB)...
September 2015: AAPS Journal
P Devillier, H Salvator, S Grassin-Delyle, E Naline, C Advenier, N Roche
The combination of an inhaled corticosteroid and a long acting beta-2 agonist is indicated for the regular treatment of persistent moderate-to-severe asthmatics whose asthma is not controlled by inhaled corticosteroids and the occasional use of a short acting beta-2 agonist. The aim of this review is to give an overview of the rationale of combining formoterol and fluticasone and to analyze the clinical data concerning a new fixed combination of fluticasone and formoterol in a pressurised metered-dose inhaler with a dose counter (Flutiform(®)) that was approved for the treatment of asthma in France in 2013...
October 2014: Revue des Maladies Respiratoires
Kate Gonski, Orli Wargon
Questions have been raised as to whether propranolol, which crosses the blood-brain barrier, when used early in life may have an adverse effect on gross motor development. A retrospective survey asking questions about gross motor development was sent to the families of children who had been prescribed oral propranolol for infantile haemangioma at Sydney Children's Hospital between 2008 and 2013. It was found that of the 84 patients surveyed, four were delayed in walking unassisted. There was a statistically significant influence if the child was taking other medications which included prednisolone, vincristine, omeprazole, ranitidine, salbutamol, Flixotide, Timoptol and antibiotics...
August 2014: Australasian Journal of Dermatology
Allen E Haddrell, James F Davies, Rachael E H Miles, Jonathan P Reid, Lea Ann Dailey, Darragh Murnane
The size of aerosol particles prior to, and during, inhalation influences the site of deposition within the lung. As such, a detailed understanding of the hygroscopic growth of an aerosol during inhalation is necessary to accurately model the deposited dose. In the first part of this study, it is demonstrated that the aerosol produced by a nebulizer, depending on the airflows rates, may experience a (predictable) wide range of relative humidity prior to inhalation and undergo dramatic changes in both size and solute concentration...
March 10, 2014: International Journal of Pharmaceutics
Paul Zarogoulidis, Konstantinos Porpodis, Ioannis Kioumis, Dimitris Petridis, Sofia Lampaki, Dionysios Spyratos, Antonis Papaiwannou, John Organtzis, Theodoros Kontakiotis, Katerina Manika, Kaid Darwiche, Lutz Freitag, Theodora Tsiouda, Despoina Papakosta, Konstantinos Zarogoulidis
BACKGROUND: Inhaled bronchodilators and corticosteroids have been used for decades with different production systems. MATERIALS AND METHODS: The following jet-nebulizers: (a) Invacare, (b) Sunmist, (c) Maxineb and ultrasound nebulizers: (a) GIMA, (b) OMRON and (c) EASY NEB II were used as production systems. The jet-nebulizers were used with different residual cups and volume filling, while the ultrasound nebulizers with different volume fillings and face mask versus inlet...
January 30, 2014: International Journal of Pharmaceutics
Artaches A Kazarian, Mark R Taylor, Paul R Haddad, Pavel N Nesterenko, Brett Paull
The comprehensive separation and detection of hydrophobic and hydrophilic active pharmaceutical ingredients (APIs), their counter-ions (organic, inorganic) and excipients, using a single mixed-mode chromatographic column, and a dual injection approach is presented. Using a mixed-mode Thermo Fisher Acclaim Trinity P1 column, APIs, their counter-ions and possible degradants were first separated using a combination of anion-exchange, cation-exchange and hydrophobic interactions, using a mobile phase consisting of a dual organic modifier/salt concentration gradient...
December 2013: Journal of Pharmaceutical and Biomedical Analysis
Mehra Haghi, Daniela Traini, Dirkje S Postma, Mary Bebawy, Paul M Young
BACKGROUND AND OBJECTIVE: We assessed whether co-deposition of a long-acting β2 -agonist and a corticosteroid affects their respective transport rates across epithelial cells. METHODS: Drug particles were deposited on the air-interface culture of Calu-3 cells using a twin-stage impinger. We compared the transport rate of salmeterol and fluticasone across the epithelial cells using commercially available formulations (Serevent, Flixotide and Seretide). The transepithelial resistance of Calu-3 cells was measured before and after each deposition to monitor epithelial resistance...
November 2013: Respirology: Official Journal of the Asian Pacific Society of Respirology
Edisa Trumic, Nurka Pranjic, Lejla Begic, Fahir Bečić
GOAL: Polypharmacy and drug-related problems (DRPs) have been shown to prevail in hospitalized patients. We evaluated the prevalence of polypharmacy; and investigated relationship between polypharmacy and: symptoms of DRPs, number of drugs and OTC, index of cumulative morbidity, length of exposure to polypharmacy and the number of days of hospital stay among hospitalized patients. METHODOLOGY: A study was performed in Pharmacies "Eufarm Edal" Tuzla from 2010 to 2011...
2012: Materia Socio-medica
Anna Bodzenta-Lukaszyk, Jan van Noord, Winfried Schröder-Babo, Kirsten McAulay, Tammy McIver
BACKGROUND: The potent inhaled corticosteroid, fluticasone propionate (fluticasone), and the long-acting β2-agonist with a rapid onset of action, formoterol fumarate (formoterol), have now been combined in a single aerosol inhaler, fluticasone/formoterol (flutiform). This study investigated the efficacy and safety of fluticasone/formoterol combination therapy compared with its individual components administered concurrently via two separate inhalers. METHODS: Patients ≥ 12 years (N = 210) with mild to moderate-severe persistent, reversible asthma were evenly randomised to 12 weeks of treatment (b...
May 2013: Current Medical Research and Opinion
Farzin M Shemirani, Susan Hoe, David Lewis, Tanya Church, Reinhard Vehring, Warren H Finlay
BACKGROUND: Existing literature has shown that high relative humidity (RH) affects in vitro aerosol drug delivery of nebulizer and pressurized metered dose inhaler (pMDI) formulations. The aim of this study is to investigate in vitro mouth-throat deposition and lung delivery of selected solution and suspension pMDI formulations, under a range of RH, temperature, and flow rate conditions. METHODS: The Alberta Idealized Throat was connected to a collection filter and placed in an environmental control chamber...
August 2013: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Alice Myers, Charles Godden
A 14-year-old girl had experienced gross peripheral oedema for nearly 2 years. She was under review by several paediatric specialists for a variety of problems. Her local paediatric team were unable to find the cause of her oedema, despite extensive investigations. Eventually, her mother discovered the cause was inhaled fluticasone, prescribed at normal dosage for asthma. As far as the authors are aware, this is the first reported case of peripheral oedema associated with the use of fluticasone. Peripheral oedema is a rare side-effect of fluticasone in the form of either seretide or flixotide...
2010: BMJ Case Reports
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