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Megha Mohan, Sau Lee, Changning Guo, S Prasad Peri, William H Doub
The full-resolution next generation impactor (NGI) and three abbreviated impactor systems were used to obtain the apparent aerodynamic particle size distribution (APSD) and other quality measures for marketed dry powder inhalers (DPIs) using the compendial method and efficient data analysis (EDA). APSD for the active pharmaceutical ingredient (API) in Spiriva(®) Handihaler(®), Foradil(®) Aerolizer(®), and Relenza(®) Diskhaler(®) was obtained using a full-resolution NGI at 39, 60, and 90 L/min, respectively...
September 13, 2016: AAPS PharmSciTech
Jaime Algorta, Laura Andrade, Marta Medina, Valentin Kirkov, Sacha Arsova, Fumin Li, Jingduan Chi
BACKGROUND AND OBJECTIVE: A novel tiotropium bromide monodose capsule dry powder inhaler (DPI) formulation and device have been developed. The formulation was based on a spray-dried matrix that enhances the aerosolizaton properties, allowing a less active tiotropium metered dose (13 µg/capsule) while maintaining the same delivered dose (10 µg/actuation). This study describes the pharmacokinetic bioequivalence to the reference product. METHODS: This randomized, two-stage, crossover, semi-replicate (three-way) study was performed in healthy volunteers...
September 2016: Clinical Drug Investigation
Oskar Eklund, Faraz Afzal, Fredrik Borgström, Jason Flavin, Andrew Ternouth, Maria Eugenia Ojanguren, Carlos Crespo, Mike Baldwin
OBJECTIVES: Tiotropium (TIO), Spiriva® Handihaler®, is a well-established bronchodilator, LAMA (long acting muscarinic antagonist), for the treatment of moderate to very severe chronic obstructive pulmonary disease (COPD). Clinical evidence from the SPARK trial suggests that TIO is superior to glycopyrronium (GLY), Seebri® Breezhaler®, in terms of severe exacerbations. This modeling study assessed the cost-effectiveness of TIO versus GLY for Canada (CAN), Spain (ESP), Sweden (SWE), and the UK, making use of this new clinical evidence...
2016: ClinicoEconomics and Outcomes Research: CEOR
Angela Marina Montalbano, Giusy Daniela Albano, Anna Bonanno, Loredana Riccobono, Caterina Di Sano, Maria Ferraro, Liboria Siena, Giulia Anzalone, Rosalia Gagliardo, Michael Paul Pieper, Mark Gjomarkaj, Mirella Profita
IL-17A is overexpressed in the lung during acute neutrophilic inflammation. Acetylcholine (ACh) increases IL-8 and Muc5AC production in airway epithelial cells. We aimed to characterize the involvement of nonneuronal components of cholinergic system on IL-8 and Muc5AC production in bronchial epithelial cells stimulated with IL-17A. Bronchial epithelial cells were stimulated with recombinant human IL-17A (rhIL-17A) to evaluate the ChAT expression, the ACh binding and production, the IL-8 release, and the Muc5AC production...
2016: Mediators of Inflammation
Sophie Willis, Ann Slattery, William King, Kimberley Benner
OBJECTIVES: Although Americans aged 65 years and older account for only 13.0% of the population, they consume one-third of all prescription medications each year. Increased life expectancy, age-related deterioration in health, and polypharmacy lead to a significant risk of potential medication errors. National Poison Data System studies have evaluated the older adult population and their interaction with poison centers; however, descriptive studies using regional poison center data to evaluate older adult-related medication errors, specifically in Alabama, have not been conducted...
June 2016: Southern Medical Journal
Hiroyuki Yoshida, Akemi Kuwana, Hiroko Shibata, Ken-Ichi Izutsu, Yukihiro Goda
Wide variation in respiratory flow rates between patients emphasizes the importance of evaluating the aerodynamic particle size distribution (APSD) of dry powder inhaler (DPI) using a multi-stage impactor at different flow rates. US Pharmacopeia recently listed modified configurations of the Andersen cascade impactor (ACI) and new sets of cut-off diameter specifications for the operation at flow rates of 60 and 90 L/min. The purpose of this study was to clarify the effect of these changes on the APSD of DPI products at varied flow rates...
May 12, 2016: AAPS PharmSciTech
Giulia Anzalone, Rosalia Gagliardo, Fabio Bucchieri, Giusy Daniela Albano, Liboria Siena, Angela Marina Montalbano, Anna Bonanno, Loredana Riccobono, Michael Paul Pieper, Mark Gjomarkaj, Mirella Profita
AIMS: IL-17A plays a key role in the persistence of airway inflammation, oxidative stress, and reduction of steroid-sensitivity in COPD. We studied the effect of IL-17A on chromatin remodeling and IL-8 production. MAIN METHODS: We measured the levels of IL-8 and IL-17A in induced sputum supernatants (ISS) from healthy controls (HCs), healthy smokers (HSs), and COPD patients by enzyme-linked immunosorbent assay (ELISA). A human bronchial epithelial cell line (16HBE) was stimulated with ISS from HCs, HSs, or COPD subjects...
May 1, 2016: Life Sciences
Yunes Panahi, Mostafa Ghanei, Mohammad Behzadi, Maryam Salehi, Sara Saffar Soflaei, Amirhossein Sahebkar
INTRODUCTION: The beneficial effects of tiotropium bromide, a long acting anticholinergic bronchodilator, in the management of chronic obstructive pulmonary disease have been shown in previous studies. The present study aimed to compare the efficacy and safety of generic (Tiova®) and brand-name (Spiriva®) tiotropium preparations in patients with COPD. METHODS AND MATERIALS: In this randomized double-blind parallel-group trial, 79 patients with documented COPD were assigned to Tiova® or Spiriva® for a period of 4 weeks...
March 2016: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
Marc Miravitlles, Jéssica Montero-Caballero, Frank Richard, Salud Santos, Juan Luis Garcia-Rivero, Francisco Ortega, Xavier Ribera
Delivery of inhaled medications via an inhaler device underpins the effectiveness of treatment for patients with chronic obstructive pulmonary disease (COPD). Correct inhaler technique among patients is also a predictor of achieving treatment compliance and adherence. Reporting of patient satisfaction with inhalers is therefore gaining increasing attention and is now recognized as an important patient-reported outcome in clinical trials involving patients with COPD or asthma. In this cross-sectional study, we use the validated Patient Satisfaction and Preference Questionnaire (PASAPQ) to assess the handling and satisfaction for Respimat(®) Soft Mist™ Inhaler (SMI) compared with the Breezhaler(®) dry powder inhaler (DPI) among patients with COPD in Spain...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Stacy J Chin, Anthony G Durmowicz, Badrul A Chowdhury
Anticholinergic drug products are not part of the current treatment paradigm for asthma, despite their widespread availability for chronic obstructive pulmonary disease (COPD) and interest in their use for asthma. Published study results, mostly of short duration and primarily with ipratropium and tiotropium, have revealed inconsistent efficacy results. Consequently, the role of inhaled anticholinergic drugs in the treatment of asthma has been unclear. This commentary discusses and comments on data from five clinical trials in adults that were submitted by Boehringer Ingelheim to the U...
February 2016: Annals of the American Thoracic Society
J L Nicolai, S Torvinen, U Comberiati, R Miles, M H Greaney, D J Howard, A Plich
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
J Nicolai, S Torvinen, D J Howard, R Miles, M H Greaney, U Comberiati, A Plich
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
(no author information available yet)
Tiotropium solution for inhalation (Spiriva Respimat - Boehringer Ingelheim) is the first long-acting muscarinic antagonist to be marketed in the UK for the management of asthma. It is licensed as add-on maintenance bronchodilator treatment in adults with asthma who are using an inhaled corticosteroid (≥800μg budesonide/day or equivalent) and a long-acting beta2 agonist, and who have had one or more severe exacerbations in the previous year. This corresponds to use at step 4 of both the British asthma guideline and the Global Initiative for Asthma (GINA) strategy for the treatment of asthma in adults...
September 2015: Drug and Therapeutics Bulletin
Madlaina Costa-Scharplatz, Björn Ställberg, Pankaj Goyal, Yumi Asukai, Jean-Bernard Gruenberger, David Price
OBJECTIVES: The objective of this study was to compare the cost effectiveness of once-daily Seebri Breezhaler(®) (glycopyrronium bromide) 50 µg with Spiriva(®) (tiotropium bromide) 18 µg in the maintenance treatment of chronic obstructive pulmonary disease (COPD) in the Swedish setting. METHODS: A previously published COPD Markov model accounting for disease progression and treatment discontinuation was used. Disease progression included the annual decline in forced expiratory volume in the first second (FEV1) and occurrence of any exacerbations...
December 2015: Applied Health Economics and Health Policy
Sharon Shui Yee Leung, Patricia Tang, Qi Tony Zhou, Zhenbo Tong, Cassandra Leung, Janwit Decharaksa, Runyu Yang, Hak-Kim Chan
The US pharmacopeia (USP) and Alberta throats were recently reported to cause further de-agglomeration of carrier-free powders emitted from some dry powder inhalers (DPIs). This study assessed if they have similar influences on commercially available carrier-based DPIs. A straight tube, a USP throat, and an Alberta throat (non-coated and coated) were used for cascade impaction testing. Aerosol fine particle fraction (FPF ≤ 5 μm) was computed to evaluate throat-induced de-agglomeration. Computational fluid dynamics are employed to simulate airflow patterns and particle trajectories inside the USP and Alberta throats...
November 2015: AAPS Journal
(no author information available yet)
No abstract text is available yet for this article.
March 30, 2015: Medical Letter on Drugs and Therapeutics
Soichiro Hanada, Shota Wada, Takeshi Ohno, Hirochiyo Sawaguchi, Masato Muraki, Yuji Tohda
BACKGROUND: Tiotropium (Spiriva) is an inhaled muscarinic antagonist for patients with chronic obstructive pulmonary disease (COPD), and is available in two forms: the HandiHaler and the Respimat inhaler. The aim of this study was to investigate the handling of and preference for each device immediately after switching from the HandiHaler to the Respimat and 2-3 years after the switch. MATERIALS AND METHODS: The study comprised two surveys. A questionnaire was first administered to 57 patients with COPD (male:female 52:5, mean age 73...
2015: International Journal of Chronic Obstructive Pulmonary Disease
Gillian M Keating
The long-acting anticholinergic agent tiotropium bromide (Spiriva(®)) is available as a solution for inhalation via Respimat(®) Soft Mist™ Inhaler in the EU and various other countries for the treatment of chronic obstructive pulmonary disease (COPD). With the Respimat(®) Soft Mist™ Inhaler there is improved lung deposition of drug (allowing a reduced dosage compared with tiotropium HandiHaler(®)), the delivered drug dose is independent of inspiratory effort and the prolonged duration of the aerosol cloud should make the co-ordination of actuation and inhalation easier...
October 2014: Drugs
Yao-Kuang Wu, Chun-Yao Huang, Mei-Chen Yang, Guo-Liang Huang, Sin-Yi Chen, Chou-Chin Lan
BACKGROUND: The chronic use of the long-acting anticholinergic agent, tiotropium, in chronic obstructive pulmonary disease (COPD) has been linked in some reports to an increase in adverse cardiovascular effects. Decreased heart rate variability (HRV) is a condition seen in COPD patients that has also been linked to poor cardiovascular outcome. We aimed in this study to investigate changes in HRV caused by tiotropium administration to COPD patients in order to determine whether changes occurred that might contribute to an increase in adverse cardiovascular events...
April 2015: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Angela Marina Montalbano, Giusy Daniela Albano, Giulia Anzalone, Anna Bonanno, Loredana Riccobono, Caterina Di Sano, Rosalia Gagliardo, Liboria Siena, Michael Paul Pieper, Mark Gjomarkaj, Mirella Profita
Cigarette smoke extract (CSE) affects the expression of Choline Acetyl-Transferase (ChAT), muscarinic acetylcholine receptors, and mucin production in bronchial epithelial cells. Mucin 5AC (MUC5AC), muscarinic acetylcholine receptor M3, ChAT expression, acetylcholine levels and acetylcholine binding were measured in a human pulmonary mucoepidermoid carcinoma cell line (H292) stimulated with CSE. We performed ChAT/RNA interference experiments in H292 cells stimulated with CSE to study the role of ChAT/acetylcholine in MUC5AC production...
August 5, 2014: European Journal of Pharmacology
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