Influence of Physicochemical Properties of Budesonide Micro-Suspensions on Their Expected Lung Delivery Using a Vibrating Mesh Nebulizer.

The efficiency of lung drug delivery of nebulized drugs is governed by aerosol quality, which depends both on the aerosolization process itself but also on the properties of aerosol precursors. This paper determines physicochemical properties of four analogous micro-suspensions of a micronized steroid (budesonide, BUD) and seeks relationships between these properties and the quality of the aerosol emitted from a vibrating mesh nebulizer (VMN). Despite the same BUD content in all tested pharmaceutical products, their physicochemical characteristics (liquid surface tension, viscosity, electric conductivity, BUD crystal size, suspension stability, etc.

Bronchodilator response after two methods of salbutamol nebulization in asthmatic children.

Introduction: Salbutamol is used in bronchodilator response testing (BDRT), which is an important diagnostic tool in bronchial obstructive diseases. Most available studies compare the bronchodilator response of salbutamol administered with a pressurized metered-dose inhaler and salbutamol in a nebulization solution.

Aim: The spirometric evaluation of the bronchodilator response of two methods of salbutamol nebulization in asthmatic children.

Obesity and disease severity magnify disturbed microbiome-immune interactions in asthma patients.

In order to improve targeted therapeutic approaches for asthma patients, insights into the molecular mechanisms that differentially contribute to disease phenotypes, such as obese asthmatics or severe asthmatics, are required. Here we report immunological and microbiome alterations in obese asthmatics (n = 50, mean age = 45), non-obese asthmatics (n = 53, mean age = 40), obese non-asthmatics (n = 51, mean age = 44) and their healthy counterparts (n = 48, mean age = 39). Obesity is associated with elevated proinflammatory signatures, which are enhanced in the presence of asthma.

Interferon alpha as antiviral therapy in chronic active Epstein-Barr virus disease with interstitial pneumonia - case report.

Background: Chronic active Epstein-Barr virus (EBV) disease (CAEBV) is defined as a severe, progressive lymphoproliferative disorder associated with active EBV infection persisting longer than 6 months and developing in patients without recognised immunodeficiency. Rarely, interstitial pneumonitis (IP) occurs as a serious complication in CAEBV patients. The standard therapeutic regimen for IP in CAEBV has not yet been defined.

Dry powder inhalers - between the doctor and the patient.

The article briefly presents currently accessible dry powder inhalers (DPI). Basing on the data from the literature, we discussed the most common mistakes related to the utilisation of DPI as well as their clinical and economic consequences. We also extensively analysed all factors that may influence the efficacy and safety of inhaler therapy of asthma and COPD, mostly with the use of DPI.

Evaluation of the Efficiency of Single-Inhaler Combination Therapy with Budesonide/Formoterol Fumarate in Patients with Bronchial Asthma in Daily Clinical Practice.

Introduction: The effectiveness of single-inhaler budesonide/formoterol fumarate combination therapy for asthma has been previously shown for the original product. The aim of this nonrandomized, open-label, postauthorization efficacy study (PAES) real-life clinical assessment was to evaluate the clinical effectiveness of a second product (Bufomix Easyhaler) in the daily clinical practice of asthma therapy.

Methods: This multicenter PAES was conducted by 220 unselected allergologists and pulmonologists who enrolled 2200 adult outpatients (age 49.

Gabapentin before laparoscopic sleeve gastrectomy reduces postoperative oxycodone consumption in obese patients: a randomized double-blind placebo-controlled trial.

Background: Postoperative pain can be prevented. Gabapentin may be effective in this role. Our primary objective was to test the hypothesis that a prophylactic administration of gabapentin in obese patients before surgery has an opioid-sparing effect and reduces postoperative oxycodone consumption more efficiently than placebo.

Inhalation devices: from basic science to practical use, innovative vs generic products.

Inhalation therapy is a convenient method of treating respiratory diseases. The key factors required for inhalation are the preparation of drug carriers (aerosol particles) allowing reproducible dosing during administration. These technical challenges are accomplished with a variety of inhalation devices (inhalers) and medicinal formulations, which are optimized to be easily converted into inhalable aerosols.

European Union pharmacovigilance capabilities: potential for the new legislation.

European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU.

Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective.

When an innovative product (innovator) is not covered anymore by intellectual property rights, cheaper equivalent medicinal products (generic products) may be marketed and used in clinical practice. The regulation of generic products is well-established, and is primarily based on standard rules for quality, therapeutic equivalence requirements (the latter in most instances proven through a bioequivalence study), and safety data for the innovator. The extensive experience from bringing generic products to the market over the last decades allows the conclusion that they are well-accepted and provide a useful alternative option for cost-effective pharmacotherapy.

[New dry powder inhalers].

The most recently approved DPI's - Ellipta™ and NEXThaler® are the most modern inhalers on the market. Both are flow independent in the physiological range of flows seen in patients with asthma and/or COPD. Both require three actions (open-load -inhaler) for a successful inhalation.

NEXThaler, an innovative dry powder inhaler delivering an extrafine fixed combination of beclometasone and formoterol to treat large and small airways in asthma.

Introduction: Airway inflammation and remodelling in asthma occur in the large airways and also in the small airways. The small airways are those < 2 mm in diameter and are significant sites of chronic asthmatic inflammation. It is important, therefore, to target the small as well as the large airways in any strategy for effective treatment of this disease.

[Influence of inhaler and fine particle on efficacy of inhalation therapy in COPD].

Orally inhaled products delivered via inhalation exert their effect directly to the target organ. This allows to administer a very low dose of a drug compared with an oral route with similar clinical effect and significantly reduced toxicity. However inhalation therapy is also limited by several factors.

Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.

Amendments to the European pharmacovigilance legislative framework are expected to come into force in 2011, following the adoption of the proposed amendments to Directive 2001/83/EC on the community code relating to medicinal products for human use (hereinafter referred to as the Directive) and to Regulation (EC) No. 726/2004 laying down community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (EMA) [hereinafter referred to as the Regulation]. The Regulation shall apply 18 months after publication in the Official Journal of the European Union.

Where is industry getting it wrong? A review of quality concerns raised at Day 120 by the Committee For Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions for Chemical Entity Medicinal Products.

Purpose: The aim of this study was to identify common trends in the deficiencies identified in the quality part of the dossier during the evaluation of marketing authorisation applications for medicinal products for human use submitted through the EU's centralised procedure.

Methods: We analysed all the adopted Day 120 list of questions on the quality module of 52 marketing authorisation applications for chemical entity medicinal products submitted to the European Medicines Agency and evaluated by the Committee for Medicinal Products for Human Use (CHMP), during 12 consecutive plenary meetings held in 2007 and 2008. Subsequently we calculated the frequency of common deficiencies identified across these applications.

100 years of lung cancer.

Lung cancer is the most common cause of cancer death in the world. It continues to have an enormous impact on health systems of all countries. The number of new cases is increasing in a rate of about 3% annually.

[The effect of fenspiride on the number of exacerbations and the time of first exacerbation in patients with chronic bronchitis].

Unlabelled: The aim of the work was evaluation of efficacy of fenspiride b.i.d.

[Plastic bronchitis and mucoid impaction--uncommon disease syndromes with expectoration mucus plugs].

Mucoid impaction and plastic bronchitis are relatively rare disorders caused by the formation of obstructive airway plugs. We observed from February 1999 to June 2000 seven patients with mucoid impaction and one with plastic bronchitis. In the group of mucoid impaction there were 4 patients with bronchial asthma and 3 without history of lung disease.

[Usefulness of CD1 expression on surfaces of cells in bronchoalveolar fluid for diagnosis of histiocytosis X--our experience].

Histiocytosis X (HX), also referred as Langerhans cell granulomatosis is a disorder characterized by the presence of destructive granulomas containing Langerhans cells, lymphocytes, eosinophils and fibroblastes in the involved organs. Three presentations are commonly observed: 1) nonproductive cough or effort dyspnea, 2) spontaneous pneumothorax 3) incidental pulmonary infiltrates on chest X-ray in asymptomatic patients. HRCT may be helpful in the initial diagnosis of pulmonary HX.

[Diagnostic difficulties with detection of foreign bodies from the lower respiratory tract--late detection].

Five cases of aspirated foreign bodies in bronchial tree were described. The clinical symptoms did not suggest the real cause of the illness and most of patients did not remember the fact of foreign body aspiration. The foreign bodies were removed during bronchofiberoscopy performed in local anaesthesia.

CEA, NSE and SCC Ag in bronchial lavage in patients with lung cancer.

CEA, NSE and SCC Ag levels were measured in bronchial lavage (BL) and serum in patients with endobronchial lung cancer (LC) and in patients with nonmalignant lung diseases (NMLD). In both groups of patients 100 ml of normal saline solution was used during the lavage procedure. Tumor markers were detected using radioimmunoassay.

[Value of neuron specific enolase levels and squamous cell carcinoma antigen in bronchial lavage fluid in patients with lung cancer].

The aim of the study was to assess a value of NSE and SCC Ag level determination in bronchial lavage fluid in patients with lung cancer. It was found out that NSE levels in bronchial lavage fluid were much lower than in serum and did not differentiate patients with small cell lung cancer from patients with non small cell lung cancer and nonmalignant lung diseases. Bronchial lavage SCC Ag levels were significantly higher than serum SCC Ag levels.