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PubMed2004

Basic techniques for aerosol delivery during mechanical ventilation.

Among the devices employed for aerosol generation (metered-dose inhalers, nebulizers, and dry powder inhalers) only metered-dose inhalers and nebulizers are routinely employed for aerosol delivery to mechanically ventilated patients. The ventilator circuit and artificial airway were previously thought to be major barriers to effective aerosol delivery to mechanically ventilated patients. In the past decade in vitro and in vivo investigations have contributed to a better understanding of the complex array of factors that influence inhaled drug delivery in mechanically-ventilated patients. Several investigators have shown that with careful attention to the administration technique aerosol delivery efficiency in mechanically-ventilated patients is comparable to that in ambulatory patients. The ability to efficiently deliver aerosols should lead to wider clinical application of inhaled therapies in patients receiving mechanical ventilation.

Administration, Inhalation↗
PubMed2005

Do patients show the same level of adherence with all dry powder inhalers?

Poor adherence with inhaled therapy presents a considerable problem. In the UK, non-adherence is estimated to occur in 10-46% of those prescribed inhaled corticosteroids and may contribute to an estimated 18-48% of asthma deaths. Before dry powder inhalers can be considered interchangeable, it is important to check that adherence is unaffected by any switching of the device dispensed to patients. Numerous studies have shown that adherence with inhaled medication is a multifactorial issue. A number of evidence-based guidelines have concluded that there is no difference in the delivery of treatments from different inhaler devices. However, many studies comparing different devices are designed to show equivalence. It is therefore difficult to determine whether the studies on which the guidelines are based were conducted with treatments already being used at the top of a dose-response curve. Furthermore, studies use selected patient populations who consent to take part and consequently receive regular contact with healthcare professionals, with emphasis on using the correct inhaler technique and on compliance. These studies do not therefore necessarily reflect real life. It is possible that patient preferences or perceptions of differences in efficacy are behind complaints when devices are switched. Patients vary in their preference for different dry powder inhalers, as shown in numerous studies of patient attitudes. There is evidence to indicate that patient claims of differences between inhalers that contain the same molecule from different manufacturers may have an objective basis. Healthcare professionals increasingly recognise the impact of patient attitudes on adherence. Accepting that patients make choices about their therapy is an integral part of achieving the partnership in management recommended by guidelines. The most effective treatment will not achieve disease control if it is not used or if it is used incorrectly. It may be short-sighted to change a device that a patient has chosen to one that is just given without consent, as this may result in poor adherence to therapy with consequent loss of control.

Administration, Inhalation↗
PubMed1990

Asthma therapy: present trends and future prospects.

The short-term treatment of asthma has for years included supplemental oxygen, IV theophylline, and subcutaneously administered and inhaled beta-adrenergic agonists, anticholinergics, and corticosteroids. This regimen has not really changed. What have changed, however, are the specificity of the drugs and the mode of their administration. Metered-dose inhalers can deliver selective beta-adrenergic agonists, anticholinergics, and corticosteroids directly to the airway mucosa. Topical delivery of medication has dramatically reduced the side effects of all classes of medication. As experience accrues, more studies indicate that inhalation therapy may become the mainstay of asthma treatment, even in the emergency department. Metered-dose inhalers have also aided in the resurgence of the use of cromolyn. There is certainly improved ease of administration and perhaps a reduced incidence of rebound bronchospasm. The appearance of newer beta 2-adrenergic agonists with improved beta 2-adrenergic selectivity and longer half-lives underscores the activity in asthma research. There is hope that selective bronchodilating corticosteroids or calcium-channel blockers can be developed. Bronchodilating prostaglandins and leukotrienes, or inhibitors of prostaglandins and leukotrienes that cause bronchoconstriction, are being investigated. An oral mast-cell membrane stabilizer is available and hopefully can be improved. Finally, the transdermal delivery of medication may open an entirely new avenue for the treatment of those suffering from asthma.

Adrenal Cortex Hormones↗
PubMed1997

Aerosol delivery to wheezy infants: a comparison between a nebulizer and two small volume spacers.

Inhalation therapy for wheezy infants with either a nebulizer or a pressurized metered-dose inhaler (pMDI) through a spacer is common practice. The aim of our study was to compare aerosol delivery to wheezy infants from a nebulizer and from a pMDI via two small volume spacers. Twenty wheezy infants (aged 4-12 months) were recruited. They inhaled salbutamol from a Pari-Baby nebulizer, from a detergent-coated Babyhaler, and from a Nebuchamber in random order. A filter was placed between the inhalation systems and the patients. The amount of salbutamol deposited on the filter was measured using an ultraviolet spectrophotometer and was expressed as a percentage of the total nebulized or actuated doses. The mean total nebulized dose for the Pari-Baby (1030 micrograms) was higher (P < 0.001) than the mean actuated dose from a pMDI for the Babyhaler (374 micrograms) and for the Nebuchamber (378 micrograms). Mean drug deposition on the filter was 40.2% (150 micrograms) of the total actuated dose for the detergent-coated Babyhaler and 40.7% (154 micrograms) of the total actuated dose for the Nebuchamber. There was no significant difference in drug deposition on the filter between the two spacers. Mean drug deposition on the filter was 25.3% (260 micrograms) of the total nebulized dose for the Pari-Baby nebulizer. There was no weight dependence in drug deposition on the filter for the two spacers, but, drug deposition increased with the subject's weight for the nebulizer. We have shown that aerosol delivery to wheezy infants from a pMDI through small volume spacers is effective and that a higher percentage of the total amount of salbutamol is delivered than from a nebulizer. The weight dependence in drug deposition for the nebulizer can be of clinical relevance.

Administration, Inhalation↗
PubMed1995

Differences in output from corticosteroid inhalers used with a volumatic spacer.

Corticosteroid inhaler therapy using a spacer device is commonly used as an important part of asthma management. Increasingly, generic corticosteroid inhalers are being used with spacer devices. We have therefore tested whether these generic inhalers yield equivalence in dose when compared to the established inhalers. We measured the in vitro output, discharged into a Volumatic spacer from beclomethasone dipropionate inhalers (250 micrograms.puff-1) made by three manufacturers, Allen & Hanburys, 3M and Baker Norton. The output from 20 of each type of inhaler was sampled, in random order, by a computer driven pump system. Beclomethasone was absorbed onto a coded filter, which was analysed independently for drug content. The output per puff differed significantly between the inhalers of each manufacturer, with a 36% difference between the highest output from the Allen & Hanburys device and the lowest output device. We conclude that there are important differences in output from these inhalers when used with a spacer, and that substitution of one device with another will not necessarily give equivalent therapy to the patient.

Adrenal Cortex Hormones↗
PubMed1997

UK guidelines for the use of inhaled nitric oxide therapy in adult ICUs. American-European Consensus Conference on ALI/ARDS.

OBJECTIVE: Although unlicensed, inhaled nitric oxide (NO) therapy is now widely used in the United Kingdom. Our aim was to produce guidelines for the clinical application of inhaled NO in adult intensive care practice, based upon the current level of published information. METHODS: The published data regarding the use of inhaled NO in the acute respiratory distress syndrome and right-sided cardiac failure was presented, analysed and discussed. Recommendations based on these data as well as on current experience in the United Kingdom were formulated. DESIGN: An expert group comprising intensive care specialists from within the United Kingdom, representatives from the European Society of Intensive Care Medicine and the Society of Critical Care Medicine and individuals from the Departments of Health and Industry related to the field was assembled. RESULTS: United Kingdom guidelines for the indications, contraindications, dose, delivery, monitoring and scavenging of inhaled NO therapy were produced. CONCLUSIONS: The need for additional quality research to establish evidence of efficacy and safety was emphasized. The guidelines are designed to act within the context of current practice and knowledge and should be revised as further data emerge.

Acute Disease↗
PubMed2006

Experimental study of the GAS process for producing microparticles of beclomethasone-17,21-dipropionate suitable for pulmonary delivery.

In this study the micronization of beclomethasone-17,21-dipropionate (BECD), used as an inhaled steroid for the treatment of asthma, was studied using the gas-antisolvent (GAS) process as a "green" alternative to pharmaceutical recrystallization. A systematic investigation of the influence of the key GAS process parameters: antisolvent addition rate (1, 50, 75 and 100 ml/min), temperature (25, 32.5, 40 and 52.5 degrees C), solute concentration (5, 25, 70 and 100%), and agitation rate (500, 1000, 2000 and 3000 rpm) were investigated on particle morphology, size distribution, and crystallinity. It was found using scanning electron microscopy (SEM) and laser diffraction, that increasing the antisolvent addition rate and the agitation rate, while decreasing the temperature and solute concentration, led to a decrease in the steroids mean particle diameter. These parameters could be tuned to give a mean particle diameter of 1.8 microm, and an average mass median aerodynamic diameter (MMAD) of 7.9 microm. High-performance liquid chromatography (HPLC) results showed the recrystallized BECD was purer than the non-processed material. The role of the solvent (acetone, methanol and ethanol) in the BECD crystal structure was investigated using X-ray diffraction (XRD), which showed acetone gave a more crystalline structure, hence having lower incorporation into the crystal structure. These results showed that the GAS process has the potential to produce steroid with powder properties suitable for inhalation therapy.

Acetone↗
PubMed1989

Rhinomanometric evaluation of two nasal steroid sprays in rhinitis.

A prospective, randomized study comparing the effectiveness of two nasal steroid sprays, flunisolide and beclomethasone dipropionate, in the treatment of nasal obstruction associated with allergic or vasomotor rhinitis has been conducted at New York University Medical Center-Bellevue Hospital. All patients underwent routine history and physical examinations and a modified radioallergosorbent test. Paranasal sinus films were used to exclude patients with sinusitis. The Rhinotest microprocessor rhinomanometer was used to quantify pretreatment and posttreatment total nasal air flow and resistance during a period of 2 months. These findings were assessed in conjunction with the patients' subjective complaints. Results demonstrated that anterior rhinomanometric assessment of the nasal airway during inhalant therapy correlated well with the patients' own subjective impressions of nasal air flow. Both steroid inhalants were effective; however, flunisolide provided for earlier and more substantial symptomatic relief. Beclomethasone dipropionate had milder side effects.

Adult↗
PubMed1984

Cold air as a bronchial provocation technique. Reproducibility and comparison with histamine and methacholine inhalation.

Bronchial provocation testing with cold air was carried out on 36 asthmatic and 13 normal subjects in order to assess the reproducibility and clinical relevance of the technique as a test of airways reactivity. Sixteen subjects underwent repeat testing after an interval of two to three weeks. Using a least squares linear regression analysis, the technique was highly reproducible, with a correlation of r = 0.93 (p less than 0.001). The 21 asthmatic subjects who had exercise-provoked symptoms required a significantly lower level of ventilation of cold air to produce a 35 percent drop in specific airways conductance (PD35) than did those who had no exercise-induced asthma (33.9 L min-1 vs 45.8 L min-1; p less than 0.02). Subjects requiring no regular treatment for their asthma had a geometric mean PD35 of 62.6 L min-1, significantly higher than those requiring inhaled therapy (44.9 L min-1; p less than 0.005). Subjects requiring oral in addition to inhaled treatment had the lowest PD35 (23.6 L min-1; p less than 0.02). Atopic status did not appear to influence the response. There was a strong correlation between the PD35 to cold air and to histamine (r = 0.92; p less than 0.001) and between the PD35 to cold air and to methacholine (r = 0.86; p less than 0.001). The three techniques of assessing bronchial reactivity were equally successful in separating the normal and asthmatic groups. The results indicate that cold air provocation may be reliably and reproducibly used to assess bronchial reactivity. The use of a naturally-occurring stimulus of asthma in all subjects has great potential as an investigational technique.

Adolescent↗
PubMed2001

Long-term treatment of pulmonary hypertension with aerosolized iloprost.

Pulmonary arterial hypertension (PAH), defined as elevated pulmonary arterial pressure and pulmonary vascular resistance, is an end-point of a variety of conditions. The only therapy that has been shown to improve both quality of life and survival is intravenous prostacyclin (prostaglandin I2 (PGI2), epoprostenol). The effect of long-term aerosolized iloprost (Ilomedin, Schering, Berlin, Germany and Vienna, Austria), a stable prostacyclin analogue and potent vasodilator, on haemodynamics and functional status was investigated in 12 patients with severe pulmonary hypertension. Haemodynamic measurements and vasodilator testing by right heart catheterization were performed prior to and after long-term iloprost inhalation therapy. Haemodynamic improvement or increased exercise tolerance was not observed in any of the patients. After a mean+/-SD treatment period of 10+/-5 months, mean+/-SD pulmonary vascular resistance had increased from 11+/-3 Wood Units (mmHg.L(-1).min) to 13+/-4 Wood Units, with unchanged arterial oxygen saturation (92+/-4%, versus 91+/-4%). Within the study period, three patients went into right heart failure and had to be placed on intravenous epoprostenol. The authors conclude that inhaled iloprost in addition to conventional therapy in the presently recommended dose of 100 microg.day(-1) delivered in 8-10 2 h portions, is not an efficient vasodilator therapy in severe pulmonary hypertension. It remains to be shown whether dose increases and/or combination protocols will be effective, or whether inhalation of iloprost may be safe for selected cases of pulmonary hypertension.

Administration, Inhalation↗
PubMed2001

Resistivities of placebo and active Diskus inhalers compared.

OBJECTIVE: Verbal instruction and demonstration of inhalation technique are essential to enhance the effectiveness of inhalation therapy. Placebo devices are commonly used to instruct patients. It is not obvious that patients, who inhale with an adequate flow through an empty placebo Diskus, would also be able to do so with active inhalers containing a strip with powder. The presence of powder may result in a change in resistivity. We compared the resistivities of a placebo Diskus being empty; a powder filled Diskus inhaler and a Diskus inhaler with an empty blister. METHODS: A Diskus inhaler was placed in a box, which enabled measurement of pressure drop and flow rates. Ten placebo and ten Ventolin Diskus inhalers were measured. Twelve pressure- and flow-profiles were recorded through each device. After each simulated inhalation through a powder filled blister, a second inhalation was performed through the empty blister. The resistivity was calculated by pressure-flow equation. RESULTS: The resistivity of the empty placebo Diskus inhaler was slightly but significantly higher than both blister filled inhalers, with or without powder (0.0215 vs. 0.0211 and 0.0211 (kPa)(0.5) (l min(-1))(-1)) (P<0.001). CONCLUSION: Patients who are capable of generating sufficient flow through a placebo Diskus will surely be capable of generating equivalent flows through a Diskus inhaler containing a strip with active drug substance.

Air Pressure↗
PubMed1994

Generation of aerosolized drugs.

The expanding use of inhalation therapy has placed demands on current aerosol generation systems that are difficult to meet with current inhalers. The desire to deliver novel drug entities such as proteins and peptides, as well as complex formulations including liposomes and microspheres, requires delivery systems of improved efficiency that will target the lung in a reproducible manner. These efforts have also been spurred by the phase out of chlorofluorocarbons (CFCs) and this has included a directed search for alternative propellants. Consequently, a variety of new aerosol devices and methods of generating aerosols are being studied. This includes the use of freon replacement propellants, dry powder generation systems, aqueous unit spray systems and microprocessor controlled technologies. Each approach has advantages and disadvantages depending upon each principle of action and set of design variables. In addition, specific drugs may be better suited for one type of inhaler device vs. another. The extent to which aerosol generation systems achieve their goals is discussed together with a summary of selected papers presented at the recent International Congress of Aerosols in Medicine.

Administration, Inhalation↗
PubMed1978

Use of exercise challenge to investigate possible tolerance to beta-adrenoceptor stimulation in asthma.

The effect of prolonged salbutamol administration on beta-adrenoceptor function in asthma has been examined. Six adult patients received salbutamol tablets (16 mg daily) for between 4 and 20 weeks and six adolescents received salbutamol aerosol (800 microgram daily) for 2--5 weeks. Before and after the treatment period the acute bronchodilator response to inhaled salbutamol and the ability of inhaled salbutamol to protect against exercise-induced asthma were examined. Lymphocyte beta-adrenoceptor function was also measured in the patients on tablet therapy. Inhaled salbutamol was less effective in protecting against exercise-induced asthma at the end of the treatment period in the patients who had received tablet therapy, but otherwise there was no significant change in beta-receptor function of either airways or lymphocytes. This apparent loss of efficacy of inhaled salbutamol in the prevention of exercise-induced asthma in some subjects, even when its acute bronchodilator effect is preserved, might reflect differences in the susceptibility of different beta-adrenoceptors to desensitization after prolonged stimulation: its clinical importance remains uncertain.

Adolescent↗
PubMedDate not supplied

[Equipment improvements for inhalatory methods of treatment].

To cut down unjustifiable consumption of compressed air and electric power in inhalation therapy rooms and to improve the response of patients to curative procedures simple and inexpensive improvements in the inhalation equipment of obsolete models, raising their functional characteristics are proposed.

Aerosols↗
PubMed1997

Airway deposition and airway effects of antiasthma drugs delivered from metered-dose inhalers.

Many different metered-dose inhalation devices are becoming available for the treatment of airway diseases. Each of these inhalers differs in its delivery characteristics. An assessment of the efficacy of drug delivery by these inhalers is essential, in view of their therapeutic use. A review of the literature on the relationship between airway deposition and airway effects of drugs delivered from metered-dose inhalers is presented. Nebulizers or spacers are not discussed. The effect of an inhaler depends on the characteristics of the inhaler and the inhalation manoeuvre performed by the patient. This review focuses on the influence of inhaler characteristics on the airway deposition and airway effects. Data from several studies show that there is a significant relationship between the amount of drug deposited in the airways and the airway effects of the drug. Studies on the relationship between airway deposition and airway effect have been troubled by methodological problems, such as the absence of multiple dose comparisons and the difficulty in obtaining steep dose-response curves. The techniques for measuring airway deposition of inhaled drugs, namely the scintigraphic and the pharmacokinetic method, are discussed and compared. The appropriate use of these techniques can help to define and compare the drug delivery characteristics of different devices, thus enabling inhaled therapy to be optimized.

Administration, Inhalation↗
PubMed1996

[Inhaled beta agonists as a bronchodilator are a mainstay of asthma therapy: focusing on inhaled beta agonists and oral theophylline].

In asthmaticus with relatively stable control, inhaled beta agonists are the primary drugs used to relieve symptoms which are mild and does not necessitate patients to visit emergency rooms. Global strategy for asthma management and prevention NHLBI/WHO workshop report gives inhaled beta agonists a specific position as a "reliever". Long-acting beta agonists such as salmeterol and formoterol were developed as a compensatory drug for "controllers". They have prolonged duration of bronchodilation effects with more than 12 hours. When asthmatic patients given high doses of inhaled corticosteroids do not enjoy best management, oral slow-releasing theophylline would be considered as one of next additional drugs of choice.

Administration, Inhalation↗
PubMed2003

Investigation into the effect of humidity on drug-drug interactions using the atomic force microscope.

The atomic force microscope (AFM) has been used to characterize the cohesive nature of a micronized pharmaceutical powder used for inhalation therapy. Salbutamol sulfate (also referred to as albuterol sulfate), a therapeutic drug commonly delivered from dry powder inhalers (DPI), was chosen as a model system because the cohesion and subsequent de-agglomeration during inhalation are critical aspects to the efficacy of such a delivery system. Salbutamol sulfate drug particulates were mounted on V-shaped AFM cantilevers using a novel micromanipulation technique. Force-distance curves obtained from the measurements between cantilever drug probes and model compacts of salbutamol sulfate were integrated to determine separation energies. The effect of humidity (15-75% RH) on the energy required to separate a drug particle from model drug surface was determined using a custom-built perfusion apparatus attached to the AFM. Separation energy measurements over 10 x 10-microm areas of the compact surface (n = 4096) exhibited log normal distributions (apparent linear regression, R(2) >or= 0.97). Significant increases in the median separation energies (p < 0.05) between the salbutamol sulfate drug probes and salbutamol sulfate model surfaces were observed as humidity was increased. This result is most likely attributed to capillary interactions becoming more dominant at higher humidities. This investigation has shown the AFM to be a powerful technique for quantification of the separation energies between micronized drug particulates, highlighting the potential of the AFM as a rapid preformulation tool.

Albuterol↗
PubMed2003

Budesonide and formoterol in a single inhaler improves asthma control compared with increasing the dose of corticosteroid in adults with mild-to-moderate asthma.

BACKGROUND: We evaluated the efficacy and safety of low-dose budesonide/formoterol, 80 micro g/4.5 micro g, bid in a single inhaler (Symbicort Turbuhaler; AstraZeneca; Lund, Sweden) compared with an increased dose of budesonide, 200 micro g bid, in adult patients with mild-to-moderate asthma not fully controlled on low doses of inhaled corticosteroid alone. METHODS: All patients received budesonide, 100 micro g bid, during a 2-week run-in period. At the end of the run-in phase, 467 patients with a mean FEV(1) of 82% predicted received 12 weeks of treatment with budesonide/formoterol in a single inhaler or budesonide alone in a higher dose. Patients kept daily records of their morning and evening peak expiratory flow (PEF), nighttime and daytime symptom scores, and use of reliever medication. RESULTS: The increase in mean morning PEF-the primary efficacy measure-was significantly higher for budesonide/formoterol compared with budesonide alone (16.5 L/min vs 7.3 L/min, p = 0.002). Similarly, evening PEF was significantly greater in the budesonide/formoterol group (p < 0.001). In addition, the percentage of symptom-free days and asthma-control days (p = 0.007 and p = 0.002, respectively) were significantly improved in the budesonide/formoterol group. Budesonide/formoterol decreased the relative risk of an asthma exacerbation by 26% (p = 0.02) compared with budesonide alone. Adverse events were comparable between the two treatment groups. CONCLUSION: This study shows that in adult patients whose mild-to-moderate asthma is not fully controlled on low doses of inhaled corticosteroids, single-inhaler therapy with budesonide and formoterol provides greater improvements in asthma control than increasing the maintenance dose of inhaled corticosteroid.

Administration, Inhalation↗