We compared aerosol characteristics and chemical stability in nebulization therapies using a procaterol hydrochloride inhalation solution unit, developed for nebulization as a test product.
The new mesh ultrasonic nebulizer NE?U22 showed high values for each drug emitted from a nebulizer, the respirable particle percent of emitted particles, and the effective index. In addition, for NE?U22, aerosol characteristics of 0.5 mL and 0.3 mL of the nondiluted procaterol hydrochloride inhalation solution unit were equivalent to those of diluted procaterol inhalation solution with saline, suggesting that the NE?U22 aerosolizes procaterol hydrochloride inhalation solution without dilution in a short time.
Compressor jet nebulizers showed a higher respirable particle percent of emitted particles, but the drug emitted from the nebulizer and the effective index were lower due to the large amount of residual drug in the jet nebulizer.
The procaterol hydrochloride inhalation solution unit was stable against different types of nebulizer, demonstrating its usefulness in different nebulization therapies.
Since aerosol characteristics differ between ultrasonic and jetnebulizers, the effective nebulizer should be selected for each patient based on its aerosol characteristics.
In conclusion, we found that nebulization therapy using the procaterol hydrochloride inhalation solution unit is highly effective in many asthmatic patients, along with the newly marketed mesh nebulizer, which provides higher convenience in downsizing, sound deadening, and improved performance.

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We studied the stability of CMX in nebulizer solution containing aromatic oil and sprayed from a jet nebulizer. Such aromatic oils as Mentha oil, strawberry essence, and vanilla essence were used. A comparison, was conducted using nebulizer solution containing aromatic oil and that without aromatic oil to determine the remaider rate and the potency of CMX in sprayed solution, CMX adhering to a mouthpiece and CMX remaining in a chemical tank. Test showed few differences between the two in both thus the remainder rate and CMX potency. We concluded that the addition of aromatic oil to nebulizer solution did not influence CMX spraying.

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Drug inhalation is regarded as the main therapy in the superior local deposition effect on the basis of drug delivery system (DDS). The local deposition fraction of drug particles is determined from an aerodynamic diameter as functions of particle size, shape, density, configuration, and orientation angle. Theoretical and experimental clarifications of the aerodynamic diameter for nonspherical drug particles are required to predict the amount of particles. A rotational ellipsoid approximation for nonspherical particles is applied to numerically determine the three-dimensional value of aerodynamic diameter. To evaluate local deposition of nonspherical drug particles in the human airway, the aerodynamic diameter is obtained experimentally from the equilibrium orientation angle and aspect ratio of nonspherical drug particles.
The orientation angle of nonspherical particles in air fluid was calculated numerically. The two-dimension configuration, orientation, and velocity of nonspherical particles were measured in fluid by optical microscopy and a high-speed camera to obtain the aerodynamic diameter of particles. The aerodynamic diameter of particles was also measured directly by time-of-flight (TOF), and was compared with experimental results for measuring validity by optical microscopy.
At a constant flow rate, the orientation angle was mainly on 0 degree and more homogeneous and the aerodynamic diameter measured by experiments agrees approximately with the date measured by TOF. We confirmed that more particles are aligned at 10-30 degrees decline with the flow direction in the shear flow. The aerodynamic diameter affected by orientation angle measured in the shear flow was slightly smaller than that measured by TOF. These results indicate that the experimental method is useful for measuring the aerodynamic diameter of particles in an arbitrary fluid. More effective treatment is expected from evaluating the physical quality of pharmaceuticals such as the alteration of the aerodynamic size distribution as functions of velocity gradient, density, and configuration of particles.

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Shen-mi-tang (Shin-pi-to, SBT) is a well-known suppressor of 5-lypoxygenase as reported by Hamazaki's et al. SBT also has many other antiallergic and antiinflammatory effects. If we can use SBT tropically on bronchoallergic portions, we see the same phenomena occurring in in vivo and in vitro experiments.To obtain a high SBT concentration on the bronchoalligopathological portion, we sutudied kampo herb medicine, i.e., SBT inhalation therapy. After informed consent was obtained, 161 patients were divided into two groups (Group A, n = 81) (Group B, n = 80). Under the same conditions for different drugs, patients in group A inhaled SBT (500 μg/1 capsule, 4 times/day) for 3 years. Patients in group B inhaled sodium cromoglicate (CSCG) (20 mg/1 capsule) in the same administraton using DSCG-spinhela. The difference between DSCG and SBT in capsules was not recognized because these capsules were identical capsule using for DSCG, i.e., baseline clinical characteristics did not significantly differ between groups. At the end point, subjective symptoms such as asthmatic score, PEF titer, and resqure time of β 2 agonist use decreased significantly. Therapeutic drugs also decreased significantly in group A (p < 0.001). In group B, these parameters increased significantly. (p< 0.05). (p< 0.001 vs Group B) Adverse side effects and the appearance of abnormal laboratory data during this trial was lower in group A. In global improvement, group A showed 61.9%, but group B only 5.6% (p< 0.001). These reasons are discussed in this paper.

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Aerosol therapy enables one to administer a drug at high concentrations to the region requiring medication and consequently to reduce general side-effects. The nasal cavity being the entrance to the airway allows easier administration of drugs compared with other regions and therefore is suitable for aerosol therapies. The current approach was to give an initial treatment using a topical nasal steroid in combination, one of the aerosol therapies for the patients with Japanese cedar pollinosis, and we were able to delay the development of clinical symptoms, thus demonstrating the clinical effect of the aerosol therapy. Mainly based on this finding, we describe the effectiveness of aerosol therapies for allergic rhinitis.

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As chronic laryngeal allergy has spred, the efficacy of steroids in treating allergic disease has been confirmed. Local exposure of aerosolizer steroid particles to the larynx should thus be effective in laryngeal allergy. Unfortunately, no reports have been made, to our knowledge, on the clinical effectiveness of local aerosol inhalation of steroids in laryngeal allergy. To determine the effectiveness of aerosol inhalation to the larynx in laryngeal allergy patients, we demonstrated clinical criteria for precise diagnosis of laryngeal allergy, methods of aerosol inhalation beneficial to the larynx, and the clinical activity of steroid aerosol particles in the larynx. We concluded that peroral aerosol inhalation of steroids is effective in treating laryngeal allergy.

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[in Japanese]

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Topical drug administration has several advantages over systemic administration, e.g., achieving a high drug concentration in the area of the allergic reaction. It should be noted that mucosal airway permeability differs with the allergic diseases, however, several factors play roles in altering mucosal permeability, At least histamine and thrombin are involved in increased mucosal permeability, which usually results in increased absorption of topically administered drugs. Drugs that alters mucosal permeability can thus enhance mucosal absorption of topically administered drugs.

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