Assessment of nicotine release from nicotine-loaded chitosan nanoparticles dry powder inhaler formulations via locomotor activity of C57BL/6 mice.

PURPOSE: This study aimed to assess the activity of controlled release nicotine from dry powder inhaler formulation via locomotor activity of C57BL/6 mice. METHODS: To achieve this we built a nose-only inhalation device for pulmonary administration of nicotine to mice and determined the optimal operational parameters. We used the locomotor activity test to compare the effects of the inhaled nicotine hydrogen tartrate-loaded chitosan nanoparticles (NHT-CS) with NHT in C57BL/6 mice. The minimum inhaled dose of NHT-CS required to alter locomotor activity was compared with inhaled and subcutaneously (s.c) injected NHT. Finally, histological examination of lung tissues was performed to ensure inhalation of NHT-CS did not cause lung damage. RESULTS: We found a flow rate of 0.9 L/min and an exposure time of 5 min achieved optimal delivery of nicotine. A minimum of 0.88 mg inhaled of NHT-CS or 0.59 mg inhaled of NHT was required to alter locomotor activity similarly to injection of 0.5 mg/kg nicotine, suggesting the reformulation process did not alter the activity of NHT-CS. No differences between untreated and NHT-CS treated lung tissue upon histological examination were observed. CONCLUSIONS: The results indicated the inhaled NHT-CS is a viable preclinical option for developing novel inhalation formulations as a potential anti-smoking therapeutic.

Assessment of inhalation flow patterns of soft mist inhaler co-prescribed with dry powder inhaler using inspiratory flow meter for multi inhalation devices.

The patients' inhalation flow pattern is one of the significant determinants for clinical performance of inhalation therapy. However, the development of inhalation flow meters for various inhalation devices has been unable to keep up with the increasing number of newly launched inhalation devices. In the present study, we developed simple attachment orifices for the inhalation flow pattern monitoring system, which are suitable for all commercial inhalers, and investigated the efficacy of the system on the clinical inhalation instruction for patients co-prescribed dry powder inhaler (DPI) and soft mist inhaler (SMI). First, we constructed simple attachment orifices that were adjusted for 13 commercial inhalers, and examined the correlation between orifice and inhalation device. Second, the inhalation flow patterns (peak inspiratory flow rate, PIFR; inhalation duration time, DT) of patients prescribed a combination of DPI and SMI were monitored before and after inhalation instruction. The inhalation resistance of commercial inhalers are listed in the following order; Twincaps® > Handihaler® > Swinghaler® = Clickhaler® > Twisthaler® > Turbuhaler® > Jenuair® > Diskus® = Ellipta® > Diskhaler® > Breezhaler® > Respimat® = pMDI. The pressure drop via orifice was significantly correlated with that via the commercial inhaler. For the confirmation, all participants achieved the DPI criterion of PIFR. On the other hand, 4 participants (6 clinical visits) of 10 experimented participants could not achieve the essential criterion of DT (> 1.5 sec) for SMI, but all participants improved their duration time after inhalation instruction by pharmacists (P<0.05). In the present study, we successfully developed simple attachment orifice suitable for 13 commercial inhalation devices. These data suggested that our simple attachment orifices for the inhalation flow pattern monitoring system can detect patients with inadequate inhalation patterns via SMI.

Inhaler device selection: special considerations in elderly patients with chronic obstructive pulmonary disease.

PURPOSE: Special considerations in the selection of medication inhaler devices for elderly patients with chronic obstructive pulmonary disease (COPD) in the ambulatory care setting are reviewed. SUMMARY: Substantial deficiencies in inhaler device technique and medication adherence are evident in patients with COPD, leading to suboptimal health outcomes. As the prevalence of COPD rises with age, elderly patients pose special challenges with regard to inhaler device selection. In elderly patients with sufficient cognitive function, manual dexterity, and hand strength, the most influential factors in inhaler selection are cost reimbursement, device availability, device convenience, and patient preference. Cost reimbursement may be a deciding factor in device selection, as nearly all elderly patients are Medicare beneficiaries. Nebulizers provide a cost-effective alternative to pressurized metered-dose inhaler (pMDI) and dry powder inhaler (DPI) devices. DPI device availability is limited to "controller" medications, while pMDI devices and nebulizers provide complete symptomatic coverage. Multiple-dose DPIs offer the convenience of rapid medication administration, ease of handling, and integral dose counters. Given the availability and expenses of medication devices, ambulatory patients may prefer combining the convenience of a hand-held inhaler (i.e., pMDI) as a rescue medication during the active hours of midday with the cost savings of a nebulized controller medication in the morning and at night. CONCLUSION: In elderly patients with sufficient cognitive function, manual dexterity, and hand strength, the most important factors in inhaler device selection are cost reimbursement issues, device availability, device convenience, and patient preference. Pharmacist knowledge of appropriate inhaler technique, competent patient education and demonstration, and follow-up assessment are instrumental in optimizing device competency and medication adherence.