On June 10, 2018, Shetty, Nivedita; Park, Heejun; Zemlyanov, Dmitry; Mangal, Sharad; Bhujbal, Sonal; Zhou, Qi published an article.Safety of 1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrochloride hydrate The title of the article was Influence of excipients on physical and aerosolization stability of spray dried high-dose powder formulations for inhalation. And the article contained the following:
The aim of this study is to investigate the influence of excipients on phys. and aerosolization stability of spray dried Ciprofloxacin dry powder inhaler formulations. The model drug, Ciprofloxacin hydrochloride, was co-spray dried with excipients such as disaccharides (sucrose, lactose, trehalose), mannitol and L-leucine. The spray dried samples were stored at two different relative humidity (RH) conditions of: (1) 20% and (2) 55% RH at 20°C. Ciprofloxacin co-spray dried with disaccharides and L-leucine in the mass ratio of 1:1 demonstrated an increase in fine particle fraction (FPF) as compared with the spray dried Ciprofloxacin alone when stored at 20% RH. However, deterioration in FPF of Ciprofloxacin co-spray dried with disaccharide and mannitol was observed upon storage at 55% RH as compared to the corresponding formulations stored at 20% RH due to particle agglomeration. Whereas, 10% and 50% weight/weight L-leucine in the formulation showed no change in aerosol performance (FPF of 71.1±3.5% and 79.5±3.1%, resp.) when stored at 55% RH for 10 days as compared to 20% RH (FPF of 68.1±0.3% and 73.6±7.1%, resp.). L-Leucine demonstrated aerosolization stability by alleviating crystallization of Ciprofloxacin to some extent and preventing significant change in particle morphol. L-Leucine is well-recognized as aerosolization enhancer; our study has shown L-leucine is also a phys. and aerosolization stabilizer for spray dried Ciprofloxacin DPI formulations. Such stability enhancing activities were attributed to the enrichment of L-leucine on the particle surface as confirmed by XPS data, and intermol. interactions between L-leucine and Ciprofloxacin as measured by FT-IR. The experimental process involved the reaction of 1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrochloride hydrate(cas: 86393-32-0).Safety of 1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrochloride hydrate
The Article related to excipient aerosolization spray drying powder formulation inhalation, antibiotics, dry powder inhaler (dpi), excipients, fine particle fraction (fpf), spray drying, Pharmaceuticals: Formulation and Compounding and other aspects.Safety of 1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrochloride hydrate
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Piperazine – Wikipedia,
Piperazines – an overview | ScienceDirect Topics