Storage stability of inhalable, controlled-release powder formulations of ciprofloxacin nanocrystal-containing liposomes

Khatib, Isra; Ke, Wei-Ren; Cipolla, David; Chan, Hak-Kim

doi:10.1016/j.ijpharm.2021.120809

Cited by 13 publications

(10 citation statements)

References 39 publications

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“…However, CIP-loaded PEtOx NPs showed reduced particle sizes from 200.2 nm to 126.3 nm after 6 months at high temperatures (40 °C) and RH (75% RH). CIP-loaded PEtOx NPs showed decreased particle sizes because of polymer fusion at high temperatures and drug decay from the surface of the polymer, which matches previous findings [ 10 , 13 ]. According to the scanning electron microscopy (SEM) images and dispersibility study, the smooth surfaces of the CIP-loaded PEtOx NPs and reduced aerosolization also revealed that the drugs might have decayed from the surface of the polymer.…”

Section: Resultssupporting

confidence: 91%

“…Thus, the reduced particle sizes of CIP-loaded PEtOx NPs match with the particle size analysis in DLS measurement. The reduced particle sizes and more smooth surfaces of CIP-loaded PEtOx NPs might occur due to the drug decay from the polymeric surface at high temperature [ 10 ]. The surface smoothness was not comparable with the freshly prepared samples and stored samples as evidenced by the TEM images.…”

Section: Resultsmentioning

confidence: 99%

“…However, most of these carriers usually absorb moisture at high RH and affect the stability of the formulations especially affecting the flow properties of the DPI formulations [ 9 ]. Additionally, the sugar molecules usually showed crystallization natures under unfavourable temperatures or RH and adversely affect the aerosol performance of the formulated compounds [ 10 ]. Thus, drug-loaded sugar molecules are usually stored in optimized conditions and needed frequent monitoring to ensure their stability [ 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

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Stability of Inhaled Ciprofloxacin-Loaded Poly(2-ethyl-2-oxazoline) Nanoparticle Dry Powder Inhaler Formulation in High Stressed Conditions

et al. 2022

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In this study, the stability of ciprofloxacin (CIP)-loaded poly(2-ethyl-2-oxazoline) (PEtOx) nanoparticles (NPs) was investigated at normal and high stressed conditions. The blank NPs were used to understand the intrinsic physicochemical properties of the polymer NPs under these storage conditions. The formulated NPs were prepared by a coassembly reaction and dried by lyophilization. The powder NPs were stored at controlled room temperature (25 °C) with normal relative humidity (RH) (43%) and high temperature (40 °C) and RH (75%). The stored samples were analyzed by determining the particle sizes, morphology, solid-state properties, thermal behavior, drug-polymer interactions, and aerosol performances over six months. The chemical stability of the formulations was determined by X-ray diffraction, attenuated total refection-Fourier transform infrared (ATR-FTIR), and high-performance liquid chromatography (HPLC) over six months under both conditions. The particle size of the blank PEtOx NPs significantly (p < 0.05) increased from 195.4 nm to 202.7 nm after 3 months at 40 °C/75% RH due to the moisture absorption from high RH; however, no significant increase was observed afterward. On the other hand, the sizes of CIP-loaded PEtOx NPs significantly (p < 0.05) reduced from 200.2 nm to 126.3 nm after 6 months at 40 °C/75% RH. In addition, the scanning electron microscopy (SEM) images revealed that the surfaces of CIP-loaded PEtOx NPs become smoother after 3 months of storage due to the decay of surface drugs compared to the freshly prepared NPs. However, transmission electron microscopy (TEM) images could not provide much information on drug decay from the nanoparticle’s surfaces. The fine particle fraction (FPF) of CIP-loaded PEtOx NPs dropped significantly (p < 0.05) after three months at 25 °C/43% RH and 40 °C/75% RH conditions. The reduced FPF of CIP-loaded PEtOx NPs occurred due to the drug decay from the polymeric surface and blank PEtOx NPs due to the aggregations of the NPs at high temperatures and RH. Although the aerosolization properties of the prepared CIP-loaded PEtOx NPs were reduced, all formulations were chemically stable in the experimental conditions.

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Section: Resultssupporting

confidence: 91%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Stability of Inhaled Ciprofloxacin-Loaded Poly(2-ethyl-2-oxazoline) Nanoparticle Dry Powder Inhaler Formulation in High Stressed Conditions

et al. 2022

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“…Recently, novel ciprofloxacin nanocrystals inside liposomes (CNL) powder formulations for controlled release and inhalation were created. The storage stability of CNL powders containing ciprofloxacin (CIP), lipids, lyoprotectant (such as sucrose or lactose), magnesium stearate or isoleucine was examined in the study [ 136 ]. These powders were made by spray drying, collected in a dry box with a relative humidity (RH) of around 15%, and then kept at room temperature with either a 4 or 20%RH.…”

Section: Applicable Cryoprotectants In Liposomal Freezingmentioning

confidence: 99%

“…However, within the first month of storage, both RHs experienced liposomal instability with a significant decrease in EE and an increase in liposome size ( p -values 0.05). In addition, regardless of the storage RHs, the IVR assay of CIP from lactose CNL revealed a less regulated release and a significant difference (f2 < 50) from its initial value after six months [ 136 ]. From the study we can see that dry powder inhalers of CNL containing sucrose when kept below 4%RH at room temperature for six months, possess more physiochemical stability compared to those containing lactose.…”

Section: Applicable Cryoprotectants In Liposomal Freezingmentioning

confidence: 99%

The Role of Cryoprotective Agents in Liposome Stabilization and Preservation

Boafo

Magar

Ekpo

et al. 2022

IJMS

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To improve liposomes’ usage as drug delivery vehicles, cryoprotectants can be utilized to prevent constituent leakage and liposome instability. Cryoprotective agents (CPAs) or cryoprotectants can protect liposomes from the mechanical stress of ice by vitrifying at a specific temperature, which forms a glassy matrix. The majority of studies on cryoprotectants demonstrate that as the concentration of the cryoprotectant is increased, the liposomal stability improves, resulting in decreased aggregation. The effectiveness of CPAs in maintaining liposome stability in the aqueous state essentially depends on a complex interaction between protectants and bilayer composition. Furthermore, different types of CPAs have distinct effective mechanisms of action; therefore, the combination of several cryoprotectants may be beneficial and novel attributed to the synergistic actions of the CPAs. In this review, we discuss the use of liposomes as drug delivery vehicles, phospholipid–CPA interactions, their thermotropic behavior during freezing, types of CPA and their mechanism for preventing leakage of drugs from liposomes.

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