The effect of vehicle on physical properties and aerosolisation behaviour of disodium cromoglycate microparticles spray dried alone or with l-leucine

Najafabadi, Abdolhossien Rouholamini; Gilani, Kambiz; Barghi, Mohammadali; Rafiee-Tehrani, Morteza

doi:10.1016/j.ijpharm.2004.07.027

Cited by 95 publications

(41 citation statements)

References 20 publications

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“…A similar result was found by Najafabadi et al 24 in their study of amorphous commercial CS, which also confirmed the …”

Section: Crystallinity and Hydrationsupporting

confidence: 91%

“…Untreated CS shows distinct diffraction peaks characteristic of the long-range order in crystalline materials; the pattern corresponds to the one reported in the literature for commercial hydrate CS. [22][23][24] The pattern of crystalline CS varies if it is equilibrated at different relative humidities. 22 SAA-processed materials show the complete absence of distinct peaks and a broad (halo) scattering pattern that is characteristic of amorphous materials and has been observed in the literature for amorphous CS.…”

Section: Crystallinity and Hydrationmentioning

confidence: 99%

“…22 SAA-processed materials show the complete absence of distinct peaks and a broad (halo) scattering pattern that is characteristic of amorphous materials and has been observed in the literature for amorphous CS. 24 The result raises a question about the possibility that amorphous CS particles can evolve rapidly to a crystalline form, modifying the morphology. This possibility may affect whether SAA-processed CS powders can be used in pharmaceutical applications in which *LS indicates laser scattering; SEM, scanning electron microscopy.…”

Section: Crystallinity and Hydrationmentioning

confidence: 99%

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Production of cromolyn sodium microparticles for aerosol delivery by supercritical assisted atomization

2007

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The purpose of this study was to produce cromolyn sodium (CS) micrometric particles with controlled particle size (PS) and PS distribution (PSD) suitable for aerosol delivery, using a supercritical fluids-based process. CS was micronized using the supercritical assisted atomization (SAA) technique at different solute concentrations in water and different precipitation temperatures. Two techniques were used to measure PS and PSD of produced particles: scanning electron microscopy image analysis and laser scattering analysis. The 2 techniques were compared to provide a complete description of the powder obtained. High-performance liquid chromatography analysis was used to verify the absence of degradation of CS after micronization; differential scanning calorimetry, thermogravimetric analysis (TGA), and X-ray analysis were performed to study the effect of operative conditions on the crystalline structure and on the water content of SAA micronized particles. The CS particles obtained were spherical, with a volumetric percentage of particles with a diameter ranging between 1 and 5 μm of 50% to 66%. The precipitation temperature had no significant effect on PSD, but high drying temperatures led to product degradation. Increasing the concentration of CS in water solution produced an increase in PS of the micronized particles. TGA showed that the micronized CS had a different hydration state than the untreated CS did. The micronized product was stable after 12 months of storage, and no modifications in structure, morphology, or crystallinity were detected. In conclusion, SAA is an efficient technique for micronization of CS, and stable spherical amorphous particles suitable for aerosol delivery can be produced.

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“…A similar result was found by Najafabadi et al 24 in their study of amorphous commercial CS, which also confirmed the …”

Section: Crystallinity and Hydrationsupporting

confidence: 91%

Section: Crystallinity and Hydrationmentioning

confidence: 99%

Section: Crystallinity and Hydrationmentioning

confidence: 99%

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Production of cromolyn sodium microparticles for aerosol delivery by supercritical assisted atomization

2007

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“…Incorporation of L-leucine in the aerosol formulation prior to spray drying affects the surface properties of PLGA/ PEG particles leading to improvement in powder flowability and aerosolization properties (34,35). This would in turn increase the respirable fraction of the total dose.…”

Section: Discussionmentioning

confidence: 99%

Immunization of Guinea Pigs with Novel Hepatitis B Antigen as Nanoparticle Aggregate Powders Administered by the Pulmonary Route

Muttil

Prego

García-Contreras

et al. 2010

AAPS J

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Abstract. Novel nanoparticle-aggregate formulations containing recombinant hepatitis B surface antigen (rHBsAg) were administered to the lungs of guinea pigs and antibodies generated to this antigen evaluated. Preparations of dry powders of: (a) rHBsAg encapsulated within poly(lactic-co-glycolic acid) (PLGA)/polyethylene glycol (PEG) nanoparticles (antigen nanoparticles, AgN SD ), (b) rHBsAg in a physical mixture with blank PLGA/PEG nanoparticles (antigen nanoparticle admixture (AgNA SD ), and (c) rHBsAg encapsulated in PLGA/PEG nanoparticles plus free rHBsAg (antigen nanoparticles and free antigen), were generated by spray drying with leucine. Control groups consisted of alum with adsorbed rHBsAg (AlumAg); reconstituted suspensions of spray-dried rHBsAg-loaded PLGA/PEG nanoparticles with leucine; and rHBsAg-loaded PLGA/PEG nanoparticles (AgN). Control preparations were administered by intramuscular injection; AgN was also spray instilled into the lungs. The IgG titers were measured in the serum for 24 weeks after the initial immunization; IgA titers were measured in the bronchio-alveolar lavage fluid. While the highest titer of serum IgG antibody was observed in guinea pigs immunized with AlumAg administered by the IM route, animals immunized with powder formulations via the pulmonary route exhibited high IgA titers. In addition, guinea pigs immunized with AgNA SD via the pulmonary route exhibited IgG titers above 1,000 mIU/ml in the serum (IgG titers above 10 mIU/ml is considered protective). Thus, the disadvantages observed with the existing hepatitis B vaccine administered by the parenteral route may be overcome by administering them as novel dry powders to the lungs. In addition, these powders have the advantage of eliciting a high mucosal immune response in the lungs without traditional adjuvants.

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“…It has been reported that Leu reduces the surface energy of drug particles. 34,35) Yang et al reported that the inhalation performance of spray-dried powders was improved by an increase in Leu up to 20%. 36) In the present study, we added 5% Leu to the powder, which seemed to be sufficient to improve the dispersibility of the powder.…”

Section: Morphologicl Analysis Of Powder Particlesmentioning

confidence: 99%

Development of New Formulation Dry Powder for Pulmonary Delivery Using Amino Acids to Improve Stability

Suzuki

Okuda

Okamoto

2016

Biological & Pharmaceutical Bulletin

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Cationic polymers are being studied as non-viral gene delivery vectors. Poly{N-[N-(2-aminoethyl)-2-aminoethyl]aspartamide} (PAsp(DET)) and their block copolymers with poly(ethylene glycol), PEG-PAsp(DET), have been reported as efficient biodegradable non-viral vectors which form a polyplex with plasmid DNA (pDNA). However, the polyplexes are not stable because PAsp(DET) and PEG-PAsp(DET) are easily subjected to hydrolysis; therefore, they need to be prepared on site. In this study, using the biodegradable polycations as non-viral vectors, PAsp(DET) and PEG-PAsp(DET), we investigated the effects of L-leucine (Leu) on the polyplex. We prepared solutions and dry powders with and without Leu. Both dry powders had large and porous particles and Leu acted as a dispersing agent. The transfection activity of the sample solutions decreased within a month. However, the decrease in the transfection activity was partially suppressed by the dry powder with Leu at 5 and 25°C at 3 months. Furthermore, transfection experiments revealed that Leu exhibited a pDNA-stabilizing effect in the solution and dry powder. Similar results were observed for pDNA integrity, where a polyplex was formed in the dry powder. The results suggest that Leu is a candidate stabilizer to protect pDNA from degradation.

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The effect of vehicle on physical properties and aerosolisation behaviour of disodium cromoglycate microparticles spray dried alone or with l-leucine

Cited by 95 publications

References 20 publications

Production of cromolyn sodium microparticles for aerosol delivery by supercritical assisted atomization

Production of cromolyn sodium microparticles for aerosol delivery by supercritical assisted atomization

Immunization of Guinea Pigs with Novel Hepatitis B Antigen as Nanoparticle Aggregate Powders Administered by the Pulmonary Route

Development of New Formulation Dry Powder for Pulmonary Delivery Using Amino Acids to Improve Stability

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