Preparation and characterization of sterile and freeze-dried sub-200 nm nanoparticles

The feasibility of producing sterile and freeze-dried polyester nanoparticles was investigated. Various poly( d,l-lactide-co-glycolide) and poly( d, l-lactide) were selected as biodegradable polymers. Using the salting-out procedure, process parameters were optimized to obtain sub-200 nm particles....

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Bibliographic Details
Published in:International journal of pharmaceutics 2002-02, Vol.233 (1), p.239-252
Main Authors: Konan, Yvette N, Gurny, Robert, Allémann, Eric
Format: Article
Language:English
Subjects:
Biodegradable polyesters
Biological and medical sciences
Capsules - chemistry
Colloids - chemistry
Drug Stability
Emulsions - chemistry
Filtration - instrumentation
Filtration - methods
Freeze Drying - instrumentation
Freeze Drying - methods
Freeze-drying
General pharmacology
Lyoprotectants
Medical sciences
Nanoparticles
Nanotechnology - instrumentation
Nanotechnology - methods
Particle Size
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Polymers - chemistry
Solvents - chemistry
Sterile filtration
Sterilization
Sterilization - instrumentation
Sterilization - methods
Viscosity
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Summary:The feasibility of producing sterile and freeze-dried polyester nanoparticles was investigated. Various poly( d,l-lactide-co-glycolide) and poly( d, l-lactide) were selected as biodegradable polymers. Using the salting-out procedure, process parameters were optimized to obtain sub-200 nm particles. After purification, the nanoparticle suspensions containing different lyoprotectants were sterilized by filtration. Freeze-drying was performed using vials covered with 0.22 μm membrane filters in order to preserve the suspensions from bacterial contamination. Sterility was assessed on the final product according to pharmacopoeial requirements using the membrane filtration method. With all polymers tested, sub-200 nm particles could be obtained. Nanoparticles with a size as low as 102 nm were prepared with good reproducibility and narrow size distribution. Upon freeze-drying, it appeared that complete redispersion of all types of polyester nanoparticles could be obtained in presence of the lyoprotectants tested such as saccharides while aggregation was observed without lyoprotectant. Sterility testing showed no microbial contamination indicating that sterile nanoparticulate formulations have been achieved.
ISSN:0378-5173
1873-3476
DOI:10.1016/S0378-5173(01)00944-9