The determination of residual moisture in several freeze-dried vaccines and a Honey Bee Venom Allergenic Extract by TG/MS

May, Joan C.; Wheeler, R.M.; Grim, Elizabeth C.

doi:10.1007/bf01914242

Cited by 8 publications

(1 citation statement)

References 6 publications

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“…This moisture content cutoff was adopted to preserve powder aerosolization and deposition properties as particles that had moisture content above 3% tended to agglomerate, altering powder properties. Beyond preserving powder properties, stabilization via residual moisture reduction is an important factor in preserving potency by inhibiting microorganism growth and other water-facilitated degradation (May et al 1986). To ensure the moisture content remains less than 3% and that the antibiotics are not exposed to UV, oxidants or other contaminants, the antibiotic dry powder can be single-dose-packaged in tightly sealed aluminum foil-polymer film laminate blister packs.…”

Section: Resultsmentioning

confidence: 99%

Inhalable Antibiotics Manufactured Through Use of Near-Critical or Supercritical Fluids

Manion

Cape

McAdams

et al. 2012

Aerosol Science and Technology

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The development of unit-dose, inhalable, antibiotic microparticles for use in primary and combined therapy approaches to treating tuberculosis (TB), multi-drug-resistant (MDR-TB), and extensively drug-resistant TB is explored using the gentle drying process of Carbon-dioxide Assisted Nebulization with a Bubble Dryer (CAN-BD). The microparticles produced using this method contain capreomycin, kanamycin, and isoniazid, respectively, imbedded in L-leucine. Antibiotics were developed into inhalable antibiotic formulations for their utility in both first line and second line antibiotic treatment regimens. Capreomycin and kanamycin are typically administered by injection making them desirable candidates for the development of a needle-free delivery system that addresses the Grand Challenges in Global Health Initiative #3. In response to this challenge, unit-dose packaging that preserves powder properties by protecting them from moisture, oxidants, and UV exposure, and a low cost "active" dry powder inhaler, the PuffHaler, were developed and used as a prototype device, in addition to the Aerolizer, to disperse the microparticle antibiotic formulations. Antibiotic formulations show yields above 50% in small-scale powder production by CAN-BD. Capreomycin and kanamycin show improved powder yields in scale up experiments. The particle properties were characterized using scanning electron microscopy, Karl Fischer moisture analysis, Anderson Cascade Impaction studies, and X-ray diffraction. The inhalable antibiotic formulations are within a respirable size range (1-5 µm), and have less than 3% residual moisture. Unit-dose dry powder antibiotics have the potential to provide easy-to-use, stable products with improved safety profiles.

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Section: Resultsmentioning

confidence: 99%