Abstract:
:The purpose of this research was to use our previously validated dynamic injection apparatus as a rapid method for screening pH-adjusted formulations of a new vancomycin analog, Van-An, for their potential to precipitate upon dilution. In 1 vial, Van-An was reconstituted according to the manufacturer's instructions. In a separate vial, the Van-An formulation's existing phosphate buffer species was supplemented with acetate buffer, which has a pKa in the desired range: between the pH values of the formulation (pH 3.9) and blood (pH 7.4). The formulations were injected using the dynamic injection apparatus into a flowing stream of isotonic Sorensen's phosphate buffer at rates of 0.25, 0.5, 1, and 2 mL/min. The peaks obtained with the spectrophotometer were reproducible for each injection rate/formulation combination. For the phosphate-buffered formulation, the least amount of precipitation was obtained at the 0.25 mL/min injection rate. Acetate buffer was able to substantially reduce such precipitation, even at the highest injection rate. The opacity peaks for the formulation with the acetate addition were significantly smaller (P<.05) than those obtained for the unaltered formulation at all 4 injection rates. The results suggest that acetate is a better buffer species than phosphate for the pH range defined. Furthermore, we present evidence to support a generally applicable approach to screening new formulations of drug products that may be clinically useful for reducing the incidence of phlebitis in humans.
journal_name
AAPS PharmSciTechjournal_title
AAPS PharmSciTechauthors
Johnson JL,Yalkowsky SHdoi
10.1208/pt070105subject
Has Abstractpub_date
2006-03-01 00:00:00pages
E33-E37issue
1issn
1530-9932pii
10.1208/pt070105journal_volume
7pub_type
杂志文章abstract::The aim of this work is to improve the understanding of the physicochemical mechanisms involved in the functionality of cross-linked carboxymethyl sodium starch (CCSS) as a tablet super disintegrant (SD). The behavior and properties of this SD (medium uptake, disintegration times, particle size, and rheology) was inve...
journal_title:AAPS PharmSciTech
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journal_title:AAPS PharmSciTech
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journal_title:AAPS PharmSciTech
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journal_title:AAPS PharmSciTech
pub_type: 杂志文章
doi:10.1208/s12249-018-1089-x
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abstract::Intra-periodontal pocket drug delivery systems, such as liquid crystalline systems, are widely utilized improving the drug release control and the therapy. Propolis is used in the treatment of periodontal diseases, reducing the inflammatory and infectious conditions. Iron oxide magnetic nanoparticles (MNPs) can improv...
journal_title:AAPS PharmSciTech
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abstract::The purpose of this study was to prepare ginkgolide B (GB) lyophilized powder for injection with excellent appearance and stable quality through a formulation screening and by optimizing the freeze-drying process. Cremophor EL as a solubilizer, PEG 400 as a latent solvent, and mannitol as an excipient were mixed to in...
journal_title:AAPS PharmSciTech
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doi:10.1208/s12249-017-0858-2
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journal_title:AAPS PharmSciTech
pub_type: 杂志文章
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journal_title:AAPS PharmSciTech
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journal_title:AAPS PharmSciTech
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journal_title:AAPS PharmSciTech
pub_type: 杂志文章
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更新日期:2013-09-01 00:00:00
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journal_title:AAPS PharmSciTech
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journal_title:AAPS PharmSciTech
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journal_title:AAPS PharmSciTech
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journal_title:AAPS PharmSciTech
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更新日期:2004-04-07 00:00:00
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journal_title:AAPS PharmSciTech
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更新日期:2008-01-01 00:00:00
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journal_title:AAPS PharmSciTech
pub_type: 杂志文章
doi:10.1208/s12249-008-9099-8
更新日期:2008-01-01 00:00:00
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journal_title:AAPS PharmSciTech
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更新日期:2008-01-01 00:00:00
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journal_title:AAPS PharmSciTech
pub_type: 杂志文章
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journal_title:AAPS PharmSciTech
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journal_title:AAPS PharmSciTech
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journal_title:AAPS PharmSciTech
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journal_title:AAPS PharmSciTech
pub_type: 杂志文章,评审
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更新日期:2020-06-26 00:00:00
abstract::The objective of this study was to design a time-controlled pulsatile release (TCPR) system containing propranolol (PNH) as an active pharmaceutical ingredient. Here, the developed dosage forms were coated with hydroxypropyl-methylcellulose (HPMC) and other excipients as barrier layer using dry-coated technology. The ...
journal_title:AAPS PharmSciTech
pub_type: 杂志文章
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更新日期:2017-10-01 00:00:00
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journal_title:AAPS PharmSciTech
pub_type: 杂志文章
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abstract::Biowaivers are recommended for immediate-release solid oral dosage forms using dissolution testing as a surrogate for in vivo bioequivalence studies. Several guidance are currently available (the World Health Organization (WHO), the US FDA, and the EMEA) where the conditions are described. In this study, definitions, ...
journal_title:AAPS PharmSciTech
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journal_title:AAPS PharmSciTech
pub_type: 杂志文章
doi:10.1208/pt040111
更新日期:2003-01-01 00:00:00
abstract::AR-12 is a novel small molecule with broad spectrum antifungal activity. Recently, AR-12 was found to be highly active against Trichophyton rubrum, one of the predominantly responsible organisms that cause onychomycosis. The primary objective of this project was to investigate the ability of AR-12 to penetrate into an...
journal_title:AAPS PharmSciTech
pub_type: 杂志文章
doi:10.1208/s12249-017-0752-y
更新日期:2017-10-01 00:00:00
abstract::The utilization of ferrets as a non-clinical model for disease is rapidly increasing within drug development. Many of these models include respiratory diseases that involve targeted drug delivery via nose-only inhalation. While the deposition patterns within other non-clinical models (mice, rats, canines, and non-huma...
journal_title:AAPS PharmSciTech
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