Document Detail


A new stressed test to predict the foreign matter formation of minodronic acid in solution.
MedLine Citation:
PMID:  12527179     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
A formulation containing 0.5 mg/ml minodronic acid, 40 mM citrate, pH 4.5, and sodium chloride, stored in regular flint glass ampoules, was stable without particulate increase under high temperature conditions, such as 40 degrees C for 6 months, or 50 or 60 degrees C for 3 months. However, when stored at 25 degrees C, there was an increase in >or=2 microm particles at the 5-month timepoint. This demonstrated that long-term stability cannot simply be predicted by the evaluation of samples just stored at higher temperatures. Therefore, a new stressed test was designed which is useful in the rapid selection of formulations that are stable and without particulate increase. Since the particulate matter is apparently a complex of minodronic acid and aluminum ions leaching from ampoules, samples were placed at 80 degrees C for up to 4 weeks to accelerate aluminum leaching. Although no particulate increase was observed directly after storage at 80 degrees C, 4 freeze-thaw cycles following the storage caused a drastic particulate increase. The evaluation of samples subjected to the freeze-thaw cycles indicated that the following formulation modifications have inhibitory effects on particulate generation: (1). addition of meglumine, diethanolamine, mannitol, or glycerol to the formulation; (2). increase of citric acid concentration; (3). decrease of minodronic acid concentration. These modifications also worked well for samples stored at 25 degrees C for 6 months, and particulate increase did not occur. This method is a powerful tool for predicting the stability of minodronic acid in solution.
Authors:
Katsutoshi Nakamura; Shigeharu Yokohama; Masataka Katsuma; Toyohiro Sawada; Takashi Sonobe
Related Documents :
19410089 - Enterococcus faecalis biofilms eradication by root canal irrigants.
7654309 - Suppressed acid formation by cofeeding of glucose and citrate in bacillus cultures: eme...
20882459 - The production of cyclopiazonic acid by penicillium commune and cyclopiazonic acid and ...
15680989 - Metabolic flux analysis in complex isotopolog space. recycling of glucose in tobacco pl...
24746509 - Ultrasound assisted immersion freezing of broccoli (brassica oleracea l. var. botrytis ...
193739 - Integration of lipid utilization with krebs cycle activity in muscle.
8447149 - Esaprazole effect on acid, peptic and alkaline secretion in duodenal ulcer patients.
24112119 - Amoeba host-legionella synchronization of amino acid auxotrophy and its role in bacteri...
46329 - Polysaccharides of metaplastic mucosa and carcinoma of the gallbladder.
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  International journal of pharmaceutics     Volume:  251     ISSN:  0378-5173     ISO Abbreviation:  Int J Pharm     Publication Date:  2003 Jan 
Date Detail:
Created Date:  2003-01-15     Completed Date:  2003-07-16     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7804127     Medline TA:  Int J Pharm     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  99-106     Citation Subset:  IM    
Affiliation:
Institute for Drug Development and Research, Yamanouchi Pharmaceutical Co, Ltd 180 Ozumi Yaizu-shi, Shizuoka-ken, 425-0072 Japan. nakamurk@yamanouchi.co.jp
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Diphosphonates / chemistry*
Drug Contamination / prevention & control*
Drug Stability
Drug Storage / methods
Forecasting
Imidazoles / chemistry*
Pharmaceutical Solutions / chemistry*
Stress, Mechanical
Technology, Pharmaceutical / methods*
Chemical
Reg. No./Substance:
0/Diphosphonates; 0/Imidazoles; 0/Pharmaceutical Solutions; 127657-42-5/YM 529

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Influence of formulation parameters on gadolinium entrapment and tumor cell uptake using folate-coat...
Next Document:  Effects of citicholine and dimethylsulfoxide on transepithelial transport of passively diffused drug...