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    
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.
Katsutoshi Nakamura; Shigeharu Yokohama; Masataka Katsuma; Toyohiro Sawada; Takashi Sonobe
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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    
Institute for Drug Development and Research, Yamanouchi Pharmaceutical Co, Ltd 180 Ozumi Yaizu-shi, Shizuoka-ken, 425-0072 Japan.
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MeSH Terms
Diphosphonates / chemistry*
Drug Contamination / prevention & control*
Drug Stability
Drug Storage / methods
Imidazoles / chemistry*
Pharmaceutical Solutions / chemistry*
Stress, Mechanical
Technology, Pharmaceutical / methods*
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

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