Document Detail


Stability of extemporaneously prepared saquinavir formulations.
MedLine Citation:
PMID:  14651667     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: The effects of pH and excipients on the stability of saquinavir in extemporaneously prepared suspensions were assessed. The stability of a developed extemporaneously prepared saquinavir suspension was then determined at 5 and 25 degrees C over 30 days. METHOD: Extemporaneous saquinavir 2 mg/mL formulations were prepared from soft gelatin capsule (Fortovase). Four batches of the formulations were buffered at pHs 2, 4, 5 and 7, whereas the other five batches were prepared in Milli-Q water, 0.5% (w/v) citric acid, 0.1% (w/v) sodium ascorbate, 10% (v/v) syrup and in vehicle containing both 0.5% (w/v) citric acid and 0.1% (w/v) sodium ascorbate. The stability of these formulations was tested at 25 degrees C. A final formulation of saquinavir suspension (60 mg/mL) containing both 10% (v/v) syrup and 0.5% (w/v) citric acid was developed and tested for stability at 5 and 25 degrees C for up to 30 days using a stability-indicating high-performance liquid chromatographic method. RESULTS: Saquinavir was most stable at pH 2-4. Formulations containing sodium ascorbate, citric acid and syrup or both citric acid and sodium ascorbate were significantly more stable than the control formulation (saquinavir 2 mg/mL in Milli-Q water). CONCLUSION: The pH for optimal stability of saquinavir was around 2-4. Besides pH adjustment, saquinavir could also be stabilized by adding anti-oxidants. The saquinavir 60 mg/mL formulation prepared with about a pH of about 4 was stable at both 5 and 25 degrees C for at least 30 days.
Authors:
L K Tan; J C Thenmozhiyal; P C Ho
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of clinical pharmacy and therapeutics     Volume:  28     ISSN:  0269-4727     ISO Abbreviation:  J Clin Pharm Ther     Publication Date:  2003 Dec 
Date Detail:
Created Date:  2003-12-03     Completed Date:  2004-04-13     Revised Date:  2008-05-28    
Medline Journal Info:
Nlm Unique ID:  8704308     Medline TA:  J Clin Pharm Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  457-63     Citation Subset:  IM    
Affiliation:
Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore 117543.
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MeSH Terms
Descriptor/Qualifier:
Capsules
Chemistry, Pharmaceutical / methods*
Child
Chromatography, High Pressure Liquid
Drug Stability
HIV Protease Inhibitors*
Humans
Hydrogen-Ion Concentration
Saquinavir*
Chemical
Reg. No./Substance:
0/Capsules; 0/HIV Protease Inhibitors; 127779-20-8/Saquinavir

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


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