| Stability of extemporaneously prepared saquinavir formulations. | |
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MedLine Citation:
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PMID: 14651667 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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L K Tan; J C Thenmozhiyal; P C Ho |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Journal of clinical pharmacy and therapeutics Volume: 28 ISSN: 0269-4727 ISO Abbreviation: J Clin Pharm Ther Publication Date: 2003 Dec |
Date Detail:
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Created Date: 2003-12-03 Completed Date: 2004-04-13 Revised Date: 2008-05-28 |
Medline Journal Info:
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Nlm Unique ID: 8704308 Medline TA: J Clin Pharm Ther Country: England |
Other Details:
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Languages: eng Pagination: 457-63 Citation Subset: IM |
Affiliation:
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Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore 117543. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Capsules Chemistry, Pharmaceutical / methods* Child Chromatography, High Pressure Liquid Drug Stability HIV Protease Inhibitors* Humans Hydrogen-Ion Concentration Saquinavir* |
| Chemical | |
Reg. No./Substance:
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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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