Stabilization of minodronic acid in aqueous solution for parenteral formulation
The composition, concentration, and buffer pH of potential minodronic acid formulations were evaluated for their drug stability and for their tendency to generate particles after storage for up to 4 weeks at 60°C. The results indicate that citrate and tartrate buffers maintain drug stability and inh...
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| Veröffentlicht in: | International journal of pharmaceutics 2001-07, Vol.222 (1), p.91-99 |
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| container_title | International journal of pharmaceutics |
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| creator | Nakamura, Katsutoshi Tanaka, Tomonari Saito, Katsumi Yokohama, Shigeharu Sonobe, Takashi |
| description | The composition, concentration, and buffer pH of potential minodronic acid formulations were evaluated for their drug stability and for their tendency to generate particles after storage for up to 4 weeks at 60°C. The results indicate that citrate and tartrate buffers maintain drug stability and inhibit the formation of particles. The stability of minodronic acid in these solutions increased slightly as the buffer concentration increased, exhibiting less particle formation than in other buffers. Since citrate buffer was considered the most promising stabilizer for minodronic acid, the pH-stability relationship in 100 mM citrate with pH ranging from 3 to 7 was evaluated during storage for 4 weeks at 60°C. The results demonstrate that solution pH of 3–5 result in optimal stability of minodronic acid with no formation of precipitates. A white precipitate was observed in citrate-containing sample solutions with pH of 6 and 7. Analysis of the isolated precipitate provided support for the hypothesis that the precipitate is a complex between minodronic acid and aluminum ions apparently leached from the glass of the ampoules. |
| doi_str_mv | 10.1016/S0378-5173(01)00704-9 |
| format | Article |
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The results indicate that citrate and tartrate buffers maintain drug stability and inhibit the formation of particles. The stability of minodronic acid in these solutions increased slightly as the buffer concentration increased, exhibiting less particle formation than in other buffers. Since citrate buffer was considered the most promising stabilizer for minodronic acid, the pH-stability relationship in 100 mM citrate with pH ranging from 3 to 7 was evaluated during storage for 4 weeks at 60°C. The results demonstrate that solution pH of 3–5 result in optimal stability of minodronic acid with no formation of precipitates. A white precipitate was observed in citrate-containing sample solutions with pH of 6 and 7. Analysis of the isolated precipitate provided support for the hypothesis that the precipitate is a complex between minodronic acid and aluminum ions apparently leached from the glass of the ampoules.</description><identifier>ISSN: 0378-5173</identifier><identifier>EISSN: 1873-3476</identifier><identifier>DOI: 10.1016/S0378-5173(01)00704-9</identifier><identifier>PMID: 11404035</identifier><identifier>CODEN: IJPHDE</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Aluminum ion ; Biological and medical sciences ; Buffers ; Chemistry, Pharmaceutical ; Chromatography, High Pressure Liquid ; Complex ; Diphosphonates - chemistry ; Drug Stability ; Drug Storage ; General pharmacology ; Hydrogen-Ion Concentration ; Imidazoles - chemistry ; Infusions, Parenteral ; Medical sciences ; Minodronic acid ; Parenteral formulation ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. Drug treatments ; Precipitate ; Spectroscopy, Fourier Transform Infrared ; Stability</subject><ispartof>International journal of pharmaceutics, 2001-07, Vol.222 (1), p.91-99</ispartof><rights>2001 Elsevier Science B.V.</rights><rights>2001 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c390t-52438915e65532e35681751b452487fa0d32fce2693d65dab2fb799e43661dae3</citedby><cites>FETCH-LOGICAL-c390t-52438915e65532e35681751b452487fa0d32fce2693d65dab2fb799e43661dae3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0378517301007049$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1061915$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11404035$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nakamura, Katsutoshi</creatorcontrib><creatorcontrib>Tanaka, Tomonari</creatorcontrib><creatorcontrib>Saito, Katsumi</creatorcontrib><creatorcontrib>Yokohama, Shigeharu</creatorcontrib><creatorcontrib>Sonobe, Takashi</creatorcontrib><title>Stabilization of minodronic acid in aqueous solution for parenteral formulation</title><title>International journal of pharmaceutics</title><addtitle>Int J Pharm</addtitle><description>The composition, concentration, and buffer pH of potential minodronic acid formulations were evaluated for their drug stability and for their tendency to generate particles after storage for up to 4 weeks at 60°C. The results indicate that citrate and tartrate buffers maintain drug stability and inhibit the formation of particles. The stability of minodronic acid in these solutions increased slightly as the buffer concentration increased, exhibiting less particle formation than in other buffers. Since citrate buffer was considered the most promising stabilizer for minodronic acid, the pH-stability relationship in 100 mM citrate with pH ranging from 3 to 7 was evaluated during storage for 4 weeks at 60°C. The results demonstrate that solution pH of 3–5 result in optimal stability of minodronic acid with no formation of precipitates. A white precipitate was observed in citrate-containing sample solutions with pH of 6 and 7. Analysis of the isolated precipitate provided support for the hypothesis that the precipitate is a complex between minodronic acid and aluminum ions apparently leached from the glass of the ampoules.</description><subject>Aluminum ion</subject><subject>Biological and medical sciences</subject><subject>Buffers</subject><subject>Chemistry, Pharmaceutical</subject><subject>Chromatography, High Pressure Liquid</subject><subject>Complex</subject><subject>Diphosphonates - chemistry</subject><subject>Drug Stability</subject><subject>Drug Storage</subject><subject>General pharmacology</subject><subject>Hydrogen-Ion Concentration</subject><subject>Imidazoles - chemistry</subject><subject>Infusions, Parenteral</subject><subject>Medical sciences</subject><subject>Minodronic acid</subject><subject>Parenteral formulation</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Precipitate</subject><subject>Spectroscopy, Fourier Transform Infrared</subject><subject>Stability</subject><issn>0378-5173</issn><issn>1873-3476</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkE1r3DAQhkVoaDZpf0KKDyUkB6czliXZp1KWfMFCDmnPQpbGoGJbG8kONL8-9u7S5taTEHrm1TsPY-cI1wgovz0BV1UuUPFLwCsABWVeH7EVVornvFTyA1v9RU7YaUq_AUAWyD-yE8QSSuBixR6fRtP4zr-a0YchC23W-yG4GAZvM2O9y_yQmeeJwpSyFLpph7UhZlsTaRgpmm659lO3S_jEjlvTJfp8OM_Yr9ubn-v7fPN497D-scktr2HMRVHyqkZBUgheEBeyQiWwKeeHSrUGHC9aS4WsuZPCmaZoG1XXVHIp0RniZ-xin7uNYW6XRt37ZKnrzLBU1QrqogCFMyj2oI0hpUit3kbfm_hHI-jFpN6Z1IsmDah3JnU9z305fDA1Pbl_Uwd1M_D1AJhkTddGM1if3qVLnBecse97jGYbL56iTtbTYMn5SHbULvj_NHkDOMiPZw</recordid><startdate>20010703</startdate><enddate>20010703</enddate><creator>Nakamura, Katsutoshi</creator><creator>Tanaka, Tomonari</creator><creator>Saito, Katsumi</creator><creator>Yokohama, Shigeharu</creator><creator>Sonobe, Takashi</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20010703</creationdate><title>Stabilization of minodronic acid in aqueous solution for parenteral formulation</title><author>Nakamura, Katsutoshi ; Tanaka, Tomonari ; Saito, Katsumi ; Yokohama, Shigeharu ; Sonobe, Takashi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c390t-52438915e65532e35681751b452487fa0d32fce2693d65dab2fb799e43661dae3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2001</creationdate><topic>Aluminum ion</topic><topic>Biological and medical sciences</topic><topic>Buffers</topic><topic>Chemistry, Pharmaceutical</topic><topic>Chromatography, High Pressure Liquid</topic><topic>Complex</topic><topic>Diphosphonates - chemistry</topic><topic>Drug Stability</topic><topic>Drug Storage</topic><topic>General pharmacology</topic><topic>Hydrogen-Ion Concentration</topic><topic>Imidazoles - chemistry</topic><topic>Infusions, Parenteral</topic><topic>Medical sciences</topic><topic>Minodronic acid</topic><topic>Parenteral formulation</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>Precipitate</topic><topic>Spectroscopy, Fourier Transform Infrared</topic><topic>Stability</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nakamura, Katsutoshi</creatorcontrib><creatorcontrib>Tanaka, Tomonari</creatorcontrib><creatorcontrib>Saito, Katsumi</creatorcontrib><creatorcontrib>Yokohama, Shigeharu</creatorcontrib><creatorcontrib>Sonobe, Takashi</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of pharmaceutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nakamura, Katsutoshi</au><au>Tanaka, Tomonari</au><au>Saito, Katsumi</au><au>Yokohama, Shigeharu</au><au>Sonobe, Takashi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Stabilization of minodronic acid in aqueous solution for parenteral formulation</atitle><jtitle>International journal of pharmaceutics</jtitle><addtitle>Int J Pharm</addtitle><date>2001-07-03</date><risdate>2001</risdate><volume>222</volume><issue>1</issue><spage>91</spage><epage>99</epage><pages>91-99</pages><issn>0378-5173</issn><eissn>1873-3476</eissn><coden>IJPHDE</coden><abstract>The composition, concentration, and buffer pH of potential minodronic acid formulations were evaluated for their drug stability and for their tendency to generate particles after storage for up to 4 weeks at 60°C. The results indicate that citrate and tartrate buffers maintain drug stability and inhibit the formation of particles. The stability of minodronic acid in these solutions increased slightly as the buffer concentration increased, exhibiting less particle formation than in other buffers. Since citrate buffer was considered the most promising stabilizer for minodronic acid, the pH-stability relationship in 100 mM citrate with pH ranging from 3 to 7 was evaluated during storage for 4 weeks at 60°C. The results demonstrate that solution pH of 3–5 result in optimal stability of minodronic acid with no formation of precipitates. A white precipitate was observed in citrate-containing sample solutions with pH of 6 and 7. Analysis of the isolated precipitate provided support for the hypothesis that the precipitate is a complex between minodronic acid and aluminum ions apparently leached from the glass of the ampoules.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>11404035</pmid><doi>10.1016/S0378-5173(01)00704-9</doi><tpages>9</tpages></addata></record> |
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| subjects | Aluminum ion Biological and medical sciences Buffers Chemistry, Pharmaceutical Chromatography, High Pressure Liquid Complex Diphosphonates - chemistry Drug Stability Drug Storage General pharmacology Hydrogen-Ion Concentration Imidazoles - chemistry Infusions, Parenteral Medical sciences Minodronic acid Parenteral formulation Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Precipitate Spectroscopy, Fourier Transform Infrared Stability |
| title | Stabilization of minodronic acid in aqueous solution for parenteral formulation |
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