Preparation and characterization of bupivacaine multivesicular liposome: A QbD study about the effects of formulation and process on critical quality attributes
[Display omitted] This study extends QbD principles to liposomal products containing a hydrophilic active pharmaceutical ingredient (API). The feasibility and advantages of the QbD concept for multivesicular liposome-based systems were demonstrated. We selected the local anesthetic drug bupivacaine...
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| Veröffentlicht in: | International journal of pharmaceutics 2021-04, Vol.598, p.120335-120335, Article 120335 |
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| container_title | International journal of pharmaceutics |
| container_volume | 598 |
| creator | Lu, Bohong Ma, Qiuyan Zhang, Jing Liu, Rong Yue, Zhanguo Xu, Chunlian Li, Zhihui Lin, Huaqing |
| description | [Display omitted]
This study extends QbD principles to liposomal products containing a hydrophilic active pharmaceutical ingredient (API). The feasibility and advantages of the QbD concept for multivesicular liposome-based systems were demonstrated. We selected the local anesthetic drug bupivacaine as a model compound. Desired properties for three critical attributes of multivesicular liposome drug products, namely, the particle size, morphology, and drug encapsulation efficiency, were defined and evaluated. The liposome preparation process significantly affected both the liposome particle size and drug encapsulation efficiency. In this study, the effects of material attributes and processing parameters during the preparation of liposomes were studied in detail using a microscope and particle size analyzer. We used risk assessment to monitor several factors that substantially affect the encapsulation rate and particle size. |
| doi_str_mv | 10.1016/j.ijpharm.2021.120335 |
| format | Article |
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This study extends QbD principles to liposomal products containing a hydrophilic active pharmaceutical ingredient (API). The feasibility and advantages of the QbD concept for multivesicular liposome-based systems were demonstrated. We selected the local anesthetic drug bupivacaine as a model compound. Desired properties for three critical attributes of multivesicular liposome drug products, namely, the particle size, morphology, and drug encapsulation efficiency, were defined and evaluated. The liposome preparation process significantly affected both the liposome particle size and drug encapsulation efficiency. In this study, the effects of material attributes and processing parameters during the preparation of liposomes were studied in detail using a microscope and particle size analyzer. We used risk assessment to monitor several factors that substantially affect the encapsulation rate and particle size.</description><identifier>ISSN: 0378-5173</identifier><identifier>EISSN: 1873-3476</identifier><identifier>DOI: 10.1016/j.ijpharm.2021.120335</identifier><identifier>PMID: 33545281</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Bupivacaine ; Encapsulation efficiency ; Liposome ; Morphology ; Particle size ; QbD</subject><ispartof>International journal of pharmaceutics, 2021-04, Vol.598, p.120335-120335, Article 120335</ispartof><rights>2021 Elsevier B.V.</rights><rights>Copyright © 2021 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c365t-c8cb8e9e63eb8971f5e4c2aac669ca411fc6ca0a587f7cd9ef39249ebb2678003</citedby><cites>FETCH-LOGICAL-c365t-c8cb8e9e63eb8971f5e4c2aac669ca411fc6ca0a587f7cd9ef39249ebb2678003</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ijpharm.2021.120335$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33545281$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lu, Bohong</creatorcontrib><creatorcontrib>Ma, Qiuyan</creatorcontrib><creatorcontrib>Zhang, Jing</creatorcontrib><creatorcontrib>Liu, Rong</creatorcontrib><creatorcontrib>Yue, Zhanguo</creatorcontrib><creatorcontrib>Xu, Chunlian</creatorcontrib><creatorcontrib>Li, Zhihui</creatorcontrib><creatorcontrib>Lin, Huaqing</creatorcontrib><title>Preparation and characterization of bupivacaine multivesicular liposome: A QbD study about the effects of formulation and process on critical quality attributes</title><title>International journal of pharmaceutics</title><addtitle>Int J Pharm</addtitle><description>[Display omitted]
This study extends QbD principles to liposomal products containing a hydrophilic active pharmaceutical ingredient (API). The feasibility and advantages of the QbD concept for multivesicular liposome-based systems were demonstrated. We selected the local anesthetic drug bupivacaine as a model compound. Desired properties for three critical attributes of multivesicular liposome drug products, namely, the particle size, morphology, and drug encapsulation efficiency, were defined and evaluated. The liposome preparation process significantly affected both the liposome particle size and drug encapsulation efficiency. In this study, the effects of material attributes and processing parameters during the preparation of liposomes were studied in detail using a microscope and particle size analyzer. We used risk assessment to monitor several factors that substantially affect the encapsulation rate and particle size.</description><subject>Bupivacaine</subject><subject>Encapsulation efficiency</subject><subject>Liposome</subject><subject>Morphology</subject><subject>Particle size</subject><subject>QbD</subject><issn>0378-5173</issn><issn>1873-3476</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNqFkUtv1DAUhS0EokPhJ4C8ZJPBjyRO2KCqPKVKgARry7m5Vj1K4tSPkdpfw0_FowywZGXp-jvn2PcQ8pKzPWe8fXPYu8N6a8K8F0zwPRdMyuYR2fFOyUrWqn1Mdkyqrmq4khfkWYwHxlgruHxKLgpaN6LjO_LrW8DVBJOcX6hZRgrF00DC4B62obd0yKs7GjBuQTrnKbkjRgd5MoFObvXRz_iWXtHvw3saUx7vqRl8TjTdIkVrEVI8uVgfivhf0ho8YCxXC4XgkgMz0btsJpeKQUrBDTlhfE6eWDNFfHE-L8nPjx9-XH-ubr5--nJ9dVOBbJtUQQdDhz22EoeuV9w2WIMwBtq2B1NzbqEFw0zTKatg7NHKXtQ9DoNoVceYvCSvN9_yrLuMMenZRcBpMgv6HLWoO8Ubweq6oM2GQvAxBrR6DW424V5zpk_l6IM-l6NP5eitnKJ7dY7Iw4zjX9WfNgrwbgOwfPToMOgIDhfA0YWyRT1695-I3wjep_k</recordid><startdate>20210401</startdate><enddate>20210401</enddate><creator>Lu, Bohong</creator><creator>Ma, Qiuyan</creator><creator>Zhang, Jing</creator><creator>Liu, Rong</creator><creator>Yue, Zhanguo</creator><creator>Xu, Chunlian</creator><creator>Li, Zhihui</creator><creator>Lin, Huaqing</creator><general>Elsevier B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20210401</creationdate><title>Preparation and characterization of bupivacaine multivesicular liposome: A QbD study about the effects of formulation and process on critical quality attributes</title><author>Lu, Bohong ; Ma, Qiuyan ; Zhang, Jing ; Liu, Rong ; Yue, Zhanguo ; Xu, Chunlian ; Li, Zhihui ; Lin, Huaqing</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c365t-c8cb8e9e63eb8971f5e4c2aac669ca411fc6ca0a587f7cd9ef39249ebb2678003</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Bupivacaine</topic><topic>Encapsulation efficiency</topic><topic>Liposome</topic><topic>Morphology</topic><topic>Particle size</topic><topic>QbD</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lu, Bohong</creatorcontrib><creatorcontrib>Ma, Qiuyan</creatorcontrib><creatorcontrib>Zhang, Jing</creatorcontrib><creatorcontrib>Liu, Rong</creatorcontrib><creatorcontrib>Yue, Zhanguo</creatorcontrib><creatorcontrib>Xu, Chunlian</creatorcontrib><creatorcontrib>Li, Zhihui</creatorcontrib><creatorcontrib>Lin, Huaqing</creatorcontrib><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>Lu, Bohong</au><au>Ma, Qiuyan</au><au>Zhang, Jing</au><au>Liu, Rong</au><au>Yue, Zhanguo</au><au>Xu, Chunlian</au><au>Li, Zhihui</au><au>Lin, Huaqing</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Preparation and characterization of bupivacaine multivesicular liposome: A QbD study about the effects of formulation and process on critical quality attributes</atitle><jtitle>International journal of pharmaceutics</jtitle><addtitle>Int J Pharm</addtitle><date>2021-04-01</date><risdate>2021</risdate><volume>598</volume><spage>120335</spage><epage>120335</epage><pages>120335-120335</pages><artnum>120335</artnum><issn>0378-5173</issn><eissn>1873-3476</eissn><abstract>[Display omitted]
This study extends QbD principles to liposomal products containing a hydrophilic active pharmaceutical ingredient (API). The feasibility and advantages of the QbD concept for multivesicular liposome-based systems were demonstrated. We selected the local anesthetic drug bupivacaine as a model compound. Desired properties for three critical attributes of multivesicular liposome drug products, namely, the particle size, morphology, and drug encapsulation efficiency, were defined and evaluated. The liposome preparation process significantly affected both the liposome particle size and drug encapsulation efficiency. In this study, the effects of material attributes and processing parameters during the preparation of liposomes were studied in detail using a microscope and particle size analyzer. We used risk assessment to monitor several factors that substantially affect the encapsulation rate and particle size.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>33545281</pmid><doi>10.1016/j.ijpharm.2021.120335</doi><tpages>1</tpages></addata></record> |
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| ispartof | International journal of pharmaceutics, 2021-04, Vol.598, p.120335-120335, Article 120335 |
| issn | 0378-5173 1873-3476 |
| language | eng |
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| source | Access via ScienceDirect (Elsevier) |
| subjects | Bupivacaine Encapsulation efficiency Liposome Morphology Particle size QbD |
| title | Preparation and characterization of bupivacaine multivesicular liposome: A QbD study about the effects of formulation and process on critical quality attributes |
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