Cameron J. Brown, John McGinty, Muhammad T. Islam, Nazer Rajoub, Omid Arjmandi-Tash, Sara Ottoboni, Muhid Shahid, Stephanie J. Urwin, Ye Seol Lee, Magdalene W. S. Chong, Foteini Papathanasiou, Aruna S. Prakash, Elke Prasad, Bronwyn Spence, Jan Sefcik, John Robertson, Rachel Smith, James D. Litster, Chris J. Price, Alison Nordon, Claire S. Adjiman, Alastair J. Florence
{"title":"洛伐他汀结晶、球形造粒和过滤的一体化连续工艺设计","authors":"Cameron J. Brown, John McGinty, Muhammad T. Islam, Nazer Rajoub, Omid Arjmandi-Tash, Sara Ottoboni, Muhid Shahid, Stephanie J. Urwin, Ye Seol Lee, Magdalene W. S. Chong, Foteini Papathanasiou, Aruna S. Prakash, Elke Prasad, Bronwyn Spence, Jan Sefcik, John Robertson, Rachel Smith, James D. Litster, Chris J. Price, Alison Nordon, Claire S. Adjiman, Alastair J. Florence","doi":"10.1007/s12247-024-09815-z","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><p>This work seeks to improve the particle processability of needle-like lovastatin crystals and develop a small-footprint continuous MicroFactory for its production.</p><h3>Methods</h3><p>General conditions for optimal spherical agglomeration of lovastatin crystals and subsequent product isolation are developed, first as batch processes, and then transferred to continuous MicroFactory operation.</p><h3>Results</h3><p>Methyl isobutyl ketone is a suitable bridging liquid for the spherical agglomeration of lovastatin. Practical challenges including coupling unit operations and solvent systems; mismatched flow rates and inconsistent suspension solid loading were resolved. The successful continuous production of lovastatin spherical agglomerates (D<sub>50</sub> = 336 µm) was achieved. Spherical agglomeration increased the density of the bulk lovastatin powder and improved product flowability from poor to good, whilst maintaining lovastatin tablet performance.</p><h3>Conclusion</h3><p>A continuous, integrated MicroFactory for the crystallisation, spherical agglomeration, and filtration of lovastatin is presented with improved product particle processability. Up to 16,800 doses of lovastatin (60 mg) can be produced per day using a footprint of 23 m<sup>2</sup>.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"19 2","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-024-09815-z.pdf","citationCount":"0","resultStr":"{\"title\":\"Integrated Continuous Process Design for Crystallisation, Spherical Agglomeration, and Filtration of Lovastatin\",\"authors\":\"Cameron J. Brown, John McGinty, Muhammad T. Islam, Nazer Rajoub, Omid Arjmandi-Tash, Sara Ottoboni, Muhid Shahid, Stephanie J. Urwin, Ye Seol Lee, Magdalene W. S. Chong, Foteini Papathanasiou, Aruna S. Prakash, Elke Prasad, Bronwyn Spence, Jan Sefcik, John Robertson, Rachel Smith, James D. Litster, Chris J. Price, Alison Nordon, Claire S. Adjiman, Alastair J. Florence\",\"doi\":\"10.1007/s12247-024-09815-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Purpose</h3><p>This work seeks to improve the particle processability of needle-like lovastatin crystals and develop a small-footprint continuous MicroFactory for its production.</p><h3>Methods</h3><p>General conditions for optimal spherical agglomeration of lovastatin crystals and subsequent product isolation are developed, first as batch processes, and then transferred to continuous MicroFactory operation.</p><h3>Results</h3><p>Methyl isobutyl ketone is a suitable bridging liquid for the spherical agglomeration of lovastatin. Practical challenges including coupling unit operations and solvent systems; mismatched flow rates and inconsistent suspension solid loading were resolved. The successful continuous production of lovastatin spherical agglomerates (D<sub>50</sub> = 336 µm) was achieved. Spherical agglomeration increased the density of the bulk lovastatin powder and improved product flowability from poor to good, whilst maintaining lovastatin tablet performance.</p><h3>Conclusion</h3><p>A continuous, integrated MicroFactory for the crystallisation, spherical agglomeration, and filtration of lovastatin is presented with improved product particle processability. 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Integrated Continuous Process Design for Crystallisation, Spherical Agglomeration, and Filtration of Lovastatin
Purpose
This work seeks to improve the particle processability of needle-like lovastatin crystals and develop a small-footprint continuous MicroFactory for its production.
Methods
General conditions for optimal spherical agglomeration of lovastatin crystals and subsequent product isolation are developed, first as batch processes, and then transferred to continuous MicroFactory operation.
Results
Methyl isobutyl ketone is a suitable bridging liquid for the spherical agglomeration of lovastatin. Practical challenges including coupling unit operations and solvent systems; mismatched flow rates and inconsistent suspension solid loading were resolved. The successful continuous production of lovastatin spherical agglomerates (D50 = 336 µm) was achieved. Spherical agglomeration increased the density of the bulk lovastatin powder and improved product flowability from poor to good, whilst maintaining lovastatin tablet performance.
Conclusion
A continuous, integrated MicroFactory for the crystallisation, spherical agglomeration, and filtration of lovastatin is presented with improved product particle processability. Up to 16,800 doses of lovastatin (60 mg) can be produced per day using a footprint of 23 m2.
期刊介绍：
The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories:
Materials science,
Product design,
Process design, optimization, automation and control,
Facilities; Information management,
Regulatory policy and strategy,
Supply chain developments ,
Education and professional development,
Journal of Pharmaceutical Innovation publishes four issues a year.
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