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Pharmaceutical Development and Technology Volume 18, 2013 - Issue 2
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Research Article

Formulation and process design for a solid dosage form containing a spray-dried amorphous dispersion of ibipinabant

Michael M. LeaneDrug Product Science and Technology, Bristol-Myers Squibb, Moreton, Wirral, UKCorrespondence[email protected]
,
Wayne SinclairAnalytical and Bioanalytical Development, Bristol-Myers Squibb, Moreton, Wirral, UK
,
Feng QianDrug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, NJ, USA
,
Raja HaddadinDrug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, NJ, USA
,
Alan BrownCERAM Research Ltd, Penkhull, Stoke-on-Trent, UK
,
Mike TobynDrug Product Science and Technology, Bristol-Myers Squibb, Moreton, Wirral, UK
&
Andrew B. DennisDrug Product Science and Technology, Bristol-Myers Squibb, Moreton, Wirral, UK
 show all
Pages 359-366 | Received 30 Jun 2011, Accepted 24 Aug 2011, Published online: 23 Jan 2012

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João Henriques, Jorge Moreira & Slavomíra Doktorovová. (2021) QbD approach to downstream processing of spray-dried amorphous solid dispersions – a case study. Pharmaceutical Development and Technology 26:3, pages 269-277.
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Abid Mehmood Yousaf, Dong Wuk Kim, Yu-Kyoung Oh, Chul Soon Yong, Jong Oh Kim & Han-Gon Choi. (2015) Enhanced oral bioavailability of fenofibrate using polymeric nanoparticulated systems: physicochemical characterization and in vivo investigation. International Journal of Nanomedicine 10, pages 1819-1830.
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Michael Leane, Kendal Pitt & Gavin Reynolds. (2015) A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms. Pharmaceutical Development and Technology 20:1, pages 12-21.
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Articles from other publishers (30)

Umesh Kestur, Anisha Patel, Sherif Badawy, Neil Mathias & Limin Zhang. (2023) Strategies for Managing Solid Form Transformation Risk in Drug Product. Journal of Pharmaceutical Sciences 112:4, pages 909-921.
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S. Doktorovová, E. H. Stone & J. Henriques. (2022) A Fundamental Study on Compression Properties and Strain Rate Sensitivity of Spray-Dried Amorphous Solid Dispersions. AAPS PharmSciTech 23:4.
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Sonal V. Bhujbal, Biplob Mitra, Uday Jain, Yuchuan Gong, Anjali Agrawal, Shyam Karki, Lynne S. Taylor, Sumit Kumar & Qi (Tony) Zhou. (2021) Pharmaceutical amorphous solid dispersion: A review of manufacturing strategies. Acta Pharmaceutica Sinica B 11:8, pages 2505-2536.
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Moshe Honick, Sharmila Das, Stephen W. Hoag, Francis X. Muller, Alaadin Alayoubi, Xin Feng, Ahmed Zidan, Muhammad Ashraf & James E. Polli. (2020) The effects of spray drying, HPMCAS grade, and compression speed on the compaction properties of itraconazole-HPMCAS spray dried dispersions. European Journal of Pharmaceutical Sciences 155, pages 105556.
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Kristin J.M. Ploeger, Paige Adack, Pavithra Sundararajan, Pedro C. Valente, João G. Henriques & Kenneth J. Rosenberg. 2019. Chemical Engineering in the Pharmaceutical Industry. Chemical Engineering in the Pharmaceutical Industry 267 292 .
Abid Mehmood Yousaf, Usman Rashid Malik, Yasser Shahzad, Talib Hussain, Ikram Ullah Khan, Fakhar Ud Din, Tariq Mahmood, Hafiz Muhammad Ahsan, Ahmed Shah Syed & Muhammad Rouf Akram. (2019) Silymarin-Laden PVP-Nanocontainers Prepared Via the Electrospraying Technique for Improved Aqueous Solubility and Dissolution Rate. Brazilian Archives of Biology and Technology 62.
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Julien Maincent & Robert O. WilliamsIIIIII. (2018) Sustained-release amorphous solid dispersions. Drug Delivery and Translational Research 8:6, pages 1714-1725.
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Sayantan Chattoraj, Patrick Daugherity, Todd McDermott, Angela Olsofsky, Wyatt J. Roth & Mike Tobyn. (2018) Sticking and Picking in Pharmaceutical Tablet Compression: An IQ Consortium Review. Journal of Pharmaceutical Sciences 107:9, pages 2267-2282.
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Mark Davis & Gavin Walker. (2018) Recent strategies in spray drying for the enhanced bioavailability of poorly water-soluble drugs. Journal of Controlled Release 269, pages 110-127.
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Vibha Puri, David Brancazio, Eranda Harinath, Alexander R. Martinez, Parind M. Desai, Keith D. Jensen, Jung-Hoon Chun, Richard D. Braatz, Allan S. Myerson & Bernhardt L. Trout. (2018) Demonstration of pharmaceutical tablet coating process by injection molding technology. International Journal of Pharmaceutics 535:1-2, pages 106-112.
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Rahul Maheshwari, Pooja Todke, Kaushik Kuche, Nidhi Raval & Rakesh K. Tekade. 2018. Dosage Form Design Considerations. Dosage Form Design Considerations 599 635 .
Khadijah Edueng, Denny Mahlin & Christel A. S. Bergström. (2017) The Need for Restructuring the Disordered Science of Amorphous Drug Formulations. Pharmaceutical Research 34:9, pages 1754-1772.
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B. Démuth, A. Farkas, B. Szabó, A. Balogh, B. Nagy, E. Vágó, T. Vigh, A.P. Tinke, Z. Kazsu, Á. Demeter, J. Bertels, J. Mensch, A. Van Dijck, G. Verreck, I. Van Assche, G. Marosi & Z.K. Nagy. (2017) Development and tableting of directly compressible powder from electrospun nanofibrous amorphous solid dispersion. Advanced Powder Technology 28:6, pages 1554-1563.
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Ryo Kinoshita, Tomoaki Ohta, Koji Shiraki, Kenjirou Higashi & Kunikazu Moribe. (2017) Effects of wet-granulation process parameters on the dissolution and physical stability of a solid dispersion. International Journal of Pharmaceutics 524:1-2, pages 304-311.
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Qiong Wu, Michael T. Kennedy, Karthik Nagapudi & Y.-H. Kiang. (2017) Humidity induced phase transformation of poloxamer 188 and its effect on physical stability of amorphous solid dispersion of AMG 579, a PDE10A inhibitor. International Journal of Pharmaceutics 521:1-2, pages 1-7.
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B. Vig & M. Morgen. 2017. Developing Solid Oral Dosage Forms. Developing Solid Oral Dosage Forms 793 820 .
K. Wlodarski, L. Tajber & W. Sawicki. (2016) Physicochemical properties of direct compression tablets with spray dried and ball milled solid dispersions of tadalafil in PVP-VA. European Journal of Pharmaceutics and Biopharmaceutics 109, pages 14-23.
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John F. Gamble, Masako Terada, Christian Holzner, Leah Lavery, Sarah J. Nicholson, Peter Timmins & Mike Tobyn. (2016) Application of X-ray microtomography for the characterisation of hollow polymer-stabilised spray dried amorphous dispersion particles. International Journal of Pharmaceutics 510:1, pages 1-8.
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Seema Thakral, Maxwell W. Terban, Naveen K. Thakral & Raj Suryanarayanan. (2016) Recent advances in the characterization of amorphous pharmaceuticals by X-ray diffractometry. Advanced Drug Delivery Reviews 100, pages 183-193.
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Abhishek Singh & Guy Van den Mooter. (2016) Spray drying formulation of amorphous solid dispersions. Advanced Drug Delivery Reviews 100, pages 27-50.
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Magnus Hoffmann, Patrick S. Wray, John F. Gamble & Mike Tobyn. (2015) Investigation into process-induced de-aggregation of cohesive micronised API particles. International Journal of Pharmaceutics 493:1-2, pages 341-346.
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B. Démuth, Z.K. Nagy, A. Balogh, T. Vigh, G. Marosi, G. Verreck, I. Van Assche & M.E. Brewster. (2015) Downstream processing of polymer-based amorphous solid dispersions to generate tablet formulations. International Journal of Pharmaceutics 486:1-2, pages 268-286.
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Helen Hughes, Michael M. Leane, Michael Tobyn, John F. Gamble, Santiago Munoz & Pauline Musembi. (2014) Development of a Material Sparing Bulk Density Test Comparable to a Standard USP Method for Use in Early Development of API’s. AAPS PharmSciTech 16:1, pages 165-170.
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Xue-Qing Chen, Kevin Stefanski, Hong Shen, Christine Huang, Christian Caporuscio, Wu Yang, Patrick Lam, Ching Su, Olafur Gudmundsson & Michael Hageman. (2014) Oral Delivery of Highly Lipophilic Poorly Water-Soluble Drugs: Spray-Dried Dispersions to Improve Oral Absorption and Enable High-Dose Toxicology Studies of a P2Y1 Antagonist. Journal of Pharmaceutical Sciences 103:12, pages 3924-3931.
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John F. Gamble, Ana P. Ferreira, Mike Tobyn, Lynn DiMemmo, Kyle Martin, Neil Mathias, Richard Schild, Balvinder Vig, John M. Baumann, Stacy Parks & Mike Ashton. (2014) Application of imaging based tools for the characterisation of hollow spray dried amorphous dispersion particles. International Journal of Pharmaceutics 465:1-2, pages 210-217.
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Amrit Paudel, Joke Meeus & Guy Van den Mooter. 2014. Amorphous Solid Dispersions. Amorphous Solid Dispersions 421 485 .
Susanne Page & Reto Maurer. 2014. Amorphous Solid Dispersions. Amorphous Solid Dispersions 395 417 .
Yushen Guo, Evgenyi Shalaev & Scott Smith. (2013) Physical stability of pharmaceutical formulations: solid-state characterization of amorphous dispersions. TrAC Trends in Analytical Chemistry 49, pages 137-144.
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Hua Ma, Duk Soon Choi, Yu-E Zhang, Hung Tian, Navnit Shah & Hitesh P. Chokshi. (2013) Evaluation on the Drug–Polymer Mixing Status in Amorphous Solid Dispersions at the Early Stage Formulation and Process Development. Journal of Pharmaceutical Innovation 8:3, pages 163-174.
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Amrit Paudel, Yves Loyson & Guy Van den Mooter. (2013) An Investigation into the Effect of Spray Drying Temperature and Atomizing Conditions on Miscibility, Physical Stability, and Performance of Naproxen–PVP K 25 Solid Dispersions. Journal of Pharmaceutical Sciences 102:4, pages 1249-1267.
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