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Pharmaceutical Development and Technology Volume 18, 2013 - Issue 3
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Research Article

Identification of critical process parameters and its interplay with nanosuspension formulation prepared by top down media milling technology – A QbD perspective

Indrajit Ghosha Pharmaceutical Development Unit, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, USACorrespondence[email protected] [email protected]
,
Daniel Schenckb College of Pharmacy, University of Iowa, Iowa City, IA, USA
,
Sonali Bosea Pharmaceutical Development Unit, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, USA
,
Frances Liua Pharmaceutical Development Unit, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, USA
&
Michael Mottoa Pharmaceutical Development Unit, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, USA
Pages 719-729 | Received 16 Jun 2012, Accepted 19 Aug 2012, Published online: 15 Oct 2012

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Sıla Gülbağ Pınar, Esra Pezik, Başaran Mutlu Ağardan & Nevin Çelebi. (2022) Development of cyclosporine A nanosuspension: cytotoxicity and permeability on Caco-2 cell lines. Pharmaceutical Development and Technology 27:1, pages 52-62.
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Manasi Chogale, Sandip Gite & Vandana Patravale. (2020) Comparison of media milling and microfluidization methods for engineering of nanocrystals: a case study. Drug Development and Industrial Pharmacy 46:11, pages 1763-1775.
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Swapnil Sharadkumar Chudiwal & Mohamed Hassan G. Dehghan. (2016) Quality by design approach for development of suspension nasal spray products: a case study on budesonide nasal suspension. Drug Development and Industrial Pharmacy 42:10, pages 1643-1652.
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Articles from other publishers (23)

Pegah Cheshmehnoor, Noushin Bolourchian, Erfan Abdollahizad, Arash Derakhshi, Simin Dadashzadeh & Azadeh Haeri. (2023) Particle Size Tailoring of Quercetin Nanosuspensions by Wet Media Milling Technique: A Study on Processing and Formulation Parameters. Iranian Journal of Pharmaceutical Research 21:1.
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Gizem Rüya TOPAL, Cansel KÖSE ÖZKAN & Yalçın ÖZKAN. (2023) DEVELOPMENT AND OPTIMIZATION OF INDOMETHACIN NANOSUSPENSIONS USING DESIGN OF EXPERIMENT APPROACHESİNDOMETAZİN İÇEREN NANOSÜSPANSİYONLARIN GELİŞTİRİLMESİ VE FAKTÖRİYEL DİZAYN YAKLAŞIMI KULLANILARAK OPTİMİZASYONU. Ankara Universitesi Eczacilik Fakultesi Dergisi.
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Julia Marushka, Jana Brokešová, Chiazor Ugo Ogadah, Arash Kazemi, Jurjen Duintjer Tebbens & Zdenka Šklubalová. (2022) Milling of pharmaceutical powder carrier excipients: Application of central composite design. Advanced Powder Technology 33:12, pages 103881.
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Davide De Grandi, Alireza Meghdadi, Gareth LuTheryn & Dario Carugo. (2022) Facile production of quercetin nanoparticles using 3D printed centrifugal flow reactors. RSC Advances 12:32, pages 20696-20713.
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Jing Tian, Ting Ting Meng, Shijie Ma, Ting Gao, Xin Di, Jing Chen & Jianhong Yang. (2022) Spatial-thermodynamic understanding of stabilization mechanism using computational approaches and molecular-level elucidation of the mechanism of crystal transformation in polymorphic irbesartan nanosuspensions. International Journal of Pharmaceutics 612, pages 121350.
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Amanpreet Kaur, Prashantkumar Khodabhai Parmar, Sanika Jadhav & Arvind Kumar Bansal. 2022. Nanoparticle Therapeutics. Nanoparticle Therapeutics 413 454 .
Bhupinder Singh, Teenu Sharma, Ranjot Kaur, Sumant Saini, Ripandeep Kaur & Sarwar Beg. 2022. Biomedical Translational Research. Biomedical Translational Research 315 350 .
Mayank Singhal, Ana Baumgartner, Elina Turunen, Bert van Veen, Jouni Hirvonen & Leena Peltonen. (2020) Nanosuspensions of a poorly soluble investigational molecule ODM-106: Impact of milling bead diameter and stabilizer concentration. International Journal of Pharmaceutics 587, pages 119636.
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Alptug Karakucuk & Nevin Celebi. (2020) Investigation of Formulation and Process Parameters of Wet Media Milling to Develop Etodolac Nanosuspensions. Pharmaceutical Research 37:6.
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Helena Bigares Grangeia, Cláudia Silva, Sérgio Paulo Simões & Marco S. Reis. (2020) Quality by design in pharmaceutical manufacturing: A systematic review of current status, challenges and future perspectives. European Journal of Pharmaceutics and Biopharmaceutics 147, pages 19-37.
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Rajan Jog & Diane J. Burgess. (2019) Comprehensive quality by design approach for stable nanocrystalline drug products. International Journal of Pharmaceutics 564, pages 426-460.
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M. Li, I. Suriel, J. Vekaria, J. Proske, P. Orbe, M. Armani, R.N. Dave & E. Bilgili. (2018) Impact of dispersants on dissolution of itraconazole from drug-loaded, surfactant-free, spray-dried nanocomposites. Powder Technology 339, pages 281-295.
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Eknath Ahire, Shreya Thakkar, Mahesh Darshanwad & Manju Misra. (2018) Parenteral nanosuspensions: a brief review from solubility enhancement to more novel and specific applications. Acta Pharmaceutica Sinica B 8:5, pages 733-755.
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Leena Peltonen. (2018) Design Space and QbD Approach for Production of Drug Nanocrystals by Wet Media Milling Techniques. Pharmaceutics 10:3, pages 104.
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Christian Siewert, Regina Moog, Rainer Alex, Philipp Kretzer & Benno Rothenhäusler. (2018) Process and scaling parameters for wet media milling in early phase drug development: A knowledge based approach. European Journal of Pharmaceutical Sciences 115, pages 126-131.
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Jing Li, Yanjiang Qiao & Zhisheng Wu. (2017) Nanosystem trends in drug delivery using quality-by-design concept. Journal of Controlled Release 256, pages 9-18.
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Meng Li, Paulina Alvarez & Ecevit Bilgili. (2017) A microhydrodynamic rationale for selection of bead size in preparation of drug nanosuspensions via wet stirred media milling. International Journal of Pharmaceutics 524:1-2, pages 178-192.
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Qiang Fu, Minchao Ma, Mo Li, Guishan Wang, Mengran Guo, Jingru Li, Yanxian Hou & Mingming Fang. (2017) Improvement of oral bioavailability for nisoldipine using nanocrystals. Powder Technology 305, pages 757-763.
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Annika Tuomela, Jouni Hirvonen & Leena Peltonen. (2016) Stabilizing Agents for Drug Nanocrystals: Effect on Bioavailability. Pharmaceutics 8:2, pages 16.
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Jianwen Li, Qiang Fu, Xiaohong Liu, Mo Li & Yongjun Wang. (2015) Formulation of nimodipine nanocrystals for oral administration. Archives of Pharmacal Research 39:2, pages 202-212.
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Leena Peltonen, Annika Tuomela & Jouni Hirvonen. 2015. Handbook of Polymers for Pharmaceutical Technologies. Handbook of Polymers for Pharmaceutical Technologies 67 87 .
M. Li, N. Yaragudi, A. Afolabi, R. Dave & E. Bilgili. (2015) Sub-100nm drug particle suspensions prepared via wet milling with low bead contamination through novel process intensification. Chemical Engineering Science 130, pages 207-220.
Crossref
Indrajit Ghosh & Bozena Michniak-Kohn. (2013) Influence of Critical Parameters of Nanosuspension Formulation on the Permeability of a Poorly Soluble Drug through the Skin—A Case Study. AAPS PharmSciTech 14:3, pages 1108-1117.
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