Application of quality by design for optimization of spray drying process used in drying of Risperidone nanosuspension

被引:33
|
作者
Nair, Anu [1 ]
Khunt, Dignesh [1 ]
Misra, Manju [1 ]
机构
[1] NIPER Ahmedabad, Dept Pharmaceut, Palaj Opp Airforce Stn Headquarter, Gandhinagar 382355, Gujarat, India
关键词
Nanosuspension; Spray drying; QbD; Risperidone; Orally dispersible tablet; PHYSICOCHEMICAL PROPERTIES; DRUG; FORMULATION; DELIVERY; NANOPARTICLE; CONVERSION; POWDERS;
D O I
10.1016/j.powtec.2018.09.096
中图分类号
TQ [化学工业];
学科分类号
0817 ;
摘要
The objective of present study was to optimize spray drying of Risperidone (RIS) nanosuspension for achieving lower particle size, higher yield and good compressibility of spray dried powder using Quality by design approach. RIS nanosuspension was prepared by anti-solvent precipitation technique using poloxamer 68 and Poloxamer 127 as stabilizers. 3 level 2 factorial design was applied using two independent factor variables viz., X1: feed pump speed (RPM) and X2: inlet temperature (degrees C) and their effect upon dependent variables viz., Y1: Size, and Y2: %Entrapment efficiency was determined at three different levels. Spray dried powder was further characterized for bulk level properties and formulated as an orally dispersible tablet (ODT). The developed ODT were characterized by various parameters like wetting time, disintegration time, hardness, friability, weight variation and dissolution for comparison. Size and PDI of formulated RIS Nanosuspension were found to be 200.00 +/- 0.40 nm and 0210 +/- 0.03 respectively. Optimized process parameters for spray dryer were obtained from design space, which gave critical quality attributes (CQA) response of lowest size and highest yield of 214.21 +/- 2.01 nm and 61.85 +/- 1.02% respectively. FTIR, DSC, XRD and AFM studies of spray dried RIS nanosuspension revealed that crystallinity of RIS was altered during spray drying process. Bulk density, Tapped density, Hausner ratio, Compressibility index and Angle of repose of spray dried RIS was found to be 0.588 +/- 0.12 g/mL, 0.641 +/- 0.20 g/mL, 1.09 +/- 0.26, 8.33 +/- 0.32 and 32.40 degrees +/- 0.98 degrees respectively. ODT formulated using optimized spray dried nanosuspension showed higher dissolution than marketed ODT formulation which may be due to increase in solubility of Risperidone during spray drying of nanosuspension. (C) 2018 Elsevier B.V. All rights reserved.
引用
收藏
页码:156 / 165
页数:10
相关论文
共 50 条
  • [31] Quality by design - Spray drying of insulin intended for inhalation
    Maltesen, Morten Jonas
    Bjerregaard, Simon
    Hovgaard, Lars
    Havelund, Svend
    van de Weert, Marco
    EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, 2008, 70 (03) : 828 - 838
  • [32] Quality by Design in the Secondary Drying Step of a Freeze-Drying Process
    Pisano, Roberto
    Fissore, Davide
    Barresi, Antonello A.
    DRYING TECHNOLOGY, 2012, 30 (11-12) : 1307 - 1316
  • [33] The drying Process in Spray drying and creation Simulation Model
    Orlovsky, Imrich
    Hatala, Michal
    Micko, Milan
    MANUFACTURING SCIENCE AND TECHNOLOGY, PTS 1-8, 2012, 383-390 : 6817 - 6824
  • [34] Integrated optimization of fish oil microencapsulation process by spray drying
    Aghbashlo, Mortaza
    Mobli, Hossien
    Madadlou, Ashkan
    Rafiee, Shahin
    JOURNAL OF MICROENCAPSULATION, 2012, 29 (08) : 790 - 804
  • [35] Engineering of an Inhalable DDA/TDB Liposomal Adjuvant: A Quality-by-Design Approach Towards Optimization of the Spray Drying Process
    Pall Thor Ingvarsson
    Mingshi Yang
    Helle Mulvad
    Hanne Mørck Nielsen
    Jukka Rantanen
    Camilla Foged
    Pharmaceutical Research, 2013, 30 : 2772 - 2784
  • [36] Optimization of spray drying process parameters for the food bioactive ingredients
    Homayoonfal, Mina
    Malekjani, Narjes
    Baeghbali, Vahid
    Ansarifar, Elham
    Hedayati, Sara
    Jafari, Seid Mahdi
    CRITICAL REVIEWS IN FOOD SCIENCE AND NUTRITION, 2024, 64 (17) : 5631 - 5671
  • [37] Engineering of an Inhalable DDA/TDB Liposomal Adjuvant: A Quality-by-Design Approach Towards Optimization of the Spray Drying Process
    Ingvarsson, Pall Thor
    Yang, Mingshi
    Mulvad, Helle
    Nielsen, Hanne Morck
    Rantanen, Jukka
    Foged, Camilla
    PHARMACEUTICAL RESEARCH, 2013, 30 (11) : 2772 - 2784
  • [38] Process analysis and global optimization for the microencapsulation of phytosterols by spray drying
    Agustina Di Battista, Carla
    Constenla, Diana
    Ramirez Rigo, Maria Veronica
    Pina, Juliana
    POWDER TECHNOLOGY, 2017, 321 : 55 - 65
  • [39] Optimization of Hypericum Perforatum Microencapsulation Process by Spray Drying Method
    Seyrekoglu, Fadime
    Temiz, Hasan
    Eser, Ferda
    Yildirim, Cengiz
    AAPS PHARMSCITECH, 2024, 25 (05)
  • [40] OPTIMIZATION OF SPRAY-DRYING PROCESS FOR CONCENTRATED ORANGE JUICE
    Pino, J. A.
    Araguez-Fortes, Y.
    Bringas-Lantigua, M.
    ACTA ALIMENTARIA, 2018, 47 (04) : 417 - 424