Simplified, High Drug-Loaded Formulations Containing Hydrochlorothiazide for Twin-Screw Granulation

被引：4
|
作者：
Meier, Robin [1 ]
Moll, Klaus-Peter [2 ]
Krumme, Markus [2 ]
Kleinebudde, Peter [1 ]
机构：
[1] Heinrich Heine Univ, Inst Pharmaceut & Biopharmaceut, Univ Str 1, D-40225 Dusseldorf, Germany
[2] Novartis AG, CH-4002 Basel, Switzerland
来源：
CHEMIE INGENIEUR TECHNIK | 2017年 / 89卷 / 08期
关键词：
Continuous manufacturing; Disintegration; Granule size distribution; Hydrochlorothiazide; Tableting; WET-GRANULATION; QUALITY; ATTRIBUTES; IMPACT;
D O I：
10.1002/cite.201600134
中图分类号：
TQ [化学工业];
学科分类号：
0817 ;
摘要：
Simplified, high drug loaded formulations for use in twin-screw granulation and tableting were introduced, using the plastically deforming drug ibuprofen. This concept was enlarged by application of hydrochlorothiazide, because opposed deformation behavior was expected to result in different product performances. In most instances the results differed. Critical quality attributes like granule size distribution, disintegration time, and tensile strength of tablets could be met. The study confirms the suitability of simplified formulation with differently behaving drugs for pharmaceutical product design in continuous manufacturing.
引用
收藏
页码：1025 / 1033
页数：9
相关论文
共 50 条
  • [31] Switch of tablet manufacturing from high shear granulation to twin-screw granulation using quality by design approach
    Miyazaki, Yuta
    Lenhart, Vincent
    Kleinebudde, Peter
    INTERNATIONAL JOURNAL OF PHARMACEUTICS, 2020, 579
  • [32] Immediate-Release Formulations Produced via Twin-Screw Melt Granulation: Systematic Evaluation of the Addition of Disintegrants
    Steffens, Kristina E.
    Wagner, Karl G.
    AAPS PHARMSCITECH, 2021, 22 (05)
  • [33] Influence of granulation temperature on particle size distribution of granules in twin-screw granulation (TSG)
    Ito, Akihiko
    Kleinebudde, Peter
    PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, 2019, 24 (07) : 874 - 882
  • [34] Elucidation of granulation mechanisms along the length of the barrel in continuous twin-screw melt granulation
    Van de Steene, S.
    Van Renterghem, J.
    Vanhoorne, V.
    Vervaet, C.
    Kumar, A.
    De Beer, T.
    INTERNATIONAL JOURNAL OF PHARMACEUTICS, 2023, 639
  • [35] Immediate-Release Formulations Produced via Twin-Screw Melt Granulation: Systematic Evaluation of the Addition of Disintegrants
    Kristina E. Steffens
    Karl G. Wagner
    AAPS PharmSciTech, 22
  • [36] Linking granulation performance with residence time and granulation liquid distributions in twin-screw granulation: An experimental investigation
    Kumar, Ashish
    Alakarjula, Maija
    Vanhoorne, Valerie
    Toiviainen, Maunu
    De Leersnyder, Fien
    Vercruysse, Jurgen
    Juuti, Mikko
    Ketolainen, Jarkko
    Vervaet, Chris
    Remon, Jean Paul
    Gernaey, Krist V.
    De Beer, Thomas
    Nopens, Ingmar
    EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2016, 90 : 25 - 37
  • [37] Effect of Hydroxypropyl Cellulose Level on Twin-Screw Melt Granulation of Acetaminophen
    Tongzhou Liu
    Shubhajit Paul
    Brian T Beeson
    Johnny Alexander
    Fengyuan Yang
    Vivian Bi
    Thomas Durig
    Changquan Calvin Sun
    Feng Zhang
    AAPS PharmSciTech, 21
  • [38] Examining the mechanics of granulation with a hot melt binder in a twin-screw extruder
    Mu, B.
    Thompson, M. R.
    CHEMICAL ENGINEERING SCIENCE, 2012, 81 : 46 - 56
  • [39] Quantitative Assessment of Mass Flow Boundaries in Continuous Twin-screw Granulation
    Schmidt, Adrian
    de Waard, Hans
    Moll, Klaus-Peter
    Krumme, Markus
    Kleinebudde, Peter
    CHIMIA, 2016, 70 (09) : 604 - 609
  • [40] Comparison of scale-up strategies in twin-screw wet granulation
    Franke, Marcel
    Riedel, Thomas
    Meier, Robin
    Schmidt, Carsten
    Kleinebudde, Peter
    INTERNATIONAL JOURNAL OF PHARMACEUTICS, 2023, 641
12345