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    In-Vitro In-Vivo Correlation (IVIVC) of Inhaled Products Using Twin Stage Impinger

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    Publication date
    2022-02
    Author
    Al Ayoub, Y.
    Buzgeia, Asma
    Almousawi, Ghadeer
    Mazhar, H.R.A.
    Alzouebi, B.
    Gopalan, Rajendran C.
    Assi, Khaled H.
    Keyword
    Twin stage impinger
    Dissolution
    Dry powder inhaler
    Budesonide
    Salbutamol
    In vitro-in vivo correlation
    IVIVC
    Peer-Reviewed
    Yes
    Open Access status
    Not Open Access
    
    Metadata
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    Abstract
    In vitro dissolution testing as a form of quality control has become a necessity in the pharmaceutical industry. As such, the need to establish a method that investigates the in vitro dissolution profile of inhaled products should be taken into account. The prime focus in this study was to examine the in-vitro in-vivo correlation utilising a modified version of the Twin Stage Impinger and to promote an in vitro dissolution model by enhancing the Fine Particle Dose (FPD) collection method for dry powder inhalers. The Twin Impinger was modified by inserting a stainless steel membrane holder disk in the base of the lower chamber. The design, with optimum drug deposition, was adopted for the dissolution study of budesonide and salbutamol. Afterwards, the membrane holder system was placed in the bottom of the dissolution vessel. Phosphate buffer saline (PBS), simulated lung fluid (SLF, Gamble solution) and Phosphate buffer (PB) were used in the study. The paddle dissolution apparatus, containing 300 mL of the medium, was operated at 75 rpm paddle speed. Samples were collected at defined time intervals and analysed using a validated HPLC method. The largest proportion of the budesonide dose was dissolved in PBS compared to PB and SLF. This was due to the presence of surfactant (0.2% w/v polysorbate), which enhances the wettability and the solubility of the poorly soluble drug (budesonide). The similarity factors for PBS and PB were 47.6 and 69.7, respectively, using SLF as a reference, whereas the similarity factor for salbutamol dissolution between PB and SLF was 81.3, suggesting PB is a suitable substitute. Comparison using both the predicted and actual in vivo pharmacokinetics (PK) values of the two drugs, as well as the pattern of their Concentration-Time (c-t) profiles, showed good similarity, which gave an indication of the validity of this in vitro dissolution method.
    URI
    http://hdl.handle.net/10454/18680
    Version
    No full-text in the repository
    Citation
    Al Ayoub Y, Buzgeia A, Almousavi G et al (2021) In-Vitro In-Vivo Correlation (IVIVC) of Inhaled Products Using Twin Stage Impinger. Journal of Pharmaceutical Sciences. 111(2): 395-402.
    Link to publisher’s version
    https://doi.org/10.1016/j.xphs.2021.09.042
    Type
    Article
    Collections
    Life Sciences Publications

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