In-Vitro In-Vivo Correlation (IVIVC) of Inhaled Products Using Twin Stage Impinger
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2022-02Author
Al Ayoub, Y.Buzgeia, Asma
Almousawi, Ghadeer
Mazhar, H.R.A.
Alzouebi, B.
Gopalan, Rajendran C.
Assi, Khaled H.
Keyword
Twin stage impingerDissolution
Dry powder inhaler
Budesonide
Salbutamol
In vitro-in vivo correlation
IVIVC
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© 2021 Elsevier. Reproduced in accordance with the publisher's self-archiving policy. This manuscript version is made available under the CC-BY-NC-ND 4.0 license.Peer-Reviewed
YesOpen Access status
openAccessAccepted for publication
2021-09-16
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Show full item recordAbstract
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.Version
Accepted manuscriptCitation
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 Version of Record
https://doi.org/10.1016/j.xphs.2021.09.042Type
Articleae974a485f413a2113503eed53cd6c53
https://doi.org/10.1016/j.xphs.2021.09.042