Stability and In Vitro Aerodynamic Studies of Inhalation Powders Containing Ciprofloxacin Hydrochloride Applying Different DPI Capsule Types

In the case of capsule-based dry powder inhalation systems (DPIs), the selection of the appropriate capsule is important. The use of gelatin, gelatin-PEG, and HPMC capsules has become widespread in marketed capsule-based DPIs. We aimed to perform a stability test according to the ICH guideline in th...

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Main Authors: Edit Benke, Patrícia Varga, Piroska Szabó-Révész, Rita Ambrus
Format: Article
Language:English
Published: MDPI AG 2021-05-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/13/5/689
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author Edit Benke
Patrícia Varga
Piroska Szabó-Révész
Rita Ambrus
author_facet Edit Benke
Patrícia Varga
Piroska Szabó-Révész
Rita Ambrus
author_sort Edit Benke
collection DOAJ
description In the case of capsule-based dry powder inhalation systems (DPIs), the selection of the appropriate capsule is important. The use of gelatin, gelatin-PEG, and HPMC capsules has become widespread in marketed capsule-based DPIs. We aimed to perform a stability test according to the ICH guideline in the above-mentioned three capsule types. The results of the novel combined formulated microcomposite were more favorable than those of the carrier-free formulation for all capsule types. The use of HPMC capsules results in the greatest stability and thus the best in vitro aerodynamic results for both DPI powders after six months. This can be explained by the fact that the residual solvent content (RSC) of the capsules differs. Under the applied conditions the RSC of the HPMC capsule decreased the least and remained within the optimal range, thus becoming less fragmented, which was reflected in the RSC, structure and morphology of the particles, as well as in the in vitro aerodynamic results (there was a difference of approximately 10% in the lung deposition results). During pharmaceutical dosage form developments, emphasis should be placed in the case of DPIs on determining which capsule type will be used for specific formulations.
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spelling doaj.art-a34ce9da75734ef29ce1809cc06436bb2023-11-21T19:07:38ZengMDPI AGPharmaceutics1999-49232021-05-0113568910.3390/pharmaceutics13050689Stability and In Vitro Aerodynamic Studies of Inhalation Powders Containing Ciprofloxacin Hydrochloride Applying Different DPI Capsule TypesEdit Benke0Patrícia Varga1Piroska Szabó-Révész2Rita Ambrus3Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, 6720 Szeged, HungaryInstitute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, 6720 Szeged, HungaryInstitute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, 6720 Szeged, HungaryInstitute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, 6720 Szeged, HungaryIn the case of capsule-based dry powder inhalation systems (DPIs), the selection of the appropriate capsule is important. The use of gelatin, gelatin-PEG, and HPMC capsules has become widespread in marketed capsule-based DPIs. We aimed to perform a stability test according to the ICH guideline in the above-mentioned three capsule types. The results of the novel combined formulated microcomposite were more favorable than those of the carrier-free formulation for all capsule types. The use of HPMC capsules results in the greatest stability and thus the best in vitro aerodynamic results for both DPI powders after six months. This can be explained by the fact that the residual solvent content (RSC) of the capsules differs. Under the applied conditions the RSC of the HPMC capsule decreased the least and remained within the optimal range, thus becoming less fragmented, which was reflected in the RSC, structure and morphology of the particles, as well as in the in vitro aerodynamic results (there was a difference of approximately 10% in the lung deposition results). During pharmaceutical dosage form developments, emphasis should be placed in the case of DPIs on determining which capsule type will be used for specific formulations.https://www.mdpi.com/1999-4923/13/5/689pulmonary drug deliverypowders for inhalationdry powder inhalernovel combined formulationciprofloxacin hydrochloride, sodium stearatemagnesium stearate
spellingShingle Edit Benke
Patrícia Varga
Piroska Szabó-Révész
Rita Ambrus
Stability and In Vitro Aerodynamic Studies of Inhalation Powders Containing Ciprofloxacin Hydrochloride Applying Different DPI Capsule Types
Pharmaceutics
pulmonary drug delivery
powders for inhalation
dry powder inhaler
novel combined formulation
ciprofloxacin hydrochloride, sodium stearate
magnesium stearate
title Stability and In Vitro Aerodynamic Studies of Inhalation Powders Containing Ciprofloxacin Hydrochloride Applying Different DPI Capsule Types
title_full Stability and In Vitro Aerodynamic Studies of Inhalation Powders Containing Ciprofloxacin Hydrochloride Applying Different DPI Capsule Types
title_fullStr Stability and In Vitro Aerodynamic Studies of Inhalation Powders Containing Ciprofloxacin Hydrochloride Applying Different DPI Capsule Types
title_full_unstemmed Stability and In Vitro Aerodynamic Studies of Inhalation Powders Containing Ciprofloxacin Hydrochloride Applying Different DPI Capsule Types
title_short Stability and In Vitro Aerodynamic Studies of Inhalation Powders Containing Ciprofloxacin Hydrochloride Applying Different DPI Capsule Types
title_sort stability and in vitro aerodynamic studies of inhalation powders containing ciprofloxacin hydrochloride applying different dpi capsule types
topic pulmonary drug delivery
powders for inhalation
dry powder inhaler
novel combined formulation
ciprofloxacin hydrochloride, sodium stearate
magnesium stearate
url https://www.mdpi.com/1999-4923/13/5/689
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AT patriciavarga stabilityandinvitroaerodynamicstudiesofinhalationpowderscontainingciprofloxacinhydrochlorideapplyingdifferentdpicapsuletypes
AT piroskaszaborevesz stabilityandinvitroaerodynamicstudiesofinhalationpowderscontainingciprofloxacinhydrochlorideapplyingdifferentdpicapsuletypes
AT ritaambrus stabilityandinvitroaerodynamicstudiesofinhalationpowderscontainingciprofloxacinhydrochlorideapplyingdifferentdpicapsuletypes