Formulation development of inhalation powders for FK888 using the E-haler® to improve the inhalation performance at a high dose, and its absorption in healthy volunteers

Nakate, Toshiomi; Yoshida, Hideya; Ohike, Atsuo; Tokunaga, Yuji; Ibuki, Rinta; Kawashima, Yasunaru

doi:10.1016/j.ejpb.2004.08.004

Cited by 15 publications

(8 citation statements)

References 13 publications

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“…Among them are, for example, low molecular weight heparin [88], lung surfactant [89] and an NK1 receptor antagonist [90].…”

Section: High Dose Dpi Formulations On the Market And In Research Andmentioning

confidence: 99%

Novel dry powder inhalation system based on dispersion of lyophilisates

Claus

Schoenbrodt

Weiler

et al. 2011

European Journal of Pharmaceutical Sciences

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“…Among them are, for example, low molecular weight heparin [88], lung surfactant [89] and an NK1 receptor antagonist [90].…”

Section: High Dose Dpi Formulations On the Market And In Research Andmentioning

confidence: 99%

Novel dry powder inhalation system based on dispersion of lyophilisates

Claus

Schoenbrodt

Weiler

et al. 2011

European Journal of Pharmaceutical Sciences

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“…Moreover, gelatin capsules were found more susceptible to loss of the shell “flap” created upon piercing by the device [ 23 , 58 ]. These “flaps” may be important for the aerosol performance of dry powders since they can potentially change the airflow profile and release from the capsule, as well as that powder could stick to them and not fully get to the patient during inspiration [ 59 ]. However, their precise effects on powder de-agglomeration are still poorly understood and require further investigation.…”

Section: Critical Materials Attributes (Cmas) In Cdpismentioning

confidence: 99%

A Quality by Design Framework for Capsule-Based Dry Powder Inhalers

et al. 2021

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Capsule-based dry powder inhalers (cDPIs) are widely utilized in the delivery of pharmaceutical powders to the lungs. In these systems, the fundamental nature of the interactions between the drug/formulation powder, the capsules, the inhaler device, and the patient must be fully elucidated in order to develop robust manufacturing procedures and provide reproducible lung deposition of the drug payload. Though many commercially available DPIs utilize a capsule-based dose metering system, an in-depth analysis of the critical factors associated with the use of the capsule component has not yet been performed. This review is intended to provide information on critical factors to be considered for the application of a quality by design (QbD) approach for cDPI development. The quality target product profile (QTPP) defines the critical quality attributes (CQAs) which need to be understood to define the critical material attributes (CMA) and critical process parameters (CPP) for cDPI development as well as manufacturing and control.

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“…Hence, it does not become brittle as it loses moisture, a common phenomenon with gelatin capsules as patients do not store them as directed resulting in broken capsules and poor performance in their DPI (Nagata, 2002;Ogura et al, 1998;Renswouw et al, 2010). In addition, it has also been shown that HPMC capsules are less influenced by triboelectrification which is common with gelatin capsules (Nakate et al, 2005). Inhalation grade HPMC capsules are made from different grades of raw material chosen for their puncturing properties (Torrisi et al, 2013) and as a result have a slightly higher moisture content; 4.5-6.5% compared to 4.0-6.0% in oral pharmaceutical grade capsules.…”

Section: Introductionmentioning

confidence: 99%

Investigation on the aerosol performance of dry powder inhalation hypromellose capsules with different lubricant levels

Saleem

Dı́ez²,

Jones³

et al. 2015

International Journal of Pharmaceutics

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HPMC capsules are made by a dipping process and a surface lubricant for the mould pins is an essential processing aid for removing dried capsules shells. For the purpose of this study, the level was determined by quantifying methyloleate (MO) a component found in the lubricant but not in the hypromellose capsules. Here we investigated the influence of the lubricant, low (10.81 μg/capsule=60 mg/kg MO), medium (15.97 μg/capsule=90 mg/kg MO) and high (23.23 μg/capsule=127 mg/kg MO) content on powder (binary mixture of salbutamol: lactose, 1:50 w/w) aerosolization properties was investigated. Results indicated significantly lower emitted dose from capsules with 60 mg/kg MO. Furthermore, the 90 and 127 mg/kg MO level of lubricant capsules produced almost double the Fine Particle Dose & Fine Particle Fraction compared with the low level of lubricant. The data indicates that lubricant level within capsules has an influence on deposition profiles and amount of drug remaining in capsule and inhaler device after actuation. It is suggested lubricant levels greater than 60 mg/kg MO per capsule are required to minimise powder retention within capsules and maximise deposition profiles. AFM (atomic force microscopy) data suggest that internal surface roughness may be related with this phenomena.

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Formulation development of inhalation powders for FK888 using the E-haler® to improve the inhalation performance at a high dose, and its absorption in healthy volunteers

Cited by 15 publications

References 13 publications

Novel dry powder inhalation system based on dispersion of lyophilisates

Novel dry powder inhalation system based on dispersion of lyophilisates

A Quality by Design Framework for Capsule-Based Dry Powder Inhalers

Investigation on the aerosol performance of dry powder inhalation hypromellose capsules with different lubricant levels

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