High shear mixing of lactose and salmeterol xinafoate dry powder blends: Biopharmaceutic and aerodynamic performances

Balducci, Anna; Steckel, Hartwig; Guarneri, Francesco; Rossi, Alessandra; Colombo, Gaia; Sonvico, Fabio; Cordts, Eike; Bettini, Ruggero; Colombo, Paolo; Buttini, Francesca

doi:10.1016/j.jddst.2015.07.010

Cited by 13 publications

(9 citation statements)

References 18 publications

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“…Low energy blending (Turbula and Resodyn Acoustic Mixer) did not modify the crystals, which maintained their original shape and size. This important morphological modification caused by high shear impact mixing has been related to the specific characteristics of the NCE-B drug, because it was not observed for NCE-A nor in a previous work focusing on salmeterol xinafoate [15].…”

Section: Figure 3 Cumulative Mass (%) Dissolution Profiles Of Lactose Blend Formulations Containing Nce-mentioning

confidence: 89%

“…It follows that a dissolution method for inhaled products should also be able to analyse the respirable fraction of the inhaled dose, excluding from the analysis not only API particles of non-respirable size but also excipients. Indeed, it has been reported that the drug aerodynamic particle size affects drug dissolution [8] and that the dissolution profile of an aerosolised product is different from that of the bulk formulation [15]. Moreover, it has been reported that the dissolution profile is affected by drug dose, the intrinsic API solubility and the drug deposition method in the dissolution apparatus [16].…”

Section: Introductionmentioning

confidence: 99%

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RespiCellTM: An Innovative Dissolution Apparatus for Inhaled Products

et al. 2021

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To overcome some of the shortfalls of the types of dissolution testing currently used for pulmonary products, a new custom-built dissolution apparatus has been developed. For inhalation products, the main in vitro characterisation required by pharmacopoeias is the deposition of the active pharmaceutical ingredient in an impactor to estimate the dose delivered to the target site, i.e., the lung. Hence, the collection of the respirable dose (<5 µm) also appears to be an essential requirement for the study of the dissolution rate of particles, because it results as being a relevant parameter for the pharmacological action of the powder. In this sense, dissolution studies could become a complementary test to the routine testing of inhaled formulation delivered dose and aerodynamic performance, providing a set of data significant for product quality, efficacy and/or equivalence. In order to achieve the above-mentioned objectives, an innovative dissolution apparatus (RespiCell™) suitable for the dissolution of the respirable fraction of API deposited on the filter of a fast screening impactor (FSI) (but also of the entire formulation if desirable) was designed at the University of Parma and tested. The purpose of the present work was to use the RespiCell dissolution apparatus to compare and discriminate the dissolution behaviour after aerosolisation of various APIs characterised by different physico-chemical properties (hydrophilic/lipophilic) and formulation strategies (excipients, mixing technology).

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Section: Figure 3 Cumulative Mass (%) Dissolution Profiles Of Lactose Blend Formulations Containing Nce-mentioning

confidence: 89%

Section: Introductionmentioning

confidence: 99%

RespiCellTM: An Innovative Dissolution Apparatus for Inhaled Products

et al. 2021

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“…Furthermore, it was also identified that the deposited mass influences dissolution rate, depending on the undissolved drug particles (Arora et al, 2010;Mees et al, 2011). Moreover, the dissolution of the individual particles and of the entire powder blend may be different (Balducci et, 2015).…”

Section: Biopharmaceutical Considerations For Inhalation Productsmentioning

confidence: 99%

“…Systems such as Transwell ® inserts or Franz cells have membranes that separate the donor and acceptor compartments, providing diffusion of dissolved drug (Balducci et al, 2015;Rohrschneider et al, 2015). Semipermeable membranes mimic the airliquid interface of the epithelial lung wall (May et al, 2012).…”

Section: Selection Of Dissolution Apparatus Typementioning

confidence: 99%

Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products

Velaga

Djuriš

Cvijić

et al. 2018

European Journal of Pharmaceutical Sciences

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In vitro dissolution testing is routinely used in the development of pharmaceutical products. Whilst the dissolution testing methods are well established and standardized for oral dosage forms, i.e. tablets and capsules, there are no pharmacopoeia methods or regulatory requirements for testing the dissolution of orally inhaled powders. Despite this, a wide variety of dissolution testing methods for orally inhaled powders has been developed and their bio-relevance has been evaluated. This review provides an overview of the in vitro dissolution methodologies for dry inhalation products, with particular emphasis on dry powder inhalers, where the dissolution behavior of the respirable particles can have a role on duration and absorption of the drug. Dissolution mechanisms of respirable particles as well as kinetic models have been presented. A more recent biorelevant dissolution set-ups and media for studying inhalation biopharmaceutics were also reviewed. In addition, factors affecting interplay between dissolution and absorption of deposited particles in the context of biopharmaceutical considerations of inhalation products were examined.

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“…The methods used for particle deposition belonging to the first category are those that do not have a particle separation step based on aerodynamic size. The airbrush method, manual sprinkling, dry powder insufflators, and the PreciseInhale aerosol generator are described for particle deposition with the purpose of subsequent dissolution testing of DPIs (41)(42)(43)(44). Several methods are available for isolating the FPD.…”

Section: Particle Collection For Dissolution Purposementioning

confidence: 99%

Towards Standardized Dissolution Techniques for In Vitro Performance Testing of Dry Powder Inhalers

Floroiu¹,

Klein²,

Krämer³

et al. 2018

Dissolution Technol.

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The pulmonary route of administration is used for both locally and systemically acting drugs. However, knowledge gaps about the fate of aerosol particles after deposition in the lung provide room for future elucidation. During pharmaceutical development as well as in quality control of oral inhalation products, in vitro performance tests are required for discriminating between formulations and to prove batch-to-batch consistency. Although the aerodynamic particle size distribution is widely recognized as the pivotal performance parameter, there is still no standardized test for in vitro dissolution testing. This review summarizes the in vitro performance testing methodologies developed for orally inhaled drug product (OIDP) evaluation, with a focus on dissolution testing of dry powders for inhalation. The dissolution setups used, together with the media, membranes, and methods employed for collecting the relevant particle fraction, are presented. With a clear focus on in vitro dissolution testing, particle size distribution is regarded as a physical reduction to the relevant moiety of the specimen to be sampled for subsequent testing.

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High shear mixing of lactose and salmeterol xinafoate dry powder blends: Biopharmaceutic and aerodynamic performances

Cited by 13 publications

References 18 publications

RespiCellTM: An Innovative Dissolution Apparatus for Inhaled Products

RespiCellTM: An Innovative Dissolution Apparatus for Inhaled Products

Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products

Towards Standardized Dissolution Techniques for In Vitro Performance Testing of Dry Powder Inhalers

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