New aspects of developing a dry powder inhalation formulation applying the quality-by-design approach

Pallagi, Edina; Karimi, Keyhaneh; Ambrus, Rita; Szabó‐Révész, Piroska; Csóka, Ildikó

doi:10.1016/j.ijpharm.2016.07.003

Cited by 39 publications

(17 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…), and the final product characteristics (e.g., nanosized range, nasal route of administration, stability etc.). This collection of the influencing factors is named the "knowledge space development" [30] and helped in the selection of critical factors for performing the initial risk assessment. The selected critical factors are listed below.…”

Section: Initial Risk Assessment and Knowledge Space Developmentmentioning

confidence: 99%

“…The key element of a QbD-guided development is the RA (it can be initial, recurrent/updated, or finalized) [28], which results in ranked CQAs and CPPs regarding their critical effect on the targeted product quality. The classical QbD model was successfully applied previously by the authors in several cases of pharmaceutical early developments [29][30][31][32], as well as in a nasal-formulation [33] and a peptide-containing product [34].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Development of Meloxicam-Human Serum Albumin Nanoparticles for Nose-to-Brain Delivery via Application of a Quality by Design Approach

et al. 2020

Self Cite

View full text Add to dashboard Cite

The aim of this study was to optimize the formulation of meloxicam (MEL)-containing human serum albumin (HSA) nanoparticles for nose-to-brain via a quality by design (QbD) approach. Liquid and dried formulations of nanoparticles containing Tween 80 and without the surfactant were investigated. Various properties, such as the Z-average, zeta potential, encapsulation efficacy (EE), conjugation of MEL and HSA, physical stability, in vitro dissolution, in vitro permeability, and in vivo plasma and brain distribution of MEL were characterized. From a stability point of view, a solid product (Mel-HSA-Tween) is recommended for further development since it met the desired critical parameters (176 ± 0.3 nm Z-average, 0.205 ± 0.01 PdI, −14.1 ± 0.7 mV zeta potential) after 6 months of storage. In vitro examination showed a significantly increased drug dissolution and permeability of MEL-containing nanoparticles, especially in the case of applying Tween 80. The in vivo studies confirmed both the trans-epithelial and axonal transport of nanoparticles, and a significantly higher cerebral concentration of MEL was detected with nose-to-brain delivery, in comparison with intravenous or per os administration. These results indicate intranasal the administration of optimized MEL-containing HSA formulations as a potentially applicable “value-added” product for the treatment of neuroinflammation.

show abstract

Section: Initial Risk Assessment and Knowledge Space Developmentmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Development of Meloxicam-Human Serum Albumin Nanoparticles for Nose-to-Brain Delivery via Application of a Quality by Design Approach

et al. 2020

Self Cite

View full text Add to dashboard Cite

show abstract

“…With evaluating a risk estimation matrix, we can truly generate a risk-and-knowledge-based quality management method by ranking CQAs and CPPs regarding their degree of impact on the targeted product quality [30]. This classical QbD model was also favorable in terms of preformulation studies of nanoDDSs, as well as for nasal formulations [31][32][33].…”

Section: Introductionmentioning

confidence: 99%

Quality by Design Based Formulation Study of Meloxicam-Loaded Polymeric Micelles for Intranasal Administration

et al. 2020

Self Cite

View full text Add to dashboard Cite

Our study aimed to develop an “ex tempore” reconstitutable, viscosity enhancer- and preservative-free meloxicam (MEL)-loaded polymeric micelle formulation, via Quality by Design (QbD) approach, exploiting the nose-to-brain pathway, as a suitable tool in the treatment of neuroinflammation. The anti-neuroinflammatory effect of nose-to-brain NSAID polymeric micelles was not studied previously, therefore its investigation is promising. Critical product parameters, encapsulation efficiency (89.4%), Z-average (101.22 ± 2.8 nm) and polydispersity index (0.149 ± 0.7) and zeta potential (−25.2 ± 0.4 mV) met the requirements of the intranasal drug delivery system (nanoDDS) and the targeted profile liquid formulation was transformed into a solid preservative-free product by freeze-drying. The viscosity (32.5 ± 0.28 mPas) and hypotonic osmolality (240 mOsmol/L) of the reconstituted formulation provides proper and enhanced absorption and probably guarantees the administration of the liquid dosage form (nasal drop and spray). The developed formulation resulted in more than 20 times faster MEL dissolution rate and five-fold higher nasal permeability compared to starting MEL. The prediction of IVIVC confirmed the great potential for in vivo brain distribution of MEL. The nose-to-brain delivery of NSAIDs such as MEL by means of nanoDDS as polymeric micelles offers an innovative opportunity to treat neuroinflammation more effectively.

show abstract

“…DPI dosage form properties can be controlled by adjusting the particle size, size distribution, particle density, particle morphology and shape [129][130][131]. The Ishikawa diagram in Figure 3 illustrates the parameters influencing the quality of DPI products in general, assembling all the influencing parameters of the aimed DPI product [97].…”

Section: Preformulation and Quality By Design Approachmentioning

confidence: 99%

Pulmonary drug delivery systems of antibiotics for the treatment of respiratory tract infections

Csóka

Karimi

Mukhtar

et al. 2019

APH

Self Cite

View full text Add to dashboard Cite

Respiratory infections cause an extensive health problem in the world. The common treatment for respiratory infections is the administration of antibiotics orally or parenterally in a high dose. Unfortunately, these therapies of high-dose antimicrobials have many disadvantages, such as severe side effects. Consequently, the development of an inhaled formulation provides the delivery of the therapeutic dose of the drug to the organ of interest without overt systemic effects. Novel technological advances have led to the development of inhaled antibiotics. Recent particle engineering techniques for dry powder inhalers (DPI) or mesh nebulizers have higher aerosolization efficiencies and promote the delivery of high-dose antibiotics to the lungs. However, advanced formulation strategies are in high demand for the development of new formulations for more types of antibiotics. Despite all the current research, patient compliance with pulmonary dosage forms remains to be very low because of the inappropriate administration techniques. Hence, this review focuses on three key aspects of the pulmonary dosage forms of antibiotics; the marketed products, the formulation approaches under research and innovative formulation strategies for achieving drug delivery through the respiratory tract.

show abstract

New aspects of developing a dry powder inhalation formulation applying the quality-by-design approach

Cited by 39 publications

References 16 publications

Development of Meloxicam-Human Serum Albumin Nanoparticles for Nose-to-Brain Delivery via Application of a Quality by Design Approach

Development of Meloxicam-Human Serum Albumin Nanoparticles for Nose-to-Brain Delivery via Application of a Quality by Design Approach

Quality by Design Based Formulation Study of Meloxicam-Loaded Polymeric Micelles for Intranasal Administration

Pulmonary drug delivery systems of antibiotics for the treatment of respiratory tract infections

Contact Info

Product

Resources

About