Application of the QbD-based approach in the early development of liposomes for nasal administration

Pallagi, Edina; Jójárt-Laczkovich, Orsolya; Németh, Zsófia; Szabó‐Révész, Piroska; Csóka, Ildikó

doi:10.1016/j.ijpharm.2019.03.021

Cited by 33 publications

(23 citation statements)

References 34 publications

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“…Besides the top-down methods, bottom-up techniques were also successfully applied, in order to incorporate the API into nanoDDS. Liposomes as lipid-based nanoDDS with reduced particle size and the bilayer lipid membrane provided high and fast transport of encapsulated lamotrigine through the nasal mucosa [17]. The in vivo studies of meloxicam (MEL)-containing human serum albumin nanoparticles corroborated the in vitro dissolution and permeability studies contributed to determine the criteria of trans-epithelial and axonal transport ensuring higher cerebral concentration of the API [18].…”

Section: Introductionmentioning

confidence: 87%

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

et al. 2020

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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.

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Section: Introductionmentioning

confidence: 87%

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

et al. 2020

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“…Optimization of micro emulsion formulation was explored by applying response surface methodology and experimental design BBD (Box Behnken Design) using 3 level factorial designs. [10][11][12] Polynomial model was constructed for optimization of Aripiprazole keeping four independent and two dependent variables [ Table 2 which will surely helpful in stable micro emulsion development. [10][11][12][13][14] Pharmaceutical evaluation of Micro emulsion Optical clarity (Percentage transmittance): Percentage transmittance of each formulation was measured at 650 nm using UV-spectrophotometer against distilled water as blank.…”

Section: Optimization Of Micro Emulsion Formulationmentioning

confidence: 99%

“…The samples were mixed thoroughly to dissolve the drug in ethanol and percentage drug content analysed using Shimadzu UV visible spectrophotometer at 255 nm. [12][13][14] Biological Evaluation: Freshly excised sheep nasal mucosa without septum part was obtained from the slaughter house. This membrane was kept in PBS at pH 6.4 for 15 min to equilibrate.…”

Section: Optimization Of Micro Emulsion Formulationmentioning

confidence: 99%

“…Microemulsion system optimized using Design space (overlay plot) with softwaresuggested levels of independent variables that could be transformed to desired responses. [10][11][12] From response model equations (1,2) it is observed that, variables X1, Oleic acid have negative effect on Particle size while variable X4, distilled water shows negative effect on drug content. Particle size of Aripiprazole is inversely proportional to drug concentration in oleic acid while drug content percentage is inversely proportional to amount of distilled water in micro emulsion.…”

Section: Pharmaceutical Evaluation Of Micro Emulsionmentioning

confidence: 99%

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Quality by Design (QbD) Approach for Optimization and Characterization of Micro emulsion based Nasal formulation of Antipsychotic/Antischizophrenic Drug-Aripiprazole

Deore¹,

Baviskar²,

Kide³

et al. 2020

IJPI

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Introduction: Present study is focused to develop micro emulsion based nasal formulation of poorly water soluble antipsychotic/anti-schizophrenic drug Aripiprazole. Materials and Methods: Different surfactants and co surfactants are screened by implementing pseudo ternary phase diagram. Effect of concentrations of four independent variables-oil (X1), Surfactant (X2), co-surfactant (X3) and water (X4) on two dependent variablesparticle size (Y1) and drug content (Y2) is studied from surface response plots obtained by application of Box Behnken Design Experiment. QTPP and CQA mediated risk assessment applied to ensure desirable quality, safety and efficacy of developed microemulsion. Developed microemulsion evaluated for appearance, particle size, viscosity, drug content, pH, conductivity, drug release, zeta potential, polydispersity index, nasal toxicity and stability. Results: DoE based QBD approach lead development of suitable optimized batch of Aripiprazole micro emulsion with particle size 95.2 nm, viscosity 120 cp, pH 6.0, 90%, drug content and about 87.33% nasal permeability release within 4 hr. Risk assessment helped in identifying identification robust design parameters for rapid development of stable aripiprazole micro emulsion. The critical quality attributes (CQAs) like solubility and compatibility with excipients, dosage form, particle size, turbidity, drug content and drug release have greater impact on the stability and therapeutic performance of micro emulsion of aripiprazole. Conclusion: Aripiprazole containing intranasal micro emulsion is successfully developed by quality by design approach for understanding the critical quality attributes and microemulsion is better alternative over conventional delivery systems.

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“…The objective of our research project was to conduct a QbD-based development process to prepare liposomal formulations and thus investigate the effects of various production parameters (filtration, pressure, and temperature) and different compositions (phospholipidcholesterol ratios, hydration media, and cryoprotectants). The liposomal formulations were prepared by the thin-film hydration method [1]. The temperature and the pressure during the production were changed in addition to the filtration, as well as the ratio of the wall-forming agents.…”

mentioning

confidence: 99%

Quality by Design-based approach to liposomal development

Németh

Dobó

Pallagi

et al. 2020

II. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science

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Application of the QbD-based approach in the early development of liposomes for nasal administration

Cited by 33 publications

References 34 publications

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

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

Quality by Design (QbD) Approach for Optimization and Characterization of Micro emulsion based Nasal formulation of Antipsychotic/Antischizophrenic Drug-Aripiprazole

Quality by Design-based approach to liposomal development

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