Freeze drying optimization of polymeric nanoparticles for ocular flurbiprofen delivery: effect of protectant agents and critical process parameters on long-term stability

In advanced medication, drug-loaded polymeric nanoparticles (NPs) appeared as a novel drug delivery system with lots of advantages over conventional medicines. Despite all the advantages, NPs do not gain popularity for manufacturing hurdles. The study focused on the formulation difficulties and implementation of statistical design to establish an effective model for manufacturing NPs. In this study, physico-chemical properties of the drug and polymer (PLGA) were incorporated to understand the mechanistic insights of nanoformulations. Primarily, the process controlling parameters were screened by Plackett–Burman design and the critical process parameters (Cpp) were further fabricated by Box–Behnken design (BBD). The TLM-PLGA-NPs (telmisartan loaded PLGA NPs) exhibited particle size, encapsulation efficiency and zeta potential of 232.4 nm, 79.21% and −9.92 mV respectively. The NPs represented drug loading of 76.31%. Korsmeyer–Peppas model ( R 2 = 0.925) appeared to be the best fitted model for in vitro release kinetics of NPs. The model identified Fickian diffusion of TLM from the polymeric nanoparticles. The ANOVA results of variables indicate that BBD is a suitable model for the development of polymeric NPs. The study successfully identified and evaluated the correlation of significant parameters that were directly or indirectly influencing the formulations which deliberately produce desired nanoparticles with the help of statistical design.

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Improving the handling properties and long‐term stability of polyelectrolyte complex by freeze‐drying technique for low‐dose bone morphogenetic protein 2 delivery

Journal of Biomedical Materials Research Part B Applied Biomaterials ◽

10.1002/jbm.b.34577 ◽

2020 ◽

Vol 108 (6) ◽

pp. 2450-2460

Author(s):

Ling Liu ◽

Wing M. R. Lam ◽

Zheng Yang ◽

Ming Wang ◽

Xiafei Ren ◽

...

Keyword(s):

Bone Morphogenetic Protein ◽

Freeze Drying ◽

Polyelectrolyte Complex ◽

Low Dose ◽

Bone Morphogenetic Protein 2 ◽

Term Stability ◽

Long Term Stability ◽

Morphogenetic Protein

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A Comparison of Spray-Drying and Freeze-Drying for the Production of Stable Silybin Nanosuspensions

Journal of Nanoscience and Nanotechnology ◽

10.1166/jnn.2020.17407 ◽

2020 ◽

Vol 20 (6) ◽

pp. 3598-3603 ◽

Cited By ~ 1

Author(s):

Yingying Ma ◽

Jin Gao ◽

Wankui Jia ◽

Yangyang Liu ◽

Lanying Zhang ◽

...

Keyword(s):

Spray Drying ◽

Freeze Drying ◽

Drying Methods ◽

Dry Powders ◽

Term Stability ◽

Long Term Stability ◽

Freeze Dried ◽

Spray Dried

Spray-drying and freeze-drying are effective approaches to improve the long-term stability of nanosuspensions. This research explored the effect of spray-drying and freeze-drying techniques on PVP K30-stabilized silybin nanosuspensions. The morphology was observed by scanning electron microscopy (SEM): The spray-dried sample was spherical, and the freeze-dried samples were rodlike with smooth surfaces. The redispersibility was studied via dynamic light scattering (DLS): The size, PDI, and zeta of the spray-dried sample were 133.27 nm, 0.214, and 24.37 mV, respectively; the size, PDI, and zeta of the freeze-dried sample were 298.70 nm, 0.114, and 20.98 mV, respectively. The in vitro dissolution was studied, and the two dry powders showed a significant increase compared to silybin. The two dried powders had better long-term stability than the liquid starting material. Overall, spray-drying and freeze-drying are appropriate drying methods for the preparation of silybin nanosuspensions with better stability and dissolution velocity.

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Effect of pH and Excipients on Structure, Dynamics, and Long-Term Stability of a Model IgG1 Monoclonal Antibody upon Freeze-Drying

Pharmaceutical Research ◽

10.1007/s11095-012-0933-z ◽

2012 ◽

Vol 30 (4) ◽

pp. 968-984 ◽

Cited By ~ 26

Author(s):

Jihea Park ◽

Karthik Nagapudi ◽

Camille Vergara ◽

Ranjini Ramachander ◽

Jennifer S. Laurence ◽

...

Keyword(s):

Monoclonal Antibody ◽

Freeze Drying ◽

Effect Of Ph ◽

Term Stability ◽

Long Term Stability ◽

Structure Dynamics ◽

Igg1 Monoclonal Antibody

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PRELIMINARY STUDY OF INSULIN DRY POWDER FORMULATION: CRITICAL PROCESS PARAMETERS ON SPRAY-FREEZE-DRYING AND CRITICAL MATERIAL ATTRIBUTE OF TREHALOSE AND INULIN AS STABILIZER

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2021.v13s4.43823 ◽

2021 ◽

pp. 83-88

Author(s):

CYNTHIA MARISCA MUNTU ◽

SILVIA SURINI ◽

CHRISTINA AVANTI ◽

HAYUN ◽

WOUTER HINRICHS

Keyword(s):

Process Parameters ◽

Freeze Drying ◽

Time Lag ◽

Physicochemical Characterization ◽

Dry Powder ◽

Critical Material ◽

Atomization Process ◽

Critical Process Parameters ◽

Spray Freeze Drying ◽

Critical Process

Objective: The aim of this study was to obtain recommendations about critical process parameters (CPP) and optimal ratio of trehalose and inulin as critical material attribute (CMA) on insulin dry powder formulation with spray-freeze-drying (SFD) method. Methods: Inulin dry powder was formulated with the SFD method, which consisted of an atomization process and freeze-drying (FD). SFD processes were optimized in order to obtain dry powder and CPP was analyzed. All seven variations of formulas proceeded with physicochemical characterization to obtain the optimal formula. Results: In the early optimization, there was a slight time lag between the atomization process and FD; as a result, some of the powder coagulated and crystallized. Another critical parameter was that the FD process should not be interrupted for at least 50 h of FD. Dry powder proceeded with physicochemical characterization, a formula without inulin showed semicrystalline properties, while six formulas had amorphous properties due to its combination. All formulas had a spherulite shape and rough surface. Five formulas with the combination of trehalose and inulin obtained dry powders with a diameter range of 30-43 μm, moisture content below 3.5% and high encapsulation efficiency (EE). Formula with the ratio of 1:1 (F4) showed optimal properties with moisture content and EE of 2.62% and 99.68%, respectively. Conclusion: This study concluded that there were two critical process parameters in the SFD method. There should be no time lag in SFD process and FD time which should not be interrupted. The optimal ratio for trehalose and inulin was shown by F4 with ratio of 1:1.

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