scholarly journals An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development

Pharmaceutics ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1071
Author(s):  
Zsófia Németh ◽  
Edina Pallagi ◽  
Dorina Gabriella Dobó ◽  
Gábor Kozma ◽  
Zoltán Kónya ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Active Pharmaceutical Ingredient ◽  
Experimental Models ◽  
Phospholipid Content ◽  
Formulation Development ◽  
Critical Material ◽  
Critical Material Attributes ◽  
Critical Process Parameters ◽  
Saline Solutions ◽  
Phosphate Buffered Saline

Liposomal formulation development is a challenging process. Certain factors have a critical influence on the characteristics of the liposomes, and even the relevant properties can vary based on the predefined interests of the research. In this paper, a Quality by Design-guided and Risk Assessment (RA)-based study was performed to determine the Critical Material Attributes and the Critical Process Parameters of an “intermediate” active pharmaceutical ingredient-free liposome formulation prepared via the thin-film hydration method, collect the Critical Quality Attributes of the future carrier system and show the process of narrowing a general initial RA for a specific case. The theoretical liposome design was proved through experimental models. The investigated critical factors covered the working temperature, the ratio between the wall-forming agents (phosphatidylcholine and cholesterol), the PEGylated phospholipid content (DPPE-PEG2000), the type of the hydration media (saline or phosphate-buffered saline solutions) and the cryoprotectants (glucose, sorbitol or trehalose). The characterisation results (size, surface charge, thermodynamic behaviours, formed structure and bonds) of the prepared liposomes supported the outcomes of the updated RA. The findings can be used as a basis for a particular study with specified circumstances.

scholarly journals Investigation of Silicone-Containing Semisolid in Situ Film-Forming Systems Using QbD Tools

Pharmaceutics ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 660 ◽  
Author(s):  
Nikolett Kis ◽  
Anita Kovács ◽  
Mária Budai-Szűcs ◽  
Attila Gácsi ◽  
Erzsébet Csányi ◽  
...  
Keyword(s):  
Mechanical Properties ◽  
Risk Assessment ◽  
Research Work ◽  
Critical Material ◽  
Drying Time ◽  
Film Forming ◽  
Critical Material Attributes ◽  
Critical Process Parameters ◽  
Critical Process

The aim of our research work was to develop dermally applicable, semisolid film-forming systems (FFSs) containing silicones, which form a film on the skin in situ, with suitable mechanical properties for skin application. FFSs were developed and investigated by means of the Quality by Design (QbD) methodology. With this QbD approach, the initial risk assessment defines the critical quality attributes (CQAs), the critical material attributes (CMAs) and the critical process parameters (CPPs) to ensure the required quality. Different semisolid systems were formed with or without silicones. During the initial risk assessment, three CQAs, namely skin adhesion, film flexibility and burst strength, were found to be critical attributes, while film appearance, film integrity and the drying time of the semisolid system, were found to be medium attributes. These parameters were investigated. The initial risk assessment also showed that there are three high CMAs: the type of silicones, film-forming excipients, drying excipients, and that there was one medium CMA: viscosity-enhancing excipients. Based on our results, the silicone content had a great effect on the film-forming systems. Different silicones affected the mechanical properties of the films in varying ways, decreased the drying time and showed promising results regarding the drying mechanism.

scholarly journals Raw Material Variability and Its Impact on the Online Adaptive Control of Cohesive Powder Blend Homogeneity Using NIR Spectroscopy

Processes ◽  
2019 ◽  
Vol 7 (9) ◽  
pp. 568 ◽  
Author(s):  
Guolin Shi ◽  
Bing Xu ◽  
Zhiqiang Zhang ◽  
Chan Yang ◽  
Shengyun Dai ◽  
...  
Keyword(s):  
Latent Variable ◽  
Near Infrared ◽  
Process Analytical Technology ◽  
Nir Spectroscopy ◽  
Active Pharmaceutical Ingredient ◽  
Raw Material ◽  
Critical Material ◽  
Critical Material Attributes ◽  
Blending Process ◽  
Cohesive Powders

It is significant to analyze the blend homogeneity of cohesive powders during pharmaceutical manufacturing in order to provide the exact content of the active pharmaceutical ingredient (API) for each individual dose unit. In this paper, an online monitoring platform using an MEMS near infrared (NIR) sensor was designed to control the bin blending process of cohesive powders. The state of blend homogeneity was detected by an adaptive algorithm, which was calibration free. The online control procedures and algorithm’s parameters were fine-tuned through six pilot experiments and were successfully transferred to the industrial production. The reliability of homogeneity detection results was validated by 16 commercial scale experiments using 16 kinds of natural product powders (NPPs), respectively. Furthermore, 19 physical quality attributes of all NPPs and the excipient were fully characterized. The blending end time was used to denote the degree of difficulty of blending. The empirical relationships between variability of NPPs and the blending end time were captured by latent variable modeling. The critical material attributes (CMAs) affecting the blending process were identified as the particle shape and flowability descriptors of cohesive powders. Under the framework of quality by design (QbD) and process analytical technology (PAT), the online NIR spectroscopy together with the powder characterization facilitated a deeper understanding of the mixing process.

Quality by Design in Action 2: Controlling Critical Material Attributes during the Synthesis of an Active Pharmaceutical Ingredient

2015 ◽  
Vol 19 (11) ◽  
pp. 1645-1654 ◽  
Author(s):  
Abdul Qayum Mohammed ◽  
Phani Kiran Sunkari ◽  
Amjad Basha Mohammed ◽  
P. Srinivas ◽  
Amrendra Kumar Roy
Keyword(s):  
Quality By Design ◽  
Active Pharmaceutical Ingredient ◽  
Critical Material ◽  
Critical Material Attributes

Assessment of critical material attributes of polyethylene oxide for formulation of prolonged-release tablets

2019 ◽  
Vol 45 (12) ◽  
pp. 1949-1958
Author(s):  
Petra Draksler ◽  
Biljana Janković ◽  
Zrinka Abramović ◽  
Zoran Lavrič ◽  
Anton Meden
Keyword(s):  
Polyethylene Oxide ◽  
Prolonged Release ◽  
Critical Material ◽  
Critical Material Attributes

Corrigendum to “In vitro experimental models for the risk assessment of antibiotic-induced QT prolongation” [European Journal of Pharmacology 553 (2007) 229–239]

2007 ◽  
Vol 577 (1-3) ◽  
pp. 221
Author(s):  
Hua Rong Lu ◽  
Eddy Vlaminckx ◽  
Andre Van de Water ◽  
Jutta Rohrbacher ◽  
An Hermans ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Experimental Models ◽  
Qt Prolongation

scholarly journals An Anti-Inflammatory Poly(PhosphorHydrazone) Dendrimer Capped with AzaBisPhosphonate Groups to Treat Psoriasis

Biomolecules ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. 949 ◽  
Author(s):  
Ranime Jebbawi ◽  
Abdelouahd Oukhrib ◽  
Emily Clement ◽  
Muriel Blanzat ◽  
Cédric-Olivier Turrin ◽  
...  
Keyword(s):  
Topical Application ◽  
Therapeutic Efficacy ◽  
Biomedical Applications ◽  
Saline Solution ◽  
Active Pharmaceutical Ingredient ◽  
Systemic Injection ◽  
Human Immune ◽  
Anti Inflammatory ◽  
Phosphate Buffered Saline

Dendrimers are nanosized, arborescent macromolecules synthesized in a stepwise fashion with attractive degrees of functionality and structure definition. This is one of the reasons why they are widely used for biomedical applications. Previously, we have shown that a poly(phosphorhydrazone) (PPH) dendrimer capped with anionic azabisphosphonate groups (so-called ABP dendrimer) has immuno-modulatory and anti-inflammatory properties towards human immune cells in vitro. Thereafter, we have shown that the ABP dendrimer has a promising therapeutic efficacy to treat models of acute and chronic inflammatory disorders in animal models. In these models, the active pharmaceutical ingredient was administered systematically (intravenous and oral administrations), but also loco-regionally in the vitreous tissue. Herein, we assessed the therapeutic efficacy of the ABP dendrimer in the preclinical mouse model of psoriasis induced by imiquimod. The ABP dendrimer was administered in phosphate-buffered saline solution via either systemic injection or topical application. We show that the topical application enabled the control of both the clinical and histopathological scores, and the control of the infiltration of macrophages in the skin of treated mice.

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