Optimization of a chromatographic process for the purification of saponins in Panax notoginseng extract using a design space approach

A reversed-phase HPLC-UV method was developed using a design space approach for the simultaneous determination of five saponins in the extracts of Panax notoginseng, which were notoginsenoside R1, ginsenosides Rg1, Re, Rb1, and Rd.

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Optimization of Panax notoginseng extraction process using a design space approach

Separation and Purification Technology ◽

10.1016/j.seppur.2014.11.020 ◽

2015 ◽

Vol 141 ◽

pp. 197-206 ◽

Cited By ~ 14

Author(s):

Xingchu Gong ◽

Huali Chen ◽

Jianyang Pan ◽

Haibin Qu

Keyword(s):

Design Space ◽

Panax Notoginseng ◽

Extraction Process ◽

Space Approach

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Design Space Approach for Preservative System Optimization of an Anti-Aging Eye Fluid Emulsion

Journal of Pharmacy & Pharmaceutical Sciences ◽

10.18433/j3j600 ◽

2015 ◽

Vol 18 (3) ◽

pp. 551 ◽

Cited By ~ 8

Author(s):

Felipe Rebello Lourenço ◽

Fabiane Lacerda Francisco ◽

Márcia Regina Spuri Ferreira ◽

Terezinha De Jesus Andreoli ◽

Raimar Löbenberg ◽

...

Keyword(s):

Design Space ◽

Challenge Test ◽

System Optimization ◽

Effective Concentration ◽

Optimization Strategy ◽

Cosmetic Products ◽

Cosmetic Product ◽

Space Design ◽

New Formula ◽

Space Approach

The use of preservatives must be optimized in order to ensure the efficacy of an antimicrobial system as well as the product safety. Despite the wide variety of preservatives, the synergistic or antagonistic effects of their combinations are not well established and it is still an issue in the development of pharmaceutical and cosmetic products. The purpose of this paper was to establish a space design using a simplex-centroid approach to achieve the lowest effective concentration of 3 preservatives (methylparaben, propylparaben, and imidazolidinyl urea) and EDTA for an emulsion cosmetic product. Twenty-two formulae of emulsion differing only by imidazolidinyl urea (A: 0.00 to 0.30% w/w), methylparaben (B: 0.00 to 0.20% w/w), propylparaben (C: 0.00 to 0.10% w/w) and EDTA (D: 0.00 to 0.10% w/w) concentrations were prepared. They were tested alone and in binary, ternary and quaternary combinations. Aliquots of these formulae were inoculated with several microorganisms. An electrochemical method was used to determine microbial burden immediately after inoculation and after 2, 4, 8, 12, 24, 48, and 168 h. An optimization strategy was used to obtain the concentrations of preservatives and EDTA resulting in a most effective preservative system of all microorganisms simultaneously. The use of preservatives and EDTA in combination has the advantage of exhibiting a potential synergistic effect against a wider spectrum of microorganisms. Based on graphic and optimization strategies, we proposed a new formula containing a quaternary combination (A: 55%; B: 30%; C: 5% and D: 10% w/w), which complies with the specification of a conventional challenge test. A design space approach was successfully employed in the optimization of concentrations of preservatives and EDTA in an emulsion cosmetic product. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

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Design Space Approach in Optimization of Fluid Bed Granulation and Tablets Compression Process

The Scientific World JOURNAL ◽

10.1100/2012/185085 ◽

2012 ◽

Vol 2012 ◽

pp. 1-10 ◽

Cited By ~ 2

Author(s):

Jelena Djuriš ◽

Djordje Medarević ◽

Marko Krstić ◽

Ivana Vasiljević ◽

Ivana Mašić ◽

...

Keyword(s):

Process Parameters ◽

Design Space ◽

Quality Attributes ◽

Dissolution Profile ◽

Compression Force ◽

Critical Quality Attributes ◽

Fluid Bed ◽

Fluid Bed Granulation ◽

Atomization Pressure ◽

Space Approach

The aim of this study was to optimize fluid bed granulation and tablets compression processes using design space approach. Type of diluent, binder concentration, temperature during mixing, granulation and drying, spray rate, and atomization pressure were recognized as critical formulation and process parameters. They were varied in the first set of experiments in order to estimate their influences on critical quality attributes, that is, granules characteristics (size distribution, flowability, bulk density, tapped density, Carr's index, Hausner's ratio, and moisture content) using Plackett-Burman experimental design. Type of diluent and atomization pressure were selected as the most important parameters. In the second set of experiments, design space for process parameters (atomization pressure and compression force) and its influence on tablets characteristics was developed. Percent of paracetamol released and tablets hardness were determined as critical quality attributes. Artificial neural networks (ANNs) were applied in order to determine design space. ANNs models showed that atomization pressure influences mostly on the dissolution profile, whereas compression force affects mainly the tablets hardness. Based on the obtained ANNs models, it is possible to predict tablet hardness and paracetamol release profile for any combination of analyzed factors.

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Development of freeze-drying cycle via design space approach: a case study on vaccines

Pharmaceutical Development and Technology ◽

10.1080/10837450.2020.1806298 ◽

2020 ◽

Vol 25 (10) ◽

pp. 1302-1313

Author(s):

Bernadette Scutellà ◽

Erwan Bourlès

Keyword(s):

Freeze Drying ◽

Design Space ◽

Space Approach

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Design space approach in the optimization of the spray-drying process

European Journal of Pharmaceutics and Biopharmaceutics ◽

10.1016/j.ejpb.2011.09.014 ◽

2012 ◽

Vol 80 (1) ◽

pp. 226-234 ◽

Cited By ~ 81

Author(s):

Pierre Lebrun ◽

Fabrice Krier ◽

Jérôme Mantanus ◽

Holger Grohganz ◽

Mingshi Yang ◽

...

Keyword(s):

Spray Drying ◽

Design Space ◽

Drying Process ◽

Space Approach

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A Novel Framework to Aid the Development of Design Space across Multi-Unit Operation Pharmaceutical Processes—A Case Study of Panax Notoginseng Saponins Immediate Release Tablet

Pharmaceutics ◽

10.3390/pharmaceutics11090474 ◽

2019 ◽

Vol 11 (9) ◽

pp. 474 ◽

Cited By ~ 1

Author(s):

Fei Sun ◽

Bing Xu ◽

Shengyun Dai ◽

Yi Zhang ◽

Zhaozhou Lin ◽

...

Keyword(s):

Process Modeling ◽

Design Space ◽

Panax Notoginseng ◽

Immediate Release ◽

Path Model ◽

Unit Operation ◽

Panax Notoginseng Saponins ◽

Holistic View ◽

Unit Operations ◽

Release Tablet

The fundamental principle of Quality by Design (QbD) is that the product quality should be designed into the process through an upstream approach, rather than be tested in the downstream. The keystone of QbD is process modeling, and thus, to develop a process control strategy based on the development of design space. Multivariate statistical analysis is a very useful tool to support the implementation of QbD in pharmaceutical process development and manufacturing. Nowadays, pharmaceutical process modeling is mainly focused on one-unit operations and system modeling for the development of design space across multi-unit operations is still limited. In this study, a general procedure that gives a holistic view for understanding and controlling the process settings for the entire manufacturing process was investigated. The proposed framework was tested on the Panax Notoginseng Saponins immediate release tablet (PNS IRT) production process. The critical variables and the critical units acting on the process were identified according to the importance of explaining the variability in the multi-block partial least squares path model. This improved understanding of the process by illustrating how the properties of the raw materials, the process parameters in the wet granulation and the compaction and the intermediate properties affect the tablet properties. Furthermore, the design space was developed to compensate for the variability source from the upstream. The results demonstrated that the proposed framework was an important tool to gain understanding and control the multi-unit operation process.

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