scholarly journals Optimization of protein loaded PLGA nanoparticle manufacturing parameters following a quality-by-design approach

RSC Advances ◽  
2016 ◽  
Vol 6 (106) ◽  
pp. 104502-104512 ◽  
Author(s):  
V. Sainz ◽  
C. Peres ◽  
T. Ciman ◽  
C. Rodrigues ◽  
A. S. Viana ◽  
...  
Keyword(s):  
Regression Model ◽  
Glycolic Acid ◽  
Quality By Design ◽  
Design Space ◽  
Double Emulsion ◽  
Solvent Evaporation Method ◽  
Quality By Design Approach ◽  
Plga Nanoparticle ◽  
Manufacturing Parameters ◽  
Nanoparticle Manufacturing

This paper explores the development of a multivariate-based regression model for estimating the critical attributes to establish a design-space for poly(lactic-co-glycolic acid) nanoparticles prepared by a double emulsion–solvent evaporation method.

scholarly journals Evaluating the Properties of Poly(lactic-co-glycolic acid) Nanoparticle Formulations Encapsulating a Hydrophobic Drug by Using the Quality by Design Approach

2017 ◽  
Vol 65 (3) ◽  
pp. 218-228 ◽  
Author(s):  
Masato Kozaki ◽  
Shin-ichiro Kobayashi ◽  
Yukihiro Goda ◽  
Haruhiro Okuda ◽  
Kumiko Sakai-Kato
Keyword(s):  
Glycolic Acid ◽  
Quality By Design ◽  
Design Approach ◽  
Hydrophobic Drug ◽  
Quality By Design Approach

scholarly journals Quality by Design Approach for Development and Validation of Stability Indicating RP-HPLC Method for Fosaprepitant Dimeglumine

2020 ◽  
Vol 32 (9) ◽  
pp. 2158-2164
Author(s):  
JALIL K. SHAIKH ◽  
MAZAHAR FAROOQUI ◽  
UMMUL KHAIR ASEMA SYED
Keyword(s):  
Mobile Phase ◽  
Quality By Design ◽  
Orthophosphoric Acid ◽  
Design Space ◽  
Acid Base ◽  
Column Temperature ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Hydrogen Sulphate ◽  
Quality By Design Approach

Quality by design approach has been used to develop simple, rapid, sensitive gradient RP-HPLC stability indicating method for fosaprepitant dimeglumine and its related impurities. The chromatographic method has been developed by using symmetry shield RP-18 (250 mm × 4.6 mm; 5 μm) column maintained at column temperature of 20 ºC. The mobile phase-A consisted of water and acetonitrile (800:200, v/v), added 2 mL of orthophosphoric acid and 0.17 g of tetrabutylammonium hydrogen sulphate. The mobile phase-B consisted of water and acetonitrile (200:800, v/v), added 2 mL of orthophosphoric acid and 0.17 g of tetrabutylammonium hydrogen sulphate. Gradient program was executed as time (min)/% MP-A: 0/80, 3/80, 12/40, 20/20, 24/20, 25/80, and 30/80. The UV detection was carried out at wavelength 210 nm and 20 μL of sample was injected. Sample cooler was maintained at 5 ºC. Stability of fosaprepitant dimeglumine sample was investigated in different stress condition as acid, base, oxidation, thermal, humidity and photolytic. The method was developed in two phases, screening and optimization. During the screening phase, the most suitable stationary phase, organic modifier, and solvent were identified based on the behaviour of each stationary phase with fosaprepitant dimeglumine and its impurities using each buffer and solvent. Total 18 experiments were performed to find out the best experimental condition. The optimization was done for secondary influential parameters like column temperature, gradient program, using six experiments to examine multifactorial effects of system suitability parameters and generated design space representing the robust region. A verification experiment was performed within the working design space and the model was accurate. Drug showed unstable behaviour under acid, base, oxidation, thermal, and humidity conditions. Apripetant was found as major degradation impurity. The method was validated as per ICH guideline for specificity, limit of detection (LOD), limit of quantitation (LOQ), linearity, accuracy, precision, ruggedness and robustness. Correlation coefficient is about 0.999 for all impurities, recovery is between 90% to 103% at all level. LOD value of each impurity is less than 0.01% w/w. DOE statistically based experimental designs proved to be an important approach in optimizing selectivity-controlling parameters for the organic impurities determination in FD API. The method was found to be specific, linear, accurate, precise and robust. The peak purity test results confirmed that the fosaprepitant dimeglumine peak was homogenous in all stress samples and the mass balance was found to be more than 99%, thus proving the stability indicating power of the method. Present method is found to be suitable for routine analysis in quality control laboratory.

scholarly journals Quality by Design approach in the development of a magnetic transducer for biomedical measurements: preliminary results on Design Space configuration

2016 ◽  
Vol 772 ◽  
pp. 012016 ◽  
Author(s):  
D R Louzada ◽  
E C Monteiro ◽  
A M Rivero ◽  
L G S Fortaleza ◽  
C R H Barbosa ◽  
...  
Keyword(s):  
Quality By Design ◽  
Design Space ◽  
Design Approach ◽  
Preliminary Results ◽  
Magnetic Transducer ◽  
Quality By Design Approach ◽  
Biomedical Measurements

scholarly journals Formulation and Evaluation of Herbal Shampoo: A Comparative Study By DoE/QbD Approach

2022 ◽  
Vol 24 (1) ◽  
pp. 273-287
Author(s):  
Nikita R.Nikam ◽  
◽  
Yogita M. Kolekar ◽  
Keyword(s):  
Quality By Design ◽  
Design Space ◽  
Response Prediction ◽  
Statistical Concept ◽  
Screening Design ◽  
Main Effect ◽  
Powder Characteristics ◽  
Quality By Design Approach ◽  
Selection Of ◽  
Plot Design

Some ancient medications were used to make the hair care herbal shampoo powder. Organoglytics, powder characteristics, foam test, and physical evaluation were performed on Tulsi, Shikakai, Heena, Bahera, Amla, Neem, and Brahmi. Existing inspections will assist set standards and assessment criteria, which will undoubtedly aid to standardise the quality and purity of these herbal powder shampoos, due to the selection of drugs once the drugs are used together or jointly. We optimise the formula with the help of the Design of Experiments as per the Quality by Design approach. This paper illustrates broad theoretical as well as practical view of advanced screening design. In addition to the statistical concept‟s regression analysis, parato chart, residual diagnosis, main effect plot, interaction effect plot, design space and multiple response prediction.

Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: Towards a global multi‐step design space

2012 ◽  
Vol 101 (10) ◽  
pp. 3604-3618 ◽  
Author(s):  
Alex Eon-Duval ◽  
Pascal Valax ◽  
Thomas Solacroup ◽  
Hervé Broly ◽  
Ralf Gleixner ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Manufacturing Process ◽  
Quality By Design ◽  
Design Space ◽  
Drug Substance ◽  
Design Approach ◽  
Fc Fusion Protein ◽  
Quality By Design Approach

Quality by design approach of a pharmaceutical gel manufacturing process, part 1: Determination of the design space

2011 ◽  
Vol 100 (10) ◽  
pp. 4432-4441 ◽  
Author(s):  
Juan G. Rosas ◽  
Marcel Blanco ◽  
Josep M. González ◽  
Manel Alcalá
Keyword(s):  
Manufacturing Process ◽  
Quality By Design ◽  
Design Space ◽  
Design Approach ◽  
Quality By Design Approach
Sign in / Sign up

Export Citation Format

Share Document