A quality by design approach on polymeric nanocarrier delivery of gefitinib: formulation, in vitro, and in vivo characterization

Srinivas, Navya Sree Kola; Verma, Ruchi; Kulyadi, Girish Pai; Kumar, Lalit

doi:10.2147/ijn.s122729

Cited by 73 publications

(29 citation statements)

References 55 publications

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“…Particle size analysis of fabricated EENPs was measured using Zetasizer 300 HAS (Malvern Instruments, Malvern, UK), while entrapment efficiency and drug content was determined using UV-visible spectrophotometer (Jasco V-530, Japan ) at 280 nm wavelength, which was used for PAT for particle size, entrapment efficiency and drug content analysis. 30,35,41…”

Section: 5 Process Analytical Technology (Pat) -Particle Size Anamentioning

confidence: 99%

“…The particle size, entrapment efficiency and drug content of fabricated EENPs was found to be in the range of 221-309 nm, 89.45-98.76 %, and 80.91 to 92.46 %, respectively. 30…”

Section: Process Analytical Technology (Pat) -Particle Analysis Ementioning

confidence: 99%

“…This indicates higher the value of desirability, more is the possibility to achieve the target. 30 The final formulation was prepared with optimized CMAs and CPPs, and its CQAs were analyzed. The actual results and predicted results of CQAs were further used to calculate the residual values to ensure the achievement of design space.…”

Section: Optimization Model Validationmentioning

confidence: 99%

“…Hence, the aim of the present study was to prepare the ethinyl estradiol NS with QbD approach in order to obtain the effect of CMAs and CPPs on critical quality attributes (CQAs), improvement of safety and quality of the formulation, reduction in the manufacturing variability, and controlling the manufacturing cost. 30 For the planning of experiments, usage of statistical design of experiments (DOE) is an efficient tool. Plackett Burman (PB) of screening experiment and the Central Composite Design (CCD) of response surface methodology (RSM) are a well-set approach for optimization and development of pharmaceutical formulations, allowing acquisition of maximal data from a lesser number of well-designed experimental batches.…”

Section: Introductionmentioning

confidence: 99%

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QbD Based Approach to Enhance the In-Vivo Bioavailability of Ethinyl Estradiol in Sprague-Dawley Rats

Powar

Hajare

2020

ACSi

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Lyophilized nanosuspension of poorly soluble Ethinyl estradiol (EE) was fabricated to enhance its solubility and bioavailability using a quality-by-design (QbD) approach. With the help of the Ishikawa diagram, prospective risk factors were identified and screened by Placket-Burman design to investigate the effects of formulation and process variables on dependent variables. The number of cycles (X4), the concentration of soya lecithin (X5) and the concentration of tween 80 (X7) were identified as significant factors (P<0.05), which were further optimized using Central Composite Design. The mean particle size, zeta potential, drug content and entrapment efficiency of optimized lyophilized EE nanosuspension (EENPs) was 220 ± 0.37 nm,-19.3 ± 6.73 mV, 92.23 ± 0.45%, 99.52 ± 0.52%, respectively. Significantly, EENPs enhances C max and AUC 0-t by 1.5, 1.7 folds and relative bioavailability by 2-fold with its distribution being at higher concentrations in the liver, spleen, and stomach. Thus, QbD based approach for the development of nanosuspension could be an absolute, optimistic approach to identify the critical process parameters and critical quality attributes.

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Section: 5 Process Analytical Technology (Pat) -Particle Size Anamentioning

confidence: 99%

“…The particle size, entrapment efficiency and drug content of fabricated EENPs was found to be in the range of 221-309 nm, 89.45-98.76 %, and 80.91 to 92.46 %, respectively. 30…”

Section: Process Analytical Technology (Pat) -Particle Analysis Ementioning

confidence: 99%

Section: Optimization Model Validationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

QbD Based Approach to Enhance the In-Vivo Bioavailability of Ethinyl Estradiol in Sprague-Dawley Rats

Powar

Hajare

2020

ACSi

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“…[10,11] Meloxicam (MLX), the member of the oxicam family is a non-steroidal anti-inflammatory drug (NSAID) and belongs to BCS class II drugs. [19,20] By using this software, various approaches such as factorial design, CCD, etc., can be implemented to develop a formulation. [17] The longer half-life is one of the important properties of oxicam family, which makes it possible to deliver the drug once a day.…”

Section: Introductionmentioning

confidence: 99%

In vitro and ex vivo assessment of hydrophilic polymer‐ and plasticizer‐based thin buccal films designed by using central composite rotatable design for the delivery of meloxicam

Zaman

Hanif

2017

Adv Polym Technol

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The purpose of the study was to design a dosage form with ability to deliver drug immediately, hence providing rapid relief in certain pain ailments. Meloxicam (MLX) was selected as a model drug and buccal films were designed by using the solvent casting technique. A central composite rotatable design (CCRD) was used as a statistical tool to design and optimize the film formulations. No noticeable interaction was found between the drug and polymer when they were subjected to Fourier transform infrared spectroscopy (FTIR). Scanning electron microscopy (SEM) revealed the smooth surface of the film and uniform mixing of drug and polymer.X-ray diffractometry (XRD) was carried out to observe crystalline and amorphous nature of meloxicam. Differential scanning calorimetric (DSC) analysis was used to investigate the thermal behavior of free drug and drug-loaded formulation. The prepared film showed good mechanical property as folding endurance was found to be greater than 100 in all formulations. The cumulative drug release was found to be more than 80% in initial at dissolution time of 5 min, when the prepared films were subjected to dissolution studies in phosphate buffer at pH 6.8. Thus, it can be concluded that the hydrophilic polymer and plasticizer have definite impact on formulation and characteristics of rapidly dissolving buccal films and have the ability to prepare a suitable immediate release buccal film of meloxicam. K E Y W O R D Sbuccal films, drug delivery system, ex-vivo permeation, hydrophilic polymer, meloxicam, plasticizer, solvent casting method

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Pharmaceutical quality by design in academic nanomedicine research: stifling innovation or creativity through constraint?

Dailey¹

2018

J of Interdiscip Nanomed

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Pharmaceutical quality by design (QbD) is a systematic approach to drug development that begins with predefined objectives and emphasises product and process understanding and control based on sound science and quality risk management. First and foremost, QbD is an experimental design philosophy, which emphasises the value of thorough intellectual planning prior to the commencement of laboratory studies. Academic researchers whose ambitions lie in translational science may benefit from the lessons learned by the pharmaceutical industry following implementation of QbD into their development philosophy. However, because of the very interdisciplinary nature of academic nanomedicine research, it is likely that very few investigators are aware of QbD and how aspects of it may be judiciously implemented in an academic research setting. This review provides an introduction to the main elements of QbD and gives examples of case studies where QbD has been applied to nanomedicine research.

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A quality by design approach on polymeric nanocarrier delivery of gefitinib: formulation, in vitro, and in vivo characterization

Cited by 73 publications

References 55 publications

QbD Based Approach to Enhance the In-Vivo Bioavailability of Ethinyl Estradiol in Sprague-Dawley Rats

QbD Based Approach to Enhance the In-Vivo Bioavailability of Ethinyl Estradiol in Sprague-Dawley Rats

In vitro and ex vivo assessment of hydrophilic polymer‐ and plasticizer‐based thin buccal films designed by using central composite rotatable design for the delivery of meloxicam

Pharmaceutical quality by design in academic nanomedicine research: stifling innovation or creativity through constraint?

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