Quality by design (QbD) approach for developing agglomerates containing racecadotril and loperamide hydrochloride by crystallo-co-agglomeration

Garala, Kevin; Patel, Jay; Dhingani, Anjali; Dharamsi, Abhay

doi:10.1016/j.powtec.2013.07.011

Cited by 15 publications

(19 citation statements)

References 73 publications

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“…Racecadotril release from three granule formulations was determined in an USP II apparatus (900 mL 50 mM phosphate buffer pH 6.8 containing 0.75% w/v SLS [29], 75 rpm, 37 °C, sink conditions, n = 3) (VK 7010, Vankel…”

Section: Conventional Dissolution Testmentioning

confidence: 99%

Development of a discriminative biphasic in vitro dissolution test and correlation with in vivo pharmacokinetic studies for differently formulated racecadotril granules

Deng

Staufenbiel

Hao

et al. 2017

Journal of Controlled Release

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Section: Conventional Dissolution Testmentioning

confidence: 99%

Development of a discriminative biphasic in vitro dissolution test and correlation with in vivo pharmacokinetic studies for differently formulated racecadotril granules

Deng

Staufenbiel

Hao

et al. 2017

Journal of Controlled Release

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“…While, Table exhibited statistical significance of Quadratic order terms in the regression equation to predict hydrodynamic size, PDI and zeta potential, and these were further validated on the basis of sequential model sum of square test, fisher‐ratio value and P value . Strong and independent mathematical relationship and their order between the independent variables to the responses established on the basis of different statistical tests such as, sequential model sum of square, and model summary statistics and their values were given Table . While, on the basis of p and F‐test value of Table and Table , analysis of variance (ANOVA) tested statistical significance and impact of coefficients of selected model i.e., linear, interaction and quadratics terms…”

Section: Resultsmentioning

confidence: 99%

“…QbD approaches during synthesis of nanoparticles, emphasis upon holistic approach for assessment of risk factors, their impact on desired quality attributes of formulation as well as mathematical modeling of parameters in such a way that it enables strict regulation of these process variables as well as predict the final performance of yield . In this perspective, on the basis of QTPPs (quality targeted product profile) role and impact of different levels of volume of gum, volume of gold and temperature were designated as CMAs (Critical material attributes) on performance of reaction i.e., CQAs (critical quality attributes) such as particle size, P.D.I (particle distribution index) and zeta potential were investigated using QbD (Box‐Benhken) integrated approach .…”

Section: Introductionmentioning

confidence: 99%

QbD approached comparison of reaction mechanism in microwave synthesized gold nanoparticles and their superior catalytic role against hazardous nirto‐dye

Alam

Javed

Pottoo

et al. 2019

Applied Organom Chemis

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Microwave irradiation (MI) process characteristically enables extremely rapid “in‐core” heating of dipoles and ions, in comparison to conventional thermal (conductance) process of heat transfer. During the process of nanoparticles synthesis, MI both modulates functionality behaviors as well as dynamic of reaction in favorable direction. So, MI providing a facile, favorable and alternative approach during nanoparticles synthesis nanoparticles with enhanced catalytic performances. Although, conventionally used reducing and capping reagents of synthetic origin, are usually environmentally hazardous and toxic for living organism. But, in absence of suitable capping agent; stability, shelf life and catalytic activity of metallic nanoparticles adversely affected. However, polymeric templates which emerged as suitable choice of agent for both reducing and capping purposes; bearing additional advantages in terms of catalyst free one step green synthesis process with high degree of biosafety and efficiency. Another aspect of current works was to understand role of process variables in growth mechanism and catalytic performances of microwave processed metallic nanoparticles, as well as comparison of these parameters with conventional heating method. However, due to poor prediction ability with previously published architect OFAT (One factor at a time) design with these nanoparticles as well as random selection of process variables with their different levels, such comparison couldn't be possible. Hence, using gum Ghatti (Anogeissus latifolia) as a model bio‐template and under simulated reaction conditions; architect of QbD design systems were integrated in microwave processed nanoparticles to establish mechanistic role these variables. Furthermore, in comparison to conventional heating; we reported well validated mathematical modeling of process variables on characteristic of nanoparticles as well as synthesized gold nanoparticles of desired and identical dimensions, in both thermal and microwave‐based processes. Interestingly, despite of identical dimension, MI processed gold nanoparticles bearing higher efficiency (kinetic rate) against remediation of hazardous nitro dye (4‐nitrophenol), into safer amino (4‐aminophenol) analogues.

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“…SA were prepared by a slight modification to the quasi-emulsion 42 and crystallo-co-agglomeration. 43 , 44 Glimepiride (150mg) was dissolved in 2ml dimethyl formamide at 25°C. To this solution were added Aerosil 200 (150mg) as dispersing agent 45 and Starlac (0.5% w/v) as carrier 46 with continuous agitation using a three-blade mechanical stirrer at 500 rpm to keep the suspension uniformly dispersed.…”

Section: Methodsmentioning

confidence: 99%

The Impact of Amorphisation and Spheronization Techniques on the Improved in Vitro & in Vivo Performance of Glimepiride Tablets

et al. 2017

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Purpose: Triple solid dispersion adsorbates (TSDads) and spherical agglomerates (SA) present new techniques that extensively enhance dissolution of poorly soluble drugs. The aim of the present study is to hasten the onset of hypoglycemic effect of glimepiride through enhancing its rate of release from tablet formulation prepared from either technique.Methods: Drug release from TSDads or SA tablets with different added excipients was explored. Scanning electron microscopy (SEM) and effect of compression on dissolution were illustrated. Pharmacodynamic evaluation was performed on optimized tablets.Results: TSDads & SA tablets with Cross Povidone showed least disintegration times of 1.48 and 0.5 min. respectively. Kinetics of drug release recorded least half-lives (54.13 and 59.83min for both techniques respectively). Cross section in tablets displayed an organized interconnected matrix under SEM, accounting for the rapid access of dissolution media to the tablet core. Components of tablets filled into capsules showed a similar release profile to that of tablets after compression as indicated by similarity factor. The onset time of maximum reduction in blood glucose in male albino rabbits was hastened to 2h instead of 3h for commercial tablets.Conclusion: After optimization of tablet excipients that interacted differently with respect to their effect on drug release, we could conclude that both amorphisation and spheronization were equally successful in promoting in vitro dissolution enhancement as well as providing a more rapid onset time for drug action in vivo.

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Quality by design (QbD) approach for developing agglomerates containing racecadotril and loperamide hydrochloride by crystallo-co-agglomeration

Cited by 15 publications

References 73 publications

Development of a discriminative biphasic in vitro dissolution test and correlation with in vivo pharmacokinetic studies for differently formulated racecadotril granules

Development of a discriminative biphasic in vitro dissolution test and correlation with in vivo pharmacokinetic studies for differently formulated racecadotril granules

QbD approached comparison of reaction mechanism in microwave synthesized gold nanoparticles and their superior catalytic role against hazardous nirto‐dye

The Impact of Amorphisation and Spheronization Techniques on the Improved in Vitro & in Vivo Performance of Glimepiride Tablets

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