Interaction between fed gastric media (Ensure Plus®) and different hypromellose based caffeine controlled release tablets: Comparison and mechanistic study of caffeine release in fed and fasted media versus water using the USP dissolution apparatus 3

Franek, Frans; Holm, Per; Larsen, Frank; Steffansen, Bente

doi:10.1016/j.ijpharm.2013.12.003

Cited by 37 publications

(24 citation statements)

References 32 publications

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“…Based on the median RSD, higher measurement reproducibility was observed with the higher dissolution volume (250 mL) and higher agitation rate (7 LPM; ANOVA p < 0.05). Although, the 100 mL of dissolution medium represented a sufficient sink condition for caffeine (>5 × volume of saturated solution; aqueous solubility 32–39 mg/mL, at 37 °C), we observed a significantly higher dissolution in 250 mL volume (ANOVA mixed models approach to within-subject factors, p < 0.001, and paired t -test for all compared pairs, p < 0.05), confirmed also by PCA biplot ( Figure 7 ) [ 19 ]. The effect of dissolution volume was statistically significant for all compartments (ANOVA mixed models approach to within-subject factors, p < 0.001, and paired t -test for all compared pairs, p < 0.05).…”

Section: Resultssupporting

confidence: 74%

Optimization of Dissolution Compartments in a Biorelevant Dissolution Apparatus Golem v2, Supported by Multivariate Analysis

et al. 2017

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Biorelevant dissolution instruments represent an important tool for pharmaceutical research and development. These instruments are designed to simulate the dissolution of drug formulations in conditions most closely mimicking the gastrointestinal tract. In this work, we focused on the optimization of dissolution compartments/vessels for an updated version of the biorelevant dissolution apparatus—Golem v2. We designed eight compartments of uniform size but different inner geometry. The dissolution performance of the compartments was tested using immediate release caffeine tablets and evaluated by standard statistical methods and principal component analysis. Based on two phases of dissolution testing (using 250 and 100 mL of dissolution medium), we selected two compartment types yielding the highest measurement reproducibility. We also confirmed a statistically ssignificant effect of agitation rate and dissolution volume on the extent of drug dissolved and measurement reproducibility.

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Section: Resultssupporting

confidence: 74%

Optimization of Dissolution Compartments in a Biorelevant Dissolution Apparatus Golem v2, Supported by Multivariate Analysis

et al. 2017

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“…I (c). The GEMM protocol includes an innovative mixed meal challenge [ 38 ] containing a well-defined macronutrient composition based on recommended daily values (Ensure Plus ® ) [ 39 ], dosed at 30% of each subject’s daily resting energy expenditure allowing a much greater opportunity to screen for early postprandial detection of an adverse metabolic response. It has been documented that risk factors for adverse cardiovascular events can be detected in the pre-diabetic insulin-resistant subject based upon the metabolic response to a meal challenge even in the absence of altered fasting parameters.…”

Section: Discussionmentioning

confidence: 99%

Deep Multi-OMICs and Multi-Tissue Characterization in a Pre- and Postprandial State in Human Volunteers: The GEMM Family Study Research Design

Bastarrachea

Laviada-Molina

Nava‐González

et al. 2018

Genes

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Cardiovascular disease (CVD) and type 2 diabetes (T2D) are increasing worldwide. This is mainly due to an unhealthy nutrition, implying that variation in CVD risk may be due to variation in the capacity to manage a nutritional load. We examined the genomic basis of postprandial metabolism. Our main purpose was to introduce the GEMM Family Study (Genetics of Metabolic Diseases in Mexico) as a multi-center study carrying out an ongoing recruitment of healthy urban adults. Each participant received a mixed meal challenge and provided a 5-hours’ time course series of blood, buffy coat specimens for DNA isolation, and adipose tissue (ADT)/skeletal muscle (SKM) biopsies at fasting and 3 h after the meal. A comprehensive profiling, including metabolomic signatures in blood and transcriptomic and proteomic profiling in SKM and ADT, was performed to describe tendencies for variation in postprandial response. Our data generation methods showed preliminary trends indicating that by characterizing the dynamic properties of biomarkers with metabolic activity and analyzing multi-OMICS data it could be possible, with this methodology and research design, to identify early trends for molecular biology systems and genes involved in the fasted and fed states.

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“…This indicates that as the polymer concentration increased, the drug release rate was found to be retarded 23 . The batch M6 offered a better sustained release profile with 130 mg HPMC K100M polymer mix, leading to release of 90.1% in 10 h Table 8.…”

Section: Fig 4: In-vitro Drug Release: (A) Sustained Release Layers mentioning

confidence: 91%

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2018

IJPSR

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In order to effectively manage the diabetic mellitus type-II hyperglycemic surge, bilayered tablets comprising of gliclazide in immediate release layer (IRL) and metformin in sustained release layer (SRL) have been designed and fabricated for years. Gliclazide suffers from reduced aqueous solubility of 0.19 mg/mL which remained a crucial problem for the biological effect as a result of reduced dissolution and bioavailability. Therefore, in this research an effort was done to improve the aqueous solubility of gliclazide in a bilayer tablet by forming solid dispersions which will provide prompt release to completely manage the postprandial effectually. In this study, a bilayer tablet of gliclazide solid dispersion in IRL and metformin in SRL were fabricated by direct compression method, with an intention that the IRL of the formulation will release the gliclazide at its earliest to combat the postprandial hyperglycemic level followed by a control of steady state plasma glucose by sustained release metformin. The compatibility studies, pre-compression studies, post-compression studies, disintegration studies, dissolution studies, and kinetic release studies were performed. The formulation B3 was found to be highly optimized and demonstrated the highest cumulative drug release where the metformin followed the either zero-order or first-order and the gliclazide followed anomalous diffusion. Therefore, the designed formulation will offer a better therapeutic regimen and provide patient friendly postprandial hypoglycemic management, where an immediate control and maintenance dose are required.

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Interaction between fed gastric media (Ensure Plus®) and different hypromellose based caffeine controlled release tablets: Comparison and mechanistic study of caffeine release in fed and fasted media versus water using the USP dissolution apparatus 3

Cited by 37 publications

References 32 publications

Optimization of Dissolution Compartments in a Biorelevant Dissolution Apparatus Golem v2, Supported by Multivariate Analysis

Optimization of Dissolution Compartments in a Biorelevant Dissolution Apparatus Golem v2, Supported by Multivariate Analysis

Deep Multi-OMICs and Multi-Tissue Characterization in a Pre- and Postprandial State in Human Volunteers: The GEMM Family Study Research Design

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