Assessing gastrointestinal motility and disintegration profiles of magnetic tablets by a novel magnetic imaging device and gamma scintigraphy

Goodman, Kirsteen; Hodges, Lee Ann; Band, Janet; Stevens, H. N. E.; Weitschies, Werner; Wilson, Clive G.

doi:10.1016/j.ejpb.2009.01.004

Cited by 46 publications

(90 citation statements)

References 34 publications

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“…The movement of tablets during this phase is rapid and tablets are subject to increased mechanical stress, especially during gastric emptying (10,11). The destructive forces in the human stomach and small intestine were measured using a "Destructive forceDependent Release System", and the results obtained were 1.9 and 1.2 N, respectively (12).…”

Section: Introductionmentioning

confidence: 99%

Correlating Cellulose Derivative Intrinsic Viscosity with Mechanical Susceptibility of Swollen Hydrophilic Matrix Tablets

Klančar¹,

Horvat²,

Baumgartner

2012

AAPS PharmSciTech

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Abstract. Hydrophilic matrix tablets are prone to mechanical stress while passing through the gastrointestinal tract, which may result in inappropriate drug-release characteristics. Intrinsic viscosity is a physical polymer property that can be directly compared across various types and grades of polymers and correlated with the mechanical susceptibility of swollen matrix tablets. Five tablet formulations containing different HPMC and HPC polymers were prepared and analyzed using an in vitro glass bead manipulation test. The dissolution rate results were modeled using the Korsmeyer-Peppas equation and a correlation was found between the fit constants k and n, goodness-of-fit measure parameters, and intrinsic viscosity. Moreover, the dissolution profiles were used to calculate the degree of mechanical susceptibility for each formulation, defined as the ratio of the average dissolution rate after manipulation and the initial dissolution rate before manipulation. It was confirmed that an increased intrinsic viscosity polymer value resulted in a decrease in mechanical susceptibility. Considering this, two simple rules were defined for designing robust matrix tablets with respect to mechanical stresses.

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Section: Introductionmentioning

confidence: 99%

Correlating Cellulose Derivative Intrinsic Viscosity with Mechanical Susceptibility of Swollen Hydrophilic Matrix Tablets

Klančar¹,

Horvat²,

Baumgartner

2012

AAPS PharmSciTech

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“…The tablets were weighed and placed on the top of the beads, and the cylinders were attached to the Bio-dis. The polypropylene mesh size on the top and (14,15). To evaluate the effect of beads, the test was run also without beads using the same DPM settings.…”

Section: Apparatus 3 and Bead Dissolution Testing Methodsmentioning

confidence: 99%

“…There is also evidence that food intake stimulates the transport of the GI content from the terminal small intestine into the colon, a mechanism that is known as the gastro-ileal or gastro-ileocecal reflex, which can again exert elevated pressures on the matrix tablet. This phenomenon can be important when administrating food some hours after the intake of the matrix tablet (14,15).…”

Section: Introductionmentioning

confidence: 99%

“…In the fasted state, the stress exerted on the tablet during a GI transit depends mostly on the migrating myoelectric complex (MMC), which cycles every 90-120 min and normally starts in the stomach. The movement of the tablets during first and second MMC phase is relatively slow; however, during the short, gastric emptying phase (phase III), the tablets are prone to a greater mechanical stress, since stomach contractions are intense (13)(14)(15)(16). The gastrointestinal transit times, hydrodynamics, gastric emptying rates, and forces have been studied in vivo using different techniques (14,15,17).…”

Section: Introductionmentioning

confidence: 99%

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A Novel Beads-Based Dissolution Method for the In Vitro Evaluation of Extended Release HPMC Matrix Tablets and the Correlation with the In Vivo Data

Klančar¹,

Markun²,

Baumgartner

et al. 2012

AAPS J

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Abstract. The aim of this work was to establish alternative in vitro dissolution method with good discrimination and in vivo predictability for the evaluation of HPMC extended release matrix tablets. For this purpose, two different HPMC matrix tablet formulations were first evaluated by a range of conventional dissolution testing methods using apparatus 1, apparatus 2, and apparatus 3 according to US Pharmacopoeia. Obtained results showed low discrimination between the tested samples. Afterward, a novel dissolution testing method which combines plastic beads and apparatus 3 was developed with the aim to better mimic the mechanical forces that occur in vivo. Results showed that sufficiently large mechanical stress with high dips per minute program setting (apparatus 3) was needed to obtain in vitro discriminative results, which are in accordance with the in vivo data. The in vivo relevance of the method was confirmed with the establishment of the level A in vitro-in vivo correlation.

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“…In fact, there are some alternative nonradionuclide procedures that the specialist in gastroenterology can use in his/her own environment (chiefly based on the breath test principle, and more recently on the use of wireless motility capsules) to obtain seemingly the same diagnostic information as that derived from a classical radionuclide gastrointestinal transit studies; however, there is no perfect correspondence between nonradionuclide and radionuclide-based investigation modalities, with the latter mirroring as closely as possible the true physiology of gastrointestinal motility [9][10][11][12][13][14][15]. This scenario favours local variations in protocols introduced to meet specific expectations of the referring specialists, making standardization among different centres difficult.…”

mentioning

confidence: 99%

Joint SNMMI and EANM guideline for small-bowel and colon transit: an important step towards long-awaited standardization

Mariani

Paglianiti

2014

Eur J Nucl Med Mol Imaging

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The recent publication in the Journal of Nuclear Medicine of the joint SNMMI and EANM practice guideline for smallbowel and colon transit [1] follows the new strategy that the two societies have adopted with the praiseworthy goal of standardizing and harmonizing the practice of nuclear medicine across nations. This was initiated about 2 years ago with a master document describing the methodology (or, preliminarily, guideline) for the two societies to develop joint practice guidelines [2]. Soon afterwards, groups of experts designated by the two societies jointly started to develop up-to-date practice guidelines for nuclear medicine procedures at the cutting edge of the discipline on the use of [ 18 F]FDG for imaging inflammation and infection [3], on peptide receptor radionuclide therapy [4], and on radioguided sentinel lymph node biopsy in patients with breast cancer [5]. Work is also in progress to define joint practice guidelines for other nuclear medicine procedures as well.In principle, the study of gastrointestinal transit is not a new cutting-edge procedure in nuclear medicine, as these studies have been employed for over 40 years [6,7]. Therefore, the technique should no longer be considered in the early phases of clinical application, when protocols vary in several respects among different centres, not unlike what is observed today in the imaging field when a new method is introduced; variable acquisition and processing protocols for magnetic resonance imaging fit well with this notion [8]. Nevertheless, radionuclide gastrointestinal transit studies (in relation especially to small-bowel and colon transit) still suffer from a considerable degree of heterogeneity among different nuclear medicine centres concerning important practical aspects not only of the procedure itself (such as, for example, preparation and composition of the radiolabelled meal, acquisition modalities, and semiquantitative assessment of the data obtained), but also in the way the results are reported. This heterogeneity is due at least in part to different availabilities among different countries of standardized basic components of a radiolabelled meal (e.g. the commercial generally used egg white preparation available only in the US). Other sources of heterogeneity stem from country-specific variations in the balance of the basic nutrients (i.e. carbohydrates, proteins, fats), and in variable palatability in different cultures in relation to food composition.On the other hand, it should not be disregarded that, from the nuclear medicine point of view, gastrointestinal transit studies constitute in general a "niche" activity with a limited number of procedures when compared with most radionuclide imaging procedures commonly performed in any nuclear medicine centre. In fact, there are some alternative nonradionuclide procedures that the specialist in gastroenterology can use in his/her own environment (chiefly based on the breath test principle, and more recently on the use of wireless motility capsules) to obtain seemingly the same ...

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Assessing gastrointestinal motility and disintegration profiles of magnetic tablets by a novel magnetic imaging device and gamma scintigraphy

Cited by 46 publications

References 34 publications

Correlating Cellulose Derivative Intrinsic Viscosity with Mechanical Susceptibility of Swollen Hydrophilic Matrix Tablets

Correlating Cellulose Derivative Intrinsic Viscosity with Mechanical Susceptibility of Swollen Hydrophilic Matrix Tablets

A Novel Beads-Based Dissolution Method for the In Vitro Evaluation of Extended Release HPMC Matrix Tablets and the Correlation with the In Vivo Data

Joint SNMMI and EANM guideline for small-bowel and colon transit: an important step towards long-awaited standardization

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