Impact of the intragastric location of extended release tablets on food interactions

Weitschies, Werner; Wedemeyer, Ralph-Steven; Kosch, Olaf; Fach, Kilian; Nagel, Stefan; Söderlind, Erik; Trahms, Lutz; Abrahamsson, Bertil; Mönnikes, Hubert

doi:10.1016/j.jconrel.2005.08.018

Cited by 116 publications

(91 citation statements)

References 20 publications

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“…Although stirring rate is an important factor in dissolution testing, it is suggested that investigations related to mixing and agitation rates encountered in vivo also be conducted. [90][91][92][93][94][95][96] …”

Section: In Vitro Factorsmentioning

confidence: 99%

Assessing the performance of amorphous solid dispersions

Newman¹,

Knipp

Zografi

2012

Journal of Pharmaceutical Sciences

337

235

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Section: In Vitro Factorsmentioning

confidence: 99%

Assessing the performance of amorphous solid dispersions

Newman¹,

Knipp

Zografi

2012

Journal of Pharmaceutical Sciences

337

235

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“…This seems to be a distinct characteristic of the OROS formulation. From the biopharmaceutical point of view, such characteristics are very important, especially under fed conditions, when released drug substance can accumulate in the stomach for some time as described by Weitchies et al (31,32). As reported, the accumulation of released API in the stomach is independent of the dosage form delivery characteristics and occurs mainly in the proximal stomach.…”

Section: Comparison With Commercial Er Systems-potential Consequencesmentioning

confidence: 97%

Melts of Octaacetyl Sucrose as Oral-Modified Release Dosage Forms for Delivery of Poorly Soluble Compound in Stable Amorphous Form

Haznar-Garbacz

Kamińska

Żakowiecki³

et al. 2017

AAPS PharmSciTech

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Abstract. The presented work describes the formulation and characterization of modified release glassy solid dosage forms (GSDFs) containing an amorphous nifedipine, as a model BCS (Biopharmaceutical Classification System) class II drug. The GSDFs were prepared by melting nifedipine together with octaacetyl sucrose. Dissolution profiles, measured under standard and biorelevant conditions, were compared to those obtained from commercially available formulations containing nifedipine such as modified release (MR) tablets and osmotic release oral system (OROS). The results indicate that the dissolution profiles of the GSDFs with nifedipine are neither affected by the pH of the dissolution media, type and concentration of surfactants, nor by simulated mechanical stress of biorelevant intensity. Furthermore, it was found that the dissolution profiles of the novel dosage forms were similar to the profiles obtained from the nifedipine OROS. The formulation of GSDFs is relatively simple, and the dosage forms were found to have favorable dissolution characteristics.

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“…This stress phase was performed as three consecutive inflations of the balloons each with a duration of 6 s and a fortitude of 300 mbar mimicking peristaltic pressure waves. These pressure events were followed by 1 min of intense rotation of the apparatus axle at 100 rpm corresponding to tablet velocities ranging from 15 up to 60 cm/s mimicking accelerated tablet transport as observed during gastric emptying of tablets in humans (12,14). Small intestinal transit was simulated as discrete events of tablet movement simulated as each time five rotations of the apparatus axle at a velocity of 10 rpm that were looped every 10 min.…”

Section: Test Algorithmsmentioning

confidence: 99%

Release Characteristics of Quetiapine Fumarate Extended Release Tablets Under Biorelevant Stress Test Conditions

et al. 2013

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Abstract. The aim of the present work was the investigation of robustness and reliability of drug release from 50 to 400 mg quetiapine extended release HPMC matrix tablets towards mechanical stresses of biorelevant intensity. The tests were performed under standard conditions (USP apparatus II) as well as under simulated gastrointestinal stress conditions. Mechanical stresses including pressure and agitation were applied by using the biorelevant dissolution stress test apparatus as it has been introduced recently. Test algorithms already established in previous studies were applied to simulate fasting gastrointestinal conditions. The dissolution experiments demonstrated striking differences in the product performance among standard and stress test conditions as well as dose strengths. In USP apparatus II, dissolution profiles were affected mainly by media pH. The dissolution experiments performed in biorelevant dissolution stress test device demonstrated that stress events of biorelevant intensity provoked accelerated drug release from the tablets.

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Impact of the intragastric location of extended release tablets on food interactions

Cited by 116 publications

References 20 publications

Assessing the performance of amorphous solid dispersions

Assessing the performance of amorphous solid dispersions

Melts of Octaacetyl Sucrose as Oral-Modified Release Dosage Forms for Delivery of Poorly Soluble Compound in Stable Amorphous Form

Release Characteristics of Quetiapine Fumarate Extended Release Tablets Under Biorelevant Stress Test Conditions

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