Dissolution testing of oral modified-release dosage forms

Garbacz, Grzegorz; Klein, Sandra

doi:10.1111/j.2042-7158.2012.01477.x

Cited by 64 publications

(44 citation statements)

References 135 publications

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“…Pellets also show a more even spread in the gastrointestinal tract in comparison with a single coated tablet. Having a high number of coated pellets also reduces the risk for dose-dumping 3,4 . Furthermore, the surface of amorphous solid dispersion formulations has also been shown to be more vulnerable to crystallization of the amorphous drug phase 5 , hence an additional coating layer could potentially stabilize these formulations.…”

Section: Introductionmentioning

confidence: 99%

Controlling the Release of Indomethacin from Glass Solutions Layered with a Rate Controlling Membrane Using Fluid-Bed Processing. Part 1: Surface and Cross-Sectional Chemical Analysis

et al. 2017

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den Mooter, Guy (2017) Controlling the release of indomethacin from glass solutions layered with a rate controlling membrane using fluid-bed processing. A note on versions:The version presented here may differ from the published version or from the version of record. If you wish to cite this item you are advised to consult the publisher's version. Please see the repository url above for details on accessing the published version and note that access may require a subscription. AbstractFluid bed coating has been shown to be an adequate manufacturing technique to formulate poorly soluble drugs in glass solutions. Layering inert carriers with a drug-polymer mixture enables these beads to be immediately filled into capsules, thus avoiding additional, potentially destabilizing, downstream processing. In this study fluid bed coating is proposed for the production of controlled release dosage forms of glass solutions by applying a second, rate controlling membrane on top of the glass solution. Adding a second coating layer adds to the physical and chemical complexity of the drug delivery system so a thorough understanding of the physical structure and phase behavior of the different coating layers is needed. This study aimed to investigate the surface and cross-sectional characteristics (employing SEM and ToF-SIMS) of an indomethacin-polyvinylpyrrolidone (PVP) glass solution, top-coated with a release rate controlling membrane consisting of either ethyl cellulose or Eudragit RL. The implications on the addition of a pore former (PVP) and the coating medium (ethanol or water) were also considered. In addition, polymer miscibility and the phase analysis of the underlying glass solution were investigated.Significant differences in surface and cross sectional topography of the different rate controlling membranes or the way they are applied (solution vs. dispersion) were observed. These observations can be linked to the polymer miscibility differences. The presence of PVP was observed in all rate controlling membranes, even if it is not part of the coating solution. This could be attributed to residual powder presence in the coating chamber. The distribution of PVP among the sample surfaces depends on the concentration and the rate controlling polymer used.Differences can again be linked to polymer miscibility. Finally, it was shown that the underlying glass solution layer remains amorphous after coating of the rate controlling membrane, whether formed from an ethanol solution or an aqueous dispersion.4

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Section: Introductionmentioning

confidence: 99%

Controlling the Release of Indomethacin from Glass Solutions Layered with a Rate Controlling Membrane Using Fluid-Bed Processing. Part 1: Surface and Cross-Sectional Chemical Analysis

et al. 2017

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“…The systems available are characterized by strikingly different construction, degree of complexity, and spectrum of covered factors (16,17). In contrast to the other test setups, the biorelevant dissolution stress test device, which was used in the present study, enables straightforward evaluation of the dosage form robustness towards GIspecific mechanical stresses (6,16). Different test programs were applied to mimic the fasting state.…”

Section: Discussionmentioning

confidence: 99%

“…The ileocecal passage of the dosage forms was simulated after 5 h as the identical high stress phase that was applied for mimicking gastric emptying. The timing of this phase was intended to mimic the ileocecal reflex induced by meal intake [16]. Accordingly, the small intestinal transit phase mimicked in program 1 lasted 4.5 h while it lasted 4.0 h in program 2.…”

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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“…In 38 addition, when high doses of lipophilic active pharmaceutical 39 ingredients are employed, e.g., in extended-release dosage forms, 40 developing discriminatory dissolution tests becomes challenging. 41 Other types of compendial dissolution apparatuses have therefore 42 been proposed for the in vitro dissolution testing of oral dosage 43 forms containing poorly water-soluble drugs (Brown et al, 2011;44 Nicolaides et al, 2000Nicolaides et al, , 2001Fotaki and Reppas, 2005;Fotaki et al, 45 2009; Jantratid et al, 2009;Kostewicz et al, 2002;Garbacz and 46 Klein, 2012). Of these apparatuses, the flow-through cell apparatus, the USP Apparatus 4 (The USP 37-NF 32, 2014), has drawn much 48 attention in pharmaceutical industry, as it enables the continuous 49 supply of fresh medium in open-loop configuration or the 50 application of a sufficient volume of medium to maintain sink 51 conditions in closed-loop configuration.…”

mentioning

confidence: 98%

Developing dissolution testing methodologies for extended-release oral dosage forms with supersaturating properties. Case example: Solid dispersion matrix of indomethacin

Tajiri

Morita

Sakamoto

et al. 2015

International Journal of Pharmaceutics

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Dissolution testing of oral modified-release dosage forms

Cited by 64 publications

References 135 publications

Controlling the Release of Indomethacin from Glass Solutions Layered with a Rate Controlling Membrane Using Fluid-Bed Processing. Part 1: Surface and Cross-Sectional Chemical Analysis

Controlling the Release of Indomethacin from Glass Solutions Layered with a Rate Controlling Membrane Using Fluid-Bed Processing. Part 1: Surface and Cross-Sectional Chemical Analysis

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

Developing dissolution testing methodologies for extended-release oral dosage forms with supersaturating properties. Case example: Solid dispersion matrix of indomethacin

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