FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms * Reprinted with permission by the American Association of Pharmaceutical Scientists. Originally published as: Brown, C, Friedel, H, Barker, A, Buhse, L, Keitel, S, et al. FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms. AAPS PharmSciTech. 2011. Doi: 10.1208/s12249-011-9634. Please send comments to the Co-Chairs of

Rubrik: Tagungsberichte

(Treffer aus pharmind, Nr. 07, Seite 1147 (2012))

Brown11 C | Friedel H | Barker A | Buhse L | Keitel S | Cecil T | Kraemer J | Morris J | Reppas C | Stickelmeyer M | Yomota C | Shah V

FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms * Reprinted with permission by the American Association of Pharmaceutical Scientists. Originally published as: Brown, C, Friedel, H, Barker, A, Buhse, L, Keitel, S, et al. FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms. AAPS PharmSciTech. 2011. Doi: 10.1208/s12249-011-9634. Please send comments to the Co-Chairs of / Brown et al. · FIP/AAPS Joint Workshop Report · Brown11 C, Friedel H, Barker A, Buhse L, Keitel S, Cecil T, Kraemer J, Morris J, Reppas C, Stickelmeyer M, Yomota C, Shah V · Eli Lilly and Company¹ und Bayer HealthCare AG² und Food and Drug Administration/CDER/OPS³ und EDQM, Council of Europe⁴ und United States Pharmacopeia⁵ und PHAST⁶ und Irish Medicines Board⁷ und National & Kapodistrian University of Athens⁸ und National Institute of Health Science⁹ und FIP Scientific Secretary¹⁰
It is important to note that the dissolution behavior of these dosage forms may be greatly influenced by their wettability, surface area, and particle size distribution. Thus, the in vitro dissolution test results constitute one of a group of physicochemical parameters needed to characterize the product. For powders, especially when exhibiting poor wettability, it may be necessary to add a surfactant to the dissolution medium to obtain reproducible dissolution results. Care should be taken to use a level of surfactant that does not increase the solubility of the drug to the extent where the test is no longer discriminatory. In ...

FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms * Reprinted with permission by the American Association of Pharmaceutical Scientists. Originally published as: Brown, C, Friedel, H, Barker, A, Buhse, L, Keitel, S, et al. FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms. AAPS PharmSciTech. 2011. Doi: 10.1208/s12249-011-9634. Please send comments to the Co-Chairs of

Rubrik: Tagungsberichte

(Treffer aus pharmind, Nr. 06, Seite 988 (2012))

Brown11 C | Friedel H | Barker A | Buhse L | Keitel S | Cecil T | Kraemer J | Morris J | Reppas C | Stickelmeyer M | Yomota C | Shah V

FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms * Reprinted with permission by the American Association of Pharmaceutical Scientists. Originally published as: Brown, C, Friedel, H, Barker, A, Buhse, L, Keitel, S, et al. FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms. AAPS PharmSciTech. 2011. Doi: 10.1208/s12249-011-9634. Please send comments to the Co-Chairs of / Brown et al. · FIP/AAPS Joint Workshop Report · Brown11 C, Friedel H, Barker A, Buhse L, Keitel S, Cecil T, Kraemer J, Morris J, Reppas C, Stickelmeyer M, Yomota C, Shah V · Eli Lilly and Company¹ und Bayer HealthCare AG² und Food and Drug Administration/CDER/OPS³ und EDQM, Council of Europe⁴ und United States Pharmacopeia⁵ und PHAST⁶ und Irish Medicines Board⁷ und National & Kapodistrian University of Athens⁸ und National Institute of Health Science⁹ und FIP Scientific Secretary¹⁰
In 2003, the FIP Dissolution Working group published a position paper on dissolution/drug release testing for special/novel dosage forms that represented the scientific opinions of many experts in the field at that time [ 1 ]. The position paper has supported activities, programs, and decisions in the scientific, technical, and regulatory community. Due to the rapid evolution of new practices and techniques for in vitro testing, the FIP Special Interest Group (SIG) on Dissolution/Drug Release decided to revise the previous paper and added proposals for further harmonization of in vitro release testing practices for different pharmaceutical dosage forms. This article ...

Automatisierung der Wirkstofffreisetzungsprüfung

Rubrik: Analytik

(Treffer aus TechnoPharm, Nr. 06, Seite 428 (2012))

Friedel H

Automatisierung der Wirkstofffreisetzungsprüfung / Friedel • Automatisierung Wirkstofffreisetzungsprüfung · Friedel H · Bayer Pharma, Berlin
Die Freisetzungsprüfung von Wirkstoffen aus Arzneiformen ist sehr arbeitsintensiv und kann sich über einen längeren Zeitraum erstrecken. Daher bietet sich die Automation dieses Prüfverfahrens an. Es wird die systematische Vorbereitung und Durchführung von Automationsprojekten mit der dazugehörenden Wirtschaftlichkeitsbetrachtung beschrieben. Die kommerziell erhältlichen Automationsmöglichkeiten für den Freisetzungstest werden diskutiert. Bei dieser Betrachtung werden semiautomatische als auch vollautomatische Freisetzungssysteme eingeschlossen. Aber auch die Analysenverfahren für die quantitative Bestimmung des freigesetzten Wirkstoffes werden erläutert, wie UV-spektroskopische Analysen nach Probenahme, in-situ UV-Bestimmungen mittels Lichtleiter-Technik und HPLC-Bestimmungen.