A Rapid 3-Day Excipient Screening Methodology and its Application in Identifying Chemical Stabilizers for Solid Formulations with Mixed Mechanisms of Degradation
This study outlines a practical approach for assessing chemical instability by heating the drug-excipient binary mixtures or multi-excipient formulations at 75°C for 3 days before characterization. Differentiating itself from other excipient compatibility methods, our methodology necessitates a saturated aqueous slurry rather than arbitrarily fixed water content. This allows bulk and surface water in the excipient to contribute to drug degradation. The synergistic impact of surface water and elevated temperature expedites degradation kinetics, resulting in accelerated data generation. Among excipient compatibility methods...
Source: AAPS PharmSciTech - January 5, 2024 Category: Drugs & Pharmacology Authors: Amol S Matharu Sundeep S Dhareshwar Yu Jade Cao Source Type: research

A Rapid 3-Day Excipient Screening Methodology and its Application in Identifying Chemical Stabilizers for Solid Formulations with Mixed Mechanisms of Degradation
This study outlines a practical approach for assessing chemical instability by heating the drug-excipient binary mixtures or multi-excipient formulations at 75°C for 3 days before characterization. Differentiating itself from other excipient compatibility methods, our methodology necessitates a saturated aqueous slurry rather than arbitrarily fixed water content. This allows bulk and surface water in the excipient to contribute to drug degradation. The synergistic impact of surface water and elevated temperature expedites degradation kinetics, resulting in accelerated data generation. Among excipient compatibility methods...
Source: AAPS PharmSciTech - January 5, 2024 Category: Drugs & Pharmacology Authors: Amol S Matharu Sundeep S Dhareshwar Yu Jade Cao Source Type: research

A Colourful Way to Unravel the Important Fluidization-Related Granule Size Effect on Semi-Continuous Drying
This study evaluates the complex fluidization behavior of wet granules in industrially relevant semi-continuous FBDs. A transparent perspex version of the dryer was used for the analysis of bed height, pressure drop, porosity, segregation, and spatial heating patterns at varying process settings. The investigated behaviors of the fluidizing bed will be helpful to derive phenomenological (sub)models for the detailed description of segregation in the semi-continuous fluidized bed system. In this study, it was found that semi-continuous FBDs are characterized by a change in fluidization regime from plug flow to a bubbling bed...
Source: AAPS PharmSciTech - January 4, 2024 Category: Drugs & Pharmacology Authors: Tuur Vandeputte Michael Ghijs Ingmar Nopens Thomas De Beer Source Type: research

A Colourful Way to Unravel the Important Fluidization-Related Granule Size Effect on Semi-Continuous Drying
This study evaluates the complex fluidization behavior of wet granules in industrially relevant semi-continuous FBDs. A transparent perspex version of the dryer was used for the analysis of bed height, pressure drop, porosity, segregation, and spatial heating patterns at varying process settings. The investigated behaviors of the fluidizing bed will be helpful to derive phenomenological (sub)models for the detailed description of segregation in the semi-continuous fluidized bed system. In this study, it was found that semi-continuous FBDs are characterized by a change in fluidization regime from plug flow to a bubbling bed...
Source: AAPS PharmSciTech - January 4, 2024 Category: Drugs & Pharmacology Authors: Tuur Vandeputte Michael Ghijs Ingmar Nopens Thomas De Beer Source Type: research

Influence of Crystal Disorder on the Forced Oxidative Degradation of Vortioxetine HBr
AAPS PharmSciTech. 2023 Dec 29;25(1):10. doi: 10.1208/s12249-023-02721-6.ABSTRACTThe present study investigates the impact of the solid-state disorder of vortioxetine hydrobromide (HBr) on oxidative degradation under accelerated conditions. A range of solid-state disorders was generated via cryogenic ball milling. The solid-state properties were evaluated by calorimetry, infrared-, and Raman spectroscopies. While salt disproportionation occurred upon milling, no chemical degradation occurred by milling. The amorphous fraction remained physically intact under ambient storage conditions. Subsequently, samples with representa...
Source: AAPS PharmSciTech - December 29, 2023 Category: Drugs & Pharmacology Authors: Dattatray Modhave Brenda Barrios Jayant Iyer Amrit Paudel Source Type: research

Effects of Apex Size on Dissolution Profiles in the USP II Paddle Apparatus
This study aimed to clarify how different apex vessel sizes affect the dissolution behavior of cone-forming formulations. Five apex vessels with different heights, centralities, and compendial vessels were used. The paddle rotation speed at which the coning phenomenon resolved was measured using standard particles of different densities. Three model formulations-USP prednisone tablets, atorvastatin calcium hydrate tablets, and levofloxacin fine granules-were selected, and dissolution tests were conducted at 30-100 revolutions per minute (rpm). Compared to the compendial vessels, the disappearance of standard particles at t...
Source: AAPS PharmSciTech - December 29, 2023 Category: Drugs & Pharmacology Authors: Hiroyuki Yoshida Tokio Morita Yasuhiro Abe Aoi Inagaki Naomi Tomita Ken-Ichi Izutsu Yoji Sato Source Type: research

Influence of Crystal Disorder on the Forced Oxidative Degradation of Vortioxetine HBr
AAPS PharmSciTech. 2023 Dec 29;25(1):10. doi: 10.1208/s12249-023-02721-6.ABSTRACTThe present study investigates the impact of the solid-state disorder of vortioxetine hydrobromide (HBr) on oxidative degradation under accelerated conditions. A range of solid-state disorders was generated via cryogenic ball milling. The solid-state properties were evaluated by calorimetry, infrared-, and Raman spectroscopies. While salt disproportionation occurred upon milling, no chemical degradation occurred by milling. The amorphous fraction remained physically intact under ambient storage conditions. Subsequently, samples with representa...
Source: AAPS PharmSciTech - December 29, 2023 Category: Drugs & Pharmacology Authors: Dattatray Modhave Brenda Barrios Jayant Iyer Amrit Paudel Source Type: research

Effects of Apex Size on Dissolution Profiles in the USP II Paddle Apparatus
This study aimed to clarify how different apex vessel sizes affect the dissolution behavior of cone-forming formulations. Five apex vessels with different heights, centralities, and compendial vessels were used. The paddle rotation speed at which the coning phenomenon resolved was measured using standard particles of different densities. Three model formulations-USP prednisone tablets, atorvastatin calcium hydrate tablets, and levofloxacin fine granules-were selected, and dissolution tests were conducted at 30-100 revolutions per minute (rpm). Compared to the compendial vessels, the disappearance of standard particles at t...
Source: AAPS PharmSciTech - December 29, 2023 Category: Drugs & Pharmacology Authors: Hiroyuki Yoshida Tokio Morita Yasuhiro Abe Aoi Inagaki Naomi Tomita Ken-Ichi Izutsu Yoji Sato Source Type: research

Design and Evaluation of Ginkgolides Gastric Floating Controlled Release Tablets Based on Solid Supersaturated Self-nanoemulsifying
In this study, supersaturated self-nanoemulsifying gastric floating tablets of ginkgolides were developed through the combination of solid supersaturated self-nanoemulsifying drug delivery system (solid S-SNEDDS) and gastric retentive floating drug delivery system (GFDDS) to solve these problems of ginkgolides. Solid S-SNEDDS was prepared by D-optimal mixture design, normalization method and single factor experiment. The properties of solid-S-SNEDDS were studied by TEM, PXRD, FT-IR, SEM and in vitro drug release profile. Then, the optimal formulation of stomach floating tablet was obtained through single factor experiment ...
Source: AAPS PharmSciTech - December 26, 2023 Category: Drugs & Pharmacology Authors: Kai Zheng Jing Zhao Qiuli Wang Yuyang Zhao Husheng Yang Xinggang Yang Lian He Source Type: research

Retraction Note: In Vitro Characterization and Evaluation of the Cytotoxicity Effects of Nisin and Nisin-Loaded PLA-PEG-PLA Nanoparticles on Gastrointestinal (AGS and KYSE-30), Hepatic (HepG2) and Blood (K562) Cancer Cell Lines
AAPS PharmSciTech. 2023 Dec 26;25(1):8. doi: 10.1208/s12249-023-02726-1.NO ABSTRACTPMID:38148388 | DOI:10.1208/s12249-023-02726-1 (Source: AAPS PharmSciTech)
Source: AAPS PharmSciTech - December 26, 2023 Category: Drugs & Pharmacology Authors: Fariba Goudarzi Asadollah Asadi Maryam Afsharpour Robab Hassanvand Jamadi Source Type: research

Design and Evaluation of Ginkgolides Gastric Floating Controlled Release Tablets Based on Solid Supersaturated Self-nanoemulsifying
In this study, supersaturated self-nanoemulsifying gastric floating tablets of ginkgolides were developed through the combination of solid supersaturated self-nanoemulsifying drug delivery system (solid S-SNEDDS) and gastric retentive floating drug delivery system (GFDDS) to solve these problems of ginkgolides. Solid S-SNEDDS was prepared by D-optimal mixture design, normalization method and single factor experiment. The properties of solid-S-SNEDDS were studied by TEM, PXRD, FT-IR, SEM and in vitro drug release profile. Then, the optimal formulation of stomach floating tablet was obtained through single factor experiment ...
Source: AAPS PharmSciTech - December 26, 2023 Category: Drugs & Pharmacology Authors: Kai Zheng Jing Zhao Qiuli Wang Yuyang Zhao Husheng Yang Xinggang Yang Lian He Source Type: research

Retraction Note: In Vitro Characterization and Evaluation of the Cytotoxicity Effects of Nisin and Nisin-Loaded PLA-PEG-PLA Nanoparticles on Gastrointestinal (AGS and KYSE-30), Hepatic (HepG2) and Blood (K562) Cancer Cell Lines
AAPS PharmSciTech. 2023 Dec 26;25(1):8. doi: 10.1208/s12249-023-02726-1.NO ABSTRACTPMID:38148388 | DOI:10.1208/s12249-023-02726-1 (Source: AAPS PharmSciTech)
Source: AAPS PharmSciTech - December 26, 2023 Category: Drugs & Pharmacology Authors: Fariba Goudarzi Asadollah Asadi Maryam Afsharpour Robab Hassanvand Jamadi Source Type: research

Design and Evaluation of Ginkgolides Gastric Floating Controlled Release Tablets Based on Solid Supersaturated Self-nanoemulsifying
In this study, supersaturated self-nanoemulsifying gastric floating tablets of ginkgolides were developed through the combination of solid supersaturated self-nanoemulsifying drug delivery system (solid S-SNEDDS) and gastric retentive floating drug delivery system (GFDDS) to solve these problems of ginkgolides. Solid S-SNEDDS was prepared by D-optimal mixture design, normalization method and single factor experiment. The properties of solid-S-SNEDDS were studied by TEM, PXRD, FT-IR, SEM and in vitro drug release profile. Then, the optimal formulation of stomach floating tablet was obtained through single factor experiment ...
Source: AAPS PharmSciTech - December 26, 2023 Category: Drugs & Pharmacology Authors: Kai Zheng Jing Zhao Qiuli Wang Yuyang Zhao Husheng Yang Xinggang Yang Lian He Source Type: research

Retraction Note: In Vitro Characterization and Evaluation of the Cytotoxicity Effects of Nisin and Nisin-Loaded PLA-PEG-PLA Nanoparticles on Gastrointestinal (AGS and KYSE-30), Hepatic (HepG2) and Blood (K562) Cancer Cell Lines
AAPS PharmSciTech. 2023 Dec 26;25(1):8. doi: 10.1208/s12249-023-02726-1.NO ABSTRACTPMID:38148388 | DOI:10.1208/s12249-023-02726-1 (Source: AAPS PharmSciTech)
Source: AAPS PharmSciTech - December 26, 2023 Category: Drugs & Pharmacology Authors: Fariba Goudarzi Asadollah Asadi Maryam Afsharpour Robab Hassanvand Jamadi Source Type: research

Design and Evaluation of Ginkgolides Gastric Floating Controlled Release Tablets Based on Solid Supersaturated Self-nanoemulsifying
In this study, supersaturated self-nanoemulsifying gastric floating tablets of ginkgolides were developed through the combination of solid supersaturated self-nanoemulsifying drug delivery system (solid S-SNEDDS) and gastric retentive floating drug delivery system (GFDDS) to solve these problems of ginkgolides. Solid S-SNEDDS was prepared by D-optimal mixture design, normalization method and single factor experiment. The properties of solid-S-SNEDDS were studied by TEM, PXRD, FT-IR, SEM and in vitro drug release profile. Then, the optimal formulation of stomach floating tablet was obtained through single factor experiment ...
Source: AAPS PharmSciTech - December 26, 2023 Category: Drugs & Pharmacology Authors: Kai Zheng Jing Zhao Qiuli Wang Yuyang Zhao Husheng Yang Xinggang Yang Lian He Source Type: research