Structural modifications of polyethylenimine to control drug loading and release characteristics of amorphous solid dispersions
Crystalline drugs with low solubility have the potential to benefit from delivery in the
amorphous form. The polymers used in amorphous solid dispersions (ASDs) influence their …
amorphous form. The polymers used in amorphous solid dispersions (ASDs) influence their …
Enhancing the Acidity of Polymers for Improved Stabilization of Amorphous Solid Dispersions: Protonation of Weakly Basic Compounds
KN Kelsall, RO Schubiner, L Schenck… - ACS Applied Polymer …, 2024 - ACS Publications
A cross-linked poly (vinylphosphonic acid)(PVPA) stabilizes compounds in amorphous solid
dispersions (ASDs). The performance of the polymer was compared to that of hydroxypropyl …
dispersions (ASDs). The performance of the polymer was compared to that of hydroxypropyl …
The importance of surface composition and wettability on the dissolution performance of high drug loading amorphous dispersion formulations
One of the limitations with an amorphous solid dispersion (ASD) formulation strategy is low
drug loading. Hydrophobic drugs have poor wettability and require a substantial amount of …
drug loading. Hydrophobic drugs have poor wettability and require a substantial amount of …
Densifying co-precipitated amorphous dispersions to achieve improved bulk powder properties
Purpose Precipitation of amorphous solid dispersions has gained traction in the
pharmaceutical industry given its application to pharmaceuticals with varying …
pharmaceutical industry given its application to pharmaceuticals with varying …
A Commentary on Co-Processed API as a Promising Approach to Improve Sustainability for the Pharmaceutical Industry
Pharmaceutical products represent a meaningful target for sustainability improvement and
emissions reduction. It is proposed here that rethinking the standard, and often linear …
emissions reduction. It is proposed here that rethinking the standard, and often linear …
Improving dissolution performance and drug loading of amorphous dispersions through a hierarchical particle approach
Co-precipitation is an emerging manufacturing strategy for amorphous solid dispersions
(ASDs). Herein, the interplay between processing conditions, surface composition, and …
(ASDs). Herein, the interplay between processing conditions, surface composition, and …
[HTML][HTML] Trends in amorphous solid dispersion drug products approved by the US Food and Drug Administration between 2012 and 2023
Abstract Forty-eight (48) drug products (DPs) containing amorphous solid dispersions
(ASDs) have been approved by the US Food and Drug Administration in the 12-year period …
(ASDs) have been approved by the US Food and Drug Administration in the 12-year period …
FDA/M-CERSI co-processed API workshop proceedings
L Schenck, P Patel, R Sood, L Bonaga… - Journal of …, 2023 - Elsevier
These proceedings contain presentation summaries and discussion highlights from the
University of Maryland Center of Excellence in Regulatory Science and Innovation (M …
University of Maryland Center of Excellence in Regulatory Science and Innovation (M …
Understanding excipient-induced crystallization of spray-dried amorphous solid dispersion
This study investigates the compatibility of excipients with the model system SDI-X and their
role in the induced crystallization of the amorphous compound-X in tablet formulations. We …
role in the induced crystallization of the amorphous compound-X in tablet formulations. We …
Regulatory Considerations for Stability Studies of Co-Processed Active Pharmaceutical Ingredient
RK Orr, T Rawalpally, LS Gorka, LR Bonaga… - The AAPS Journal, 2024 - Springer
A co-processed active pharmaceutical ingredient (CP API) is the combination of an active
pharmaceutical ingredient (API) with non-active component (s). This technology has been …
pharmaceutical ingredient (API) with non-active component (s). This technology has been …