European Journal of Pharmaceutics and Biopharmaceutics This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Retrospective analysis of the biopharmaceutics characteristics of solid oral Modified-Release drug products in approved US FDA NDAs designated as Extended-Release or Delayed-Release formulations
CONCLUSION: The results of this study help the reader understand the design, characteristics, and pharmacological advantages of the ER and DR drug products for patient benefit; as well as the regulations governing the FDA's assessment of ER claims.PMID:37984592 | DOI:10.1016/j.ejpb.2023.11.014 (Source: European Journal of Pharmaceutics and Biopharmaceutics)
Source: European Journal of Pharmaceutics and Biopharmaceutics - November 20, 2023 Category: Drugs & Pharmacology Authors: Ahmed Nadia Ly Holly Pan Amanda Chiang Brian Raines Kimberly Janwatin Timothy Hamed Salaheldin Dave Kaushalkumar Source Type: research

Investigating bevacizumab and its fragments sustained release from intravitreal administrated PLGA Microspheres: A modeling approach
This study discusses certain issues related to the sustained release of bevacizumab from intravitreal poly(lactic-co-glycolic acid) (PLGA) microspheres. A computational model elucidating the ocular kinetics of bevacizumab is demonstrated, wherein the release of the drug from PLGA microspheres is modeled using the Koizumi approach, complemented by an empirical model that links the kinetics of bevacizumab release to a size-dependent hydrolytic degradation of the drug-loaded polymeric microparticles. The results of the simulation were then rigorously validated against experimental data. The as-developed model proved remarkabl...
Source: European Journal of Pharmaceutics and Biopharmaceutics - November 20, 2023 Category: Drugs & Pharmacology Authors: Marcin K Heljak Wojciech Swieszkowski Source Type: research

Multi-Cavity Molecular Descriptor Interconnections: Enhanced Protocol for Prediction of Serum Albumin Drug Binding
Eur J Pharm Biopharm. 2023 Nov 18:S0939-6411(23)00292-8. doi: 10.1016/j.ejpb.2023.11.003. Online ahead of print.ABSTRACTThe role of human serum albumin (HSA) in the transport of molecules predicates its involvement in the determination of drug distribution and metabolism. Optimization of ADME properties are analogous to HSA binding thus this is imperative to the drug discovery process. Currently, various in silico predictive tools exist to complement the drug discovery process, however, the prediction of possible ligand-binding sites on HSA has posed several challenges. Herein, we present a strong and deeper-than-surface c...
Source: European Journal of Pharmaceutics and Biopharmaceutics - November 20, 2023 Category: Drugs & Pharmacology Authors: Oluwole B Akawa Felix O Okunlola Mohammed Issa Alahmdi Nader E Abo-Dya Peter A Sidhom Mahmoud A A Ibrahim Mohamed F Shibl Shahzeb Khan Mahmoud E S Soliman Source Type: research

Industry perspective on a holistic container closure integrity approach to parenteral combination products
Eur J Pharm Biopharm. 2023 Nov 17:S0939-6411(23)00299-0. doi: 10.1016/j.ejpb.2023.11.010. Online ahead of print.ABSTRACTBiologics are being developed more and more as parenteral combination products with drug delivery devices. The maintenance of sterility is imperative for such medical devices throughout their lifecycle. Therefore, the container closure integrity (CCI) should, preferably, be built into the overall process, and not just demonstrated during the final testing of the combination product. The integrity is an important Critical Quality Attribute (CQA) and in the scope of specific considerations and studies durin...
Source: European Journal of Pharmaceutics and Biopharmaceutics - November 19, 2023 Category: Drugs & Pharmacology Authors: Klaus Wuchner Helen C Brown Fabiana Canal Debora Bonvin Craig Goldhammer Henri Hebting Carine Huon Sebastian M Kuhn Prudvi Raj Mudumala Karen Neuhold David Riesop Jean-Sebastien Steffen Florian Woelfle Source Type: research

Improved antitumor activity through a tyramidyl maslinic acid derivative. Design and validation as drug-loaded electrospun polymeric nanofibers
Eur J Pharm Biopharm. 2023 Nov 14:S0939-6411(23)00300-4. doi: 10.1016/j.ejpb.2023.11.011. Online ahead of print.ABSTRACTAmong the most harmful tumors detected in the human body, such as breast, colon, brain or pancreas, breast (BC) and colorectal cancer (CRC) are the first and third most frequent cancer worldwide, respectively. The current existing chemotherapeutic treatments present serious side effects due to their intravenous administration can induce cytotoxicity in healthy cells. Thus, new treatment methods based on drug-loaded polymeric nanofibers (NFs) have gained significant potential for their use in localized can...
Source: European Journal of Pharmaceutics and Biopharmaceutics - November 16, 2023 Category: Drugs & Pharmacology Authors: Cristina Luque Mar ía de la Cabeza Fernández David Fuentes-Rios Ana Cepero Rafael Contreras-C áceres Manuel Do ña Gloria Perazzoli Laura Lozano-Chamizo Marco Filice Marzia Marciello Victor Gonzalez-Rumayor Juan Manuel L ópez-Romero Laura Cabeza Conso Source Type: research

An in vitro gastrointestinal model to evaluate the tolerance of encapsulated Lactobacillus and Lactococcus strains with synbiotic containing lactobionic acid via lyophilization technique to harsh gastric conditions during storage time
This study used a gastrointestinal model to represent the pH variation and gastric enzymes that are involved in the digestion process. Eight Lactobacillus strains and one Lactococcus strain were encapsulated using sodium alginate. The aim of this study was to compare free probiotic bacteria with encapsulated probiotic bacteria and determine the number of viable probiotic cells that might reach the human intestine. Microencapsulation of probiotic organisms followed the extrusion method with an alginate compound. Microencapsulated and free probiotic bacteria were inoculated into 200 ml of MRS (Man, Rogosa, Sharpe) broth. Sim...
Source: European Journal of Pharmaceutics and Biopharmaceutics - November 15, 2023 Category: Drugs & Pharmacology Authors: Kamila Goderska Sonia Agudo Pena Source Type: research