This article discusses the range of outcomes from biopharmaceutical studies of specific modified release (MR) product examples in preclinical models and humans. It touches upon five major biopharmaceutical areas for MR drug products: (1) evidence for regional permeability throughout the GI tract, (2) susceptibility to food-effect, (3) susceptibility to pH-effect, (4) impact of chronopharmacology in designing MR products, and (5) implications to narrow therapeutic index products. Robust bioperformance requires that product quality is met through a thorough understanding of the appropriate critical quality attributes that ensure reliable and robust manufacture of a MR dosage form. The quality-by-design (QbD) aspects of MR dosage form design and development are discussed with the emphasis on the regulatory view of the data required to support dosage form development.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1208/s12248-017-0112-6 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
FRESH extrusion 3D printing of type-1 collagen hydrogels photocrosslinked using ruthenium.
PLoS One
January 2025
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, Maryland, United States of America.
The extrusion bioprinting of collagen material has many applications relevant to tissue engineering and regenerative medicine. Freeform Reversible Embedding of Suspended Hydrogels (FRESH) technology is capable of 3D printing collagen material with the specifications and details needed for precise tissue guidance, a crucial requirement for effective tissue repair. While FRESH has shown repeated success and reliability for extrusion printing, the mechanical properties of completed collagen prints can be improved further by post-print crosslinking methodologies.
View Article and Find Full Text PDFTreatment of 50 Acute and Chronic Wounds of Multiple Etiologies: A Case Series Looking at Outcomes and Utility of an Extended-Wear Transforming Powder Dressing.
Adv Skin Wound Care
January 2025
In the Department of Surgery, NYU Long Island School of Medicine, Mineola, New York, Sawyer Cimaroli, MD, is Surgical Resident; Danilo Lozada, MS, is Medical Student; and James Daniels, MD, is Surgical Resident. Brian Gillette, PhD, is Research Scientist, Department of Foundation of Medicine, NYU Long Island School of Medicine and Department of Surgery, NYU Langone Hospital Long Island. Scott Gorenstein, MD, is Clinical Assistant Professor, Department of Surgery, NYU Long Island School of Medicine.
Increasing healthcare costs, limited healthcare resources, an aging population, and lifestyle-related diseases make wound management a growing clinical, social, and economic burden. This case series investigated the use of a novel, biocompatible, polymer-based transforming powder dressing (TPD) that transforms in situ to a shape-retentive wound matrix upon hydration for treating wounds of various etiologies.In this institutional review board-approved single-center retrospective case series, the researchers evaluated various acute and chronic wounds treated with TPD over a period of 2 years.
View Article and Find Full Text PDFTreatment With Long-Acting Injectable Aripiprazole During Pregnancy in Bipolar Disorder: A Scoping Review.
Am J Ther
January 2025
Faculty of Medicine, Transilvania University of Brasov, Brasov, Romania.
Background: The management of bipolar disorder during pregnancy presents a significant challenge, particularly regarding the safety and effectiveness of long-acting injectable (LAI) antipsychotics like aripiprazole. Despite the growing use of LAI antipsychotics in psychiatric disorders, data on their use during pregnancy are limited, especially for bipolar disorder. This study aimed to shed light on this issue through a scoping review.
View Article and Find Full Text PDFSmartphone-assisted hydrogel sensing platform based on double emission carbon dots for portable on-site tetracycline detection.
Mikrochim Acta
January 2025
Department of Chemistry and Material Engineering, Lyuliang University, Lyuliang, 033000, P. R. China.
Innovative double-emission carbon dots (DE-CDs) were synthesized via a one-step hydrothermal method using fennel and m-phenylenediamine (m-PD) as precursors. These DE-CDs exhibited dual emission wavelengths at 432 and 515 nm under different excitations, making them highly versatile for fluorescence-based applications. The fluorescence of the DE-CDs was efficiently quenched by tetracycline (TC) through the inner filter effect (IFE), allowing for the construction of a sensitive dual-response fluorescent sensor.
View Article and Find Full Text PDFBrief Report: Stated Preferences for Long-Acting Injectable ART Among Mobile Men Living With HIV in Malawi: A Qualitative Study.
J Acquir Immune Defic Syndr
December 2024
Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA; and.
Background: Long-acting injectable (LAI) antiretroviral medications are as effective as daily oral antiretroviral therapy (ART) and offer discreet, less frequent dosing. LAIs may be ideal treatment options for people who experience challenges with adherence to daily oral ART, including mobile men living with HIV (MLHIV).
Methods: We conducted a qualitative substudy within two parent trials in 24 health facilities in Malawi that enrolled MLHIV ≥15 years not on ART.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!