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Nanoparticle PEGylation for imaging and therapy

Gold nanoparticles (GNPs) with controlled geometrical, optical, and surface chemical properties are the subject of intensive studies and applications in biology and medicine. To date, the ever increasing diversity of published examples has included genomics and biosensorics, immunoassays and clinical chemistry, photothermolysis of cancer cells and tumors, targeted delivery of drugs and antigens, and optical bioimaging of cells and tissues with state-of-the-art nanophotonic detection systems. This critical review is focused on the application of GNP conjugates to biomedical diagnostics and analytics, photothermal and photodynamic therapies, and delivery of target molecules. Distinct from other published reviews, we present a summary of the immunological properties of GNPs. For each of the above topics, the basic principles, recent advances, and current challenges are discussed (508 references).

Gold nanoparticles in biomedical applications: recent advances and perspectives

Polymeric nanoparticles-based therapeutics show great promise in the treatment of a wide range of diseases, due to the flexibility in which their structures can be modified, with intricate definition over their compositions, structures and properties. Advances in polymerization chemistries and the application of reactive, efficient and orthogonal chemical modification reactions have enabled the engineering of multifunctional polymeric nanoparticles with precise control over the architectures of the individual polymer components, to direct their assembly and subsequent transformations into nanoparticles of selective overall shapes, sizes, internal morphologies, external surface charges and functionalizations. In addition, incorporation of certain functionalities can modulate the responsiveness of these nanostructures to specific stimuli through the use of remote activation. Furthermore, they can be equipped with smart components to allow their delivery beyond certain biological barriers, such as skin, mucus, blood, extracellular matrix, cellular and subcellular organelles. This tutorial review highlights the importance of well-defined chemistries, with detailed ties to specific biological hurdles and opportunities, in the design of nanostructures for various biomedical delivery applications.

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Design of polymeric nanoparticles for biomedical delivery applications

Depending on the context, nanotechnologies developed as nanomedicines (nanosized therapeutics and imaging agents) are presented as either a remarkable technological revolution already capable of delivering new diagnostics, treatments for unmanageable diseases, and opportunities for tissue repair or highly dangerous nanoparticles, nanorobots, or nanoelectronic devices that will wreak havoc in the body. The truth lies firmly between these two extremes. Rational design of “nanomedicines” began almost half a century ago, and >40 products have completed the complex journey from lab to routine clinical use. Here we critically review both nanomedicines in clinical use and emerging nanosized drugs, drug delivery systems, imaging agents, and theranostics with unique properties that promise much for the future. Key factors relevant to the design of practical nanomedicines and the regulatory mechanisms designed to ensure safe and timely realization of healthcare benefits are discussed.

Nanomedicine(s) under the Microscope

Targeting nanoparticles to cancer.

Today nanotechnology is finding growing applications in industry, biology, and medicine. The clear benefits of using nanosized products in various biological and medical applications are often challenged by concerns about the lack of adequate data regarding their toxicity. One area of interest involves the interactions between nanoparticles and the components of the immune system. Nanoparticles can be engineered to either avoid immune system recognition or specifically inhibit or enhance the immune responses. We review herein reported observations on nanoparticle-mediated immunostimulation and immunosuppression, focusing on possible theories regarding how manipulation of particle physicochemical properties can influence their interaction with immune cells to attain desirable immunomodulation and avoid undesirable immunotoxicity.

Minireview: Nanoparticles and the Immune System

Regulatory perspective on the importance of ADME assessment of nanoscale material containing drugs

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

The concept of quality by design (QbD) was introduced to the pharmaceutical industry about a decade ago. Design of experiments (DoE) is an excellent and important tool for a QbD approach. This project’s aim is to obtain an overview of how DoE is being applied to assist pharmaceutical development in New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) submissions for oral solid dosage forms including immediate release (IR) tablet, extended release (ER) tablet, IR capsule, and ER capsule. A total of 131 NDA submissions and 606 randomly selected ANDA submissions with submission dates between 2012 and 2016 were chosen based on the Biopharmaceutics Classification System (BCS) of drug substances. The ratios of applying DoE studies in NDA and ANDA submissions were calculated and compared based on the BCS classes of the active pharmaceutical ingredients (APIs). For the Reference Listed Drug (RLD)-based cluster ANDA submissions, the percentage of applying DoE studies in BCS II ANDA submissions is statistically higher than those of the ANDA submissions in the other three BCS classes. Some common issues of the DoE studies were found in the selected submissions. DoE has been used as an important tool for QbD approach in NDA submissions but has not yet become a routine common practice to assist the implementation of QbD approach during the pharmaceutical development for NDA and ANDA submissions for oral solid dosage forms. By conducting DoE studies, researchers can gather critical information (i.e., CMAs, CQAs, CPPs, potential interactions) during the pharmaceutical development which can help to improve the quality of applications.

Banu S. Zolnik

Papers

Minireview: Nanoparticles and the Immune System

Regulatory perspective on the importance of ADME assessment of nanoscale material containing drugs

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

Assessment of Applications of Design of Experiments in Pharmaceutical Development for Oral Solid Dosage Forms