Case studies with new excipients: development, implementation and regulatory approval.

The purpose of this article is to describe the process whereby new excipients become accepted and to describe three case studies to illustrate the process. New excipients are defined according to the 2005 FDA Guidance on Nonclinical Safety Evaluation of New Excipients. The requirements for safety data submission for new excipients used in different classes of products for different durations are outlined in the guidance.

Nanomedicines for inflammatory diseases.

Inflammation is the body's natural defense mechanism in response to many diseases including infection, cancer, and autoimmune disease. Since the birth of nanotechnology at the end of the twentieth century, scientists have been utilizing the pathophysiologic features of inflammation, mainly leaky vasculature and the overexpression of biomarkers, to design nanomedicines that can deliver drugs with passive and active targeting mechanisms to inflamed tissue sites and achieve effective therapy. Recent advances in nanomedicine research have provided scientists with nanocarriers of many unique and tunable properties to match the specific requirements for the treatment of different inflammatory disease conditions.

Effect of powder substrate on foaml drainage and collapse: implications to foam granulation.

Foam granulation is a relatively newer wet granulation process whereby foamed binder solutions are added to powders in a mixer. It is essential to understand the effect of powder substrate on foam drainage and half-life, which are relevant to nucleation and agglomeration during foam granulation. Hydroxypropyl methylcellulose (HPMC) and hydroxypropyl cellulose (HPC) foams were characterized.

Investigation into stability of poly(vinyl alcohol)-based Opadry® II films.

Poly(vinyl alcohol) (PVA)-based formulations are used for pharmaceutical tablet coating with numerous advantages. Our objective is to study the stability of PVA-based coating films in the presence of acidic additives, alkaline additives, and various common impurities typically found in tablet formulations. Opadry® II 85F was used as the model PVA-based coating formulation.

Actively targeted low-dose camptothecin as a safe, long-acting, disease-modifying nanomedicine for rheumatoid arthritis.

Purpose: Camptothecin (CPT), a potent topoisomerase I inhibitor, was originally discovered as an anticancer agent to induce programmed cell death of cancer cells. Recent evidence suggests that, similar to cancer, alterations in apoptosis and over-proliferation of key effector cells in the arthritic joint result in rheumatoid arthritis (RA) pathogenesis. Initial in vitro studies have suggested that camptothecin inhibits synoviocyte proliferation, matrix metalloproteinases expression in chrondrocytes and angiogenesis.

Use of cyclodextrins as a cosmetic delivery system for fragrance materials: linalool and benzyl acetate.

The aim of this study was to increase the stability and water solubility of fragrance materials, to provide controlled release of these compounds, and to convert these substances from liquid to powder form by preparing their inclusion complexes with cyclodextrins (CDs). For this purpose, linalool and benzyl acetate were chosen as the fragrance materials. The use of beta-cyclodextrin (beta CD) and 2-hydroxypropyl-beta-cyclodextrin (2-HP beta CD) for increasing the solubility of these 2 fragrance materials was studied.

Camptothecin in sterically stabilized phospholipid nano-micelles: a novel solvent pH change solubilization method.

Camptothecin (CPT) is a topoisomerase I inhibitor that acts against a broad spectrum of cancers. Unfortunately clinical application of CPT is limited by insolubility, instability, and toxicity problems. To circumvent these delivery problems of CPT, we propose biocompatible, targeted sterically stabilized micelles (SSM) as nanocarriers for CPT (CPT-SSM).