A Pilot Study - Comparison between a Novel Combination of Bioactive Glass with Clodronate and Bioactive Glass Alone as a Treatment for Chronic Periodontitis

Bioactive glass (BAG) and clodronate are both used for bone regeneration. In this pilot clinical study, we compared the effect of BAG and a novel BAG+clodronate combination as a topical maintenance phase treatment for chronic periodontitis. Two dental residual pockets were treated in each subject (n=10): one with BAG alone and the other with combination product, by applying the products subgingivally for 10 min once a week for four weeks. We describe the effects of these investigational products to the clinical parameters of periodontitis and two bone metabolism markers (osteoprotegerin and osteocalcin). Additionally, subjective satisfaction for the treatment was evaluated. The results must be considered as directional, understanding that further investigation is needed to confirm the findings. Based on clinical parameters measured both treatments could benefit as maintenance therapy for chronic periodontitis. The positive effect of the combination product on tooth sensitivity may bring additional benefits in comparison to the use of BAG alone. Both treatments were well tolerated and safe.  </p

Time-Gated Raman Spectroscopy for Quantitative Determination of Solid-State Forms of Fluorescent Pharmaceuticals

Raman spectroscopy is widely used for quantitative pharmaceutical analysis, but a common obstacle to its use is sample fluorescence masking the Raman signal. Time-gating provides an instrument-based method for rejecting fluorescence through temporal resolution of the spectral signal and allows Raman spectra of fluorescent materials to be obtained. An additional practical advantage is that analysis is possible in ambient lighting. This study assesses the efficacy of time-gated Raman spectroscopy for the quantitative measurement of fluorescent pharmaceuticals. Time-gated Raman spectroscopy with a 128 X (2) X 4 CMOS SPAD detector was applied for quantitative analysis of ternary mixtures of solid-state forms of the model drug, piroxicam (PRX). Partial least-squares (PLS) regression allowed quantification, with Raman-active time domain selection (based on visual inspection) improving performance. Model performance was further improved by using kernel-based regularized least-squares (RLS) regression with greedy feature selection in which the data use in both the Raman shift and time dimensions was statistically optimized. Overall, time-gated Raman spectroscopy, especially with optimized data analysis in both the spectral and time dimensions, shows potential for sensitive and relatively routine quantitative analysis of photoluminescent pharmaceuticals during drug development and manufacturing

Evaluation of the physicochemical properties and compaction behavior of melt granules produced in microwave-induced and conventional melt granulation in a single pot high shear processor

10.1208/s12249-011-9706-yAAPS PharmSciTech1241374-138

Industrially feasible alternative approaches in the manufacture of solid dispersions: A technical report

The purpose of this report was to compile relevant technical information on various alternative strategies that can be used as feasible approaches in the development of solid dispersions. The technologies discussed in the report are spray coating on sugar beads with a fluidized bed coating system, hot melt extrusion, direct capsule filling, electrostatic spinning, surface active carriers, and supercritical fluid technology. The focus is on basic principles, the equipment involved, and the relevant scale-up work. These technologies have been found to eliminate several drawbacks posed by the conventional methods of manufacturing of solid dispersions such as laborious preparation methods, reproducibility, scaling up of manufacturing processes, stability of drug, and vehicle