NIR Spectroscopy as an Online PAT Tool for a Narrow Therapeutic Index Drug: Toward a Platform Approach Across Lab and Pilot Scales for Development of a Powder Blending Monitoring Method and Endpoint Determination.

An online near-infrared (NIR) spectroscopy platform system for real-time powder blending monitoring and blend endpoint determination was tested for a phenytoin sodium formulation. The study utilized robust experimental design and multiple sensors to investigate multivariate data acquisition, model development, and model scale-up from lab to manufacturing. The impact of the selection of various blend endpoint algorithms on predicted blend endpoint (i.

An Study to Compare the Release of Fluoride from Glass Ionomer Cement (Fuji IX) and Zirconomer.

Unlabelled: Mercury toxicity from amalgam dental fillings and their potential for creating problems in the environment and for human health have prompted the development of new restorative materials. The leading alternatives among these are glass ionomer cements. According to current understanding, restorative materials that slowly release fluoride exert a local cariostatic effect.

Development and Scale-Up of Diversion Strategy for Twin Screw Granulation in Continuous Manufacturing.

Successful implementation of Continuous Manufacturing technology requires real time product quality monitoring that can result into rejection strategies for material manufactured outside process control limits. In a twin screw granulation process, parameters like water content, powder feed rate, and granulator screw speed can influence granule quality. Deviations in any of these parameters from the set-point may affect granule quality.

Effect of casein phosphopeptide-amorphous calcium phosphate as a remineralizing agent - An study.

Introduction: Demineralization and remineralization have a crucial impact on the hardness and strength of teeth. Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) Trident white chewing gum has anticariogenic property and also stimulates saliva, which buffers the oral cavity and promotes remineralization. Trident sugar-free gum, therefore, is an excellent delivery vehicle for promoting enamel remineralization.

Ectodermal dysplasia - A rare case report.

Ectodermal dysplasia (ED) is a rare genetic disease caused by developmental disturbances of embryonic ectoderm derived tissues, organs, and other accessory appendages. The congenital missing of teeth is usually bilateral. Anodontia or hypodontia may be associated with other ectodermal disturbances, such as anhidrosis, asteatosis, hypotrichosis, and salivary glands defects.

A "Large-N" Content Uniformity Process Analytical Technology (PAT) Method for Phenytoin Sodium Tablets.

Accurate assessment of tablet content uniformity is critical for narrow therapeutic index drugs such as phenytoin sodium. This work presents a near-infrared (NIR)-based analytical method for rapid prediction of content uniformity based on a large number of phenytoin sodium formulation tablets. Calibration tablets were generated through an integrated experimental design by varying formulation and process parameters, and scale of manufacturing.

Depletion of Key Meiotic Genes and Transcriptome-Wide Abiotic Stress Reprogramming Mark Early Preparatory Events Ahead of Apomeiotic Transition.

Molecular dissection of apomixis - an asexual reproductive mode - is anticipated to solve the enigma of loss of meiotic sex, and to help fixing elite agronomic traits. The Brassicaceae genus comprises of both sexual and apomictic species, permitting comparative analyses of meiotic circumvention (apomeiosis) and parthenogenesis. Whereas previous studies reported local transcriptome changes during these events, it remained unclear whether global changes associated with hybridization, polyploidy and environmental adaptation that arose during evolution of might serve as (epi)genetic regulators of early development prior apomictic initiation.

Enabling real time release testing by NIR prediction of dissolution of tablets made by continuous direct compression (CDC).

A method for predicting dissolution profiles of directly compressed tablets for a fixed sustained release formulation manufactured in a continuous direct compaction (CDC) system is presented. The methodology enables real-time release testing (RTRt). Tablets were made at a target drug concentration of 9% Acetaminophen, containing 90% lactose and 1% Magnesium Stearate, and at a target compression force of 24kN.

Effect of Shear Applied During a Pharmaceutical Process on Near Infrared Spectra.

This study describes changes observed in the near-infrared (NIR) diffuse reflectance (DR) spectra of pharmaceutical tablets after these tablets were subjected to different levels of strain (exposure to shear) during the mixing process. Powder shearing is important in the mixing of powders that are cohesive. Shear stress is created in a system by moving one surface over another causing displacements in the direction of the moving surface and is part of the mixing dynamics of particulates in many industries including the pharmaceutical industry.

Prediction of dissolution profiles by non-destructive near infrared spectroscopy in tablets subjected to different levels of strain.

This study describes how the strain on formulation components affects dissolution and how near infrared spectroscopy can be used to predict dissolution. Strain (exposure to shear stress) applied during powder mixing affects the interaction between formulation components. Particles experience shear strain when they move relative to each other in a process affecting the properties of the final product.

Ameliorating effect of S-2(ω-aminoalkylamino) alkylaryl sulfide (DRDE-07) on sulfur mustard analogue, 2-chloroethyl ethyl sulfide-induced oxidative stress and inflammation.

Sulfur mustard (SM; 2,2'-dichloro diethyl sulfide), an alkylating chemical warfare agent, poses a major threat in both military conflict and chemical terrorism situations. 2-chloroethyl ethyl sulfide (CEES) is a monofunctional analogue of SM, frequently used in laboratory settings, therefore increasing chances of its exposure. S-2(ω-aminoalkylamino) alkylaryl sulfide (DRDE-07) is an analogue of amifostine reported to have protective effects against SM but its effect on CEES is largely unexplored.

Cholesterol assimilation and biotransformation by Lactobacillus helveticus.

Lactobacillus helveticus, grown at 37°C in MRS medium supplemented with 3 mM cholesterol, assimilated all the cholesterol in 42 h having 68 U mg(-1) of intracellular cholesterol oxidase activity. The strain transformed 1 g cholesterol to 0.05 g of androsta-1, 4-diene-3, 17-dione and 0.

Effect of Plant Extracts Formulated in Different Ointment Bases on MDR Strains.

Extracts of Aloe vera whole plant, Eucalyptus globulus leaves, Ficus infectoria bark, Ficus religiosa bark and Piper betel leaves were studied for antibacterial activity on resistant and sensitive strains, isolated from skin and soft tissue infections. A combination of hot alcoholic extracts of Ficus infectoria, Ficus religiosa and Piper betel were found to be more effective against all the isolates. The combined extract was formulated in different ointment bases such as polyethylene glycol, gelatin, sodium alginate, carbopol, cream base and honey.