The cover presents the active pharmaceutical ingredient paclitaxel (PTX) loaded in nanorocket propelling to malignant proliferative cells. It illustrates a “three-vector” design for nanomedicine development, drug payload on nanocarrier, accompanied by functional molecules implement targeted delivery and stimulus-responsive release. This is reported Xin-Ming Xu, Hui Tao Zhang, co-workers article...

A swab-sampling method was developed for cleaning validation of a residual active pharmaceutical ingredient in samples collected after cleaning the sampling suite. A summary of the strategies and results of the method development is presented. The developed extraction method produced an acceptable level of recovery and precision. ross contamination with active ingredients is a real concern. The...

Development of quality estimation models using near infrared spectroscopy (NIRS) and multivariate analysis has been accelerated as a Process Analytical Technology (PAT) tool in the pharmaceutical industry. Although linear regression methods such as partial least squares (PLS) are widely used, they may not be able to achieve high estimation accuracy because physical and chemical properties of a ...

Process Analytical Technology (PAT) is a system for design, analysis, and control of manufacturing processes, based on continuous monitoring/rapid measurements of critical quality and performance attributes of raw material, intermediates and products. PAT involves measurement science by using conventional process sensors such as pressure, temperature and pH probes, as well as novel analyzer tec...

Clinical studies have shown that circadian patterns influence the pharmacokinetics of certain drugs used in the treatment of different diseases. For such drugs, the bioavailability is influenced by the time of administration. The objective of this study was to investigate differences in the pharmacokinetic patterns between a pulsatile drug delivery system using a pulsatile capsule, pure active ...

In the pharmaceutical world, an impurity is considered as any other organic material, besides the drug substance, or ingredients, arise out of synthesis or unwanted chemicals that remains with API’s. Impurity profiling is the process of acquiring and evaluating data that establishes biological safety of an individual impurity; thus, revealing its need and scope in pharmaceutical research. The c...

Três impurezas no intervalo de 0,08%-0,12% por área de pico foram detectadas no ingrediente farmacêutico ativo, anastrazol, por cromatografia líquida de alta eficiência (CLAE) em fase-reversa isocrática. Essas impurezas foram isoladas por prep-CLAE e caracterizadas por CL-EM/EM, CG/EM e dados experimentais de RMN. Com base nos resultados obtidos a partir de diferentes experimentos espectroscópi...

This communication demonstrates the possibility to nucleate and grow different crystalline polymorphic forms of gabapentin (GBP) using, as nucleation templates, Langmuir monolayers of an amphiphilic calixarene at different packing densities.

Pharmacists use various sources for obtaining the active pharmaceutical ingredient for compounding medications. In many cases, it is the pure drug (United States Pharmacopeia, National Formulary, or similar grade); in some cases, it can be a commercial dosage form; and, in some cases, it may be a dilution or concentrate. If the drug is not present at full strength, then adjustments may be neces...

Near infrared spectroscopy (NIRS) methods were developed for the determination of analytical content of an antimalarial-antibiotic (artesunate and azithromycin) co-formulation in hard gelatin capsule (HGC). The NIRS consists of pre-processing treatment of spectra (raw spectra and first-derivation of two spectral zones), a unique principal component analysis model to ensure the specificity and t...