Polymeric Nanoparticles

Animal-based testing is important for understanding the performance, mechanism, and translational capacities of floating tablets and in-vitro testing for stomach retention, which is the focus of the current review.  With a limited window for absorption in the upper gastrointestinal tract, drug delivery systems (FDDS) are designed to improve the residence time, bioavailability, and controlled release of medications.  The recipes that employed gas-producing agents like sodium bicarbonate and citric acid, as well as hydrophilic polymers like HPMC, carbopol, and sodium alginate, demonstrated exceptional floating properties with a lag time of less than 12 hours. In vitro research studies showed sustained release profiles along the zero-order or non-Fickian kinetics, whereas in vivo testing in albino rats and rabbits showed long gastric retention and better pharmacokinetic results. Gastric safety and biocompatibility was confirmed by histopathological assessments. Direct compression was determined to have the best formulation through comparative analysis based on stable and efficient formulations compared to wet granulation. All in all, animal tests will be a critical preclinical base to determine optimal proportions of polymers, buoyancy, and release characteristics which will make floating pills safe and effective when applied to the clinical setting.

Pharmaceutical formulations stability is an important factor in drug development and drug quality control. The goals of this work were to establish and qualify a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method to measure active pharmaceutical ingredients in a fixed- dose combination admixture tablet simultaneously and to assess the degradation kinetics of the Active pharmaceutical ingredients under different stress conditions. The concentration using C18 column and acetonitrile-phosphate buffer mobile phase proved to be optimal in terms of separating the APIs with great resolution, symmetric peaks and reproducibility. The results of the forced degradation studies indicated that stress due to acidic and oxidative conditions appeared to be the most significant stressors, whereas thermal and photolytic stress had little effect. First-order kinetic models were used to describe the degradation that was confirmed to be significantly different under different stress conditions using statistical testing. The validated technique was robust and sensitive and could be applied in regular quality checks; the information helped understand the stability of the formulation and shelf-life.