Insights on the Critical Parameters Affecting the Probiotic Viability During Stabilization Process and Formulation Development.

Probiotics have gained a lot of interest in recent years as an alternative as well as adjuvant therapy for several conditions owing to their health benefits. These live microorganisms have proven efficacy for treating gut disorders, inflammation, bacterial vaginosis, hepatic and depressive disorders, and many more. There are conventional as well as non-conventional formulations available for the delivery of probiotics with the latter having fewer regulatory guidelines. The conventional formulations include the pharmaceutical formulations specifically designed to deliver an efficacious number of viable microorganisms. Studies have indicated 108-109 CFU/g as an ideal dose of probiotics for achieving health benefits, and hence, all the formulations must at least contain the said number of viable bacteria to show a therapeutic effect. The most crucial feature of probiotic formulations is that the bacteria are prone to several environmental and processing factors which all together reduce the viability of the bacteria in the final formulation. These factors include processing parameters like temperature, humidity, pressure, and storage conditions. Thus, the present review primarily focuses on the critical process parameters affecting the probiotic viability during stabilization process and formulation development. Understanding these factors prior to processing helps in delivering probiotics in the required therapeutic numbers at the target site.

Formulation, characterization, pharmacokinetics and antioxidant activity of phloretin oral granules.

Phloretin (PHL), a flavonoid of the dihydrogen chalcone class, is reported to have low oral bioavailability due to its poor solubility and absorption. A common approach to enhance the solubility of such flavonoids is solubilization in a polymeric or lipidic matrix which would help in enhance dissolution rate and solubility. Accordingly, in the current study PHL was dissolved in Gelucire® 44/14 by melt-fusion technique and the viscous semisolid melt was adsorbed on a solid carrier to obtain free flowing granules. SeDeM-SLA (Solid-Liquid Adsorption) expert system was employed to select the most suitable carrier. This study achieved positive outcomes through the successful development of formulated oral PHL granules. The granules exhibited good stability, and favourable pharmacokinetic properties. In addition, the selected carrier effectively retained the antioxidant properties of PHL.

Determination of Microstructural Impact on the Release of Drug from Hydroxypropyl Cellulose Gel by Validated In Vitro Release Test Method.

Microstructure of a semisolid system is greatly influenced by the formulation composition and the processing parameters. Different polymers exhibit different three-dimensional structure and these have a great impact on the drug release properties. The current research focuses on studying the impact of hydroxypropyl cellulose gel microstructure on the release properties of chlorhexidine gluconate (CHX G). The two main investigating methods of microstructure were used namely, rheology and texture analysis to determine the differences in the formulations studied. The CHX G drug release study was performed using a developed and validated in vitro release test method, which is reproducible, discriminative, and robust to detect the formulation differences. The drug release results showed that there was appreciable difference in the release rates of the different formulations. The rheology and texture analysis data correlated well with the difference in the release rates. The formulations differences were further confirmed by a statistical approach using analysis of variance.