Film Coating as a New Approach to Prepare Tablets Containing Long-Term Stable Lactobacillus acidophilus

This work presents a study of film coating with the vaginal strain of Lactobacillus acidophilus, the aim of which was to manufacture administrable probiotic tablets in one step and to enhance the survival rate of bacteria and their viability during storage. The results show that the film coated lactose-based tablets contained viable bacteria and the survival rate after the process was 21%, which could be enhanced up to 59% by applying protective media (trehalose, sucrose, reconstituted skim milk (RSM) during dehydration. Additionally, protective agents improved the viability of bacteria during storage too. After one year, 20% of the embedded bacteria were active when stored at –20°C, and viability dropped only one order of magnitude when stored at 7°C. It was verified that the bacteria in film coated tablets were not sensitive to higher levels of humidity owing to the moisture-moderating PVA-based coating composite

Soft sensor for content prediction in an integrated continuous pharmaceutical formulation line based on the residence time distribution of unit operations

In this study, a concentration predicting soft sensor was achieved based on the Residence Time Distribution (RTD) of an integrated, three-step pharmaceutical formulation line. The RTD was investigated with color-based tracer experiments using image analysis. Twin-screw wet granulation (TSWG) was directly coupled with a horizontal fluid bed dryer and an oscillating mill. Based on integrated measurement, we proved that it is also possible to couple the unit operations in silico. Three surrogate tracers were produced with a coloring agent to investigate the separated unit operations and the solid and liquid inputs of the TSWG. The soft sensor’s prediction was compared to validating experiments of a 0.05 mg/g (15% of the nominal) concentration change with High-Performance Liquid Chromatography (HPLC) reference measurements of the active ingredient proving the adequacy of the soft sensor (RMSE < 4%)

Prediction of Bioequivalence and Food Effect Using Flux- and Solubility-Based Methods

In this work, two different approaches have been developed to predict the food effect and the bioequivalence of marketed itraconazole (ITRA) formulations. Kinetic solubility and simultaneous dissolution–permeation tests of three (ITRA) formulations (Sporanox capsules and solution and SUBA-ITRA capsules) were carried out in simulated fasted and fed states. Fraction of dose absorbed ratios estimating food effect and bioequivalence were calculated based on these results and were compared to the in vivo study results published by Medicines Agencies. The comparison demonstrated that kinetic solubility and flux values could be used as input parameters for biopharmaceutics modeling and simulations to estimate food effect and bioequivalence. Both prediction methods were able to determine a slightly negative food effect in the case of the Sporanox solution and also a pronounced positive food effect for the Sporanox capsule. Superior bioavailability was predicted when the Sporanox solution was compared to the Sporanox capsule (in agreement with in vivo data)