Holding times for raw materials are relevant, since they enable us to understand the allowable time that a raw material can be kept under ideal storage conditions before the start of the manufacturing process without its quality attributes being affected. The quantification of water activity can be used as an indicator of the microbiological, physicochemical, and organoleptic stability of a specimen, since low water activity retards autohydrolysis and microbiological growth. The main purpose of this investigation was to test the stability of powdered raw materials for a maximum holding time of 8 days through water activity measurements. Thus microbiological, physicochemical, and organoleptic measurements were carried out in parallel and simultaneously in order to experimentally establish a relationship between the status of the water activity of processed raw materials and the microbiological, physicochemical, and organoleptic results. The raw materials were stored for a maximum holding time of 8 days, in accordance with USP monographs. For all the raw materials tested, water activity measurements were performed using the dew point chilled-mirror method on days 0, 3, and 8. On days 0 and 8, microbiological, physicochemical, and organoleptic assessments were performed. It was established that under these storage conditions, the processed raw materials exhibited water activity below 0.60 during the entire holding time. However, there were statistically significant differences in water activity levels between days 0, 3, and 8 (ANOVA P < 0.05). Despite observing statistically significant differences between days, the microbiological, physicochemical, and organoleptic features were within specification at those water activity levels, below 0.60. Water activity below 0.60 does not allow the growth of microorganisms, and the organoleptic and physicochemical features remain unperturbed. The results indicate that water activity can be used as an indicator of the microbiological load and chemical stability of the raw materials tested.

Introduction: The gut microbiota is vital for human health, and its modulation through dietary and pharmaceutical compounds has gained increasing attention. Among gut microbes, Akkermansia muciniphila has been extensively researched due to its role in maintaining intestinal barrier integrity, regulating energy metabolism, and influencing inflammatory responses. Subject: To analyze and synthesize the available scientific evidence on the influence of various bioactive compounds, including prebiotics, polyphenols, antioxidants, and pharmaceutical agents, on the abundance and activity of A. muciniphila, considering underlying mechanisms, microbial context, and its therapeutic potential for improving metabolic and intestinal health. Methods: A systematic literature review was conducted in accordance with the PRISMA 2020 guidelines. Databases such as PubMed, ScienceDirect, Scopus, Web of Science, SciFinder-n, and Google Scholar were searched for publications from 2004 to 2025. Experimental studies in animal models or humans that evaluated the impact of bioactive compounds on the abundance or activity of A. muciniphila were prioritized. The selection process was managed using the Covidence platform. Results: A total of 78 studies were included in the qualitative synthesis. This review compiles and analyzes experimental evidence on the interaction between A. muciniphila and various bioactive compounds, including prebiotics, antioxidants, flavonoids, and selected pharmaceutical agents. Factors such as the chemical structure of the compounds, microbial environment, underlying mechanisms, production of short-chain fatty acids (SCFAs), and mucin interactions were considered. Compounds such as resistant starch type 2, GOS, 2′-fucosyllactose, quercetin, resveratrol, metformin, and dapagliflozin showed beneficial effects on A. muciniphila through direct or indirect pathways. Discussion: Variability across studies reflects the influence of multiple variables, including compound type, dose, intervention duration, experimental models, and analytical methods. These differences emphasize the need for a contextualized approach when designing microbiota-based interventions. Conclusions: A. muciniphila emerges as a promising therapeutic target for managing metabolic and inflammatory diseases. Further mechanistic and clinical studies are necessary to validate its role and to support the development of personalized microbiota-based treatment interventions.

Alternative and rapid microbiological methods are effective and profitable technologies that can be safely use in the pharmaceutical industry. This report studies the efficacy of the Soleris® direct yeast and mold automated method for the quantitative detection of C. albicans and A. brasiliensis at three different microbial bioburden. Validation testing was carried out using an antacid oral suspension (aluminum hydroxide 4% + magnesium hydroxide 4% + simethicone 0.4%). Equivalence of data between detection time vs. colony-forming units was established for both, alternative and conventional methodologies. Using probability of detection, linear Poisson regression, Fisher's test, and multifactorial analysis of variance ANOVA, all results from the rapid method were prove to be in statistical agreement with the reference plating procedures. The limits of detection and quantification were statistically similar for both methods (Fisher's exact test, P >0.05), showing that the alternative method was not inferior in performance to the reference method. Essential validation parameters such as precision (standard deviation < 5, coefficient of variance < 35%), accuracy (>70%), linearity (R2 >0.9025), and ruggedness (ANOVA, P <0.05) were determined. It was proved that all test results obtained from the alternative method were in statistical agreement with the standard plate count method. Thus, this new technology was found to meet all the validation criteria needed to be considered as an alternative method for yeast and mold quantification in the antacid oral suspension tested.

Despite the broad adoption of Soleris® technology in the food industry as semiquantitative method, they are almost completely unexplored in the pharmaceutical industry as a quantitative method for quantification of Burkholderia cepacia complex. The efficacy of an automated growth-based system for a quantitative determination of the Burkholderia cepacia complex in an antacid oral suspension was studied. The main purpose of this validation study was to prove that the alternative method’s entire performance is not inferior to the conventional method for a quantitative determination of Burkholderia cepacia complex. The antacid oral suspension’s preservatives were neutralized, leading to the Burkholderia complex’s recovery by means of the alternative method and the reference method. A calibration curve was generated for each strain by plotting DTs relative to the corresponding log CFU values. An equivalence of results was done through the construction of calibration curves that allowed the establishment of numerically equivalent results between the enumeration data from the reference method and the alternative method. Thus following the guidelines of USP, essential validation parameters were shown, such as equivalence of results (CC > 0.95), linearity (R² >0.9025), accuracy (% recovery >70%), operating range, precision and ruggedness (DS < 5 and CV < 35%), specificity (inclusivity and exclusivity), limit of detection, and limit of quantification. It was shown that all the test results obtained from the alternative method were in statistical agreement with the standard method. Thus this new technology was found to meet all the validation criteria needed to be considered to be an alternative method for the quantification of the Burkholderia complex in the antacid oral suspension tested. mplementation of alternative methods can offer benefits in execution and automation while improving accuracy, sensitivity, and precision and reduce the microbiological process time compared to the traditional ones.

The objective of this investigation is to validate the dew point chilled mirror method for quantifying water activity in tablets and capsules, evaluating the effects of different temperatures, sample preparations, and local environmental exposure times. The validation of an acute and precise water activity measurement method has become an important goal in the pharmaceutical industry, because it may help to predict the microbiological bioburden on solid products, since most xerophilic and osmophilic microorganisms are unable to grow at water activity levels below 0.60, to safely reduce the frequency of routine microbiological analysis using conventional methods. For all the solid samples tested, a suitability of method was carried out, considering the sample preparation, environmental exposure times, and different measuring temperatures. Following USP guidelines, essential parameters such as precision (SD < 0.5), accuracy (% recovery in the 95%–105% range), linearity (R² > 0.99), ruggedness (ANOVA, P < .05), robustness, operative range (aw 0.17–1), limits of detection (aw = 0.17), and limit of quantification (aw = 0.25) were met by the dew point methodology. The dew point chilled mirror method was proven to yield accurate, precise, and robust data, making it an outstanding methodology to be implemented in the pharmaceutical industry for measuring the water activity status in tablets and capsules as a direct assessment of the microbial burden.

The present investigation studies the efficacy of an automated growth-based system for a quantitative determination of Candida albicans and Aspergillus brasiliensis in several personal care products. The main purpose of this validation study was to prove that the alternative method’s entire performance is not inferior to the conventional pour-plate method for a quantitative determination of yeasts and molds. Thus, a performance equivalence was established in accordance with the United Stated Pharmacopeia (USP-NF) Validation of Alternative Microbiological Methods ˂1223˃. C. albicans and A. brasiliensis were pooled to use as inoculum (equivalent to 1.0 × 10⁸ CFU/mL) in the suitability of the method test. PCP's preservatives were chemically neutralized leading to the yeast and mold recovery by means of the alternative microbiological method (AMM) and the pour-plate method. A correlation curve was generated for each PCP by plotting DTs relative to the corresponding log CFU values. Thirty PCPs have been tested for quantification of yeasts and molds using an AMM. An equivalence of results was made through the construction of correlation curves that allowed the establishment of numerically equivalent results between the enumeration data from the reference method (CFU) and the alternative method (Detection times, DTs). Thus, following the guidelines of USP Ch.1223, essential validation parameters were tested, such as equivalence of results (Correlation coeficient, CC >0.95), linearity (R² >0.9025), accuracy (% recovery >70%), operating range, precision (CV  0.05), specificity, LOD, and LOQ. It was shown that all the test results obtained from the alternative method were in statistical agreement with the standard plate-count method (PCM). Thus, this new technology was found to meet all the validation criteria needed to be considered for an alternative method for yeast and mold quantification in the PCPs tested. In accordance with the United Stated Pharmacopeia (USP-NF) Validation of Alternative Microbiological Methods ˂1223˃, the implementation of alternative methods can offer benefits in execution and automation while improving accuracy, sensitivity, and precision and reduce the microbiological process time compared to the traditional ones.