A Review of Probiotic Ingredient Safety Supporting Monograph Development Conducted by the United States Pharmacopeia (USP).

The United States Pharmacopeia (USP) is an independent, nonprofit science-based organization whose mission is to improve global health through public standards and related products for medicines, food and dietary supplements. Probiotic-based dietary supplements are increasingly popular in the marketplace and USP has developed fourteen monographs specific to probiotic ingredients, including representatives from the Genera Lactobacillus, Bacillus, Streptococcus, and Bifidobacterium. These monographs include the definition of the article, tests for identification, quantification assays (enumeration in the case of probiotics), limits for contaminants, and other quality parameters when appropriate. In addition to quality, the USP also considers the safety of probiotics for monograph development. This report includes an overview of the USP admission evaluation process for probiotics as well as a tabular summary of the probiotic monographs currently available. Pharmacopeia monographs can guide manufacturers and brand owners and protect consumers through establishment of quality standards.

Immune Thrombocytopenia Secondary to COVID-19 in a Vitamin B12-Deficient Patient: A Diagnostic Dilemma and Therapeutic Challenge.

Immune thrombocytopenia (ITP) caused by infectious and non-infectious conditions has been reported in coronavirus disease 2019 (COVID-19) patients too. Here we present a 64-year-old male patient with post-COVID-19 pneumonia who presented with a gastrointestinal bleed and was found to have severe isolated thrombocytopenia (22,000/cumm) diagnosed as ITP with extensive investigations. He was treated with pulse steroid therapy and later was also given intravenous immunoglobin in view of poor response. The addition of eltrombopag also resulted in a sub-optimal response. He was also having low vitamin B12, and his bone marrow also supported the megaloblastic picture. Hence, injectable cobalamin was added to the regimen, which resulted in a sustained rise in platelet count that reached 78,000/cumm, and the patient got discharged. This shows the possible hindrance to treatment response by concomitant B12 deficiency. Vitamin B12 deficiency is not an uncommon entity and should be tested in those who show no or slow response to thrombocytopenia.

Improving and Comparing Probiotic Plate Count Methods by Analytical Procedure Lifecycle Management.

Probiotics are live microorganisms that confer a health benefit to the host when administered in adequate amounts. This definition links probiotic efficacy to microbial viability. The current gold standard assay for probiotic potency is enumeration using classical microbiology plating-based procedures, yielding results in colony-forming units (CFU). One drawback to plating-based procedures is high variability due to intrinsic and extrinsic uncertainties. These uncertainties make comparison between analytical procedures challenging. In this article, we provide tools to reduce measurement uncertainty and strengthen the reliability of probiotic enumerations by using analytical procedure lifecycle management (APLM). APLM is a tool that uses a step-by-step process to define procedure performance based on the concept that the reportable value (final CFU result) must be fit for its intended use. Once the procedure performance is defined, the information gathered through APLM can be used to evaluate and compare procedures. Here, we discuss the theory behind applying APLM and give practical information about its application to CFU enumeration procedures for probiotics using a simulated example and data set. Data collected in a manufacturer's development laboratory is included to support application of the concept. Implementation of APLM can lead to reduced variability by identifying specific factors (e.g., the dilution step) with significant impact on the variability and providing insights to procedural modifications that lead to process improvement. Understanding and control of the analytical procedure is improved by using these tools. The probiotics industry can confidently apply the information and analytical results generated to make decisions about processes and formulation, including overage requirements. One benefit of this approach is that companies can reduce overage costs. More reliable procedures for viable cell count determinations will improve the quality evaluation of probiotic products, and hence manufacturing procedures, while ensuring that products deliver clinically demonstrated beneficial doses.

Persistent cough: An unexpected diagnosis.

Esophageal cancer is the eighth most common cancer and the sixth most common cause of cancer death globally. Esophageal squamous cell carcinoma (ESCC) accounts for 70%-90% of esophageal cancers worldwide, 5% are adenocarcinoma, and 5% represent rare malignancies and metastases from other organs. We present a case where a 54-year-old lady, with multiple readmissions for persistent dry cough and respiratory symptoms, turns out to be an esophageal malignancy. CECT thorax revealed an enhancing wall thickening of the esophagus with paraoesophageal fat stranding, mediastinal lymphadenopathy, and subsegmental right lobe atelectasis, suggestive of a probable esophageal malignancy. An upper gastrointestinal endoscopy showed a circumferential esophageal growth which on biopsy and histopathological examination turned out to be a moderately differentiated squamous cell carcinoma of esophagus.