Tapentadol: navigating the complexities of abuse, patient safety & regulatory measures.

Aim: To evaluate tapentadol abuse cases by analyzing real-world data and identifying under-reporting countries from Southeast Asian Region (SEAR) to enhance vigilance.

Method: A retrospective, observational study from 2013 to March 2024 using VigiBase was conducted.

Result: Tapentadol-related abuse falls within the System Organ Class (SOC) categories of psychiatric disorder, nervous system disorder and injury, poisoning, and procedural complications.

Overview of cloning in lactic acid bacteria: Expression and its application of probiotic potential in inflammatory bowel diseases.

Inflammatory bowel disease (IBD) imposes a significant impact on the quality of life for affected individuals. However, there was a current lack of a systematic summary regarding the latest epidemic trends and the underlying pathogenesis of IBD. This highlights the need for a thorough examination of both the epidemiological aspects of IBD and the specific mechanisms by which lactic acid bacteria (LAB) contribute to mitigating this condition.

Pivotal role of Pharmacovigilance Programme of India in containment of antimicrobial resistance in India.

Misuse of antimicrobials has become one of the grave concerns of public health. In last two decades, this has been largely contributing in the emergence of antimicrobial resistance (AMR) among all the pathogens. A 2013 report of Centres for Disease Control and Prevention, USA figured that at least 2 million people get an antibiotic-resistant infection every year and as many as 23,000 people lost their life.

Sexual Dysfunction among Men in Rural Tamil Nadu: Nature, Prevalence, Clinical Features, and Explanatory Models.

Background And Aim: There is a dearth of community data on nature, prevalence, clinical features, and explanatory models related to sexual dysfunction among men, particularly from rural India. This study attempted to examine different aspects of male sexual dysfunction and misconceptions in the community.

Materials And Methods: Villages in Kaniyambadi Block, Vellore district were stratified, and four were randomly selected.

Quantitative Methods for the Identification of Signals for Individual Case Safety Reports in India.

Background: The Pharmacovigilance Programme of India (PvPI) is responsible for collecting reports of adverse drug reactions (ADRs) to assess the association between particular drugs and ADRs. The aim of the present study was to apply statistical tools to determine associations between drugs and ADRs for signal detection in the PvPI.

Methods: Four methods were proposed for quantitative signal detection: one was based on Bayesian inference and others on classical inference procedures.

Status of documentation grading and completeness score for Indian individual case safety reports.

The quality of individual case safety reports (ICSRs) generated under Pharmacovigilance Programme of India (PvPI) plays a pivotal role in detecting a signal from Indian drug safety data. Currently, more than hundred thousand ICSRs were generated under PvPI and reported to Uppsala Monitoring Centre. The documentation grading and completeness score of Indian ICSRs were rapidly increasing, and the current score was 0.

Quality Standards and Current Status of Ophthalmic Formulations in Indian Pharmacopoeia and National Formulary of India.

The global ophthalmic formulations (OFs) market is expanding dramatically with the approval of new drug formulations for a variety of ophthalmic indications by competent authorities in various countries. In India, the Central Drug Standards Control Organization (CDSCO) and Indian Pharmacopoeia Commission (IPC) are making efforts for approval and setting the standards for OFs, respectively. In fulfillment of the requirements of the Drugs and Cosmetics Act of 1940, the IPC is publishing an official book of standards for drugs known as the Indian Pharmacopoeia (IP).

Identification of isocephalomannine in the presence of cephalomannine isomers and alkali metal ion adducts in a paclitaxel active pharmaceutical ingredient using electrospray tandem mass spectrometry.

A strategy is developed for the identification of isocephalomannine in the presence of alkali metal ion adducts and other cephalomannine isomers in a paclitaxel active pharmaceutical ingredient. Intact molecular ion analyses and a sub-structural study have been performed for the differentiation of isocephalomannine (2-debenzoylpaclitaxel-2-pentenoate) from cephalomannine and 7-epi-cephalomannine. A comparative study of the cephalomannine isomers was carried out using molecular ions (MS) and fragmentation patterns (MS/MS) for sub-structural analysis.

Identification of degradation products from aqueous carboplatin injection samples by electrospray mass spectrometry.

Four different carboplatin injection samples in water ( approximately 10mg/ml) stored at room temperature were investigated for degradation products by electrospray liquid chromatography-mass spectrometry (ESI/LC-MS). A mass spectrometer compatible mobile phase system with 0.02% formic acid and methanol was used to resolve the impurities.

A simple method of isolation of chloramphenicol in honey and its estimation by liquid chromatography coupled to electrospray ionization tandem mass spectrometry.

To detect sub-ppb levels of the antibiotic chloramphenicol in honey matrix, a convenient method of extraction and measurement using liquid chromatography with detection by tandem mass spectrometry (LC/MS/MS) was developed. Honey samples fortified with chloramphenicol and isotopically labeled chloramphenicol were extracted using diatomaceous-based supported liquid-liquid extraction cartridges to generate a standard calibration curve. Four MS/MS transitions were used for quantification and four other transitions for confirmation of chloramphenicol.