Quality Of Pharmaceutical Products Research Articles

A Review on Analytical Methods of Anti-fungal Agents used for the Treatment of Onychomycosis

Background: Analytical methods have an essential function in the healthcare sector, particularly when it emanates from the creation and approval of medications. These methods are essential for identifying the active ingredients, ensuring the purity of compounds, and quantifying the existence of any impurities or degradation products. Objective: The objective of the research article is to discuss an analytical method available for the drug Onychomycosis, which is indeed crucial in treating nail infection, to confirm the efficacy and quality of pharmaceutical products. Among various analytical techniques available, UV Spectroscopy, RP-HPLC (high performance-liquid chromatography) and tandem mass spectrometry are normally employed due to their speed and accuracy. Method: Literature surveys typically reveal the predominance of UV, RP-HPLC and LC-MS/MS methods for estimating azole derivatives due to their established reliability, sensitivity, and applicability to an extensive range of compounds. Researchers often select the most suitable method based on factors such as sample complexity, sensitivity requirements, and available instrumentation. Results: This present art states most of the validation parameters like LOQ, Linearity range, Column and mobile phase used in different dosage forms as well as versatile techniques. Conclusion: This review article provides a comprehensive evaluation of various analytical methods employed in the estimation of antifungal agents, particularly those used to treat Onychomycosis. Onychomycosis, a prevalent infection on nails caused by fungi, demands precise and accurate analytical techniques to ensure the safety and effectiveness of antifungal therapies. In this review, we discussed and compared a range of analytical technologies, highlighting their applications and sensitivity in the context of Onychomycosis drug analysis. This critical assessment aims to guide researchers and practitioners in selecting the most suitable methods for their specific analytical needs.

Particle and bacterial colony emissions from garments and humans in pharmaceutical cleanrooms

Particles and bacteria released from operators in pharmaceutical cleanrooms significantly impact the quality of pharmaceutical products. Therefore, it is necessary to study particle and bacteria emissions from operators and their garments. This paper presents the results of experimental measurements of numbers of particles and bacterial emissions from integrated and split cleanroom garments, under different movement types and laundry conditions. The experiment demonstrated that the emission rate of 0.5 μm particles from split-type garments is approximately 2.0–3.5 times higher than that of integrated cleanroom garments, and 7.0–22.7 times for 5.0 μm particles. The particle emission rate of humans is closely related to the movement types, number of laundry cycles, and garment types. The maximum particle emission rates were obtained when wearing split cleanroom garment after 100 washes and performing knee bend, with 654603 P/min for 0.5 μm and 27185 P/min for 5.0 μm particles, respectively. The particle emission rate of humans is mainly caused by personnel movement, since the emission rate of garments accounts for at most 3.89 %. The bacteria colony of humans increases with the increase of laundry cycles of cleanroom garments. The maximum bacteria colony of integrated and split cleanroom garment were 4 CFU/plate and 9 CFU/plate with the laundry cycles of 100 times. The quantitative results of bacteria and particles emitted from pharmaceutical cleanroom operators are expected to ensure drug quality during production.

Enhancing Pharmaceutical Product Quality With a Comprehensive Corrective and Preventive Actions (CAPA) Framework: From Reactive to Proactive.

Corrective and preventive actions (CAPA) are crucial components of quality assurance (QA) within the pharmaceutical industry, essential for maintaining product quality, safety, and regulatory compliance. The review explores the multifaceted role of CAPA in pharmaceutical manufacturing, emphasizing its structured approach to detecting, addressing, and preventing quality issues. CAPA systems are integral to the broader quality management system (QMS), functioning as a dual-loop mechanism that is reactive and proactive approach aligned with continuous improvement principles outlined by the International Organization for Standardization (ISO) 9001:2000. It details the three distinct phases of CAPA: correction or remedial action, corrective action (CA), and preventive action (PA). It highlights the importance of root cause analysis and the necessity for immediate corrections and long-term preventive measures to avoid recurring issues. Regulatory expectations, such as those from the Food and Drug Administration (FDA) under the Code of Federal Regulations (CFR) title 21 part 820 and theInternational Council for Harmonisationof Technical Requirements for Pharmaceuticals for Human Use (ICH) Q10, are discussed, underscoring the need for a comprehensive CAPA plan that integrates data analysis and ongoing process enhancements. Additionally, the paper introduces the 8D methodology as a structured problem-solving approach to complement CAPA efforts. By providing an in-depth examination of CAPA procedures and their implementation, this article aims to contribute to the understanding and effectiveness of quality systems in pharmaceutical manufacturing.

Recent approaches of regulatory perspectives for the registration of drugs in southern states in India

Recent approaches in regulatory perspectives for the registration of drugs in Southern states of India have been characterized by a focus on enhancing efficiency, transparency, and safety in the drug approval process. This involves the adoption of stringent regulatory frameworks aligned with international standards to ensure the quality, efficacy, and safety of pharmaceutical products. One significant development is the implementation of electronic submission systems for the registration of drugs, streamlining the application process and reducing administrative burdens for regulators and pharmaceutical companies. Additionally, there has been an emphasis on strengthening post-marketing surveillance mechanisms to monitor the safety and efficacy of drugs once they are in the market, enabling prompt identification and mitigation of potential risks or adverse reactions. Collaborative efforts between regulatory authorities, industry stakeholders, and healthcare professionals have also been encouraged to facilitate knowledge exchange and capacity building in regulatory compliance and pharmacovigilance. Overall, these recent approaches reflect a concerted effort to uphold public health standards and ensure access to safe and effective medications for the population of Southern states in India.

A practical approach to estimate analytical method variability from routine testing

The performance of analytical test methods is critical to ensure decisions that affect efficacy and quality of pharmaceutical products are based on accurate and reliable results. As described in USP <1220> and advocated for in ICH Q14, continued verification of critical method attributes linked to bias and precision is essential to ensure method performance throughout the lifecycle of an analytical test method. As continued verification programs for analytical methods within the pharmaceutical industry mature, additional monitoring tools are required to deliver robust and cost-effective verification programs. Herein, a novel methodology is presented to evaluated analytical method variability directly from results generated during routine method execution. The implementation of the methodology is demonstrated for a small molecule liquid chromatographic assay method utilizing a single-point external reference calibration. Approaches to reduce the required data to be collected and broaden the applicability of the methodology to a wide range of analytical methods is described. Finally, the application of the methodology to method development activities is discussed to aid in the identification of variability sources and effectively select replication strategies, thus allowing a holistic understanding of method variability throughout the entirety of the method lifecycle.

QUALITY ASSESSMENT AND STABILITY STUDIES OF METRONIDAZOLE TABLETS FORMULATIONS OBTAINED VIA CRYSTALLO CO-AGGLOMERATION TECHNIQUE

Stability studies are essential for assessing the quality, safety, and efficacy of pharmaceutical products, ensuring they maintain their properties over time. This study aimed to assess the stability of metronidazole tablets stored in a desiccator with charged silica gel following the International council for harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines. Metronidazole tablets were formulated from metronidazole co-agglomerates using different excipients by direct compression method and stored for 6 and 12 months at 25±2°C/60±5% relative humidity. Quality parameters such as weight variation, diameter, thickness, hardness, friability, content uniformity, and dissolution rate were evaluated at intervals using the United States Pharmacopeia – National Formulary and British Pharmacopeia specifications. The tablets maintained uniformity in weight, diameter, thickness and content over 12 months, meeting pharmacopeial standards. They exhibited high crushing strength, low friability, and consistent disintegration times (&lt;5 min), across formulations and storage durations with no significant changes after storage, indicating stable performance. The sustained high crushing strength, friability ratio (CSFR) and crushing strength, friability, disintegration time (CSFR/Dt) ratios suggested high tablet strength and quality. In-vitro dissolution studies showed release rates of 87.31 – 100.81 %, with a significant decrease at 6 months within pharmacopeial standards but no change at 12 months. Content uniformity was maintained throughout storage. Metronidazole tablets formulated from crystallo co-agglomerates demonstrated good stability and mechanical strength over 12 months of storage. Storage in air-tight containers with desiccants at controlled room temperature (25±2°C) or below their relative humidities is recommended for maintaining tablet quality

Evaluating the impact of periodic product review on pharmaceutical production process improvement: A case study

The aim of this study was to evaluate the impact of Periodic Product Review (PPR) on improvements in the production process of pharmaceuticals by statistically analyzing the in-process control of the parameters average weight by coating and hardness. Methods. For this purpose, a case study was conducted in a pharmaceutical industry analyzing the statistical PPR data of a coated tablet from 2021 and 2022. Diagrams and tables based on probability and statistical theory were used for the analysis. Results. The data analysis revealed that PPR was effective in helping to identify problems in the production process, which were then resolved. As a result, the production performance of this drug product was significantly improved, as evidenced by the reduction in the variability of analytical results and process performance indicators within the acceptable range. Conclusion. The results of this work show that PPR is an important tool for ensuring the quality of pharmaceutical products. Statistical analysis of PPR data makes it possible to identify trends and patterns that may indicate the need for improvements in the production process.

Determination of the influence of hemp oil-based emulsion systems composition on the oxidation products content during storage

The object of the study is the content of antioxidants and the induction period of accelerated oxidation under simulated conditions of the lipid component of the emulsion system. The way to solve the problem of developing compositions of oxidation-stable emulsion systems based on nutritionally valuable oils, in particular hemp oil, by adding natural physiologically active antioxidants is considered. The research is relevant in the context of finding effective storage methods and extending the shelf life of products using hemp oil. The feature of the work lies in determining the influence of the composition of emulsion systems based on hemp oil on chemical oxidation during storage. The content of stabilizers in the hemp oil emulsion system (lecithin – 0.8...1.0 %; xanthan gum – 0.0...0.1 %) is proposed, which is effective in the inhibition of oxidative spoilage. The content range of β-carotene (0.012 %) in model emulsion systems is outlined, the addition of which increases the induction period of accelerated lipid oxidation by 1.58...2.08 times. The peroxide value of the lipid component of the emulsion system during storage at different temperature conditions (0...15 °C) and during different storage periods (15...60 days) was studied. The results of the study confirm the significant influence of the composition of emulsion systems on the chemical oxidation of the lipid component, which is important for ensuring the quality and stability of food, pharmaceutical and cosmetic products. An applied aspect of the obtained scientific result is the possibility of modeling the composition of emulsion systems based on valuable hemp oil depending on the ratio of polyfunctional antioxidants of the oil component

Editorial

Dear Authors, Reviewers, Editors, and Staff of Current Analytical Chemistry, First of all, I would like to thank Current Analytical Chemistry for the opportunity to prepare this special issue and the authors who entrusted their work to our care and contributed to the creation of this thematic issue. This special edition contains manuscripts addressed to the topic of physicochemical analyses of pharmaceutical products in the context of white and/or green analytical chemistry, including environmentally friendly methods using HPLC, UV-Vis, thin layer chromatography, infrared, capillary electrophoresis, and others. This is an effort to highlight that analytical methods can be both accurate and precise as well as clean and optimized. In this context, the use of less aggressive solvents, miniaturization of samples and waste, elimination of steps, costs involved, and direct/in-situ analysis are presented. Additionally, the use of tools, such as ESA, GAPI, and NEMI, to evaluate the greenness of analytical methods is also highlighted. Further, the special edition shows sustainable analysis options for chemical-pharmaceutical laboratories around the world. Thus, they will be able to verify the quality of final pharmaceutical products reliably, safely, and with less damage to operators and the environment, in addition to benefiting from all the other advantages of white and/or green analytical chemistry. Organizations are investing heavily in the development and improvement of their processes, analyses, and products based on white and/or green analytical chemistry, as sustainability has been a growing global concern since national and international bodies, mediated by the United Nations, reached a consensus that Earth's resources are finite and pollution can have harmful effects on people and the planet. Several world conferences on the environment and sustainability have already been held. Another factor that encourages organizations to invest in sustainable products is the rise in the inflation rate, the costs of disposing of toxic waste, and the fines for pollution. Therefore, an analytical method must be ecoefficient; that is, it must reduce or eliminate the use of solvents or the generation of toxic waste for both the environment and the operator, ensuring the quality of life of everyone involved. Moreover, universities have played a fundamental role by serving as research centers, contributing to health control activities and scientific enrichment in this area. In this way, this special edition aims to contribute to a cycle of sustainability in which there is a guarantee of product quality and analytical awareness about health, time, waste generation, environment, and cost coexistence. Lastly, I wish you all a fruitful read, which will surely generate new ideas and opportunities for continuous improvement.

Optimizing MEP Design in Pharmaceutical Cleanroom with the Integration of 2D To 7D in BIM

Abstract: This paper examines the optimization of pharmaceutical cleanroom design using 2D to 7D Modelling in Building Information Modelling (BIM). The goal is to enhance the reliability, different methods, statistical data, and performance of pharmaceutical production plants by effectively allocating components within design constraints. Mathematical optimization techniques improve facility design, ensuring robustness and operational efficiency. The study proposes a reliable optimal design for air-conditioning systems in pharmaceutical cleanrooms, considering uncertainties in design parameters and operational strategies. Resilient cleanroom systems are developed, and adaptable to various conditions while maintaining high performance standards. Additionally, the research explores the application of experimental design methodologies in optimizing drug delivery systems, such as factorial and etc, to enhance the quality and efficiency of pharmaceutical products and processes.

Unlocking the electrochemical signature of Naringenin: Implications for screening in pharmaceutical formulations

Naringenin (NAR) is a versatile herbal flavonoid known for its broad pharmacological benefits, including antioxidant, anti-inflammatory, and anticancer properties. These properties underscore its potential and necessity for industrial applications within the pharmaceutical sector, making its detection and quantification crucial for ensuring the quality and efficacy of pharmaceutical products. Addressing the imperative for a sensitive and sustainable screening approach, this research leverages electrochemical analysis techniques including electrochemical impedance spectroscopy (EIS), cyclic voltammetry (CV), and differential pulse voltammetry (DPV). Complementary to experimental investigations, the electronic structure of NAR was probed using B3LYP/Def2-TZVPPD calculations alongside Fukui and dual descriptor analyses. Our findings delineate the dissociation kinetics of the hydroxyl groups within NAR, with particular emphasis on the phenolic group’s proton as the primary dissociation site, elucidating pivotal insights into the oxidation mechanism of NAR. Noteworthy is the irreversibility of the electrochemical oxidation process observed on both non-modified glassy carbon electrode (GCE) and gold electrode (GE), indicating a one-electron-one-proton mechanism. Utilizing the external calibration method and GCE, a linear range from 1.36 to 19.1 mg L-1 in Britton-Robinson (BR) supporting electrolyte was established, exhibiting a limit of detection (LOD) of 0.11 mg L-1 (R2 = 0.9945). For GE, the standard addition calibration approach revealed one linear range, from 0.27 to 0.48 mg L-1 (LOD of 0.04 mg L-1, R2 = 0.9960). Importantly, the proposed methodologies demonstrate satisfactory selectivity against potential interferences, with intra- and inter-day precision exhibiting low relative standard deviation (RSD) values. This study introduces a simple, sensitive, stable, selective, and sustainable electroanalytical method for the detection of NAR in pharmaceutical formulations, harnessing the advantages of unmodified electrodes and rigorous experimental validation.

Digital Transformation in the Pharmaceutical Industry: Ensuring Data Integrity and Regulatory Compliance

The pharmaceutical industry is undergoing a significant digital transformation to improve efficiency, productivity, and regulatory compliance. One critical aspect of this transformation is ensuring data integrity, which is essential for maintaining the quality and safety of pharmaceutical products. This article explores the reasons behind the digital transformation in the pharmaceutical industry, focusing on the need for better data integrity. It examines the challenges pharmaceutical companies face in achieving data integrity, such as legacy systems, data silos, resistance to change, cybersecurity risks, and the validation of computerized systems. The article also discusses the benefits of regulatory compliance, including enhanced product quality and patient safety, reduced risk of non-compliance, improved operational efficiency, and increased brand reputation and customer trust. The author proposes strategies for successful digital transformation and data integrity, such as developing a comprehensive roadmap, investing in modern IT infrastructure, implementing data governance and quality management systems, fostering a culture of continuous improvement, and collaborating with technology partners and industry consortia. The article concludes by discussing future trends and opportunities, such as the adoption of blockchain technology, the integration of Internet of Things devices, the use of big data analytics for predictive quality control, and the need for collaboration with regulators to develop industry-wide data integrity standards. This comprehensive review provides valuable insights for pharmaceutical professionals, researchers, and regulators seeking to navigate the complex landscape of digital transformation and data integrity in the pursuit of improved patient outcomes and business success.

Quality assessment of oral antimalarial and antiretroviral medicines used by public health systems in Sahel countries

Malaria and Human Immunodeficiency Virus infections are among the top 10 causes of death in low income countries. Furthermore, many medicines used in these treatment areas are substandard, which contributes to the high death rate. Using a monitoring system to identify substandard and falsified medicines, the study aims to evaluate the quality of antimalarial and antiretroviral medicines in Sahel countries, assessing site conditions, compliance of medicines with pharmacopoeia tests, formulation equivalence with a reference medicine, and the influence of climate on quality attributes. Ultra Performance Liquid Chromatography methods for eight active pharmaceutical ingredients were validated following the International Conference for Harmonization guideline for its detection and quantification. Quality control consists of visual inspections to detect any misinformation or imperfections and pharmacopeial testing to determine the quality of pharmaceutical products. Medicines which complied with uniformity dosage units and dissolution tests were stored under accelerated conditions for 6 months. Artemether/Lumefantrine and Lopinavir/Ritonavir formulations failed uniformity dosage units and disintegration tests respectively, detecting a total of 28.6% substandard medicines. After 6 months stored under accelerated conditions (40 °C // 75% relative humidity) simulating climatic conditions in Sahel countries, some medicines failed pharmacopeia tests. It demonstrated the influence of these two factors in their quality attributes. This study emphasizes the need of certified quality control laboratories as well as the need for regulatory systems to maintain standards in pharmaceutical manufacturing and distribution in these countries, especially when medicines are transported to rural areas where these climatic conditions are harsher.

Insights into folic acid mixtures compounded with commercially available vitamin syrups

Stability assessments are crucial in determining the shelf-life and quality of compounded pharmaceutical products. Folic acid, an essential B-vitamin, is widely used to prevent and treat folate deficiency-related conditions. However, because of patient-specific demands or customised dose requirements, compounded folic acid syrups are frequently used in pediatric patients. This study aims to examine the stability of compounded folic acid mixtures prepared with some commercially available vitamin syrups. Three commercially available vitamin syrups were utilized as compounding vehicles for folic acid tablets, ensuring a representative sample of products commonly used in compounding practices in hospitals when conventional compounding vehicles are not available. The compounded folic acid mixtures were stored under ambient (21- 25 ºC) and refrigerated conditions (2-8 ºC), to simulate real-life scenarios, and tested using parameters such as, organoleptic characteristics, sedimentation rate, pH, microbial growth and drug content determination at day 7, 14 and 30. The extemporaneous preparations of the compounded folic acid in vitamin syrups generally maintained their physical characteristics over the 30-day study period. However, there was either decrease in folic acid concentration or microbial contamination of the preparations at day 7. Therefore, folic acid compounded in vitamin syrups are generally stable for less than seven days. The data obtained will aid healthcare professionals and compounding pharmacies in decision making concerning the choice of vehicle, compounding practices and strategies to ensure the preparation of wholesome extemporaneous products.

Development and validation of a sensitive and robust chiral method for (R)-propylene oxide: From chiral gas chromatography to chiral liquid chromatography with pre-column derivatization

Propylene oxide (PO) is an important chemical commodity and a chiral building block to prepare pharmaceutical compounds. It is crucial to develop a sensitive and robust chiral method that can be used to assess the enantiomeric purity of PO and safeguard the quality and safety of pharmaceutical products in commercial quality control (QC) laboratories. A chiral gas chromatography (GC) method based on direct enantioseparation of PO enantiomers on a 50-meter Chiraldex™ A-TA open capillary column was successfully developed for determination of enantiomeric impurity (S)-PO in (R)-PO. However, it was revealed that the chiral GC method lacked adequate robustness for routine use. Consequently, a chiral high-performance liquid chromatography (HPLC) method was developed through pre-column derivatization of PO with 2-naphthalenethiol followed by enantioseparation on a Lux Cellulose-1 (250 mm × 4.6 mm, 5 µm) column. The chiral HPLC method has been demonstrated excellent specificity, sensitivity, accuracy and robustness through method validation and robustness evaluation, thus establishing its suitability for routine use in QC laboratories.

Literature Review of Practice Evaluation of Good Drug Distribution Methods at Public and Private Sector Pharmaceutical Distribution Facilities in Indonesia

To ensure that the quality of pharmaceutical products is maintained throughout the distribution chain, it is necessary to implement Good Distribution Practices at distribution facilities that distribute pharmaceutical products. This literature review explores the evaluation of Good Drug Distribution (GDP) or CDOB guideline practices in pharmaceutical product distribution facilities engaged in the public and private sectors in Indonesia. The literature review method used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol. Articles were searched using the Google Scholar database and restricted to those related to GDP published from 2018 to 2022. The literature was reviewed using questions to assess studies organized by Population, Exposure, and Outcome (PEO) criteria. Articles obtained were then identified, screened, eligibility, then selected based on inclusion and exclusion criteria resulting in 19 pieces that will be extracted data. Of the 19 articles, the study was conducted in several pharmaceutical distribution facilities such as the Health Office, Puskesmas, Hospitals, Pharmacies, and Pharmaceutical Wholesalers spread across Indonesia. All articles used descriptive methods to show the conformity of implementing Good Distribution Practices guidelines. Some studies still do not use the latest regulation, namely the Food and Drug Administration Regulation Number 6 of 2020 concerning Amendments to BPOM Regulation Number 9 of 2019 concerning Technical Guidelines for Good Distribution Methods. The suggestions that can be made include the need for studies related to the evaluation of Good Distribution Practices of pharmaceutical distribution facilities in the public or government sector and studies on distribution facilities in Eastern Indonesia

Quality assessment of metformin hydrochloride tablets retailed in Lagos, Nigeria

Background: Metformin is a biguanide antihyperglycemic drug used with diet and exercise for glycemic control in type 2 diabetes mellitus.Objectives: This research aims to compare and analyze different metformin products to ascertain their critical quality parameters. The goal is to ensure that prescribed medicine effectively treats patients and protects the public.Materials and Methods: We evaluated the quality of ten metformin tablet brands in Lagos (Mushin and Surulere area) using official methods to assess weight, hardness, friability, disintegration time, and dissolution. Active ingredient content was also measured.Results: Out of all the tablets tested, only 10 % had weights outside of the official British Pharmacopoeia 2002 limits (not more than two tablets should deviate from ±5% and none of the tablets should deviate by ± I0). The hardness test was passed by all the tablets (A minimum hardness of 4 kgF is a pass), while 80 % passed the friability test (weight loss of ≤ 1 %w/w is a pass). Additionally, all film-coated tablets disintegrated within 30 minutes according to United States Pharmacopoeia/National Formulary 2003 (film-coated tablets disintegrate within 30 minutes). Ninety percent of the tablets passed the dissolution test (drug release within 60 minutes should be between 93 and 103 %) and 90 % of all brands examined passed the assay test for the active ingredient contents. The British Pharmacopoeia 2019 standard was used for the dissolution test.Conclusion: Routine pharmaceutical analysis is essential for the quality of pharmaceutical products and the safety of consumers.

Pharmaceutical Promotions and Compliance with Community-Acquired Pneumonia Prescribing Guidelines by General Practitioners in Mbarara

Background: Generic prescribing effectively reduces dispensing errors and promotes the availability, access and quality of pharmaceutical products in health facilities or pharmacies. However, in Uganda, non-compliance with treatment guidelines is prevalent, with evidence of some General Practitioners (GPs) prescribing non-essential and obsolete drugs. This study examines the role of pharmaceutical promotions in creating awareness of new medicines among GPs and the potential influence of these promotions on prescribing practices.&#x0D; Methods: The study used a qualitative phenomenological research design. Key informant interviews were conducted with 33 experienced GPs from nine hospitals in Mbarara City, Uganda. The transcribed interviews were analysed using content analysis.&#x0D; Results: Most GPs were male (78.79%), aged between 41-50 years (30.30%), with a work experience of 6-10 years (39.39%). All GPs had at least been exposed to pharmaceutical promotions such as free samples, visits from medical representatives, and Continuing Medical Education sessions. Most GPs had a positive outlook on these promotions, which they believed were informative, educational, and beneficial. However, the more GPs depend on pharmaceutical promotions, the less likely they are to follow the national or international guidelines for generic prescribing.&#x0D; Conclusion: The study highlights the importance of ethical pharmaceutical promotion and the need for strict regulation by the National Drug Authority (NDA) to ensure that promotional activities do not compromise patient care and public health outcomes. The study recommends that GPs be more critical of the information and incentives provided during such promotions and should be trained in rational prescribing and evidence-based medicine.

Insight into Metabolomic Profiling of Tinospora cordifolia: Recent Advances and Future Perspectives of Quality Control

Abstract The objective of this study was to offer a review of previous works on Tinospora cordifolia (TC) metabolomics with a highlight on the use of metabolomics in comparative evaluations between varieties and selection of optimum cultivation, collection, and extraction procedures, providing insights into pharmaceutical and food product quality monitoring. Scholarly databases were searched to gather relevant information on TC’s therapeutic usefulness, phytoconstituent studies, metabolomics, and applications. PubChem was used to learn the structures of several of the metabolites. The various medicinal properties of TC were extensively researched. The most essential portions of the plant in Ayurvedic medicines are the stems. Bioactive phytochemicals such as steroidal lactones, alkaloids, diterpenoids, and phenolic compounds are present in the roots and leaves. Metabolomic analysis revealed that, in addition to the season and geographical region of the sample collected, the metabolite profiles of TC also depend on the parts of the plant taken as a sample and also the plant’s stage of growth. The amounts of secondary metabolites differed between morpho/chemotypes within the TC species. Despite the fact that research on TC began several decades ago, the diversity of phytoconstituents was not appreciated because of a lack of reliable techniques for phytochemical fingerprinting. The uncovering of several novel metabolites was aided by advances in chromatography combined with mass spectrometry. To produce a full metabolomic profile, researchers used mutually complementary techniques. Following that, data analysis and searches against spectrum databases allowed for signal annotation and interpretation of metabolites in large quantities without separating them separately. The current review includes a critical assessment of metabolomic data and an overview of the technique’s various applications. It is vital to establish the metrics of quality control of herbal medicines in order to accomplish formulation purity assessments. Such information would assist us in determining the best geolocation for the plants and the best time to harvest them. Metabolomic investigation of TC-based herbal products is recommended for quality standards and the identification of novel bioactive components.

აფთიაქების საქმიანობის უფლებამოსილების მინიჭების მექანიზმები

Pharmacy is a crucial healthcare service that ensures access to safe and effective medicines for the population. As such, the regulation of pharmacy and the licensing of pharmacies and pharmacists is essential to ensure the quality and safety of pharmaceutical products and services. The regulatory body is responsible for issuing licenses and permits, conducting inspections, and enforcing laws and regulations related to pharmacy practice. A pharmacy license can have different meanings depending on the context, but generally speaking, a pharmacy license is a legal authorization granted by a government or regulatory agency that allows a pharmacy to operate within a particular jurisdiction. In some cases, the license may be tied to the physical location of the pharmacy, which means that if the pharmacy changes ownership, the license can be transferred automatically to the new owner, as long as the new owner meets all the other requirements for operating a pharmacy. In other cases, the license may be tied to the responsible pharmacist who manages the pharmacy, which means that if the responsible pharmacist changes, the license may need to be revoked and a new one issued to the new responsible pharmacist. To summarize, a pharmacy is a healthcare facility that provides services related to the distribution of medicines. Licensing requirements for pharmacies vary by country, but typically involve both a license for the physical location of the pharmacy and a license for the responsible pharmacist operating the pharmacy. These licenses may be subject to specific conditions and mechanisms for issuance and revocation, depending on the country's legal framework and other factors. Ultimately, the goal of pharmacy licensing is to ensure that patients have access to safe and effective medications, regardless of their geographic location or economic status.