Pharmaceutical Industry Research Articles

Artificial intelligence as a tool in drug discovery and development

The rapidly advancing field of artificial intelligence (AI) has garnered substantial attention for its potential application in drug discovery and development. This opinion review critically examined the feasibility and prospects of integrating AI as a transformative tool in the pharmaceutical industry. AI, encompassing machine learning algorithms, deep learning, and data analytics, offers unprecedented opportunities to streamline and enhance various stages of drug development. This opinion review delved into the current landscape of AI-driven approaches, discussing their utilization in target identification, lead optimization, and predictive modeling of pharmacokinetics and toxicity. We aimed to scrutinize the integration of large-scale omics data, electronic health records, and chemical informatics, highlighting the power of AI in uncovering novel therapeutic targets and accelerating drug repurposing strategies. Despite the considerable potential of AI, the review also addressed inherent challenges, including data privacy concerns, interpretability of AI models, and the need for robust validation in real-world clinical settings. Additionally, we explored ethical considerations surrounding AI-driven decision-making in drug development. This opinion review provided a nuanced perspective on the transformative role of AI in drug discovery by discussing the existing literature and emerging trends, presenting critical insights and addressing potential hurdles. In conclusion, this study aimed to stimulate discourse within the scientific community and guide future endeavors to harness the full potential of AI in drug development.

Steering through Regulatory Currents: The Journey of India’s Pharma Industry with the USFDA

Introduction and Objective: India's pharmaceutical industry faces challenges in meeting USFDA quality standards, impacting exports and reputation. This review examines the causes of non-compliance and proposes strategies to enhance compliance, predicting fu-ture trends. Methods: This study conducts an analysis of USFDA warning letters to Indian manufacturers, an assessment of non-compliance issues, and an exploration of technological advancements in compliance, such as automation and AI. Results: The study reveals a rise in non-compliance incidents, emphasizing the need for a ro-bust quality culture, updated regulatory knowledge, and implementation of advanced technol-ogies to improve compliance. Conclusion: To maintain global competitiveness, India's pharma industry must adopt compre-hensive strategies, leverage technology, and prepare proactively for regulatory changes. Future compliance will rely on remote auditing and real-time monitoring.

Nanoemulgel: A Comprehensive Review of Formulation Strategies, Characterization, Patents and Applications

<p>Background: Delivering hydrophobic or poorly soluble drugs has become increasingly challenging, with issues like stability and bioavailability complicating the process. Among various strategies devised to address these problems, nanoemulgels have proven effective. Nanoemulgels combine a gel base and an emulsion at the nanoscale, making them excellent for drug delivery. The nanoemulsion component protects the active ingredient from degradative reactions like hydrolysis and enzymatic degradation. Meanwhile, the gel base enhances the emulsion's thermodynamic stability by increasing the viscosity of the aqueous phase and reducing surface and interfacial tension. </p><p> Objective: The primary objective of this review was to explore nanoemulgels as a drug delivery system in the pharmaceutical industry. It delves into the advantages and applications of nanoemulgels in various medical fields, compares them with conventional emulgel, and examines formulation strategies, preparation methods, patent trends, future prospects, and evaluation methods in detail. </p><p> Method: An exhaustive literature survey was conducted keeping in view the various aspects of nanoemulgel. Information from various resources, such as books, review articles, scientific reports, research articles, and patents, were searched, read, analyzed, and summarized. </p><p> Conclusion: This review article thoroughly examines nanoemulgels, discussing their formulation strategies, characterization techniques, and applications in various fields. It highlights their benefits, such as enhanced drug solubility, controlled release, improved stability, and targeted delivery. The article also covers patents related to nanoemulgel technology and explores its future prospects, emphasizing potential applications in pharmaceuticals, cosmetics, dermatology, and other industries.</p>

Enhanced functionalization of superparamagnetic Fe3O4 nanoparticles for advanced drug enrichment and separation applications

Backgroundsuperparamagnetic ferroferric oxide (Fe3O4) nanoparticles can be extensively functionalized for applications in drug enrichment and separation. Their high magnetic responsiveness and controllable surface modification enable rapid drug enrichment and separation under external magnetic fields. This study aimed to enhance the application potential of superparamagnetic Fe3O4 nanoparticles in the field of drug enrichment and separation by functionalizing these nanoparticles to improve their biocompatibility and targeting capabilities.Methodssuperparamagnetic Fe3O4 nanoparticles functionalized with dopamine were synthesized using benzyl alcohol as the solvent and iron acetylacetonate as the precursor. The dopamine-functionalized superparamagnetic iron oxide nanoparticles were used to analyze protein enrichment and separation. Characterization of the nanoparticles was conducted, including analysis of particle size distribution, Zeta potential, and fluorescence spectra using a fluorescence spectrophotometer.Resultsthe Fe3O4 nanoparticles maintained high magnetism from the original material and exhibited uniform particle size distribution and stable Zeta potential. The saturation magnetization of dopamine-functionalized superparamagnetic Fe3O4 nanoparticles showed no significant difference compared to before coating, indicating minimal influence of dopamine on the internal magnetic core of the nanoparticles. The Fe3O4 nanoparticles demonstrated good biocompatibility and stability.Conclusionfunctionalization of superparamagnetic Fe3O4 nanoparticles significantly enhances their efficiency in drug enrichment and separation processes, suggesting broad applications in the pharmaceutical industry.

Genus Ribes: Ribes aureum, Ribes pauciflorum, Ribes triste, and Ribes dikuscha—Comparative Mass Spectrometric Study of Polyphenolic Composition and Other Bioactive Constituents

This study presents the metabolomic profiles of the four Ribes species (Ribes pauciflorum Turcz., Ribes triste Pall., Ribes dicuscha Fisch., and Ribes aureum Purch.). The plant material was collected during two expeditions in the Russian Far East. Tandem mass spectrometry was used to detect target analytes. A total of 205 bioactive compounds (155 compounds from polyphenol group and 50 compounds from other chemical groups) were tentatively identified from the berries and extracts of the four Ribes species. For the first time, 29 chemical constituents from the polyphenol group were tentatively identified in the genus Ribes. The newly identified polyphenols include flavones, flavonols, flavan-3-ols, lignans, coumarins, stilbenes, and others. The other newly detected compounds in Ribes species are the naphthoquinone group (1,8-dihydroxy-anthraquinone, 1,3,6,8-tetrahydroxy-9(10H)-anthracenone, 8,8′-dihydroxy-2,2′-binaphthalene-1,1′,4,4′-tetrone, etc.), polyhydroxycarboxylic acids, omega-3 fatty acids (stearidonic acid, linolenic acid), and others. Our results imply that Ribes species are rich in polyphenols, especially flavanols, anthocyanins, flavones, and flavan-3-ols. These results indicate the utility of Ribes species for the health and pharmaceutical industry.

Evaluating the Efficacy and Safety of Cymbopogon Schoenanthus Syrup for Asthma and Allergies: A Two-Decade Clinical Study

Asthma and allergies are prevalent respiratory conditions affecting millions worldwide, often necessitating long-term management and treatment. Synthetic medications, while effective, may pose risks and adverse effects, prompting exploration into natural alternatives. This study investigates the efficacy and safety of a botanical syrup supplement derived from Cymbopogon Schoenanthus subsp. proximus, known as “Binj” or “Abba” in the United Arab Emirates (UAE), for the management of asthma and allergies. Through collaborative efforts with reputable laboratories and universities, the botanical syrup’s therapeutic potential was rigorously evaluated, encompassing phytochemical analysis, biological testing, and extensive clinical trials spanning two decades. Results demonstrate notable improvements in lung function and skin health among patients with asthma and allergies, evidenced by enhanced vital capacity, forced vital capacity, and visible reduction in skin allergy symptoms. Furthermore, safety assessments indicate a favorable profile, with minimal adverse events reported. The recognition of the botanical syrup by the UAE Ministry of Health and international pharmaceutical companies underscores its significance and potential for widespread application. This discovery represents a promising advancement in natural medicine, offering a safe and effective alternative for individuals seeking holistic respiratory wellness. Future research should focus on large-scale clinical trials and long-term safety studies to further elucidate its therapeutic benefits and optimize clinical outcomes.

Short-term safety and tolerability profile of 5-methoxy-N,N-dimethyltryptamine in human subjects: a systematic review of clinical trials

IntroductionPsychedelic agents have regained the attention of pharmaceutical companies as promising treatments for depressive episodes. 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), an atypical psychedelic, is emerging as a potentially effective, novel rapid-acting antidepressant. In this systematic review, we analyze the safety and tolerability evidence from clinical trials.MethodsFollowing the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, electronic databases (PubMed, SCOPUS, Web of Science, EMBASE, and EBSCO) were searched from inception until 15 May 2024 to identify clinical trials (regardless of phase) reporting on short-term safety and tolerability profile of 5-MeO-DMT using the following keywords in various combinations: 5-methoxy-N, N-dimethyltryptamine, 5-MeO-DMT, safety, adverse, adverse reaction, side effects, tolerability, dropout, healthy volunteer, healthy participant, depression, major depressive disorder. Only studies written in English were considered.ResultsInitial search yielded 100 records, out of which 3 met the inclusion criteria. These studies reported on the results from clinical trial phases I and I/II, with a total of 78 participants included; two studies involved healthy volunteers, and one included patients with treatment-resistant depression. Although the data is limited, it confirms a good short-term safety and tolerability profile for 5-MeO-DMT, with no serious adverse events (SAEs) reported. Furthermore, no drop-outs were reported.Conclusion5-MeO-DMT administration in human subjects presents favorable short-term safety and tolerability profile. Importantly, no SAEs have been documented, and no adverse events led to participant withdrawal from the studies There is a need for future randomized, double-blind, placebo-controlled trials with larger samples and follow-up to assess potential chronic adverse events.

Antifungal, Antioxidant, and Irritative Potential of Citronella Oil (Cymbopogon nardus) Associated with Phenethyl Ester of Caffeic Acid (CAPE)

The present study aimed to analyze the antifungal, antioxidant, and irritant potential of citronella oil, both isolated and combined with caffeic acid phenethyl ester (CAPE), for topical oral candidiasis. The antioxidant potential was evaluated using two methods, the DPPH test and the reducing power test (FRAP), while the irritant potential of the solutions was assessed through the hen’s egg chorioallantoic membrane test (HET-CAM). The DPPH test (IC50) values for the CITRO III + CAPE III combination were 32 ± 9 mg/mL, and for isolated CAPE, 13 ± 3 mg/mL. The results from the FRAP method revealed a low iron-reducing power for the combination of 1.25 mg/mL of citronella and 0.0775 mg/mL of CAPE (CITRO III + CAPE III), showing no significant difference compared to the isolated solution of 0.15 mg/mL of CAPE. The antibacterial activity of CAPE and isolated citronella in vitro against microorganisms was evaluated using two methods: microdilution and biofilm assay. The results showed that the MIC and MFC values were 0.5 mg/mL for citronella at both tested times (24 h and 48 h). For CAPE, the MFC values were 0.031 mg/mL. For the biofilm assay, the isolated compounds and combinations at 1 min and 6 h showed significantly different results from the controls (p < 0.05). Furthermore, the HET-CAM results demonstrated the absence of irritability. Based on these premises, the antifungal and antioxidant actions, and absence of irritability were proven. Moreover, this work presents a natural antifungal of interest to the pharmaceutical industry.

Unveiling investor behavior: An investigation into India’s pharmaceutical sector during COVID-19

This study examines the factors influencing retail investors’ decision to invest into the Indian pharmaceutical sector amidst the COVID-19 global health crisis. Confronting the obstacles introduced by the pandemic has helped create a robust foundation for the Indian pharma sector to grow rapidly in the future. As the industry demonstrated signs of considerable future growth, investors favored pharmaceutical investments during COVID-19. Retail investors were mainly the ones who went on a shopping spree during the pandemic. This backdrop provides a unique context to explore the retail investors’ behavior in the Indian pharmaceutical landscape. Leveraging the Theory of Planned Behavior (TPB), this study marks the first attempt to introduce behavior toward market fundamentals as a mediating factor into the TPB framework. To conduct the study, data were collected from 305 retail investors located in Karnataka’s South Canara region, who invested into the Indian pharmaceutical industry during the pandemic, using snowball sampling. The e-survey was employed for data collection. The results reveal that attitudes toward pharmaceutical investments, subjective norms, Perceived Behavioral Control (PBC), and behavior toward market fundamentals have significantly influenced investor decisions. Notably, behavior toward market fundamentals has partially mediated the relationship between attitude toward pharma investment and investment decision and PBC and investment decision. However, the mediation effect of behavior toward market fundamentals was not evident between the subject norm and the investment decision. The study holds pivotal implications for policymakers, government bodies, and industry stakeholders to promote pharmaceutical investments.

Pectin from Agro-waste to Utility Product

The study aims to discuss innovative extraction approaches as compared to available traditional methods to optimize the yield and quality of pectin by eco-friendly techniques and emphasizes purification and analytical techniques for quality toward sustainable development of pectinbased products. Pectin is a complex polysaccharide present in plants, forming a protective barrier and providing mechanical strength to the plant cell. Therefore pectin, a by-product of the food industry, can be an efficient waste valorization product for utilization in the food and pharmaceutical industry as a thickener, stabilizer, and gelling agent. Pectin complex chemistry provides a wide scope for modification of monomers that can alter the properties of pectin and thereby add to the varied applications of pectin enlisted in the review. The review synthesizes findings from meticulously conducted research investigations and authorized scholarly articles. Information retrieval used reputable academic search engines, including PubMed, Elsevier, and Bentham publications with keywords such as “pectin” “chemical modification of pectin”, “drug delivery”, “green methods” and “agro-industrial residues" for a comprehensive exploration. The comprehensive review delves into pectin chemistry and extraction methods, modification, and characterization techniques are discussed along with versatile applications in the food, pharmaceutical, and other industries. Pectin abundantly present in the outer coat or peels of fruits and vegetables has been the best example of a circular economy and has led to zero waste in agricultural industries. The review has elaborated modifications in pectin for its use as an excipient in the pharmaceutical industry, therapeutic use, targeted drug delivery, and food industries.

Comparative effects of drug interventions for the acute management of migraine episodes in adults: systematic review and network meta-analysis

ObjectiveTo compare all licensed drug interventions as oral monotherapy for the acute treatment of migraine episodes in adults.DesignSystematic review and network meta-analysis.Data sourcesCochrane Central Register of Controlled Trials, Medline, Embase,...

Achieving synchrony: bridging the gap between pharmaceutical companies and regulators on safety labeling updates

Achieving synchrony: bridging the gap between pharmaceutical companies and regulators on safety labeling updates

Evaluation of Drug and Herbal Medicinal Promotions on Social Media During the COVID-19 Pandemic in Relation to World Health Organization Ethical Criteria and South African Health Products Regulatory Authority Guidelines in South Africa: Cross-Sectional Content Analysis.

Consideration of ethics in the promotion of medications is essential to safeguard the health of consumers, particularly during health crises. The World Health Organization (WHO) and the South African Health Products Regulatory Authority (SAHPRA) have established stringent standards to ensure the integrity of pharmaceutical promotions and safeguard public health, including advertisements on the internet and social media platforms. However, the dynamic nature of online advertising poses challenges for monitoring and enforcing ethical standards. The study aimed (1) to examine the COVID-19 drug and medicinal promotions across online platforms and social media from 2020 to 2022 in South Africa and (2) to ensure that drug promotions adhere to ethical guidelines outlined by the WHO and SAPHRA. A cross-sectional content analysis was conducted to assess drug and medicinal advertisements across various internet and social media platforms. A systematic approach was used to identify and analyze promotional content, focusing on adherence to ethical guidelines outlined by WHO and SAPHRA. Data were collected and analyzed to determine the extent of compliance and identify any potential violations or areas for improvement. A total of 14 online drug advertisements were included in this analysis. Our findings show that most of the drugs advertised did not meet the regulations and guidelines provided by WHO and SAHPRA. There were omissions about active ingredients, proprietary names, adverse drug responses, precautions, and overdosage and adverse drug reactions. Traditional medicines were not fully consistent with the approved WHO ethical criteria data sheet. Our analysis highlights the critical importance of ensuring compliance with ethical guidelines in drug promotions on the internet and social media platforms. There is a need for continued vigilance and enforcement efforts to uphold ethical standards and protect the health of the public. Ongoing monitoring and collaboration between national drug regulatory agencies, pharmaceutical companies, and online platforms will be essential for promoting responsible advertising. In addition, safety monitoring and pharmacovigilance systems for herbal medicinal products are yet to be established.

The application of nanodiscs in membrane protein drug discovery & development and drug delivery

The phospholipid bilayer nanodiscs (LNDs), as a rapidly-developing tool in recent years, provide a natural bio-memebrane environment to maintain the native conformation and functions of membrane proteins as well as a versatile delivery vehicle for a variety of hydrophobic and hydrophilic drugs. We have seen unprecedented advantages of phospholipid bilayer nanodiscs in membrane protein structure characterization, biochemical and physiological studies of membrane proteins, membrane environment studies, drug discovery & development, and drug delivery. Many previous reviews have been mainly focused on the advantages of nanodiscs in membrane protein researches, but few have touched upon the importance and potential application of nanodiscs in pharmaceutical industries. This review will provide general description of the structural characteristics, advantages, classification, and applications of phospholipid nanodiscs, with particular focus on nanodisc-enabled membrane protein drug discovery & development as well as drug delivery.

Literature Review: The Use Of Artificial Intelligence In The Pharmaceutical Industry

Artificial intelligence (AI) is having an increasingly significant impact on the pharmaceutical industry, which is now undergoing a period of profound transformation as a consequence of this effect. In order to study the uses of artificial intelligence in the fields of drug research and development as well as patient care, the goal of this literature review is to investigate some of the applications. It places an emphasis on the most important breakthroughs, the difficulties that are now being faced, and the possible future orientations.

Radical 6-Endo Addition Enables Pyridine Synthesis under Metal-Free Conditions.

Metal-free synthesis of heterocycles is highly sought after in the pharmaceutical industry and has garnered widespread attention due to its environmental sustainability and cost-effectiveness. We report a radical 6-endo addition method for pyridine synthesis from cyclopropylamides and alkynes under metal-free conditions. Various terminal and substituted alkynes are inserted as C2 units into cyclopropylamides to synthesize versatile pyridines with more than 51 examples. Mechanistic investigations and computational studies indicate the unprecedented 6-endo-trig addition of vinyl radicals to the imine nitrogen atom rather than the conventional 5-exo-trig addition to the imine carbon atom, in which the hypervalent iodine(III) plays a critical role. This reaction easily scales up with excellent functional group compatibility and suits the late-stage pyridine installation on complex molecules.

Comparative phytochemical analysis, antioxidant and anti-inflammatory activities of rhizome and leaves of Curcuma caesia Roxb. and Curcuma longa L.

Turmeric is a well-known medicinal herb used for traditional and medicinal purposes since ancient times. It is also an important ingredient in the cosmetic, food and pharmaceutical industries. Two common species, Curcuma longa L. (yellow turmeric) and Curcuma caesia Roxb. (black turmeric), are noted for their medicinal potential. However, commercially, yellow turmeric is more extensively explored than black turmeric. In the present study, a comparative phytochemical analysis was conducted, along with in vitro anti-inflammatory and antioxidant activity assessment of the rhizome and leaves of both yellow and black turmeric. GC-MS and FTIR analysis revealed a wide range of phytocompounds with known medicinal properties in both yellow and black turmeric rhizome. The presence of biologically significant phytocompounds such as methyl stearate, glycidyl oleate, curcumenol and eucalyptol in higher proportion in the rhizome of C. caseia compared to yellow turmeric supports further exploration of the commercial and medicinal potential of C. caseia. Antioxidant and anti-inflammatory analyses indicated that the rhizome of C. caseia possesses anti-inflammatory and antioxidant activities comparable to those of C. longa. This study also reports the presence of bioactive metabolites in the leaves of both black and yellow turmeric, along with anti-inflammatory and antioxidant activities in the leaves comparable to their respective rhizomes. These findings suggest that turmeric leaves could be as significant as turmeric rhizomes for medicinal and industrial applications.

Radical 6‐Endo Addition Enables Pyridine Synthesis under Metal‐Free Conditions

AbstractMetal‐free synthesis of heterocycles is highly sought after in the pharmaceutical industry and has garnered widespread attention due to eliminating the need to remove trace metal catalysts from the reaction. We report a radical 6‐endo addition method for pyridine synthesis from cyclopropylamides and alkynes under metal‐free conditions. Various terminal and substituted alkynes are inserted as C2 units into cyclopropylamides to synthesize versatile pyridines with 57 examples. Mechanistic investigations and computational studies indicate the unprecedented 6‐endo‐trig addition of vinyl radicals to the imine nitrogen atom rather than the conventional 5‐exo‐trig addition to the imine carbon atom, in which the hypervalent iodine(III) plays a critical role. This reaction easily scales up with excellent functional group compatibility and suits the late‐stage pyridine installation on complex molecules.

EXAMINATION OF THE COMPOSITION OF WHEY FROM MIXED CHEESE

In recent years, the ingredients of milk represent a functional food, because their use has a great effect on health. Whey is a byproduct of cheese production, which was previously considered waste. Whey proteins strengthen the immune system by helping the body produce the antioxidant glutathione, which protects against free radicals, pollution, toxins and infections. In this research we examine the composition of whey (minerals: Ca, K, Fe and P, total proteins and albumins) from mixed cheese from the "Ideal Shipka" dairy factory - Bitola. All parameters were determined spectrophotometrically, spectrophotometric, photometric - colorimetric and nephelometric methods were applied to prove the amount of certain components present in the whey composition. From the obtained results we can see that whey has the highest amount of total proteins, it contains 17.6 g/L, from which amount of albumen is 1,99 g/L. Of the minerals, the highest value was obtained for potassium 26,6 mmol/l, followed by calcium 9,47 mmol/l, amount of phosphorus was 9,39 mmol/l, while iron is found in a very small percentage 11,74 µmol/l. From the research we can conclude that whey contains a large percentage of total proteins, and of the minerals potassium. Thus, whey can be used as a dietary supplement for protein and potassium and it is attractive product for both the food and pharmaceutical industries and consumers.

Thermal Behavior and Infrared Absorbance Bands of Citric Acid

Citric acid is widely used in the Food and Pharmaceutical Industry. Various issues regarding its thermal behavior and infrared spectrum require clarification. Here, we studied citric acid monohydrate (raw, heated, freeze-dried and recrystallized from D2O) via Differential Scanning Calorimetry, Thermogravimetric Analysis, Infrared Spectroscopy, and antioxidant capacity assay. Also, we used ab initio Density Functional Theory calculations for further supporting the interpretations of the experimental results. Citric acid monohydrate exhibits desolvation inability and upon heating does not dehydrate but esterifies. Nor by freeze drying can it be dehydrated. The heated sample is not anhydrous, it exhibits melting inability, and any fluidization occurs simultaneously with decomposition. In other words, the interpretations regarding the two endothermic peaks in the DSC curve of citric acid that have been attributed to water evaporation and melting are not correct. The increase in the molecular weight due to esterification is most likely responsible for the increased antioxidant/chelation capacity of the heated sample. We concluded that what we call citric acid monohydrate and anhydrous do not exist in a pure form (in the solid state) and actually are mixtures of different compositions of citric acid, water and a citric acid oligomer that is produced through esterification. The esterification reaction seems to be able to proceed easily under mild heating or even at room temperature. The presence of the ester oligomer and water affect the infrared spectrum of citric acid monohydrate and anhydrous and is responsible for the existence of multiple peaks in the C=O stretching region, which partially overlaps with the water H-O-H bending vibration. The insights presented in this work could be useful for optimizing the design, performance and quality of food and drug products in which citric acid is used.