Pharmaceutical Industry Research Articles

Surface polarity modulation enables high-performance polyamide membranes for separation of polar/non-polar organic solvent mixtures

Achieving highly selective separation of organic mixtures is crucial to modern fine chemicals and pharmaceutical industries. The membrane-based organic solvent reverse osmosis (OSRO) technology is expected to break through this barrier. The key to achieving the separation of organic mixed liquids is to design the OSRO membrane as needed based on the physical and chemical properties of the target separation solvent. However, this poses a huge challenge to traditional OSRO membranes. In this work, we report composite polyamide (PA) OSRO membranes with ultrahigh polar/non-polar organic mixture selectivity. The surface polarity of the composite PA membrane is increased by coating a layer of Fe3+/tannic acid (Fe3+/TA) layer on the surface of the PA membrane. The enhanced surface polarity increases the interaction difference between polar and non-polar solvents and the membrane. And a polarization layer is formed on the membrane surface, which weakens the concentration polarization effect on the membrane surface. Under high-concentration feed liquid (the mass ratio of methanol/hexane is 7:3), the separation factor of the prepared membrane reaches 218, which is the highest value of all OSRO membranes reported so far. For the first time, we establish a partial flux analysis for the OSRO process. This analysis unravels the pressure, concentration dependence, and sensitivity of separation performance. It provides novel insights into the design of high-performance OSRO membranes.

Potentials of TPC and TFC as Free Radical Scavengers and Microbial Growth Inhibitors in Himalayan Endemic Artemisia sieversiana Ehrhl Ex Willd. (Asteraceae) Plant from Northeastern, Pakistan

Background: In various microorganisms, various defense mechanisms have evolved against the commercially available antimicrobial agents with increased resistance. Natural antimi-crobial agents of plant origin are better alternatives when an infectious disease arises due to resistant microbial strains. Here, we have evaluated the efficacy of total phenolics and total flavonoids with antioxidant and antimicrobial potential of Artemisia sieversiana Ehrhl Ex Willd. plant extracted with methanol, ethyl acetate, ethanol, n-hexane, and chloroform using soxhlet procedures Methods: The evaluation of TPC was achieved with Folin-Ciocalteu’s reagent method and quanti-tative estimation of TFC was done with the aluminum chloride colorimetric method. The antioxi-dant activities were estimated using FRSA-DPPH and TAC methods. The inhibitory activities of five solvent extracts of A. sieversiana against 2 gram-positive and 2 gram-negative pathogenic bac-terial strains (B. subtilis, P. aerogenosa, S. aureus, and E. coli) were evaluated using the well dif-fusion technique. Results: The highest percentage yields of A. sieversiana extracts were obtained in ethanol (4.8 g, 12.1%) and methanol (4.01 g, 10%), while minimum extract yield was obtained in n-hexane (0.53 g, 1.34%). Both phenolics and flavonoids were higher in ethanol, methanol, and ethyl acetate ex-tracts while minimal in n-hexane extracts. Ethanol extract has shown maximum (69%) DPPH ac-tivity with a lower IC50 value (181 μg/ml), while the highest IC50 values of 330 and 325μg/ml were recorded for n-hexane and ethyl acetate extracts. The ethyl acetate and chloroform extracts dis-played overall highest TAC values. All the tested extracts of A. sieversiana exhibited variable in-hibitory effects in a dose-dependent manner against the tested bacterial strains with minimum 9.08 ± 0.23 to maximum 21.23 ± 7.04 mm inhibition zones. Methanol and ethyl acetate extracts at 2 to 4 mg/ml showed greater MIC results against P. aeruginosa in comparison to the B. subtilis strain. Conclusion: The extracts of A. sieversiana have been found to be rich in TPC and TFC with re-markable antibacterial and antioxidant efficacies, and the plant extracts could be employed as pos-sible alternatives to synthetic drugs in various nutraceutical and pharmaceutical industries.

Green Approach Toward Triazole Forming Reactions for Developing Anticancer Drugs.

Compounds containing triazole have many significant applications in the dye and ink industry, corrosion inhibitors, polymers, and pharmaceutical industries. These compounds possess many antimicrobial, antioxidant, anticancer, antiviral, anti-HIV, antitubercular, and anticancer activities. Several synthetic methods have been reported for reducing time, minimizing synthetic steps, and utilizing less hazardous and toxic solvents and reagents to improve the yield of triazoles and their analogues synthesis. Among the improvement in methods, green approaches towards triazole forming biologically active compounds, especially anticancer compounds, would be very important for pharmaceutical industries as well as global research community. In this article, we have reviewed the last five years of green chemistry approaches on click reaction between alkyl azide and alkynes to install 1,2,3-triazole moiety in natural products and synthetic drug-like molecules, such as in colchicine, flavanone cardanol, bisphosphonates, thiabendazoles, piperazine, prostanoid, flavonoid, quinoxalines, C-azanucleoside, dibenzylamine, and aryl-azotriazole. The cytotoxicity of triazole hybrid analogues was evaluated against a panel of cancer cell lines, including multidrug-resistant cell lines.

Transition Metal-free α-C-H Functionalization of Tertiary Amines Catalysed/ Promoted by Acids: A Brief Review

Abstract: C-H Functionalization of α-carbon of tertiary amines has been of great importance for the past two decades as N-heterocycles can be synthesized by this approach and these heterocycles are highly useful as drugs or drug precursors in the pharmaceutical industry. In this review article, we have summarized only the α-C-H functionalization reactions of tertiary amines that are catalysed or promoted by acids. These C-H functionalization reactions are usually catalysed by transition metal salts, although metal-free catalysts are also used. However, several such reactions have been reported that are efficiently catalysed by acids. They are cost-effective, have a simple purification process, less sensitive to air/moisture, and are relatively environmentally benign. However, this area has not received enough focus due to the lack of review articles, which encouraged us to write this review.

Enantioselective liquid-liquid extraction of 2-cyclohexylmandelic acid enantiomers using chiral ionic liquids.

Obtaining optically pure compounds in an eco-friendly and cost-efficient manner plays an important role in human health and pharmaceutical industry. Racemic separation using multistage stereoselective liquid-liquid extraction has become one of the most practical and effective approach to access homochiral enantiomers. Currently, chiral ionic liquids (CILs) with structural designability have become a promising chiral additive and enable them as adjustable candidates for racemic separation. Herein, a high-effective stereoselective liquid-liquid extraction process composed of imidazolium cations and amino acid-derived anions as the chiral additive was established for racemic 2-cyclohexylmandelic acid (CHMA) separation. We have systematically investigated the choice of organic solvent, concentration of CIL, extraction temperature, and the pH of aqueous phase. For three-stage stereoselective extraction, the maximum enantiomeric excess (e.e.) for CHMA was reached up to 40.6%. Furthermore, the mechanism of steric effect and stereoselective capacity between the CILs and racemic CHMA was discussed and simulated. We envision that the work will facilitate the development of CILs in multistage liquid-liquid extraction and promote the large-scale production of optically pure enantiomers.

Effect of demographic factors on attitudes to purchase children’s supplement products

Children's supplements are products widely offered by drug manufacturers. Their benefits and uses are essential for supporting the growth and health of children. Nevertheless, there is a lack of research in Indonesia examining the relationship between parental demographic factors and attitudes towards purchasing children’s supplements. This study employs a mixed-method approach to investigate the impact of demographic factors on attitudes toward purchasing children’s supplement products, aiming to fill the research gap. A total of 124 parents from diverse backgrounds participated as respondents, with 29.8% being male and 70.2% female. Their education levels ranged from high school (7.3%), bachelor’s degree (26.6%), master’s degree (50%), to doctoral degree (16.1%). The results of the regression analysis indicate that only income level plays a positive role in shaping attitudes towards purchasing children’s supplements. Notably, 89.5% of respondents believe in the benefits of these supplements. This study highlights the influence of income level on buying attitudes regarding children’s supplements. Future research should consider a larger sample size to better represent the population.

Whole-cell Lipase Catalytic Synthesis of Short-chain Fragrance Esters using Aspergillus flavus

Background: Fragrances are the collection of unlike functional assemblies, most likely alcohols, esters, aldehydes, ketones, and acids in organic products/hydrocarbons. Short-chain aliphatic fragrance esters have immense applications as flavors in the food, pharmaceutical and cosmetic industries and also have remarkable commercial significance in cosmetics and personal care products like perfumes, face creams, shampoos, soaps, lotions, jams, jellies, etc. Objective: This study aimed to synthesize short-chain fragrance esters using a whole-cell lipase catalyst from Aspergillus flavus (RBD-01). Method: The present study emphasizes the synthesis of artificial flavoring compounds by using a wholecell biocatalytic process, which can have wide significance. Herein, the preparation of ethyl alkanoates (ethyl propanoate to ethyl decanoate) was performed to investigate the flavors and fragrance excellence. The biomass from Aspergillus flavus (RBD-01) was used as a catalyst to facilitate the remarkable esterification activities towards the synthesis of important aroma esters with the help of a series of short-chain acids and alcohols. Result: The ethyl hexanoate (4) among all synthesized alkanoates was found to have a fruity fragrance with a good conversion rate. Further synthesized alkyl hexanoates (4A-4I) were found to have good fruity/pineapple/berry flavors and significant aroma quality. Conclusion: These results implied that whole-cell lipase of Aspergillus flavus (RBD-01) is a promising biocatalyst in the production of flavor aroma esters and can boost production in the food/cosmetic manufacturing industries.

A Brief Insight into Nanotherapeutic Approaches in the Management of Analgesia

Background: Growing public awareness of chronic pain resulting from illness and injury has prompted pharmaceutical researchers and drug corporations to create better, more targeted painkillers. For effective pain management, prolonged analgesic medication delivery at the intended areas continues to be a major problem such as addiction, tolerance and other serious side effects, which can prolong suffering and decrease painkiller effectiveness. Objective: The present paper focuses on review of current advances in the field of pain treatment by different nanoparticles formulations of various drugs, by enhancing their pharmacokinetic factors and diminishing associated adverse effects. Results: According to literature survey, usage of nano-carriers enables the delivery of these drugs to target locations with less systemic toxicity. Nanotechnology for varied therapeutic purposes, different analgesics have been loaded onto different nano carriers, including those that are natural, synthetic, and polymeric and proven to be beneficial in pain management. Conclusion: Overall, new nano based preparations and new ways to utilize existing medications in a variety of circumstances is a multimodal approach to pain relief, have resulted in recent advancements in the pharmacological management of pain.

Sparsentan: A First-in-Class Dual Endothelin and Angiotensin II Receptor Antagonist.

To provide an overview of the guidelines on the management of immunoglobulin A nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS), review the evidence for sparsentan, and discuss its place in therapy. A literature search was conducted using MEDLINE, EMBASE, and clinicaltrials.gov using the search terms "sparsentan" and "RE-021" up to the end of Jun 2023. English studies were included if they evaluated the pharmacology, pharmacokinetics, efficacy, and safety of sparsentan in human subjects. Information from the Food and Drug Administration (FDA) and manufacturer's monograph were also extracted. In comparison with irbesartan, sparsentan reduced urine protein-to-creatinine ratio (UPCR) in both IgAN (-49.8% vs -15.1% at interim 36 weeks) and FSGS (-44.8% vs -18.5% at 8 weeks). Hypotension and edema were the most common adverse events in the sparsentan groups. Hepatotoxicity appears to be comparable between sparsentan and irbesartan in short-term results. Sparsentan provides a new option for patients with IgAN who are otherwise at high risk of progressive kidney disease. Continued FDA approval is dependent on long-term study results on renal function decline and safety. Sparsentan reduces proteinuria in IgAN and FSGS, and has expedited approval by the FDA for IgAN in patients at risk of rapid disease progression, generally at urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. Interim results from PROTECT and results from DUET showed promise for improving proteinuria in IgAN and FSGS. Long-term renal function benefit and safety data are pending.

A Comparative Analysis of Brand Management of Cipla and Sun Pharma

Abstract: This research presents a comparative analysis of brand management strategies employed by two leading pharmaceutical companies, Cipla and Sun Pharma. The study aims to provide insights into how these companies manage their brands in the highly competitive pharmaceutical industry. The analysis encompasses various dimensions of brand management, including market share, brand equity, product portfolio, global reach, and innovation/R&D strategies. Data was collected from primary and secondary sources, including financial reports, industry publications, and customer surveys. The findings reveal significant differences between Cipla and Sun Pharma in terms of market share, brand strength, product diversity, international presence, and innovation focus. These differences highlight the unique approaches each company takes in managing their brands and positioning themselves in the market. The research contributes to the understanding of brand management practices in the pharmaceutical industry and provides valuable insights for practitioners and scholars alike.

Counterfeit Medicine Detection using Blockchain

The healthcare industry has grappled with the challenge of monitoring genuine medicines while counterfeit drugs continue to proliferate, posing significant risks to patient safety. These fraudulent pharmaceuticals not only have detri- mental effects on health but also result in substantial financial losses, with reports indicating annual losses of approximately 200 billion dollars for US pharmaceutical companies. Particu- larly concerning is the World Health Organization’s revelation that in underdeveloped nations, one in every ten medicines consumed by patients is counterfeit and of low quality. To address this critical issue, we use blockchain technology to track the supply chain, from the manufacturing stage to the end- user. Leveraging blockchain technology, our system enhances reliability, transparency, and security in healthcare data. This paper focuses on bolstering transaction security, safeguarding medicine quality, and fortifying data protection through the utilization of blockchain technology.

Cordycepin in the fruiting body of Cordyceps militaris cultured from 5 different materials in Vietnam: Analysis and comparison

Cordyceps militaris is frequently employed in pharmacology and nutrition for its well-documented health benefits. The advancement of Cordyceps militaris farming technology has facilitated the establishment of a reliable supply source capable of effectively meeting the expanding market demand. This study aimed to analyze and compare cordycepin concentrations in the fruiting bodies of Cordyceps militaris cultivated from five raw material sources in Vietnam. The results revealed significant variations in cordycepin concentrations among the samples, with average concentrations (measured in mg/g) as follows: Sample 1 (0.8), Sample 2 (1.2), Sample 3 (0.6), Sample 4 (1.0), and Sample 5 (0.9). Notably, Cordyceps militaris from Sample 2 exhibited the highest cordycepin concentration, while Sample 3 had the lowest. Differences in cordycepin content between Cordyceps militaris samples from different raw material sources may be attributed to variations in manufacturing technology. The results of this study provided the necessary information to evaluate the quality of Cordyceps militaris products on the market and propose quality standards for raw materials in the food and pharmaceutical industries.

Recovery of Propionic Acid from Aqueous Phase using Alamine 336 in 1 - Octanol by Reactive Extraction

The by-products of carboxylic acids are useful in chemical industry, pharmaceutical industry, preservations, drug delivery towards a more economical energy efficient technology. Physical and chemical equilibria results are presented as equilibrium distribution, distribution co -efficient, extraction efficiency, loading ratio and volume percentage by varying concentrations. The distribution of propionic acid between aqueous phase and organic phase reaches equilibrium over a concentration range of 0.009 kmol/m3 – 0.055 kmol/m3 . The optimum TOA concentration is found to be 40% at which KD value for 1 - octanol is 16.7. The modified separation increases with decrease in TOA & acid concentration and alamine loading with acid Z decreases with increase in alamine concentration in 1 – octanol. Optimum extraction efficiency is 43.82% for a conc. of 40% TOA at 0.2 kmol/m3.

Exploring cocrystals and polymorphism in pharmaceutical science: A comprehensive review

The pharmaceutical industry has been working hard in recent years to find ways to control polymorphism, which involves many solid drug forms due to their various physical and chemical characteristics. Creating cocrystals and salts of active pharmaceutical ingredients (APIs) is one potential research direction. These substances have drawn a lot of attention because they can improve crucial pharmacological features without reducing therapeutic efficacy. It is significant to note that not all compounds having multiple hydrogen bond donor/acceptor groups and polymorphism properties will form cocrystals; this behavior varies. Pharmaceutical firms and researchers alter APIs, frequently by generating cocrystals, salts, or polymorphs. This review discusses analytical approaches for solids drug forms such as diffraction, spectroscopy, thermal analysis, and pharmaceutical characterization. These techniques enable us to investigate solid APIs thoroughly, from their bulk characteristics to their molecular composition. They offer vital details regarding the composition, attributes, purity, and probable changes of the substance. These technologies are also useful for continuous monitoring and analysis of drug development physical procedures.

Polar Fungi Pseudogymnoascus: Secondary Metabolites and Ecological Significance

Fun gi are widely distributed organisms known to produce secondary metabolites and other biochemical compounds. However, fungi from the polar regions with extreme environmental conditions such as low temperatures, high ultra-violet exposure, nutrient scarcity, and dryness are understudied. They produced many secondary metabolites that are yet to be identified, to adapt and survive the extreme conditions. These polar fungi with potential in secondary metabolites are promising in biotechnological applications such as pharmaceutical, textile, and food manufacturing. Pseudogymnoascus is a genus within the Pseudeurotiaceae family that has been reported in the Antarctic regions. This genus plays an important role in the decomposition process in the polar regions. To date, there are 24 species identified within the genus Pseudogymnoascus in the world. The true potential of Pseudogymnoascus, especially those from the polar region, is yet to be explored. This review gives an overview of the polar Pseudogymnoascus spp. Based on their secondary metabolites production and understanding their ecological perspective in the extreme environment.

Pharmaceutical serialization dynamics to restrain illicit trade and counterfeiting of drugs

Every individual has a fundamental entitlement to healthcare access. It falls upon governments to guarantee the delivery of high-quality healthcare services and infrastructure to their populace.. Over the past few decades, both governments and healthcare industries have been grappling with the challenge of minimizing the adverse effects on public health caused by counterfeit medicines. The World Health Organization has estimated that 40 % medicines in developing and impoverished countries are either counterfeit or potentially adulterated. The global economy suffers billions of dollars in losses due to counterfeit drugs, which also divert funds away from research and development (R&D) initiatives. In the United States, the Food and Drug Administration (FDA) has devised a 10-year roadmap to implement drug traceability measures. The Healthcare Distribution Alliance (HDA) has been tasked with mandating the printing of multiple barcodes and human-readable data on product packaging. Additionally, the FDA is actively involved in pilot projects with leading pharmaceutical manufacturers and wholesalers to leverage blockchain technology within interoperable digital networks for secure data transfer and traceability among authorized trading partners. Preventing counterfeit medicines from infiltrating the supply chain remains a significant challenge for governments and regulatory authorities. Consequently, there is a growing emphasis on implementing stringent guidelines to deter criminals and counterfeiters from distributing fake medicines in the market. The healthcare industry requires robust regulations and secure technologies to ensure the delivery of safe and authentic drugs to patients.

Validation of ERP software and system architectures in a GxP controlled environment

ERP (Enterprise Resource Planning) is a software system which integrates all the business processes to run a company successfully. These software systems are widely used across all the industries like Manufacturing, Retail, Life Sciences, Banking and Finance etc. However, for pharmaceutical companies, the ERP systems must comply with GxP regulations which poses unique challenges. This whitepaper explores how to design and implement the software architecture of an ERP system in a GxP controlled environment.

A REVIEW ON FAST DISSOLVING FILM

Orally fast dissolving films (OFDFs) have been introduced in the market recently as they provide convenience and ease of use over other dosage forms such as orally disintegrating tablets. This technology evolved over the past few years from the confection and oral care markets in the form of breath strips and became a novel and widely accepted form by consumers, so OFDFs are gaining the interest of large number of pharmaceutical industries. Orally fast dissolving film is the type of drug delivery system which when placed in the oral cavity, disintegrate or dissolve within few seconds without the intake of water. OFDFs are very similar to postage stamp in their shape, size and thickness. These films have a potential to deliver the drug systemically through intragastric, sublingual or buccal route of administration and also has been used for local action. This type of technology offer a convenient way of dosing medication, not to special population groups like pediatric, geriatric, bedridden patients, mentally ill patients, but also to the general population. The present review provides an account of various formulation considerations, method of preparation and quality control of the OFDFs.

Comparison the effect of plant extracts and antibiotics on gram negative bacteria isolated from patients with urinary tract infection in Tikrit city

Background: With increasing bacterial resistance for antibiotic, there is an increasing interest in medicinal herbal as a new source of an antimicrobial agents and with less side effects than conventional drugs. Objective: Was to evaluate the potential of Syzygium aromaticum and rosemarinus officinalis extract on Proteus mirabilis isolates in vitro. Methods: Six pathogenic gram negative bacilli belonging to three different genus (E.coli, Proteus mirabilis, and Enterobacter aerogenes) and two isolates from each species were used in this study and four concentration (100%, 75%, 50%, 25% mg/ml ) from each plant extracts (aqueous and ethanolic of Syzygium aromaticum and rosemarinus officinalis extracts ) were prepared to be antibacterial agent. antibacterial activity was measured by using wells method and five antibiotics using to compare with the activity of antibacterial agent. Results: The result of the study shown that the ethanolic extracts of Syzygium aromaticum is a strong antibacterial agent (with diameter of inhibition zone 25 mm) against Proteus mirabilis. Enterobacter aerogenes with (15mm) of inhibition zon, E.coli did not show any inhibition zone also the aqueous and ethanolic of rosemarinus officinalis extracts and aqueous of Syzygium aromaticum extracts did not show any activity towards any gram negative bacilli also the results of the study show resistance isolates of E.coli and Proteus mirabilis toward several antibiotic while Enterobacter aerogenes is sensitive for more antibiotics that used in this study. Conclusions: Our study concluded that the extract of Syzygium aromaticum has high potential as antibacterial agent against UTI that caused by Proteus mirabilis, clove (syzygium aromaticum) can be used in pharmaceutical for the production of new synthetic agents. There is an increasing interest in phytochemicals as new sources of natural antioxidant and antimicrobial agents. The natural compounds which have biological activities are interest to pharmaceutical industries especially for treatment of human disease of microbial origin and several pathological disorders such as cancergenesis, coronary atherosclerosis, as well as in ageing processes.

Desymmetric Hydrogenation of meso-Dicarboxylic Acids.

Efficient transformation of platform chemicals into key intermediates has been increasingly important for the pharmaceutical industry. The development of the catalytic reduction of abundant carboxylic acids with molecular hydrogen has been of both practical and theoretical value. We herein report the homogeneous hydrogenation of dicarboxylic acids with the strategy of desymmetrization. Using a rhodium/bisphosphine catalyst, one carboxyl group of meso-diacids was selectively reduced to yield chiral lactones with satisfactory enantioselectivity. This method provides a straightforward approach to produce chiral lactone intermediates for the manufacture of biotin, telaprevir, and other antivirus drugs. Both experimental and computational investigations were carried out, revealing a novel neighboring group coordination mechanism in the catalytic cycle.