Pharmaceutical Industry Research Articles

Accelerating pharmaceutical tablet development by transfer of powder compaction equipment across types and scales

Roller compaction is a key unit operation in a dry granulation line for pharmaceutical tablet manufacturing. During product development, one would like to find the roller compactor (RC) settings that are required to achieve a desired ribbon solid fraction. These settings can be determined from the compression profile of the powder mixture being compacted and a mathematical model that interprets it. However, establishing compression profiles in an RC requires relatively large amounts of powder, which are expensive and may not be available during drug development. As a cost-effective alternative to an RC, a compactor simulator (CS) can be used, which is a small-scale equipment that uses minimal amounts of powder to build the compression profile. However, since the working principles of a CS and an RC are different, the compression profiles obtained from the two devices for a given powder are also different. In this study, we propose a transfer learning approach that allows the RC compression profile of a given powder to be easily predicted from the compression profile obtained in a CS for the same powder. Based on the well-known Johanson model and on the mass correction factor theory, we examine the compaction behavior of six formulations, two of which including active ingredients, and we find that the mass correction factor does not depend significantly on the powder being compacted. We develop a simple, generalized correlation (transfer model) that allows the mass correction factor to be predicted solely as a function of the pressure at which the compaction is carried out. By using the proposed transfer model, the prediction of the RC compression profiles for the validation powders is significantly improved over the case where a constant value of the mass correction factor is used.

Interconnected influence: Unraveling purdue pharmaceutical's role in the global response to the opioid crisis

BackgroundThe global pharmaceutical industry has a long history of prioritizing profits over public health through widespread practices such as price gouging, deceptive marketing, and fraud. A prominent example of this issue is the mislabeling and mass-marketing of OxyContin by Purdue Pharmaceuticals (Purdue) that catalyzed the opioid crises in and beyond the United States. MethodsGuided by Actor-Network Theory, this case study employs Visual Network Analysis to map the actors-networks involved in responding to the harms caused by Purdue. Data was generated from peer-reviewed and grey literature published between 2007 and 2022 (n = 40) and imported into Gephi visualization software where centrality metrics were applied. ResultsA total of 39 actors and 99 relationships were visualized based on the relational thinking that actors who are heavily interconnected with others are rendered important. Centrality measures identified the socio-technical centrality of Purdue in influencing the response to the harms it caused. Purdue exerted influence through various avenues, most prominently through the creation and cooptation of pain advocacy groups, their close ties with United States elected officials, and through embedding pro-opioid messaging in international guidance documents. In doing so, Purdue was able to extend the reach and impact of their opioid promotion, while simultaneously limiting the capacity of regulatory bodies to pursue accountability and implement policies to mitigate opioid-related harms. ConclusionThis study advances understandings of the complex interplay between transnational pharmaceutical companies, global health systems, regulatory bodies, and public health. In doing so, we underscore the need for stronger regulation and increased transparency surrounding the interactions between pharma, patient groups, governments, and international organizations to better address and prevent future harms.

Medical Science Liaisons: A Guide for Advanced Practice Registered Nurses

Medical science liaisons (MSLs) are part of the field medical affairs (FMA) department of pharmaceutical companies and are scientific resources for advanced practice registered nurses (APRNs). Following strict regulations and antikickback statutes, MSLs operate differently from sales and engage in unbiased, nonpromotional scientific exchange to provide clinical resources to APRNs. They also collaborate with shareholders like professional organizations, clinical trial sites, and academic institutions. Understanding MSL engagement allows APRNs multiple avenues both externally and within the pharmaceutical industry to leverage their experience to enhance clinical practice.

Recombinant Antibody Fragments for Neurological Disorders: An Update.

Recombinant antibody fragments are promising alternatives to full-length immunoglobulins, creating big opportunities for the pharmaceutical industry. Nowadays, antibody fragments such as antigen-binding fragments (Fab), single-chain fragment variable (scFv), single-domain antibodies (sdAbs), and bispecific antibodies (bsAbs) are being evaluated as diagnostics or therapeutics in preclinical models and in clinical trials. Immunotherapy approaches, including passive transfer of protective antibodies, have shown therapeutic efficacy in several animal models of Alzheimer's disease (AD), Parkinson's disease (PD), frontotemporal dementia (FTD), Huntington's disease (HD), transmissible spongiform encephalopathies (TSEs) and multiple sclerosis (MS). There are various antibodies approved by the Food and Drug Administration (FDA) for treating multiple sclerosis and two amyloid beta-specific humanized antibodies, Aducanumab and Lecanemab, for AD. Our previous review summarized data on recombinant antibodies evaluated in pre-clinical models for immunotherapy of neurodegenerative diseases. Here, we explore recent studies in this fascinating research field, give an update on new preventive and therapeutic applications of recombinant antibody fragments for neurological disorders and discuss the potential of antibody fragments for developing novel approaches for crossing the blood-brain barrier (BBB) and targeting cells and molecules of interest in the brain.

Demystifying the ambidextrous internationalization of firms: A multiple case study in the pharmaceutical industry of an emerging economy in turbulent environment

Demystifying the ambidextrous internationalization of firms: A multiple case study in the pharmaceutical industry of an emerging economy in turbulent environment

Does Government Environmental Concern Affect Enterprise Sustainable Development? Evidence from China

As the executor and agent of China’s environmental policy, local governments’ environmental concern reflects local governments’ determination in environmental governance. To figure out how the strengthening environmental concerns affect enterprises’ long-term activities, this study focuses on pharmaceutical manufacturing enterprises due to the enormous and complex composition of emissions. We apply bag of words to summarize relevant environmental words from the annual work reports in local governments to measure environmental concern. The empirical results of the OLS method reveal that the increasing environmental concerns of local governments did decrease the growth rate of chemical oxygen demand (COD) emission authentically. At the same time, it will inhibit the research and experimental development (R&D) activity intensity, but promote production efficiency of pharmaceutical manufacturing enterprises. After that, we discuss the heterogeneity of enterprise ownership, corporate social responsibility and regional regulatory strength of enterprises. Overall, we conclude that environmental concern did reduce COD emission and promote production efficiency, but it also has negative spillover effects. The novel contribution of this paper is that it enriches the trade-off between strengthening environmental compliance costs and long-term production and innovation activities. These results indicate that pharmaceutical manufacturing enterprises prioritize optimizing existing production processes instead of adopting efficient technology when complying with stricter environmental regulation. The reduction of R&D activities may pose risks to the long-term sustainable development of enterprises.

Pharmaceutical Company's Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United States.

We analyzed factors shaping the choice of the lead indication (i.e., cancer type) in the first clinical development projects of new oncological drugs in the United States (US), and how the type of pharmaceutical company is related to this choice. We selected 576 new clinical development projects in the US since 2000 for analysis. These projects were characterized according to three potential perspectives detected by multiple correspondence analysis: the morbidity of the cancer type which corresponds to market size of each cancer type, the company's previous experience with the cancer type, and the company's attitude to development risks. Mega firms tend to choose cancer types with higher morbidity (and large-market), previously experienced cancer types, while diverse small firms choose both major and rare cancers and both high- and low-risk projects, indicating that different sizes of firms utilize different development entry patterns. Common tendencies concerning the choice of lead indication were found across all companies. Cancer types the company had developed and launched in the past were more likely to be chosen; cancer types with high five-year survival rates and those with high competition were less likely to be chosen. The study showed that pharmaceutical companies seem to enter clinical development from cancer types where they can demonstrate their strengths and advantages through experience, depending on each cancer type's different market sizes and development difficulties. The results could provide clues for considering what support measures and incentives are appropriate to balance the efficiency of industrial development and the fulfillment of society's unmet medical needs.

Phytochemical Analysis, Antioxidant Activity of Wild Medicinal Plants of Himalayan Range

Plants that are indigenous to the Himalayas have been exploited for their therapeutic properties for over 6,500 years. Using their deep knowledge of the local flora and fauna, traditional healers in the region are able to treat a wide variety of maladies with herbal treatments. People who live in rural areas of the Himalayas rely on wild medicinal plants for their health, and we need to do everything in our power to ensure that these plants continue to thrive in the harsh desert climate of the Himalayas. Raw materials that are obtained from wild plants are in high demand all around the world, particularly among pharmaceutical companies, ethnomedics, and practitioners of traditional medicine as well as other medical practitioners. India has been a top exporter of raw herbal medications all over the world. This is mostly due to the number of medicinal plants that can be found in the Himalayas. The aim of this study was to determine the Phytochemical analysis and antioxidant activity of various parts of 20 selected wild medicinal plants, found in the Himalayan regions in India, China, Nepal, Bhutan and Pakistan including Swertia bimaculate, Ficus neriifolia, Rubus treutleri, Periploca calophylla, G. depressa, Buddleja napaulensis, Habenaria edgeworthii, Pyracantha crenulate, Roscoea procera, Allium rubellum, Berberis chitria, Capsella bursa-pastoris, Artemisia maritima, C. glanduliferum, C. distans, Juniperus macropoda, Origanum vulgare, Valeriana jatamansi, Polygonatum verticillatum, Meconopsis aculeate and Fragaria nubicolais. There were several different parts of the species that were examined to determine their total polyphenol, flavonoid, alkaloid, saponin, and tannin concentrations. One fraction of the plant extracts was found to contain a higher quantity of phytochemicals when compared to the other portions. Through the utilisation of the DPPH and FRAP model systems, the antioxidant capacity of a number of different components was assessed. The high-performance liquid chromatography (HPLC) technique can be combined with the DPPH and/or ABTS tests in order to rapidly screen extracts for the presence of active chemicals.

Long-Term Impact of Mergers and Acquisitions on Firm Performance: A Panel Data Study

Purpose - This study aims to examine the long-term impact of mergers and acquisitions (M&As) on firm performance, particularly within the pharmaceutical industry. Using a panel data regression model, the study assesses how key financial ratios such as Net Profit Margin, Return on Capital Employed (ROCE), Debt to Equity Ratio, and Enterprise Value influence postmerger firm performance over time. Design/methodology/approach - A panel data approach has been conducted using data from 10 pharmaceutical companies from their post-merger period, focusing on the effects of M&As on firm performance as measured by Net Profit Margin. Financial ratios related to profitability, liquidity, and valuation were used as independent variables. Findings - The study finds that M&As have a positive long-term impact on firm performance, particularly in companies with strong Earnings per Share (EPS), efficient capital management, and good liquidity. ROCE, Debt to Equity Ratio, and Current Ratio were significant predictors of improved Net Profit Margin, highlighting the importance of financial efficiency and debt management in the post-merger phase. Research limitations/implications - The focus on the pharmaceutical industry limits the generalizability of the findings to other sectors. Future studies should examine a broader range of industries to better understand the effects of M&As across different contexts

Расчетно-экспериментальное исследование и идентификация матричной модели струйного измельчения сыпучих материалов

Grinding powders in jet mills makes it possible to obtain materials uncontaminated by wear products of grinding media to prepare pure products in chemical and pharmaceutical industries. It should be noted that for different technologies, the requirements for the granulometric composition of powders vary significantly, and to meet these requirements, specific approaches are often required. Experimental determination of optimal conditions to obtain new powders is often associated with significant costs, which is not always justified from an economic point of view. Mathematical modeling allows us to obtain effective solutions in a shorter time and at lower costs in most cases. Thus, the development of adequate models, methods of calculation and optimization of jet grinding technology is an urgent scientific and practical task. To simulate grinding, a matrix methodology is used to describe technological processes. To identify the model, the results of specially conducted experimental studies are used. During experimental studies, the granulometric compositions of powders after single and multiple grinding in a jet mill have been determined. The results obtained have been used to identify and verify the matrix grinding model. Within the framework of the resulting model, a method for technological calculation of a jet mill operating in an open grinding cycle has been developed. The presented approach allows us to propose the ways to develop and implement new jet grinding technologies to obtain highly pure products in open and closed grinding cycles.

Serialization And Aggregation Solution Overview to Combat Counterfeit Drugs in The Pharmaceutical Industry

Serialization And Aggregation Solution Overview to Combat Counterfeit Drugs in The Pharmaceutical Industry

Phytochemical Investigation and Biological Activities of Desmodium heterocarpon Extract as Anti-Tyrosinase: Isolation of Natural Compounds, In Vitro and In Silico Study

Tyrosinase is an important enzyme in the biosynthesis of melanin. Many skin-whitening agents that inhibit tyrosinase activity from natural sources have been identified because they are harmless and non-toxic. In this work, 114 samples of 54 Fabaceae plants were assessed for their anti-tyrosinase activity using a dopachrome method. The results found that Desmodium heterocarpon stems and roots demonstrated the highest tyrosinase inhibitory activity at 20 µg/mL (92.50 ± 1.09%), whereas the water extract of Artocarpus lacucha and kojic acid demonstrated 87.41 ± 0.61% and 95.71 ± 0.33%, respectively. Six compounds were isolated from this plant, including genistein (1); hexadecanoic acid (2); salicylic acid (3); β-sitosterol-D-glucoside (4); 2,3-dihydroxybenzoic acid (5); and 2,5-dihydroxybenzoic acid (6). Among them, 2,5-dihydroxybenzoic acid demonstrated a potential effect for tyrosinase inhibition with an IC50 of 57.38 µg/mL, while standards of kojic acid and the water extract of A. lacucha showed 2.46 and 0.15 µg/mL, respectively. 2,3-dihydroxybenzoic acid had a similar structure as 2,5-dihydroxybenzoic acid; however, it was shown to have tyrosinase inhibitory activity, with an IC50 of 128.89 µg/mL. Studies using computer simulations confirmed this reservation. The determination of antimicrobial activities found that 2,5-dihydroxybenzoic acid showed the strongest inhibitory activity against Staphylococcus aureus, with MIC and MBC of 5 and 5 µg/mL, respectively. In addition, it inhibited MRSA, S. epidermidis, Propionibacterium acnes, Escherichia coli, and Pseudomonas aeruginosa, with MIC and MBC of 15–30 and 15–40 µg/mL. It showed potential activities against yeast and filamentous fungi, such as Candida albicans, Microsporum gypseum, Trichophyton rubrum, and T. mentagrophytes, with MIC and MFC of 15 µg/mL. So, 2,5-dihydroxybenzoic acid could inhibit tyrosinase activity and microorganisms that cause skin diseases. Therefore, it can be concluded that this plant has advantageous properties that will be investigated and further developed for possible uses, particularly in the cosmetic and pharmaceutical industries.

Design an Energy-Conserving Pathway for Efficient Biosynthesis of 1,5-Pentanediol and 5-Amino-1-Pentanol.

1,5-Pentanediol (1,5-PDO) is an important five-carbon alcohol, widely used in polymer and pharmaceutical industries. Considering the substantial energy (ATP and NADPH) requirements of previous pathways, an energy-conserving artificial pathway with a higher theoretical yield (0.75 mol/mol glucose) was designed and constructed in this study. In this pathway, lysine is converted into 1,5-PDO by decarboxylation, two transamination, and two reduction reactions. For the purpose of full pathway construction, 5-aminopetanal reductase and 5-amino-1-pentanol (5-APO) transaminase were identified and characterized. By implementing strategies such as modular optimization of gene expression, enhancing lysine biosynthesis and increasing NADPH supply, the engineered strains were able to produce 1502.8 mg/L 5-APO and 726.2 mg/L 1,5-PDO in shake flasks and 11.7 g/L 1,5-PDO in a 3 L bioreactor. This work provides a new and promising pathway for the efficient production of 5-APO and 1,5-PDO.

Nexus between board characteristics and financial performance: Evidence from developing economy

Corporate performance is the key indicator of availing the economic performances in all economies. Especially for the emerging economy, it is the oxygen for smooth economic operations. The study aims to investigate the influence of board characteristics on the corporate performance of the listed pharmaceuticals and chemicals sector from a developing country, namely Bangladesh. This empirical study examines eight attributes of the board and four financial performance indicators of the businesses. Here, the annual reports of the DSE-listed pharmaceutical and chemicals companies are considered to examine the impact of board attributes on corporate performance. Based on panel data analysis, this empirical study concludes that the fixed effect regression model is suitable for all four models. Except board size, the results demonstrate that all board attributes are generally statistically significant. Furthermore, it confirms that all the significant characteristics of the board are positively associated with corporate performance, except for board independence. The research offers valuable insights for policymakers, investors, organizations, and scholars, promoting optimal board structures, innovative solutions, and an enhanced understanding of corporate governance matters. This research explores the challenges in board attributes, which enhances our understanding of corporate governance matters and their impact over the last decade in the listed pharmaceutical and chemicals sectors in Bangladesh.

Design of cold storage as a storage space for animal vaccines at PT. XYZ

A refrigeration system is a system used to cool a room or an industrial product in the food, pharmaceutical, beverage, vegetable, fruit, and other industries to maintain product quality. One of its uses is as storage for various kinds of pharmaceutical needs, including vaccines for both animals and humans. The problem with cold storage is that existing vaccine storage has been in operation for a long time so it is necessary to study whether it is still able to maintain the vaccine storage temperature, namely -80C. The aim of designing cold storage is to maintain a stable vaccine storage temperature. Because vaccines consist of various kinds of microorganisms that are easy to activate. To maintain the quality of the vaccine, cold storage is needed. The research methodology for writing this thesis is to collect design data from one of the vaccine storage industry companies, and literature studies, then analysis of cooling load planning studies, vaccine storage capacity in cold storage measuring 10 x 10 x m 3 meters and determine the power of the cooling machine using a system. standard vapor compression cooler. The results of the analysis of the refrigeration system planning study showed that the indoor vaccine capacity was 30,600 bottles or 2056,701 lbs (822,680 kg), storage temperature -80C, cooling load 308,133 Btu/hr, or 90,283 W, this system uses R 134 A refrigeration. Using refrigerant, power compressor 23.32 kW, or 32 HP, COP 3.9.

Extraction and Structural Characterization of Four Grape Polysaccharides and Their Protective Effects in Alcohol-Induced Gastric Mucosal Injury

Grapes, recognized as a nutritionally rich fruit, have been found through extensive research to contain various bioactive components. However, the roles of polysaccharides and their bioactive properties remain unclear. Based on this, in our research, four different grape polysaccharides were obtained using an enzymatic-assisted extraction method. We investigated and compared their physicochemical properties, antioxidant activities, and protective effects on gastric mucosa in mice. The results indicated that the monosaccharide compositions of these specific grape polysaccharides were similar; however, their molar ratios, molecular weights, and morphological characteristics varied. The results of radical scavenging tests revealed that red-fleshed grape polysaccharide (RFP) exhibited superior antioxidant properties. In vivo assessments demonstrated that RFP protects against gastric mucosal injury in mice by inhibiting inflammation and radical generation. Therefore, the polysaccharide from red-fleshed grape holds potential application value in the pharmaceutical and food industries.

A New Starches Extracted from Non- Conventional Sources are the Vogue for Pharmaceutical Industry: A Review

Industrially, starch is obtained from cereal grains such as wheat and maize (corn), or from tubers, such as potatoes, tapioca, and arrowroot, or from the pith of the sago plant. By far, the larger part of the starch is obtained from maize, wheat, potato, and tapioca. Starch is present in almost all the tissue such as leaves, roots, tubers, seeds, stems, flowers, etc. of green plants however there are some plants which are grown commercially for the starch which includes cereal such as wheat, corn, sorghum, and rice, tuber mainly potato, root like tapioca and arrowroot, stem of sago, and legume crops mainly pea. Worldwide production of an overview on applications of starch 142 starch is depending on the use of cereals as the raw materials. Normally starch from Conventional sources of starch include sources like cereal corps and legume seeds, tuber crops, and some root tubers is used in large amount in the field of pharmacy. Due to unbelievable increasing demand for starch some nonconventional starch resources have been investigated in recent Years.

Solubility and Dissolution Improvement of Paramethoxycinnamic Acid (PMCA) Induced by Cocrystal Formation using Caffeine as a Coformer

Para-methoxy cinnamic acid (pMCA) is a derivative compound of ethyl p-methoxycinnamate that could be obtained in nature. pMCA has excellent pharmacological properties. However, in their application as a drug, pMCA has poor water solubility. In this present research, we try to increase the water solubility of pMCA using the cocrystal formation (cocrystallization) strategy. Here, we use caffeine as a coformer that can interact very well with pMCA via non-covalent bonding and Van der Waals interaction to achieve cocrystal formation. The cocrystal samples were successfully synthesized using various synthesis techniques; physical mixture, solvent evaporation, and microwave radiation methods. It shows that the solubility of the samples synthesized using microwave-assisted and solvent evaporation increases about 3.30 and 3.12 times, respectively, whereas the dissolution rate profile increases 2.50 and 2.39 times, respectively, compared to pure APMS. Our findings explain the importance of the cocrystal formation strategy to enhance the solubility of active material pMCA. This strategy can also be used as a standard formulation of a new drug system with excellent solubility and dissolution which is very important for the pharmaceutical industry.

ВЗАИМОСВЯЗЬ СОЦИАЛЬНО-ПСИХОЛОГИЧЕСКИХ И ОРГАНИЗАЦИОННЫХ АСПЕКТОВ КОРПОРАТИВНОЙ КУЛЬТУРЫ ПРОИЗВОДСТВЕННОЙ ФАРМАЦЕВТИЧЕСКОЙ КОМПАНИИ

In the context of the risks of business process transformation and digitalization of production, an important aspect is the search and implementation of new approaches to the company's human resource management system. The purpose of this study is to describe the results of a study of the relationship between the socio-psychological and organizational aspects of the corporate culture of a pharmaceutical manufacturing company and their management capabilities. The main research methods used are: system analysis, survey-questionnaire, rating-scaling and expert assessments. Factors such as the socio-psychological climate in the team and the development of sports activities in a pharmaceutical company are considered. It is shown that these aspects play an important role in strengthening corporate culture and increasing employee motivation. Taking into account socio-psychological and organizational factors in activities contributes to achieving the common goals of the employee and the employer, maintaining values that affect the level of the company's reputation. Conclusions are drawn about the need to take into account the interrelationship of socio-psychological and organizational aspects necessary for effective management of the corporate culture of a particular pharmaceutical company.

A strategic brand development framework for expanding cardiovascular and endocrinology treatments in emerging markets

This paper introduces a conceptual framework for strategic brand development in the pharmaceutical industry, specifically targeting the cardiovascular and endocrinology treatment sectors in emerging markets. The framework explores how stakeholder engagement, market segmentation, and brand positioning can enhance access to critical treatments, addressing growing public health challenges in these regions. Cardiovascular and endocrinological disorders, such as heart disease and diabetes, are rising rapidly in emerging markets due to lifestyle changes, urbanization, and increased life expectancy. Pharmaceutical companies face unique challenges in expanding their market presence in these regions, including varying healthcare infrastructure, economic disparities, and regulatory environments. The proposed framework emphasizes the importance of engaging key stakeholders—such as healthcare professionals, policymakers, and patients—through targeted educational campaigns, partnerships, and advocacy. Effective stakeholder engagement fosters trust and collaboration, which is essential for expanding access to life-saving treatments. In addition, market segmentation is a critical component of this strategy, allowing companies to tailor their marketing efforts to specific demographic groups, economic conditions, and healthcare needs in each region. By identifying the most relevant segments and understanding their unique needs, companies can ensure that their treatments reach the populations most at risk for cardiovascular and endocrinological diseases. Brand positioning is another cornerstone of this framework. By clearly defining and communicating the value of their treatments in terms of efficacy, affordability, and accessibility, pharmaceutical companies can differentiate themselves in increasingly competitive markets. Strategic positioning not only enhances brand visibility but also builds long-term customer loyalty, which is crucial for sustaining market growth in emerging economies. Overall, this conceptual framework provides a roadmap for pharmaceutical companies to strategically develop their brands in the cardiovascular and endocrinology sectors, ultimately contributing to improved public health outcomes in emerging markets.