Drug delivery using reduction-responsive hydrogel based on carboxyethyl-succinoglycan with highly improved rheological, antibacterial, and antioxidant properties.

The development of exopolysaccharide-based polymers is gaining increasing attention in various industrial biotechnology fields for materials such as thickeners, texture modifiers, anti-freeze agents, antioxidants, and antibacterial agents. High-viscosity carboxyethyl-succinoglycan (CE-SG) was directly synthesized from succinoglycan (SG) isolated from Sinorhizobium meliloti Rm 1021, and its structural, rheological, and physiological properties were investigated. The viscosity of CE-SG gradually increased in proportion to the degree of carboxyethylation substitution. In particular, when the molar ratio of SG and 3-chloropropionic acid was 1:100, the viscosity was significantly improved by 21.18 times at a shear rate of 10 s-1. Increased carboxyethylation of SG also improved the thermal stability of CE-SG. Furthermore, the CE-SG solution showed 90.18 and 91.78 % antibacterial effects against Escherichia coli and Staphylococcus aureus and effective antioxidant activity against DPPH and hydroxyl radicals. In particular, CE-SG hydrogels coordinated with Fe3+ ions, which improved both viscosity and rheological properties, while also exhibiting reduction-responsive drug release through 1,4-dithiothreitol. The results of this study suggest that SG derivatives, such as CE-SG, can be used as functional biomaterials in various fields such as food, cosmetics, and pharmaceutical industries.

Adjusting starting points for initial price offers: the example of ibrutinib.

The Inflation Reduction Act of 2022 (IRA) allows the Medicare program to negotiate drug prices beginning in 2024. Based on the guidance in the statute, CMS has selected specific data items to use to adjust initial price offers for 10 drugs in the decision-making process. Although much of the data are publicly available, some of these data items will need to be collected directly from drug companies. A 2019 US House of Representatives Committee on Oversight and Accountability investigative report collected a wide range of data from manufacturers of 12 high-revenue drugs that show what is available from the drug companies, including development costs, marketing, pricing, competition, and patent status. This article focuses on the data obtained for ibrutinib, an oral medication for treating hematologic malignancies, which is one of the only drugs reviewed by the committee that also has been selected for Medicare price negotiation. We examine data that can be obtained only from the drug manufacturer that the IRA has explicitly identified as being used to determine the price and suggest potential negotiation strategies for CMS in response.

Conflicts of Interest Among Cardiology Clinical Practice Guideline Authors in Japan.

BACKGROUND: Clinical practice guidelines (CPGs) offer disease management recommendations based on scientific evidence. However, financial conflicts of interest between CPG developers and the pharmaceutical industry could bias these recommendations, potentially affecting patient care. Proper management of these conflicts of interest is particularly crucial for maintaining the integrity of CPGs. The study aimed to evaluate the extent of financial relationships between the pharmaceutical industry and authors of CPGs for cardiovascular diseases in Japan. METHODS AND RESULTS: The study analyzed personal payments from the pharmaceutical industry to authors of cardiovascular disease CPGs published by the Japanese Circulation Society from January 2015 to December 2022. Payment data, including speaking, consultancy, and writing fees from 2016 to 2020, were extracted from a publicly available database containing personal payments disclosed by all major pharmaceutical companies. A total of 929 unique authors from 37 eligible Japanese Circulation Society CPGs were identified. Notably, 94.4% of these authors received personal payments from pharmaceutical companies, totaling >US $70.8 million. The mean±SD payment per author was US $76 314±138 663) and the median payment per author was US $20 792 (interquartile range: US $4262-US $76 998) over the 5-year period. Chairs of CPGs received significantly higher payments than other authors. More than 80% of authors in each CPG received personal payments. CONCLUSIONS: The study elucidated that there were considerable financial relationships between pharmaceutical companies and cardiology CPG authors in Japan. This finding deviates from international conflict of interest management policies, suggesting the need for more stringent conflict of interest management strategies by the Japanese Circulation Society to ensure the development of trustworthy and evidence-based CPGs.

Which Data Analytics Tool Should We Use to Evaluate Risk in Upstream Drug Supply Chains?

Drug shortages are a persistent and serious problem in the United States, affecting patient care and health care costs. This article canvasses factors that contribute to drug shortages, such as manufacturing complexity, price, and quality inspection records. This article further proposes an early warning system and payment, contracting, and pricing innovations to mitigate drug shortages and offers data-driven recommendations to stakeholders looking to protect the supply of quality medicines.

Microbial chassis design and engineering for production of gamma-aminobutyric acid.

Gamma-aminobutyric acid (GABA) is a non-protein amino acid which is widely applied in agriculture and pharmaceutical additive industries. GABA is synthesized from glutamate through irreversible α-decarboxylation by glutamate decarboxylase. Recently, microbial synthesis has become an inevitable trend to produce GABA due to its sustainable characteristics. Therefore, reasonable microbial platform design and metabolic engineering strategies for improving production of GABA are arousing a considerable attraction. The strategies concentrate on microbial platform optimization, fermentation process optimization, rational metabolic engineering as key metabolic pathway modification, promoter optimization, site-directed mutagenesis, modular transporter engineering, and dynamic switch systems application. In this review, the microbial producers for GABA were summarized, including lactic acid bacteria, Corynebacterium glutamicum, and Escherichia coli, as well as the efficient strategies for optimizing them to improve the production of GABA.

["If you are a woman, read this, it's good for you": the advertising of medicines targeted at mothers in the Colombian press, 1903-1945]. / "Si usted es mujer lea esto que le conviene": la publicidad de medicamentos de patentes dirigidos a las madres en la prensa colombiana, 1903-1945.

This article analyses the advertising of patent medicine directed at mothers, which circulated in newspapers between 1903 and 1945. It demonstrates that these advertisings played an important role in shaping women as a consumer demographic, promoting a scientific approach to motherhood intertwined with health challenges. The methodology employed included the analysis of advertisements in the newspapers El Tiempo, La Prensa, Rigoletto, El Faro and Evolución. Additionally, it examines the historiography of the subject in Colombia and other latitudes. The conclusion of this study asserts that motherhood was a significant target for pharmaceutical industries, leading to a commercial concept of motherhood.

Este artículo analiza la publicidad de medicamentos de patentes dirigida a las madres en la prensa colombiana entre 1903 y 1945. Muestra cómo estos anuncios jugaron un papel importante al momento de moldear a la mujer como una población objeto de consumo, estableciendo una maternidad científica por medio de la medicalización. La metodología incluyó el análisis de los avisos publicitarios en los periódicos El Tiempo, La Prensa, Rigoletto, El Faro y Evolución. Igualmente, dialogó con la historiografía de la temática producida en Colombia y otras latitudes. Concluyó que la maternidad fue un nicho importante para la venta de medicamentos, provocando la conformación de una idea comercial de lo materno.

Complejo Farmaceútico del Estado Venezolano

Ente adscrito al Ministerio del Poder Popular para la Salud. Empresa sin fines de lucro, dedicada a la elaboración y comercialización de hemoderivados y otros productos químicos y biológicos de alta calidad. Cuenta con una Planta Productora de Derivados Sanguíneos (PPDS), cuya materia prima fundamental es el plasma humano, y una Planta Productora de Fármacos Recombinantes (PPFR), con instalaciones en un área de más de 5.000 metros cuadrados.

Empresa Socialista Productora de Medicamentos, C.A.

Ente Adscrito al Ministerio del Poder Popular para la Salud dedicada a la elaboración de productos biológicos como vacunas, interleukinas y anticuerpos; igualmente, especialidades farmacéuticas como tabletas, cápsulas y granulados, para ofrecer a nuestro país una solución de carácter social viable y eficiente a la creciente demanda en el sector de la salud.

[The Applications of qNMR in Drug Quality Control].

NMR is well known as one of the most important methods for elucidating the structure of organic compounds. Furthermore, it has recently been recognized as a powerful tool for quantitative analysis. The quantitative NMR (qNMR) has become an official analytical method described in detail in the Japanese Pharmacopoeia. And today, it is widely applied in drug development. The qNMR method offers many new advantages over traditional and conventional quantitative analysis methods. For example, this method requires only a few milligrams of the analyte and allows absolute quantitation of the analyte without using a qualified reference standard as a control sample. Then, it can be easily applied to most chemicals without expending significant time and resources on method development. In addition, residual solvent can be determined using qNMR methods. The peak area of an NMR spectrum is directly proportional to the number of protons contributing to the resonance. Based on this principle, the residual solvent can be determined by counting the signal corresponding to the residual solvent in the sample solution. We have applied qNMR as an alternative to GC. Thus, qNMR is an innovative and promising analytical technique that is expected to make significant progress in the future. Recently, the analytical research and quality control departments have been working together to expand this technology to a wide range of areas in the pharmaceutical industry.

Machine vision-based non-destructive dissolution prediction of meloxicam-containing tablets.

Machine vision systems have emerged for quality assessment of solid dosage forms in the pharmaceutical industry. These can offer a versatile tool for continuous manufacturing while supporting the framework of process analytical technology, quality-by-design, and real-time release testing. The aim of this work is to develop a digital UV/VIS imaging-based system for predicting the in vitro dissolution of meloxicam-containing tablets. The alteration of the dissolution profiles of the samples required different levels of the critical process parameters, including compression force, particle size and content of the API. These process parameters were predicted non-destructively by multivariate analysis of UV/VIS images taken from the tablets. The dissolution profile prediction was also executed using solely the image data and applying artificial neural networks. The prediction error (RMSE) of the dissolution profile points was less than 5%. The alteration of the API content directly affected the maximum concentrations observed at the end of the dissolution tests. This parameter was predicted with a relative error of less than 10% by PLS models that are based on the color components of UV and VIS images. In conclusion, this paper presents a modern, non-destructive PAT solution for real-time testing of the dissolution of tablets.

Industry Payments to US Physicians by Specialty and Product Type.

This study examines the distribution of payments within and across specialties and the medical products associated with the largest total payments.

Beliefs and practices of physicians in Lebanon regarding promotional gifts and interactions with pharmaceutical companies.

Background: Pharmaceutical companies invest greatly in promotional gifts to influence prescription of medications by physicians, yet there is limited published information evaluating its impact on healthcare. Aim: This study aimed to assess the beliefs and practices of physicians in Lebanon regarding promotional gifts and their interactions with representatives of pharmaceutical companies. Methods: This cross-sectional study was conducted between December 2019 and January 2020 through an email-based questionnaire sent to 5936 physicians of different specialties registered in the Lebanese Order of Physicians. Assessment was done using a validated tool and data analysis was conducted using SPSS version 26.0. Results: Of the 268 respondents, 188 (70.4%) reported that physicians in Lebanon accepted gifts from representatives of pharmaceutical companies. Most of the physicians (31.7%) interacted with company representatives more than once a week. Medication samples (251 respondents) and stationary items (222 respondents) were the most common gifts accepted by physicians who admitted accepting gifts. Overall, 225 (84.9%) respondents believed that prescriptions by physicians in Lebanon were influenced by the gifts. Only 74 (40.0%) of those who accepted gifts from pharmaceutical companies believed that it was unethical, and around half did not know if the Lebanese Code of Medical Ethics allowed them to accept gifts from pharmaceutical companies. Conclusion: Although physicians in Lebanon were aware of the effect that gifts from pharmaceutical companies could have on their prescription behaviours, many of them still accepted the gifts. This study provides evidence to policymakers for decision-making regarding ethical guidance on interactions between physicians and pharmaceutical companies in Lebanon.

Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations.

The Access Consortium New Active Substance Work-Sharing Initiative, or "Access" for simplicity, allows regulatory authorities (RAs) of the Access Consortium countries to jointly review applications for the registration of new active substances or for new indications. Using a survey developed by the pharmaceutical industry trade associations of the five Access Consortium countries-Australia, Canada, Singapore, Switzerland, and the United Kingdom (UK)-this study gathered insights into the perceptions and experiences of the Access pathway held by affiliates of pharmaceutical companies. Understanding industry perceptions of Access is important for the success of the initiative, as participation is voluntary. Findings indicate that affiliates who participated in Access had mostly positive experiences with this pathway; most affiliates were satisfied with their interactions with the Access RAs and appeared willing to continue to participate in the initiative. Affiliates' reasons for not having yet participated in Access included a lack of opportunity to do so and perceived barriers, such as the Access pathway being too complicated to manage. Recommendations to improve Access cover six key areas: ensure predictability, increase guidance and transparency, streamline processes, maintain flexibility, increase harmonization, and advance RA-industry cooperation. This study should facilitate informed discussions among relevant stakeholders on how to improve Access to maximize efficiencies, accelerate approvals, and improve patient access to innovative medicines.