Hasil untuk "Pharmaceutical industry"

H. Bienaymé, C. Hulme, G. Oddon et al.

J. Breitenbach

P. Bautista, Á. F. Mohedano, J. Casas et al.

M. Jahurul, I. Zaidul, K. Ghafoor et al.

M. Grembecka

Epidemic obesity and diabetes encouraged the changes in population lifestyle and consumers’ food products awareness. Food industry has responded people’s demand by producing a number of energy-reduced products with sugar alcohols as sweeteners. These compounds are usually produced by a catalytic hydrogenation of carbohydrates, but they can be also found in nature in fruits, vegetables or mushrooms as well as in human organism. Due to their properties, sugar alcohols are widely used in food, beverage, confectionery and pharmaceutical industries throughout the world. They have found use as bulk sweeteners that promote dental health and exert prebiotic effect. They are added to foods as alternative sweeteners what might be helpful in the control of calories intake. Consumption of low-calorie foods by the worldwide population has dramatically increased, as well as health concerns associated with the consequent high intake of sweeteners. This review deals with the role of commonly used sugar alcohols such as erythritol, isomalt, lactitol, maltitol, mannitol, sorbitol and xylitol as sugar substitutes in food industry.

H. Lorenz, A. Seidel‐Morgenstern

S. Baptista-Silva, S. Borges, O. Ramos et al.

ABSTRACT Essential oils are products obtained from plants, by steam distillation, mechanical processes of citrus fruit epicarp, or dry distillation after separation of the aqueous phase by physical processes. They are usually composed of secondary metabolites of aromatic plants with oxygenated structures such as alcohols, ketones, aldehydes, and esters, presenting therapeutic properties such as antibacterial, antifungal and antioxidant activities. Essential oils are used in the pharmaceutical, food, and fragrance industries. The increasing use of plants by the pharmaceutical industry makes the study of essential oils crucial to design new bioactive delivery systems. This paper presents aliterature review that summarizes the best advanced data regarding the use of essential oils and their volatile constituents for biomedical applications with focuses on innovative pharmaceutical formulations. Nonetheless, it seems clear that more clinical evaluations are required until essential oils can be considered as possible applications in pharmacy or as adjuvants to current medications.

Carol Silva Nascimento, Andreia Rocha Moreira, Ivana Santana Farias et al.

Introdução: Problema Relacionado a Medicamento (PRM) é qualquer evento ou circunstância que envolve a farmacoterapia, interferindo na segurança ou efetividade do tratamento, associados a desfechos clínicos negativos. A atuação do farmacêutico hospitalar é essencial para a identificação, prevenção e resolução de PRMs, sobretudo em maternidades e unidade de terapia intensiva neonatal (UTIN), devido à complexidade da polifarmácia e frequentes mudanças de medicamentos. Análises que avaliam tipos de PRMs e intervenções farmacêuticas (IF) permitem compreender melhor o perfil da atuação farmacêutica frente aos desfechos em saúde dos pacientes de modo a identificar áreas prioritárias para a atuação clínica, contribuindo para a segurança paciente nos processos de cuidado e para a racionalização da farmacoterapia. Objetivo: Avaliar e descrever o perfil dos PRMs identificados por farmacêuticos de uma maternidade pública de ensino da Bahia. Métodos: Estudo observacional, descritivo, com delineamento longitudinal, conduzido em maternidade de ensino. Foram incluídas notificações entre março e julho de 2025 registradas na plataforma REDCap seguindo o sistema Pharmaceutical Care Network Europe (PCNE) v.9.1, com adaptações locais, através de avaliação criteriosa das prescrições e prontuários de pacientes internados nas Unidades de Terapia Intensiva Neonatal, de Obstetrícia e de Centro Obstétrico. As análises foram conduzidas no software R. Resultado: Durante o período estudado foram admitidos 2 477 pacientes, sendo registrados 1 151 PRMs em 527 destes (21,3% dos pacientes, apresentando em média, 2,2 PRMs cada). Dentre os problemas, 491 (42,7 %) estavam relacionados à efetividade do tratamento, seguido por segurança (359; 31,2%), indicação do tratamento (199; 17,3%) e outros tipos de PRMs (102; 8,8%). Foram registrados 547 erros de prescrição em um total de 87419 medicamentos prescritos, o que equivale a aproximadamente 0,6% de itens com erro. Como causas mais frequentes estavam processos relacionados à administração do medicamento (478; 41,5%), seguidos por seleção da dose (274; 23,8%) e transição de cuidado (136; 11,8%). Apesar da equipe médica ter sido o maior alvo das intervenções farmacêuticas (602; 52,3%), a enfermagem teve a maior taxa de aceitação (419; 98,6) frente aos prescritores (567; 94,2%). Dos PRMs registrados, 964 foram totalmente resolvidos, representando 83,8% destes. A análise dos dados indicou que 91,9% dos PRMs foram identificados antes de atingirem o paciente. Conclusão: Nossos resultados indicam que as intervenções farmacêuticas apresentam alta taxa de aceitação pela equipe assistencial e contribuem para o fortalecimento das barreiras de segurança, evitando que os incidentes cheguem ao paciente, haja visto que 1 em cada 5 pacientes apresentaram algum PRM. Esses achados reforçam a importância do monitoramento contínuo da farmacoterapia e direcionam prioridades para atuação clínica do farmacêutico em maternidades de ensino.

Wei Wang, Zhuyifan Ye, Hanlu Gao et al.

Alexandria P. Taylor, R. Robinson, Y. M. Fobian et al.

J. Sangshetti, Mrinmayee Deshpande, Z. Zaheer et al.

Abstract In this era of competition quality has been given prime magnitude; failure to meet such quality allied goals produces massive shift of company in share of market. In this context pharmaceutical industry is utmost regulated industry as it is governed by authoritative regulatory bodies. “Quality could be planned and most of quality deficit arises in the way process is planned and developed”, this thought of well known quality expert Joseph Moses Juran gives foundation to the concept of quality by design (QbD). USFDA launched a pilot programme in 2005 to permit participating firms a prospect to submit chemistry, manufacturing, and controls (CMC) of NDA information representing application of QbD. Now USFDA is accelerating QbD drive by making warning to generic manufacturers from January 2013. QbD has its perspectives to contribute the drug design, development, and manufacture of high-quality drug products. In the present review basic consideration of the QbD approach, its historical background, and regulatory needs are discussed. In detail explanation of elements of QbD i.e. method intent, design of experiment, and risk assessment is given. Application of QbD to pharmaceutical and biopharmaceutical processes, development and unit operation associated with it are briefly mentioned. Detail account of QbD to analytical technique is explained thoroughly by referencing examples.

Xiaofang Luo, Huifang Chen, Ya Song et al.

Among other health related issues, the rising concerns on drug resistance led to look for alternative pharmaceutical drugs that are effective both against infectious and noninfectious diseases. Antimicrobial peptides (AMPs) emerged as potential therapeutic molecule with wide range of applications. With their limitations, AMPs have gained reputable attentions in research as well as in the pharmaceutical industry. This review highlighted the historical background, research trends, technological advancements, challenges, and future perspectives in the development and applications of peptide drugs. Some vital questions related with the need for pharmaceutical production, factors for the slow and steady journey, the importance of oral bioavailability, and the drug resistance possibilities of AMPs were raised and addressed accordingly. Therefore, the current study is believed to provide a profound understanding in the past and current scenarios and future directions on the therapeutic impacts of peptide drugs.

Rama Krishna R Rao

Decentralized clinical trials (DCTs) recently gained attention in research necessary for drug development. While the COVID-19 pandemic proved to be a challenging time in this arena, drug development was a critical area of emphasis in the rapid development of vaccines. DCTs were necessary to allow research activities to occur across many locations. Although the use of DCTs play a pivotal role in reshaping healthcare, as technology expands further into the digital space implementation challenges must be considered. A working group of experts assembled, during an interactive learning exercise at the Conv2X conference (2023), to explore challenges related to the diffusion of innovation among key stakeholders. Common “pain points” of technology and an innovative approach that used a blockchain anchored solution were presented. Experts were divided into three stakeholder groups (patients, payers, and pharmaceutical sponsor) which reconvened for an overall discussion. Several themes, that can be supported by blockchain technology, emerged. These include enhanced efficiencies, patient experience / demographic diversity, data integrity / privacy / security, and cost-effectiveness. Future research may focus on additional stakeholder groups that are less familiar with these technological advances and using technology to increase diversity in study populations.

Thiago Miguel Rosa da Silva, Inajara Rotta, Maryana Albino Clavero et al.

Introdução: O câncer colorretal é o segundo câncer mais incidente na população brasileira e o terceiro com maior taxa de mortalidade. No SUS, a assistência oncológica é custeada via sistema de Autorização de Procedimentos de Alta Complexidade – APAC/Oncologia. Objetivo: Avaliar se o ressarcimento disponibilizado pelo SUS aos centros de tratamento em oncologia é suficiente para o custeio da terapia do câncer colorretal. Método: Foram avaliados os custos diretos referentes aos antineoplásicos, medicamentos de suporte, soluções/materiais em geral e capela de fluxo laminar. Quatro cenários foram avaliados, considerando a incorporação de inovações na terapia de antiemética e / ou de segurança na manipulação e administração. Resultados: Foram analisados 68 protocolos de tratamento nos contextos neoadjuvante, adjuvante e metastático. No contexto neoadjuvante e adjuvante de câncer de reto, a maioria apresentou APACs deficitárias em todos os cenários. No contexto adjuvante de câncer de cólon, a APAC foi deficitária apenas para o mFOLFOX6, no cenário 4. No contexto de terapia paliativa do câncer colorretal, foram avaliados 44 protocolos, sendo que 75% possuíram APACs deficitárias no cenário 1 e 81.8% no cenário 4. Considerando os protocolos contendo apenas quimioterapia citotóxica convencional, quando comparados nos cenários 1 a 3, 91.6% dos protocolos apresentaram APACs superavitárias. Conclusão: Sugere-se reavaliação dos valores de ressarcimento para o tratamento adjuvante e neoadjuvante dos cânceres de reto, enquanto no tratamento adjuvante do câncer de cólon e no tratamento paliativo baseado em terapia citotóxica convencional, as inovações na terapia de suporte e manipulação/administração são passíveis de implementação no SUS.

E. Yu. Soloveva, I. P. Amelina, E. K. Plieva

Neuropathic pain is one of the most common complaints in outpatient clinical practice, and its relevance is associated with the difficulties that arise in the process of diagnosis and rational pharmacotherapy. In accordance with the modern classification, acute pain (lasting up to 90 days) and chronic pain are distinguished. Acute pain is a sensory reaction with subsequent involvement of emotional, motivational, vegetative and other factors that occur when the integrity of the body is violated. Chronic pain is defined as pain that continues beyond the normal healing period. According to experts in the study of pain, it is possible to speak of chronicity if the duration of the existence of pain exceeds 3 months. Understanding the pathophysiological mechanisms underlying the disruption of the processes of generation and conduction of a nociceptive signal in nerve fibers, as well as the response to control the excitability of nociceptive neurons in the structures of the spinal cord and brain in neuropathic pain, provide the key to modern therapy strategies, forming the foundation for an adequate, pathogenetically substantiated drug correction. This impact should be comprehensive and individualized. Due to the fact that neuropathic pain syndrome most often develops in patients with comorbid pathology, as well as in people of the older age group, the use of oral and injectable forms of the above drugs is significantly limited. In conditions of polypharmacy, when patients are forced to take several different drugs at the same time, priority is given to topical drugs in the treatment of this pathological condition. Today, capsaicin drugs show great promise as an effective treatment for neuropathic pain, thereby opening a new chapter in the pharmaceutical industry in the field of pain relief. Topical capsaicin, used as monotherapy or in combination with other analgesics, allows patients with a minimal risk of developing adverse events to significantly reduce the severity of neuropathic pain syndrome and, as a result, improve their quality of life.

Ravi Jandhyala

Background: Medical affairs pharmaceutical physicians (MAPPs) have unique value to pharmaceutical companies due to their accountability for activities that benefit regulators, payors, prescribers and patients. This study assessed whether MAPPs’ specialist training and education in pharmaceutical medicine could account for this level of value by determining whether there was significant variation in education and training between MAPPs and other internal stakeholders of pharmaceutical companies. Methods: A systematic search of LinkedIn profiles from the 10 pharmaceutical companies by revenue was conducted between June and October 2021. Job title and type and year of undergraduate and postgraduate qualifications were extracted. A one-sided Mann-Whitney test assessed for differences in the total number of qualifications between MAPPs and other internal stakeholders involved in medical affairs using MAPPs as the reference group. Other internal stakeholders included medical affairs pharmacists (MAPharm), other medical affairs professionals (MAOth), and market access (MAcc), commercial (COmm) and sales professionals. Sub-group analysis determined differences in undergraduate and postgraduate education. Results: In total, 524 profiles were included. Compared to all other internal stakeholders, MAPPs had a significantly higher number of undergraduate (p < 0.001) and postgraduate (MAPharm, p = 0.003; MAOth, p = 0.004; MAcc, COmm and Sales, p < 0.001) qualifications. Additionally, MAPPs had a significantly longer time to industry than other internal stakeholders apart from MAPharm. Of those with clinical qualifications, MAPPs were almost twice as likely to have business qualifications. Conclusions: Of all internal stakeholders, MAPPs had the highest number of qualifications and the best match between expertise and the contextual demands of decision-makers in the pharmaceutical industry. Pharmaceutical companies in the UK can use these findings to clarify role boundaries and decision-making power based on the nature and level of expertise of each internal stakeholder.

Jingjing Yang, Xingzhen Song, Huabin Hu et al.

<i>Zanthoxylum acanthopodium</i> DC. is a widely used traditional medicinal plant to treat fever, flu, stomachache, traumatic injury, and mosquito bite in tropical and subtropical Asia. This study aimed to investigate the antifungal, anti-inflammatory, antiviral, and larvicidal activities of its fruit essential oil. The essential oil sample from China (EOZC) was mainly composed of limonene (29.78%) and β-myrcene (26.65%), while the sample from Myanmar (EOZM) was dominated by Terpinen-4-ol (43.35%). Both essential oils showed antifungal activity, with 90% minimum inhibitory concentration (MIC₉₀) values ranging from 26.3 to 499 μg/mL. By obviously inhibiting nitric oxide (NO) in RAW 264.7 cells, EOZC (IC₅₀, 16 μg/mL) showed comparable anti-inflammatory activity to the positive control L-NMMA (IC₅₀, 12.2 μg/mL). EOZM showed significant antiviral activity against the dengue virus with an IC₅₀ value of 13 μg/mL. Additionally, both EOZC and EOZM demonstrated dose-dependent larvicidal activity against <i>Aedes albopictus</i>, with LC₅₀ and LC₉₀ values ranging from 45.8 to 144.0 μg/mL. Our results contribute a theoretical foundation for the further application of <i>Zanthoxylum acanthopodium</i> DC. as an antifungal and anti-inflammatory ingredient in the pharmaceutical industry and further indicate that it has the potential to be developed as a new source of natural and eco-friendly medicine for the prevention and treatment of dengue virus.

N. A. Kovaleva, O. V. Trineeva, A. A. Gudkova et al.

Introduction. Sea buckthorn – Hippophaё rhamnoides is a perennial shrub, the fruits of which are a source of carotenoids and are harvested on an industrial scale to obtain a number of drugs. Recently, not only fruits, but also other parts of the plant, such as buds, leaves, shoots and bark, are of increasing interest. It is known that sea buckthorn leaves are rich in compounds such as tannins, polyunsaturated fatty acids and vitamins (C and E). The rich composition of biologically active substances with a sufficient content of components allows us to consider leaves as a new type of medicinal plant material for the further development of various preparations based on them. In addition, the leaves are an annually renewable raw material and it is possible to harvest them on an industrial scale, since this valuable medicinal plant is cultivated everywhere in Russia. Data on the microscopic characteristics of the fruits of sea buckthorn are described in detail in the scientific literature, which cannot be said about the leaves. The scientific literature also does not describe the features of the luminescence of the tissues of the leaves of the sea buckthorn.Aim. The aim of this work was to study the possibility of using the luminescent and stereomicroscopic methods of analysis to determine the main morphological features of the leaves of the sea buckthorn.Materials and methods. Dried whole leaves of a plant of the genus Hippophaës collected in the Voronezh region were used as the object of the study. The study of microdiagnostic signs was carried out according to the State Pharmacopoeia of the XIV RF GPA.1.5.3.0003.15 «Technique of microscopic and microchemical examination of medicinal plants and herbal medicinal products». A stereomicroscopic study was carried out using a Biomed 2 microscope. The luminescence of the tissues of the sea buckthorn leaves was investigated using a luminescent microscope of the Miсromed 3 LUM brand.Results and discussion. Stereomicroscopic analysis of sea buckthorn leaves was carried out. High-resolution volumetric images were obtained in a short period of time. It was found that the characteristic microscopic features of the leaves are the presence of a large number of corymbose hairs along the upper and corymbose-stellate along the lower surfaces, including the vein and petiole (from colorless to white, yellow and dark brown). Single simple stellate hairs are rare. When removing the layer of hairs, the spongy structure of the epidermis of the leaf is visible. The carried out luminescent analysis made it possible to reveal the features of the luminescence of the tissues of the leaves of the sea buckthorn. Diagnostic luminescent features include: the most pronounced yellow glow is observed for the cells of the base of the corymbose hair; the plates that make up the corymbose hairs do not have bright fluorescence; stellate hairs do not have a glow; pronounced yellow-green fluorescence is characteristic of the leaf vein.Conclusion. For the first time, stereomicroscopic and luminescent analyzes of sea buckthorn leaves were carried out and the main morphological features of this type of medicinal plant material and their biometric characteristics were established. The carried out luminescent analysis made it possible to reveal the features of the luminescence of the tissues of the leaves of the sea buckthorn.

A. V. Aleshina, T. N. Komarov, O. A. Archakova et al.

Introduction. Tranexamic acid is one of the most common drugs used to stop bleeding after trauma, in surgery and gynecology. The most common analytical method for the determination of this compound is reversed-phase high-performance liquid chromatography (HPLC). However, this compound belongs to the group of so-called poorly retained compounds due to its chemical structure. It is necessary to develop an analytical method that will allow the determination of tranexamic acid in human blood plasma with the least time, resource costs and without the use of specialized columns.Aim. The aim of this study is to develop a method for tranexamic acid in human plasma by high performance liquid chromatography with tandem mass-spectrometry (HPLC-MS/MS) for pharmacokinetic studies.Materials and methods. Determination of tranexamic acid in plasma by HPLC-MS/MS. The samples were processed by acetonitrile protein precipitation.Results and discussion. This method was validated by next parameters: selectivity, matrix effect, calibration curve, accuracy, precision, recovery, lower limit of quantification, carry-over effect and stability.Conclusion. The method of the determination of tranexamic acid in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 100.00–15000.00 ng/ml. Method could be applied to tranexamic acid determination in plasma for pharmacokinetics and bioequivalence studies.

Hector S. Alvarez-Manzo, Rafael Badillo-Davila, Alejandro Olaya-Gomez et al.

The COVID-19 pandemic forced the scientific community and the pharmaceutical industry to develop new vaccines, in an attempt to reach herd immunity and stop the SARS-CoV-2 from spreading. However, to ensure vaccination among the general population, COVID-19 vaccine intention must be measured. So far, no studies have focused on rural residents in Latin America, which represent approximately 20% of the population of this geographical region. In this study, we present the validation of a self-developed questionnaire, which was validated in a pilot study with 40 Spanish-speaking Mexican rural residents in the state of Guerrero, Mexico. In this study, we describe the chronological validation of the questionnaire, including the assessment of its internal consistency and temporal reliability, which we measured with the Cronbach’s alpha and Spearman’s rank correlation coefficient, respectively. After the psychometrical analysis, we were able to validate a 20-item questionnaire, which intends to assess vaccine intention among the rural population. Aiming to develop a comprehensive policy and vaccination strategies, we hope this instrument provides valuable insight regarding COVID-19 vaccination willingness across rural communities in Mexico and Latin America. Finally, if we want to reach worldwide herd immunity, it is important to understand rural residents’ position towards COVID-19 vaccination.