Pharmaceutical Systems Research Articles

Pre-formulation Study of Tamoxifen and Excipients in Formulation of Nanoparticle Drug Delivery System

The inactive ingredients (excipients) are integral to the pharmaceutical drug delivery system. If not selected intelligently and added without a proper scientific approach can lead to the instability of the active pharmaceutical ingredient (API), low therapeutic outcome, or untoward effects. In this investigation, pre-formulation studies were carried out to confirm that the excipients used in the preparation of the nanoparticles were compatible with tamoxifen. The high-performance liquid chromatography-ultra-violet assay, Fourier-transform infrared spectroscopy (FTIR), X-ray diffraction (XRD), and thermogravimetric analysis (TGA) of the stored preparation showed that the nanoparticles were stable, indicating that the ingredients were not reactive and compatible with each other. The tamoxifen drug content was above 98%. Also, the FTIR spectrum of the optimized and physical mixture showed that the API retained its major (1357.89 cm-1, 1589.34 cm-1, 1739.79 cm-, 12870.08 cm-1, and 3402.43 cm-1) characteristic peaks. The XRD confirmed that the drug is very well dispersed in amorphous form with no extraneous peaks. The TGA isotherm indicated that the melting point of the optimized formulation was 400 oC which is significantly higher than the pure tamoxifen, which is 150 oC. the TGA results indicated that the formulation is heat stable.

Медицинские информационные системы: современные реалии и перспективы.

Introduction. Medical information systems (MIS) are becoming increasingly important in modern healthcare. Materials and methods. The search, analysis and systematization of publications in the eLibrary and PubMed databases were carried out using keywords «MIS», «Medical Information System», «Pharmacological information System», «Health information system», «Hospital information system», «Pharmaceutical information system». The varieties of MIS, including pharmacological ones, are given. The advantages and disadvantages of the most used Russian MIS are analyzed. Their functionality is compared with those foreign analogues. Results and discussion. As a result of the analysis of publications, the historical aspects of the development of MIS in different countries are presented. Classification of MIS based on their technical design and functionality is proposed. A number of problems faced by developers and consumers of MIS are outlined. The characteristics of the MIS, the most commonly used at present in the Russian Federation, are given. A number of disadvantages characteristic of the implemented information systems and the ap- proach to their application, as well as the benefits for the medical organizations from their implementation are noted. Conclusions. The formation of the MIS market in Russia occurred about a decade behind the Western countries, but today this process is gaining speed thanks to government initiatives as well as the efforts of software developers and healthcare organizers. This process is hindered by the lack of qualified personnel in the field of information technology and insufficient technical literacy of doctors. The introduction of MIS at the initial stage may be costly, but the costs can quickly pay off by improving the organization of internal processes, increasing the efficiency and coherence of the work of health care units.

Novel Approaches of Polyherbal Matrix Tablet and its Evaluation Parameters

According to WHO, approximately 80 percent of people in developing countries still rely on traditional medicine, which is based primarily on plant and animal species, for primary health care. Because of the toxicity and side effects of allopathic drugs, herbal therapy is becoming more popular. Medicinal plants are crucial in the development of powerful therapeutic agents. Natural products derived from plants, animals, and minerals have long been used to treat human disease Plant medicines are frequently used in combination rather than alone to maximise the benefit of their combined strength. Because of synergism, polyherbalism provides a variety of benefits not found in single herbal formulations. Polymers are the building blocks of a pharmaceutical drug delivery system because they control drug release from the device. Polymers are used to protect drugs from the physiological environment and to extend their release time in order to improve their stability. This review focuses on matrix tablets, which are one of the most practical methods for developing sustained-release dosage forms, as well as the approaches used in their formulation and evaluation. The therapeutic efficacy of a sustained release matrix tablet with improved efficacy can be increased. It also emphasizes the significance of polyherbalism and matrix Tablet.

Developing Trusted IoT Healthcare Information-Based AI and Blockchain

The Internet of Things (IoT) has grown more pervasive in recent years. It makes it possible to describe the physical world in detail and interact with it in several different ways. Consequently, IoT has the potential to be involved in many different applications, including healthcare, supply chain, logistics, and the automotive sector. IoT-based smart healthcare systems have significantly increased the value of organizations that rely heavily on IoT infrastructures and solutions. In fact, with the recent COVID-19 pandemic, IoT played an important role in combating diseases. However, IoT devices are tiny, with limited capabilities. Therefore, IoT systems lack encryption, insufficient privacy protection, and subject to many attacks. Accordingly, IoT healthcare systems are extremely vulnerable to several security flaws that might result in more accurate, quick, and precise diagnoses. On the other hand, blockchain technology has been proven to be effective in many critical applications. Blockchain technology combined with IoT can greatly improve the healthcare industry’s efficiency, security, and transparency while opening new commercial choices. This paper is an extension of the current effort in the IoT smart healthcare systems. It has three main contributions, as follows: (1) it proposes a smart unsupervised medical clinic without medical staff interventions. It tries to provide safe and fast services confronting the pandemic without exposing medical staff to danger. (2) It proposes a deep learning algorithm for COVID-19 detection-based X-ray images; it utilizes the transfer learning (ResNet152) model. (3) The paper also presents a novel blockchain-based pharmaceutical system. The proposed algorithms and systems have proven to be effective and secure enough to be used in the healthcare environment.

Ultrafast Magic Angle Spinning Solid-State NMR Spectroscopy: Advances in Methodology and Applications.

Solid-state NMR spectroscopy is one of the most commonly used techniques to study the atomic-resolution structure and dynamics of various chemical, biological, material, and pharmaceutical systems spanning multiple forms, including crystalline, liquid crystalline, fibrous, and amorphous states. Despite the unique advantages of solid-state NMR spectroscopy, its poor spectral resolution and sensitivity have severely limited the scope of this technique. Fortunately, the recent developments in probe technology that mechanically rotate the sample fast (100 kHz and above) to obtain "solution-like" NMR spectra of solids with higher resolution and sensitivity have opened numerous avenues for the development of novel NMR techniques and their applications to study a plethora of solids including globular and membrane-associated proteins, self-assembled protein aggregates such as amyloid fibers, RNA, viral assemblies, polymorphic pharmaceuticals, metal-organic framework, bone materials, and inorganic materials. While the ultrafast-MAS continues to be developed, the minute sample quantity and radio frequency requirements, shorter recycle delays enabling fast data acquisition, the feasibility of employing proton detection, enhancement in proton spectral resolution and polarization transfer efficiency, and high sensitivity per unit sample are some of the remarkable benefits of the ultrafast-MAS technology as demonstrated by the reported studies in the literature. Although the very low sample volume and very high RF power could be limitations for some of the systems, the advantages have spurred solid-state NMR investigation into increasingly complex biological and material systems. As ultrafast-MAS NMR techniques are increasingly used in multidisciplinary research areas, further development of instrumentation, probes, and advanced methods are pursued in parallel to overcome the limitations and challenges for widespread applications. This review article is focused on providing timely comprehensive coverage of the major developments on instrumentation, theory, techniques, applications, limitations, and future scope of ultrafast-MAS technology.

Integrating private health facilities in government-led health systems: a case study of the public–private mix approach in Ethiopia

BackgroundPrivate health care facilities working in partnership with the public health sector is one option to create sustainable health systems and ensure health and well-being for all in low-income countries. As the second-most populous country in Africa with a rapidly growing economy, demand for health services in Ethiopia is increasing and one-quarter of its health facilities are privately owned. The Private Health Sector Program (PHSP), funded by the United States Agency for International Development, implemented a series of public–private partnership in health projects from 2004 to 2020 to address several public health priorities, including tuberculosis, malaria, HIV/AIDS, and family planning. We assessed PHSP’s performance in leadership and governance, access to medicines, health management information systems, human resources, service provision, and finance.MethodsThe World Health Organization’s health systems strengthening framework, which is organized around six health system building blocks, guided the assessment. We conducted 50 key informant interviews and a health facility assessment at 106 private health facilities supported by the PHSP to evaluate its performance.ResultsAll six building blocks were addressed by the program and key informants shared that several policy and strategic changes were conducive to supporting the functioning of private health facilities. The provision of free medicines from the public pharmaceutical logistics system, relaxation of strict regulatory policies that restricted service provision through the private sector, training of private providers, and public–private mix guidelines developed for tuberculosis, malaria, and reproductive, maternal, newborn, child, and adolescent health helped increase the use of services at health facilities.ConclusionsSome challenges and threats to sustainability remain, including fragile partnerships between public and private bodies, resource constraints, mistrust between the public and private sectors, limited incentives for the private sector, and oversight of the quality of services. To continue with gains in the policy environment, service accessibility, and other aspects of the health system, the government and international communities must work collaboratively to address public–private partnerships in health areas that can be strengthened. Future efforts should emphasize a mechanism to ensure that the private sector is capable, incentivized, and supervised to deliver continuous, high-quality and equitable services.

Production and Optimization of Hyaluronic Acid Extracted from Streptococcus thermophilus Isolates.

Biopolymers, particularly exopolysaccharides produced by microorganisms such as bacteria, yeasts, and algae, have gained popularity in recent years due to their physical, chemical, and functional properties that are widely useful in food, industrial, cosmetic, and pharmaceutical systems. Hyaluronic acid is one type of these polysaccharide. This study investigated the optimal conditions for producing hyaluronic acid from the Streptococcus thermophilus bacterial strain. The isolated Streptococcus thermophilus were cultured on MRS broth, Skim milk, and M17 broth with an addition of 1% lactose. The diagnosed bacterial strains were grown in 100 ml of culture media, placed in volumetric flasks of 250 ml capacity, and incubated at 42˚C for 24 hours, pH 6.8, inoculum volume 1%, and a vibrating incubator at 150 rpm. After the end of the fermentation period, the isolation and purification of HA have performed accordingly: proteins were removed using 1% trichloroacetic acid (TCA), and HA in the supernatant was collected by isopropanol precipitation. The collected HA was dialyzed against ultrapure water and lyophilized. The amount of acid produced was estimated. The results show that the best production of hyaluronic acid was from the S. thermophilus bacterial strain grown on the alternative medium containing whey at a ratio of 450 ml/L and 7.5 g/L yeast extract at 40 ˚C, with a 3% of inoculum volume and 102×108 colony-forming units/ml of bacterial cells, in pH 6.8 and agitation speed of 150 rpm for 18 h, which had the most significant effect on the fermentation process and gave the highest value of HA production of 0.598 g/L and biomass of 6.08 g/L. These results showed the best production method for HA to achieve maximal production yelled.

PP151 VALIDATE Methodology On A Medication-Related Clinical Decision Support System: Holistic Assessment For Optimal Technology Adoption

IntroductionIn the past decade, health technology assessment (HTA) has narrowed its scope to analyses of mainly clinical and economic benefits. Technology challenges in the 21st century emphasize the need for holistic assessments to obtain accurate recommendations for decision-making, as in HTA’s foundations. Using the VALues In Doing Assessments of health TEchnologies (VALIDATE) methodology for complex technologies provides a deeper understanding of problems through analysis of stakeholders’ views, allowing for more comprehensive HTAs. This study aimed to assess a pharmaceutical clinical decision support system (CDSS) using VALIDATE.MethodsSemi-structured interviews with different stakeholders were conducted in the following domains: problem definition (medication error [ME] occurrence and prevention); judgement of solution (existing preventive methods and previous experiences of the CDSS); background theories (future impact and personal beliefs); and barriers to and facilitators of implementation. The following individuals were interviewed: medical informatic specialists (n=3), pharmacists (n=2), nurses (n=2), physicians (n=2), CDSS company representatives (n=1), electronic health record developer (n=1), and health consultancy firm representatives (n=1). Content analysis was used to integrate and analyze the data.ResultsThe multistakeholder interviews identified various barriers to the acceptance and implementation of a pharmaceutical CDSS that were different from those reported in the literature. These included: (i) occurrence of ME (no traceability of medication taken or poor patient medication empowerment); (ii) perception of current level of MEs (huge improvement from ten years ago); (iii) perception of technology as a tool to prevent ME (not enough if only implemented at one point of care); (iv) previous experiences with a CDSS (low rates of development of CDSSs are due to medication prescriptions being digitalized last in hospitals); (v) CDSS metrics (input data should be measured to control CDSS performance); and (vi) other barriers.ConclusionsIncluding facts and stakeholders’ values in problem definition and the scoping of health technologies is essential for the proper conduct of HTAs. Incorporating views from multiple stakeholders when scoping the assessment of health technologies brings additional values to literature findings, resulting in a more holistic evaluation. The lack of multistakeholder scoping can lead to inaccurate information and result in wrong decisions about if, when, and how to adopt a CDSS.

The pharmaceutical potential of AR‐65, a novel Alzheimer’s disease drug targeting the immunoproteasome

AbstractBackgroundPreviously, we reported that inhibition of the immunoproteasome (iP), which is upregulated in reactive glial cells near amyloid‐β (Aβ) deposits in the brains of patients with Alzheimer’s disease (AD), leads to improved cognitive function in an AD mouse model of Aβ amyloidosis (Tg2576) via suppression of microglia‐mediated inflammation, independent of Aβ accumulation.MethodHere, we investigated the pharmaceutical properties of our lead iP inhibitor (AR‐65), a macrocyclic peptide epoxyketone, selected based on in vitro and cellulo iP inhibitory activities and cell‐based anti‐inflammatory efficacy. Specifically, the metabolic stability of AR‐65 was assessed using pooled human liver microsomes. In addition, the flux rate of AR‐65 was measured to evaluate the permeability across Caco‐2 monolayers over‐expressing ABCB1 and ABCG2, two major efflux drug transporters present in the human brain.ResultThe macrocyclic AR‐65 displayed improved metabolic stability (6‐fold increased half‐life), permeability, and solubility (in an injectable pharmaceutical buffer system with no cyclodextrin) compared to the FDA‐approved linear peptide epoxyketone proteasome inhibitor, carfilzomib (Kyprolis®). Finally, pilot PK studies performed using ICR mice confirmed that AR‐65 is metabolically more stable than carfilzomib and can cross the blood‐brain barrier to inhibit the brain iP.ConclusionTaken together, the results suggest that AR‐65 may hold great potential to be further investigated in clinical settings.

Novel drug delivery systems for the treatment of glaucoma

AbstractGlaucoma is a group of chronic irreversible neuropathies in which a progressive death of retinal ganglion cells (RGC) and a glaucomatous optic disc neuropathy occurs leading to an irreversible visual field alteration. Intraocular pressure (IOP) increase is a major risk factor strongly associated with the onset and progression of the disease although a non IOP‐dependent neurodegeneration also occurs. Taking all this into account, the glaucoma therapy is based on two different targets: lowering the IOP and neuroprotection.The treatment of choice in patients with high IOP values is topical administration of hypotensive active agents on the ocular surface. The chronicity of the pathology, together with the low bioavailability of the antiglaucomatous drugs applied topically, make it necessary daily instillations, which are associated, in many cases, with the appearance of surface eye alterations and dry eye disease (DED). For these reasons, the development of therapeutic platforms able to increase the bioavailability of the drug while being soft with the ocular surface is getting special attention. Novel formulations involve pharmaceutical systems such as liposomes, nanoemulsions and microemulsions including also compounds with protective activity on the corneal surface (osmoprotective, antioxidants and/or bioadhesive polymers)(1–3).It is well known that therapies lowering IOP does not address neurodegeneration. Moreover, pathophysiological studies of glaucoma have shown that even in patients presenting IOP values within the normal limits, neuronal degeneration occurs. For this reason, the use of neuroprotective therapy in the treatment of glaucoma alone or simultaneously with the therapy based on the control of IOP results of great interest. Treatments destined to lower IOP, in which the target is the anterior segment of the eye are administered topically. By the contrary, neuroprotective therapies require the administration of the drugs near to the retinal target as well as their maintenance during long term Due to the multifactorial nature of the disease there is special interest in the design of novel drug delivery systems able to include a combination of active agents in the same formulation and provide long term effects with a single administration(4).Acknowledgements: Acknowledgements‐ Grant: Fondo Europeo de Desarrollo Regional (FEDER‐CICYT), grant: FIS‐PI17/00079 and PI17/00466, Research Group UCM 920415 ‘Innovation, Therapy and Pharmaceutical Development in Ophthalmology (InnOftal)’ and the ISCII‐FEDER RETICS (OFTARED) (RD16/0008/0004 and RD16/0008/0009)PID2020‐113281RB‐C21 funded by MCIN/AEI/ 10.13039/501100011033.References.1. López‐Cano J.J, González‐Cela‐Casamayor M.A., Andrés‐Guerrero V.,Herrero‐Vanrell R. Molina‐Martínez I.T. “Liposomes as vehicles for topical ophthalmic drug delivery and ocular surface protection”. Expert Opinion on Drug Delivery. 2021. 18(7):819–847. DOI: 10.1080/17425247.2021.1872542.2. M. Gómez‐Ballesteros; J. López‐Cano; I. Bravo‐Osuna; R. Herrero‐Vanrell; I.T. Molina‐Martínez. “Osmoprotectants in Hybrid Liposome/HPMC Systems as Potential Glaucoma Treatment”. Polymers. 2019; 11(6): 929. DOI: 10.3390/polym110609293. I Bravo‐Osuna; V Andrés‐Guerrero; P Pastoriza Abel; IT Molina‐Martínez; R Herrero‐Vanrell. Pharmaceutical microscale and nanoscale approaches for efficient treatment of ocular diseases. Drug Deliv Translational Research.2016. 6(6):686–707.DOI: 10.1007/s13346‐016‐0336‐5.4. R Herrero‐Vanrell; I. Bravo‐Osuna; V. Andrés‐Guerrero; M. Vicario‐de‐la‐Torre; I.T. Molina‐Martínez. The potential of using biodegradable microspheres in retinal diseases and other intraocular pathologies. Progress in Retinal and Eye Research. 2014. 42; 27–43. DOI: 10.1016/j.preteyeres.2014.04.002.

АКТУАЛЬНЫЕ ВОПРОСЫ РАЗРАБОТКИ ДОПОЛНИТЕЛЬНЫХ ПРОФЕССИОНАЛЬНЫХ ПРОГРАММ ДЛЯ СПЕЦИАЛИСТОВ С ФАРМАЦЕВТИЧЕСКИМ И МЕДИЦИНСКИМ ОБРАЗОВАНИЕМ

The paper deals with topical issues of developing additional professional advanced training programs for specialists in several specialties with a secondary pharmaceutical and medical education. For many years, postgraduate medical and pharmaceutical education provided for a one-time advanced training of specialists over a five-year period. At the same time, such a training format lasting, as a rule, 144 hours, hardly allowed the student to master a significant amount of relevant professional information accumulated by science and practice over the past five years. It is obvious that the current pace of development of domestic healthcare in general and pharmacy, in particular, the emergence and active use of innovative educational technologies, the existing need for pharmaceutical personnel to regularly receive updated and systematized professional knowledge could not but lead to the transformation of the previously existing model of postgraduate education. However, to date, two inextricably linked components of this process have been clearly defined: the introduction of continuing medical and pharmaceutical education and the accreditation of specialists. Moreover, in the current conditions, continuous education is becoming a necessary condition for the formation of a portfolio and admission to the accreditation procedure for a specialist, while accreditation serves as a fundamental licensing tool for professional activities. An active participant in the continuing medical and pharmaceutical education system are educational organizations that have been delegated the functions of developing and implementing additional professional advanced training programs. The purpose of this work was to popularize the experience of the Department of Pharmacy of the Kuban State Medical University of the Ministry of Health of Russia in the development of additional educational programs for specialists with medical and pharmaceutical education. The methodological basis for the process of developing a development of additional educational programs for specialists with medical and pharmaceutical education was the professional competencies presented in the Federal State Educational Standards in the specialty "Pharmacy", Nursing, Federal State Educational Standards "General Medicine", Federal State Educational Standards "Obstetrics" and labor functions given in the relevant professional standards. On the example of additional professional advanced training programs developed at the Department of Pharmacy of the Kuban State Medical University of the Ministry of Health of Russia, modern approaches are shown that allow harmonizing their content with the requirements of the Federal State Educational Standards for medical and pharmaceutical specialties with professional standards "Pharmacist", "Nursing Organization Specialist", "Nurse/Nurse Brother", "Midwife", "Nurse Anesthetist", "Paramedic".

Biochemistry of Antioxidants: Mechanisms and Pharmaceutical Applications.

Natural antioxidants from fruits and vegetables, meats, eggs and fish protect cells from the damage caused by free radicals. They are widely used to reduce food loss and waste, minimizing lipid oxidation, as well as for their effects on health through pharmaceutical preparations. In fact, the use of natural antioxidants is among the main efforts made to relieve the pressure on natural resources and to move towards more sustainable food and pharmaceutical systems. Alternative food waste management approaches include the valorization of by-products as a source of phenolic compounds for functional food formulations. In this review, we will deal with the chemistry of antioxidants, including their molecular structures and reaction mechanisms. The biochemical aspects will also be reviewed, including the effects of acidity and temperature on their partitioning in binary and multiphasic systems. The poor bioavailability of antioxidants remains a huge constraint for clinical applications, and we will briefly describe some delivery systems that provide for enhanced pharmacological action of antioxidants via drug targeting and increased bioavailability. The pharmacological activity of antioxidants can be improved by designing nanotechnology-based formulations, and recent nanoformulations include nanoparticles, polymeric micelles, liposomes/proliposomes, phytosomes and solid lipid nanoparticles, all showing promising outcomes in improving the efficiency and bioavailability of antioxidants. Finally, an overview of the pharmacological effects, therapeutic properties and future choice of antioxidants will be incorporated.

Design and realization of pharmaceutical survey data acquisition and analysis system based on principal component analysis algorithm

With the rapid development of electronic communication technology, data acquisition systems have been widely used in all aspects of people's daily lives. Especially in the medical field, there is an urgent need for a pharmaceutical survey data collection and analysis system. In the massive pharmaceutical survey data, the principal component analysis algorithm is used to condense the attribute variables of the original data, which greatly improves the efficiency of data collection and analysis. Based on this, this article will study the pharmacy survey data collection and analysis system based on principal component analysis algorithm. This text first carries on the system function structure design, designs the system development framework from the hardware layer, the interface layer, and the middle layer. This paper designs the functional modules of the system in detail, including account management, file management, and report management. Finally, the system found through testing that the average delay for obtaining diagnostic reports, previous inspections, static files, and querying patient information were all about 40ms. This shows that the system runs at a high speed and can meet practical applications.

Formulation Development & Evaluation of Controlled Drug Delivery System: An Overview

The therapeutic effect is brought about by the drug delivery system dispensing the active medicinal ingredient. Due to fluctuations in plasma drug levels, traditional drug delivery devices have poor bioavailability and cannot generate a continuous release. The drug must also be supplied at a tightly regulated rate and to the correct location for it to be most effective and safe. To solve the problems inherent in the current methods of administering medication, scientists are working on perfecting controlled drug delivery systems. Controlled pharmaceutical delivery systems have come a long way in the last twenty years, from bulk distribution to nanoscale precision to smart, patient-specific dosing. The paper's initial portion provides background knowledge on drug delivery methods, emphasizing pharmacokinetics. The article also discusses the pros and cons of more conventional drug delivery methods. Controlled drug delivery systems' design factors, categorizations, and schematics are also discussed in length. In addition, recent advances in nano-drug delivery, targeted, and innovative drug delivery utilizing stimuli-responsive, intelligent biomaterials are discussed. The limitations of regulated medicine distribution and some possible solutions are discussed at the end of the study.

Development and characterization of sumatriptan-loaded soy bean polysaccharide nanofiber using electrospinning technique

The use of electrospinning fibers in rapid-dissolving drug delivery systems accelerates the release of the active substance due to their extensive contact surface and porosity. Sumatriptan succinate (SS), an antimigraine drug has beneficial and proven effects on human health, but it has some shortcomings such as bitter-taste, low oral absorption and low half-life that limit its application in pharmaceutical systems. In this work, the new nanofiber mats were developed to increase oral absorption and improve the efficacy of drug. The mean fiber diameters were 313.29 ± 31 nm, 373.37 ± 29 nm and 453 ± 42 nm for those loaded by 0.15% SS, 0.5% SS and 1% SS, respectively. By adding sumatriptan succinate to the electrospinning solution, viscosity, electrical conductivity and tensile strength in fibers increased, but pH decreased. Fourier transform infrared (FT-IR), differential scanning calorimetry (DSC) and X-Ray diffraction (XRD) analyses confirmed the absence of interactions between drug and polymer membrane. A fast release rate was obtained for sumatriptan-loaded soluble soy bean polysaccharide (SSPS) nanofiber mats, where 95% of the sumatriptan released within 20 s. Cytotoxicity evaluation revealed that none of the nanofibers had toxic properties on the fibroblasts cells. Overall, sumatriptan can be loaded well in SSPS nanofibers and released more quickly in oral space, which will be effective in improving the onset of therapeutic effects and reducing migraine headaches.

Derivation of the toxicological threshold of silicon element in the extractables and leachables from the pharmaceutical packaging and process components.

Silicon is one of the most monitored elements in extractables and leachables studies of pharmaceutical packaging systems and related components. There is a need to review and evaluate toxicological thresholds of silicon because of its direct contact with drug products (DP) especially a liquid form of DP with the widely used pharmaceutical packaging systems made of silicon materials like glass and silicone. It is required by regulatory authorities to test silicon content in DP; however, there are no official guidelines on the toxicology of silicon that are currently available, yet the knowledge of toxicological thresholds of silicon is critical to justify the analytical limit of quantification (LOQ). Therefore, we reviewed the toxicity of silicon to derive a toxicological threshold by literature review of toxicity studies of both inorganic and organic silicon compounds. Oral toxicity is low for inorganic silicon like silicon dioxide or organic silicon polymers such as silicone tube/silicone oil (polydimethylsiloxane, or namely, PDMS as the major ingredient). In comparison, inhalational toxicity of silicon dioxide leads to pulmonary silicosis or even lung cancer. When orally administered, the toxicity of silicon dioxide, glass, polymers, or PDMS oligomers varies depending on their morphology, molecular weight (MW), and degrees of polymerization. PDMS with high MW has minimal toxic symptoms with non-detectable degradation/elimination by both intraperitoneal and subcutaneous administration routes, while exposure to either PDMS or small molecule dimethyl silicone compounds by the intravenous administration route may lead to death. We here determined a general parenteral permitted daily exposure (PDE) of 93μg/day for inorganic silicon element and 100μg/day for organic silicon element by reviewing toxicological data of both forms of silicon. In conclusion, this work provides evidence for pharmaceutical companies and regulatory agencies on the PDEs of silicon elements in pharmaceutical packaging and process components through a variety of administration routes.

The Ttreatise “Khan’s Treasury” – on Methods of Treatment” as a Source of Information about the Adaptation of Medical Measurements in Mongolian Traditional Medicine

The article is dedicated to the early adaptation and development of the medical and pharmaceutical measurements system in traditional Mongolian medicine as shown in the example of the treatise “Khan Treasury” – about methods of treatment”. This work is a little-known translation into the classic Mongolian language of one of the oldest Tibetan medical treatises “GyalpoKorzo”, that belongs to the medical tradition of the Sakyapa school (11th century). The purpose of this study is to reveal the traditional medicine features of Mongolian peoples’ metric system on the example of the said work. The authors use a comparative historical method and historical-lexical analysis. The medical metric terminology available in the Mongolian text of the “Khan Treasury” was identified and systematized, the origin of the measurement units used in it, was determined. The scientific novelty is that new data have been obtained on the adaptation by Mongolians of the complex system of knowledge accumulated in traditional medical systems. It is shown that the studied lexical layer reflects economic and living conditions of nomads, features of cultural ties in East and Central Asia. The example of measurement terminology shows that Mongolians, while adapting and mastering Buddhist knowledge, apart from directly borrowing new categories and concepts, tried to rethink them in the realities of their own culture. Text and analytical materials of medical treatise “Khan Treasury” – about methods of treatment” are housed in the diachronic corpus of the old Mongolian language and will serve as the basis for the creation of a machine translation system based on artificial intelligence technologies (“deep learning”).

Implementation and Effectiveness of a Pharmacotherapeutic Follow-Up Service for People with Tuberculosis in Primary Healthcare.

Tuberculosis (TB) is a disease of great relevance, responsible for 1.5 million deaths worldwide. Therefore, actions to control TB are necessary, and pharmacists may play an important role, especially in primary healthcare (PHC), where the diagnosis and management of this infection occurs. In a large Brazilian city, pharmacotherapeutic follow-up in PHC has been offered by pharmacists to people with TB since 2018. The objective of this study was to evaluate the implementation and effectiveness of this service though a longitudinal type 1 effectiveness-implementation hybrid study. Data were collected from January 2018 to February 2020 in the pharmaceutical services system. The service indicators were described and effectiveness was evaluated using Poisson regression analysis to compare the incidence of cure among patients using and not using the service. The service was performed in 148 PHC units by 82 pharmacists. Of the total of 1076 treatments, 721 were followed up by pharmacists, and TB was cured more frequently in these cases (90.4% attended vs. 73.5% unattended). The adjusted hazard ratio of cure among patients enrolled in the pharmacotherapeutic follow-up service was 2.71 (2.04-3.61; p < 0.001). Pharmacotherapeutic follow-up for people with TB significantly increased the incidence of cure and should be encouraged.

Exploring three-dimensional space of extractables and leachables in volatility, hydrophobicity, and molecular weight and assessment of roles of gas and liquid chromatographic methods in their comprehensive analysis

The three-dimensional (3D) global space of organic extractables and leachables (E&L) in volatility, hydrophobicity, and molecular weight (MW), covering the pharmaceutical container-closure system, biopharmaceutical single use equipment, and tissue-contacting medical devices, has been quantitatively explored by an extensive collection of E&L compounds from the publicly available sources. The total number of compounds collected is 776, including name, CAS number, MW, and boiling point (BP). The hydrophobicity of these compounds in logPo/w are computed by Abraham solvation parameter model, using compounds’ descriptors generated by an online computational program “RMG: Solvation Tools”. A “global” 3D space is built to represent the physicochemical property limits of E&L quantitatively, envisioned to cover a variety of materials extracted by different solvents. This 3D space also represents the scope and capability requirements of general-purpose chromatography-based methods to profile unknown material samples, if a limited number of analytical methods are used in a routine laboratory analysis. It is concluded from the study that the 3D space corresponding to MW of 1000 Da are: BP up to 857 °C and hydrophobicity in logPo/w between − 2.3–19. Additionally, the roles of temperature programmed GC (TPGC) and reversed-phase liquid chromatographic (RPLC) methods are quantitively and critically examined in the comprehensive analysis of the 3D space, particularly for RPLC methods in retention and resolution requirements, and it is also concluded that the current concept of analytical E&L testing strategies based on volatility needs to be challenged. Finally, this study proposes a semi-empirical method in correlation and prediction of the retention time of TPGC using Abraham solvation parameter model.

Past, present, and future of the International Pharmaceutical Federation (FIP) Academic Pharmacy Section: Interviews with past presidents

Introduction: The Academic Pharmacy Section (AcPS) of the International Pharmaceutical Federation (FIP) celebrates 50 years of its establishment in 2022. In the last decade, the Section had significant growth in membership and strategic planning development. Description: The AcPS challenges in in the past and present times, as well as possible future directions, are described based on the reflections of four AcPS past presidents. They responded to semi-structured interviews from January to March 2022. Evaluation: The collected data were analysed using a qualitative descriptive approach. The reflections and perceived challenges in the history of the AcPS, as well as future plans about the pharmaceutical workforce, capacity building, educational systems, and modern curricula, were summarised. Conclusion: The future direction of the FIP AcPS suggests a focus on collaboration, faculty development and strong and engaged membership.