Medicamentos: breve historia y su evolución el mercado global / Drugs: brief history and evolution the global market

La Historia del Medicamento tiene su origen ya en la vida y civilizaciones primitivas hasta la actualidad fantástica hoy en la Biotecnología Farmacéutica, en el escenario de las vacunas contra el Covid-19 que han salvado millones de vidas. Las plantas medicinales aún hoy son de uso común en la mayoría de los países de Latinoamérica. “Las Farmacopeas son un conjunto de normas sobre principios activos, productos farmacéuticos auxiliares, productos medicamentos o terminados, y métodos recomendados a fin de constatar si éstos las cumplen y que han sido publicados y reconocidos por la autoridad sanitaria competente.” Estas normas regulan el circuito de los medicamentos en los distintos países. El acceso a los medicamentos es un factor esencial para el uso adecuado de los mismos. Según la Organización Mundial de la Salud, la tercera parte de la población mundial no tiene acceso a medicamentos esenciales para la salud (más de 2,5 mil millones de seres humanos). Las compañías farmacéuticas de investigación dedicaron un total de 198.000 millones de USD en I+D en el año 2020 (último año con datos oficiales).Esto significa una inversión muy superior a otros sectores de Alta Tecnología. Así es 8,1 veces mayor que lo dedicado a la Industria Aeroespacial y de Defensa, 7,2 veces superior a la Industria Química y 1,2 veces que las de las compañías de Software y Servicios Informáticos.Para el año 2026 se estima se alcance un monto de 254 mil millones de USD.La Federación Europea de la Industria Farmacéutica (EFPIA) estima en 8.000 el número de medicamentos en ensayos clínicos (10% para enfermedades raras).(AU)

The main protagonist of Pharmacy is Medicine; Without it, there would be no such thing, and its companion, medicine, would be in a very bad light, for it would have lost its main purpose.”The History of Medicines has its origins in primitive life and civilizations until the present fantastic today in Pharmaceutical Biotechnology, in the scenario of vaccines against Covid-19 that have saved millions of lives. Medicinal plants are still in common use today in most Latin American countries. “The Pharmacopoeias are a set of standards on active ingredients, ancillary pharmaceutical products, medicinal or finished products, and recommended methods in order to verify whether they comply with them and that have been published and recognized by the competent health authority.” These rules govern the circuit of me- dicines in the various countries. Access to medicines is an essential factor for the proper use of medicines. According to the World Health Orga- nization, one third of the world’s population does not have access to essential health medicines (more than 2.5 billion human beings). Pharmaceutical research companies dedicated a total of USD 198,000 million in R+D in 2020 (the last year with official data). This means a much higher investment than other high-tech sectors. This is 8.1 times higher than that dedicated to the Aerospace and Defense Industry, 7.2 times higher than the Chemical Industry and 1.2 times that of Soft- ware and Computer Services companies.By 2026, it is estimated that it will reach an amount of USD 254 billion.The European Federation of the Pharmaceutical Industry (EFPIA) estimates the number of medicines in clinical trials at 8,000 (10% for rare diseases).(AU)

A droga como dispositivo de controle social: uma análise das representações sociais do álcool, maconha e crack na imprensa brasileira / Las drogas como dispositivo de control social: un análisis de las representaciones sociales del alcohol, la marihuana y el crack en la prensa brasileña / Drugs as a social control device: an analysis of the social representations of alcohol, marijuana and crack in the brazilian press

RESUMO. As drogas se consolidam como um dos arquétipos culturais predominantes no cotidiano das sociedades urbanas, sendo sua presença ubíqua em praticamente todas as culturas. Os registros históricos apresentam ampla variabilidade de substâncias que em dado momento eram classificadas como o perigo social da época e que em outro se tornavam banalizadas ou tipificadas como inofensivas. Assim, esse estudo teve como objetivo analisar como dispositivo droga que se consolida em diferentes períodos históricos. Para isso, foram coletadas 4.227 matérias dos jornais Folha da Manhã, Folha da Noite e Folha de São Paulo, que abordassem questões relativas ao álcool (década de 1920), maconha (décadas de 1930 a 1960) e crack (década de 1980 a 2005) e realizada Análise Temática de Conteúdo. Os resultados permitem afirmar que a característica central que define todas as substâncias analisadas nos distintos momentos históricos é o risco social que ela apresenta. A droga se constitui como um risco aos usuários ao mesmo tempo que os institui enquanto uma figura de ameaça social. Ao se referenciar uma substância como uma droga, são ativados sentidos que remetem a um quadro de decadência e criminalidade.

RESUMEN. Las drogas se consolidan como uno de los arquetipos culturales predominantes en la vida cotidiana de las sociedades urbanas, y su presencia ubicua en prácticamente todas las culturas. Los registros históricos muestran una amplia variabilidad de sustancias que en un momento se clasificaron como el peligro social de la época y en otro momento se trivializaron o tipificaron como inofensivas. Así que este estudio tuvo como objetivo analizar cómo diferentes sustancias psicoactivas se encuentran en la prensa como un riesgo social en diferentes momentos. Para ello, se recogieron 4.227 artículos del periódico Folha da Manhã, Folha da Noite y Folha de São Paulo, que abordasen temas relacionados con el alcohol (1920), marihuana (1930 a 1960) y el crack (1980 a 2005) y se realizó un Análisis Temático de Contenido. Los resultados muestran que la característica definitoria de todas las drogas examinadas en los diferentes momentos históricos es el riesgo social que presenta. La droga se constituye como un riesgo para los usuarios mientras los establece como una figura de amenaza social. Al hacer referencia a una sustancia como droga, se activan sentidos que conducen a un marco de decadencia y criminalidad.

ABSTRACT Drugs are one of the predominant cultural archetypes in the daily life of urban societies, and their ubiquitous presence in almost all cultures. Historical records show a wide variability of substances that at one point were classified as the social danger of the time and at another time trivialized or typified as harmless. Thus, this study aimed to analyze how different psychoactive substances are constituted in the press as a social risk at different times. For this, we collected 4,227 articles of newspapers Folha da Manhã, Folha da Noite and Folha de São Paulo, that addressed issues related to alcohol (1920), marijuana (1930s to 1960) and crack (1980s to 2005) and performed a Thematic Content Analysis. The results indicate that the central defining characteristic of all drugs examined in the different historical moments is the social risk it has. The drug is constituted as a risk to users while establishing them as a figure of social threat. When referring a substance as a drug, senses are activated that denote to a situation of decadence and crime.

Are Ancestral Medical Practices the Future Solution to Today's Medical Problems?

Our cells and organs are threatened and, in most cases, constantly subjected to the aggression of numerous situations, both endogenous, characterized by unfavorable genetics, and exogenous, by deficient or inadequate nutrition, and even by a hostile environment; in most cases, they ultimately cause a cascade of degenerative and cardiovascular diseases, cancer, and infections, as well as those related to the metabolic syndrome, all of which eventually generate irreversible damage to the organism and, consequently, a significant deterioration in its survival [...].

Adolf Thierry and the first pharmaceutical factory in Southeast Europe.

The paper explores the beginnings of pharmaceutical industry development in Croatia and the establishment of the first pharmaceutical factory in Southeast Europe. Adolf Thierry de Chateauvieux (St. Pölten, 1854 - Pregrada, 1920), a nobleman hailing from France, immigrated to Croatia at the end of the 19 th century. He bought the Angjelu cuvaru ( Guardian Angel ) pharmacy (1892) in the small town of Pregrada and established the first pharmaceutical factory (1894) in this part of Europe. The factory had an equipped laboratory, a production facility, a storage room for raw materials and balsams, a room for packaging and shipping finished products and a commercial office. Production was mainly based on herbal remedies. The most famous were Thierry's Balsam and Thierry's Centifolia Ointment, both registered and patented in London (1900). By virtue of Adolf Thierry's entrepreneurial spirit and skilful product advertisement, his medicinal preparations were distributed across Europe, America, India and Africa, a testament to which is the well-preserved and researched documentation.

Why are certain age bands used for children in paediatric studies of medicines?

Rational prescribing of medicines requires evidence from clinical trials on efficacy, safety and the dose to be prescribed, based on clinical trials. Regulatory authorities assess these data and information is included in the approved summary of product characteristics. Regulatory guidelines on clinical investigation of medicinal products in the paediatric population generally propose that studies are done in defined age groups but advise that any classification of the paediatric population into age categories is to some extent arbitrary or that the age groups are intended only as a guide. The pharmaceutical companies tend to plan their studies using age groups the regulatory guidelines suggest, to avoid problems when applying for marketing authorisation. These age bands end up in the paediatric label, and consequently into national paediatric formularies. The age bands of the most commonly used age-subsets: neonates, infant/toddlers, children and adolescents, are more historical than based on physiology or normal development of children. Particularly problematic are the age bands for neonates and adolescents. The age of 12 years separating children from adolescents, and the upper limit of the adolescents set by the definition of paediatric age in healthcare, which varies according to the region, are particularly questionable. Modern pharmacometric methods (modelling and simulation) are being increasingly used in paediatric drug development and may allow assessment of growth and/or development as continuous covariables. Maybe time has come to reconsider the rational of the currently used age bands.

Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors.

INTRODUCTION: Medications are compounded when a formulation of a medication is needed but not commercially available. Regulatory oversight of compounding is piecemeal and compounding errors have resulted in patient harm. We review compounding in the United States (US), including a history of compounding, a critique of current regulatory oversight, and a systematic review of compounding errors recorded in the literature. METHODS: We gathered reports of compounding errors occurring in the US from 1990 to 2020 from PubMed, Embase, several relevant conference abstracts, and the US Food and Drug Administration "Drug Alerts and Statements" repository. We categorized reports into errors of "contamination," suprapotency," and "subpotency." Errors were also subdivided by whether they resulted in morbidity and mortality. We reported demographic, medication, and outcome data where available. RESULTS: We screened 2155 reports and identified 63 errors. Twenty-one of 63 were errors of concentration, harming 36 patients. Twenty-seven of 63 were contamination errors, harming 1119 patients. Fifteen errors did not result in any identified harm. DISCUSSION: Compounding errors are attributed to contamination or concentration. Concentration errors predominantly result from compounding a prescription for a single patient, and disproportionately affect children. Contamination errors largely occur during bulk distribution of compounded medications for parenteral use, and affect more patients. The burden falls on the government, pharmacy industry, and medical providers to reduce the risk of patient harm caused by compounding errors. CONCLUSION: In the US, drug compounding is important in ensuring access to vital medications, but has the potential to cause patient harm without adequate safeguards.

Disclosing the composition of unknown historical drug formulations: an emblematic case from the Spezieria of St. Maria della Scala in Rome.

This paper reports a pioneering study of an unknown historical drug formulation preserved in the Spezieria of Santa Maria della Scala in Rome, founded at the end of the seventeenth century by the Discalced Carmelites. Due to limited literature related to pharmaceutical remedies and drugs of the Early Modern Era (between the XV and XVIII centuries) and the complexity in their formulations, the study of these drugs represents a great challenge. The untargeted nature of the selected drug required a multi-analytical approach with complementary techniques to formulate a compositional hypothesis: FT-IR spectroscopy, gas chromatography-associated/mass spectrometry (GC-MS) and nuclear magnetic resonance (NMR) were successfully employed to identify different organic compounds. Systematic archaeobotanical research was performed as well, allowing us to acquire data related to the possible genus of plants from which these natural compounds derive and their geographical origin. The unknown drug formulation turned out to be a complex mixture used as an ointment with an anti-inflammatory purpose. It mainly contains a mixture of Venetian turpentine; a Pine resin (colophony) from the Pinaceae family; an exudate of a plant from South America, whose identified components are triterpenic compounds such as alpha- and beta-amyrins, betulin and lupeol; and saturated fatty acids which act as carriers and/or to reduce the viscosity of abovementioned exudates and resins. The study of historical drugs is important not only in order to know the practices handed down by the speziali in the past but also to reconstruct historical recipes, which can inspire new dermatological, cosmetic, hygienic and current healing products.Graphical abstract.

Portable medicine chests and supply of medicines in Serbia from the 1830s to the mid-20th century: analysis of medicines list.

The first portable medicine chests appeared in Serbia immediately after liberation from Ottoman rule around 1830. The network of portable medicine chests grew very quickly and became the first effective public health method of supplying medicines and medical items to people living in cities without community pharmacies and to the rural population in villages. According to their purposes, three categories of portable medicine chests could be identified: Portable medicine chests owned by physicians or veterinarians in the cities, portable medicine chests established by the Department of Workers Health Insurance, and portable medicine chests of the Health Cooperatives that operated in the villages This paper analyzes all three types of portable medicine chests. We specifically examine the regulations concerning the management of portable medicine chests, their content, and supply chains of medicines from the third decade of the 19 th century through the first half of the 20th century. We conclude that portable medicine chests represent a specific type of pharmacy in the territory of Serbia that provided very effective medical service. The medicines in these pharmacies were handled and dispensed to patients by physicians not by pharmacists. Patent medicines, compounded medicines, sanitary items and bandage materials were dispensed as well. Future research is needed to ascertain if physicians who owned or worked with the portable medicine chests actually prepared and compounded simple preparations as they were specified in the laws.

Sulfobutylether-ß-cyclodextrin.

This review presents the early history, the motivation, the research and some of the backstories behind the discovery and development of sulfobutylether-ß-cyclodextrin as a novel parenterally safe solubilizer and stabilizer. A specific sulfobutylether-ß-cyclodextrin with an average degree of 6.5 sulfobutyl-groups variably substituted on the 2-, 3- and 6-hydroxyls of the seven glucopyranose (dextrose) units of ß-cyclodextrin, is known by its commercial name, Captisol®. Today it is in 13 FDA approved injectables and numerous clinical candidates. It is also an example of a novel product discovered and initially preclinically developed at an academic institution.

Pre-Chemistry Concepts and Medical Therapy among Ancient Physicians through the Pre-Socratic Philosophers.

BACKGROUND: Chemistry as experimental science began in the seventeenth century, when it began moving away from being one of the alchemical doctrines and toward analyzing matter and its transformations using scientific methods. Previously, the ancient Pre-Socratic philosophy through observation of nature was concerned with the laws that govern the natural world and the property of matter. Later, the Hellenistic Alexandrian culture took possession of the Hermetic doctrines of the Egyptians, mixing them with pre-Socratic thought and Gnosticism. At this historical moment, therefore, there was a fusion of the Greek philosophical patrimony and the Hellenistic and Alexandrian influences on medicine. The Hermetic gnosis evolved over time to become alchemy and then to usher in the birth of chemical science. Many doctors were wandering philosophers who dealt with cosmogony to understand the body and diseases and to discover new healing drugs for treatment, and thus they were the first chemist therapists. METHODS: The influence of ancient physicians through the pre-Socratic philosophy for these prochemical theories and practice has been researched through ancient texts, so these texts have been referenced to determine the legacy of paleo-chemicals doctrines. RESULTS: The study of various texts in particular from the Pre-Socratic age and the eminent physicians underline that, despite a different approach to the cosmogonic concepts of nature and the matter, the medicine of that age had an important influence on chemistry as an experimental science, especially concerning therapy with drugs. CONCLUSION: The Pre-Socratic philosophers have influenced the medical practice and guided it toward the concept of the properties of matter for medical treatment and an understanding of the causes of diseases.

Paradigmas de salud y políticas de medicamentos: continuidades y rupturas en el caso argentino en la etapa posguerra hasta finales del siglo XX / Health paradigms and drug policies: Continuities and ruptures in the Argentine case in the postwar period until the end of the 20th century

En este trabajo se recuperan elementos conceptuales relacionados con los paradigmas en salud, así como sus implicancias históricas en torno a la cuestión de los medicamentos. La salud internacional, el panamericanismo y la nueva agenda de salud global se ubican como paradigmas hegemónicos con un fuerte anclaje desde una perspectiva biologicista donde la atención médica y los medicamentos juegan un papel predominante. La medicina social latinoamericana se presenta como un paradigma contra hegemónico desde una perspectiva que, orientada desde categorías sociales, analiza el proceso de salud de la población, en tanto colectivo y determinado por condiciones preexistentes. Estos paradigmas signaron las políticas de salud de modo alternante. Se analizan, particularmente, el caso de las políticas de medicamentos en Argentina y cómo las estrategias en ese campo manifiestan características de dichos paradigmas. Se concluye que existieron continuidades y rupturas con éstos. También describe los preceptos de las organizaciones internacionales y su relación con lo que estaba pasando en el territorio nacional. Las políticas de medicamentos fueron un reflejo de la posición de los gobiernos de turno con vaivenes que expresan un debate sin resolver (AU)

In this work, conceptual elements related to the paradigms in health are recovered, as well as their historical implications around the issue about medication. International health, pan-Americanism and the new global health agenda are located as hegemonic paradigms with a strong anchorage from a biological perspective where medical care and medication play a predominant role. Latin American social medicine is presented as a counter-hegemonic paradigm from a perspective that, oriented from social categories, analyzes the health process of the population, both collective and determined by pre-existing conditions. These paradigms alternately signified health policies. In particular, the case of medication policies in Argentina are analyzed, and how the strategies in this field show characteristics of said paradigms. It is concluded that, this paradigms showed continuities and breaks. It also describes the views under the precepts of international organizations and their relation to what was happening in the national territory. Medication policies were a reflection of the position of the governments in office with swings that express an unsolved debate (AU)

Miracle cures: advertisements for various medications in the Santa Fe press, Argentina (1890 -1918). / Curas milagrosas: publicidades de medicamentos varios en la prensa santafesina, Argentina (1890-1918).

In the late nineteenth century, as in other regions of Argentina and Latin America, the Santa Fe press featured a growing number of offers of health products such as tonics, pills and syrups. Aimed at a lay audience, these claimed to cure a series of conditions defined as belonging to "modern life." This article analyzes the discursive dimension of the advertisements printed between 1890 and 1918: how they organized meanings associated with these conditions, an issue that is inscribed within a broad line of research aimed at analyzing social representations of health and disease, and how they participated in the different social spheres in the constitution of modern-day Argentina.

A fines del siglo XIX, en consonancia con otras regiones de Argentina y Latinoamérica, en la prensa santafesina se incrementó la oferta de productos para la salud como tónicos, pastillas y jarabes. Ofrecidos a un público no experto, prometían curar una serie de dolencias que definían como propias "de la vida moderna". El artículo analiza la dimensión discursiva de los avisos publicitarios aparecidos entre 1890 y 1918: cómo organizaron los sentidos sobre estas dolencias, interrogante que se inscribe en una amplia línea de estudios abocada a analizar las representaciones sociales sobre la salud y la enfermedad y cómo éstas participaron en las distintas esferas sociales en la constitución de la Argentina moderna.

Curas milagrosas: publicidades de medicamentos varios en la prensa santafesina, Argentina (1890-1918) / Miracle cures: advertisements for various medications in the Santa Fe press, Argentina (1890 -1918)

Resumen A fines del siglo XIX, en consonancia con otras regiones de Argentina y Latinoamérica, en la prensa santafesina se incrementó la oferta de productos para la salud como tónicos, pastillas y jarabes. Ofrecidos a un público no experto, prometían curar una serie de dolencias que definían como propias "de la vida moderna". El artículo analiza la dimensión discursiva de los avisos publicitarios aparecidos entre 1890 y 1918: cómo organizaron los sentidos sobre estas dolencias, interrogante que se inscribe en una amplia línea de estudios abocada a analizar las representaciones sociales sobre la salud y la enfermedad y cómo éstas participaron en las distintas esferas sociales en la constitución de la Argentina moderna.

Abstract In the late nineteenth century, as in other regions of Argentina and Latin America, the Santa Fe press featured a growing number of offers of health products such as tonics, pills and syrups. Aimed at a lay audience, these claimed to cure a series of conditions defined as belonging to "modern life." This article analyzes the discursive dimension of the advertisements printed between 1890 and 1918: how they organized meanings associated with these conditions, an issue that is inscribed within a broad line of research aimed at analyzing social representations of health and disease, and how they participated in the different social spheres in the constitution of modern-day Argentina.

[Pooled Human Immunoglobulin Preparations as Immunomodulating Drugs].

It is time to celebrate the 125th anniversary of the first successful attempt to develop and use a specific high-titer antitoxic serum for treating diphtheria, a deadly infectious disease. This was followed by major advances in passive immunotherapy 75 years ago (production of pooled human IgG for subcutaneous injection) and 50 years ago (widespread technology for producing immunoglobulin preparations for intravenous administration). More than 200 tons of pooled human IgG are produced per year worldwide. The preparation is used primarily for IgG substitution in patients with primary and secondary immunodeficiencies, as well as for an immunomodulating treatment of a growing number of autoimmune and inflammatory diseases. These preparations contain the pooled IgG antibody repertoire of a large population of healthy plasma donors. This repertoire includes antibodies that neutralize pathogens and their factors of virulence, anti-idiotypic antibodies, and antibodies to other foreign and own proteins, as well as to carbohydrate antigens. Naturally polyspecific antibodies that are present in all healthy individuals play an important role as a first-line defense against bacteria and viruses. After exposure to protein-modifying agents, some IgG molecules can acquire the ability to bind novel structurally unrelated antigens. This phenomenon is referred to as induced polyspecificity. The list of these protein-modifying molecules was shown to include low-pH buffers, free heme, pro-oxidative ferrous ions, reactive oxygen species, etc. Such modified antibody preparations may have a therapeutic potential, since their administration to animals with experimental sepsis or aseptic systemic response syndromes significantly improved survival rates, while the same dose of the native preparation had no effect. We also hypothesize that the aggressive protein-modifying molecules released in sites of inflammation and tissue damage could also modify the antigen-binding behavior of surface immunoglobulin B cell receptors and the structurally related T cell receptors. This "specificity editing" of both types of receptors may play a major role in the body's defense mechanisms.