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The use of natural products has been a practice carried out by people throughout history to take care of their health and to alleviate a wide variety of ailments. The reasons for the use of natural medicine at this time, with so many advances in pharmacology, are varied, among which are the dissatisfaction of the immediate needs of people to feel better about themselves and the economic factor. It must be considered that not everything natural is good. Therefore, the products manufactured and distributed under the line of Natural Medicinal Products must go through a verification and certification process, ensuring that they contain sufficient information on their composition and effects to avoid the risks that they may bring to those who consume them. This research describes good practices in the manufacture of natural products and shows the establishment of a Quality Management System in the pharmaceutical industry in different countries of the world. Finally, the use of natural products in Costa Rica is detailed, certain aspects to establish a Quality Management System in the country, as well as its importance. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR) UCR::Vicerrectoría de Docencia::Salud::Facultad de Farmacia

Radiopharmaceuticals are a group of medicines known for their radioactive agents, known as radioisotopes. They are employed in various areas, primarily clinics for the diseases' diagnosis or treatment. Their structure comprises a radionuclide (regulates the physical characteristics) and a drug (determines the biological behavior). The following review describes the general and innovative applications of radiopharmaceuticals, the manufacturing process, and the regulation they must have to be administered safely. This work showed various functions of radiopharmaceuticals in the pharmaceutical industry for diagnostic and therapeutic purposes (99m Tc, 131 I, 67 Ga, 153 Sm, 201 Tl, 81m Kr, 223 Ra, 18 F, 90 Y, 186 Re, and 169 Er) and the innovation being developed to treat pathologies more efficiently and safely. The rigor required for the manufacturing as well as the quality control during their preparation, dispensation, and use was also appreciated. Concerning Costa Rica, their utilization continues to grow, so it is essential to maintain strict security protocols. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

Introduction: Garlic has been used as a food and medicinal plant through the years. Antimicrobial, antiviral, and immunostimulatory effects are attributed to garlic, so it is widely recommended to treat diseases like asthma, bronchitis, influenza, and some others. Method: This work’s objective was to conduct a literature review and analysis related to garlic medicinal-use, and it’s potential as a therapeutic agent and immunostimulant in different diseases and health conditions. The literature review was carried out in the databases Scielo, Clinical Key, Medline and ClinicalTrials.gov, among others. Results: The information consulted supports the health benefits associated with garlic consumption. The crushing of garlic bulbs allows obtaining alliin, which turns into allicin due to enzymatic oxidation. This compound has a fundamental role in the garlic’s medicinal properties, and the garlic plant’s activity depends on its ability to produce allicin. Preclinical studies have shown the improvement of the immune system, and specific proteins associated with its immunostimulating effect have been identified. In clinical studies, supplements with garlic derivatives have been administered to patients, and a decrease in the incidence of influenza and acute respiratory diseases has been observed. Conclusions: Garlic has been shown to have a significant clinical potential to treat many diseases, and immunomodulatory effects and viral acute respiratory disease prevention have been observed. Introducción: El ajo ha sido utilizado como alimento y planta medicinal a través de los años. Se le atribuyen cualidades antimicrobianas, antivirales e inmunoestimuladoras, razón por la que es ampliamente recomendado en el tratamiento de enfermedades como asma, bronquitis, influenza, entre otras. Método: El objetivo de este estudio fue realizar una revisión y análisis de la literatura relacionada con el uso medicinal del ajo, y su potencial como agente terapéutico e inmunoestimulante en diferentes enfermedades y condiciones de salud. La búsqueda de literatura se realizó en las bases de datos de Medline a través del buscador Pubmed, Scielo, Clinical Key y ClinicalTrials.gov, entre otros. Resultados: La información consultada respalda los beneficios para la salud asociados con el consumo del ajo. La trituración de los bulbos de ajo permite la obtención de aliína, que al sufrir oxidación enzimática, se convierte en alicina. Este compuesto tiene un rol fundamental en las propiedades medicinales del ajo y se dice que la actividad de esta planta medicinal radica en su capacidad de producir alicina. Estudios preclínicos han demostrado el mejoramiento del sistema inmune y se han identificado proteínas específicas asociadas a su efecto inmunoestimulante. En estudios clínicos se han administrado suplementos con derivados de ajo y se ha observado una disminución en la incidencia de influenza y enfermedades respiratorias agudas. Conclusiones: El ajo ha demostrado tener un potencial clínico muy importante en el tratamiento de gran cantidad de enfermedades. Se han observado efectos inmunomoduladores y en la prevención de enfermedades respiratorias agudas de origen viral UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

Soft gelatin capsules are solid, single-dose dosage forms consisting of a shell, usually made from gelatin, that generally contain liquids. Gelatin is the most widely used film-forming agent, and it is extracted from collagen through hydrolysis. However, it is also possible to use starch and cellulose derivatives, such as hydroxypropyl methylcellulose, to form the thin ribbons required for the production of soft gel capsules. The most widely used method for making and filling soft gel capsules is using a rotary die process which is known as the first continuous manufacturing process. Due to the nature of soft gelatin capsules, the to-be-encapsulated liquid formulation must be within well-established moisture and pH limits. These liquids can be either hydrophilic or hydrophobic and can be formulated as solutions or suspensions. There are currently many soft capsules patents, some covering formulations and others covering the processes of soft capsules without incorporating gelatin. The main objective of this paper was to review both soft gelatin and non-gelatin capsules as to their general aspects, composition, manufacturing processes, and controls affecting this pharmaceutical dosage form. Additionally, some patents for soft gelatin and non-gelatin capsules are cited. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

The quality management systems are tools that can be implemented in different types of industry with the purpose of achieving improved quality standards on the products or services they develop, mainly looking to satisfy the customer and position themselves in the market with an advantage over the products offered. Within the pharmaceutical industry there are numerous regulations and laws that regulate and supervise the production of these products worldwide, ensuring that the industries dedicated to this area have certain regulations and meet minimum quality objectives, because they are products that have a high impact on human life and their improper use can mean major problems for it. This is why, over the years, organizations have been formed. It corresponds to a bibliographic review of international regulations on the manufacture of cosmetic products. Multiple sources are reviewed, from the original standards that contain the minimum requirements for a company that manufactures this type of product, to reviews by auditing and consulting organizations, as well as research on the same subject. It is important to note that basically all regulations, rules and standards specify the same requirements to meet the needs of the customer, and at the same time, meet the safety and quality of a product that will circulate both in domestic and international markets. In this sense, it is clear that the most widely used standard worldwide is ISO 22716:2007, which is widely disseminated across all continents, and is used as the basis for many of the national regulations implemented in countries. The changes made by local regulations are minimal to the content of the standard, adding some clauses to it, but leaving its basic structure intact. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

Introduction: Ginger is a medicinal plant native to India. Its potential use in cosmetics, medicines and natural products has been reported, however depending on the conditions of cultivation the medicinal components of the different parts of the plant not only changes in its concentration, but in its composition, this modifies its action medicinal. Objective: Characterize the chemical composition of the essential oil obtained from the rhizomes of Zingiber officinale cultivated in the San Carlos area, Costa Rica, and to compare its antifungal and antibacterial effect in order to standardize future crops of the plant. Hydroponic form and validate its pharmacological effect and, or Cosmetic a posteriori. Materials and Methods: The rhizomes of the plant were used, the active ingredients were extracted by ethanolic extraction with Soxhlet and steam distillation, the analysis was performed by a qualitative phytochemical profile for the ethanolic extract, and the composition of the essential oil was studied by means of Gas Chromatography coupled to a mass detector (GC-MS). In addition, microbiological tests were performed by plate diffusion for ethanolic extracts and essential oil with strains of bacteria and fungi common in cutaneous pathologies. By means of a scanning electron microscope. Results and Conclusions: The presence of flavonoids, alkaloids, saponins, tannins and triterpenes in the ethanolic extract was qualitatively determined. In the characterization of the essential oil by GC-MS, geranial (27.42%), neral (20.11%), 1,8-cineol (13.35%), camphene (4.65%) and E-geraniol%). The composition obtained with the composition reported in the literature was compared, obtaining a clear difference with that reported in other studies, which allows to predict an antimicrobial behavior different from most of the traditional essential oils of this rhizome. It was determined that the essential oil inhibited the growth of Staphylococcus aureus, Escherichia coli, Streptococcus pyogenes, Stahylococcus epidermidis, Candida albicans, Enteroccocus faecalis, but not against Pseudomonas aureginosa, the ethanolic extract showed no antifungal or antibacterial activity, in addition it was demonstrated that the oil Essential has a stronger anti-Candida Albicans effect than inhibition halo at the same concentration of essential oil and that its mechanism of action included destruction of the membrane by pore formation and an osmotic shock. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR) UCR::Vicerrectoría de Docencia::Salud::Facultad de Farmacia

The cuayote (Gonolobus taylorianus) is a very unknown, endemic plant from the Central America zone. In Costa Rica, two species of the genus Apocynaceae, Gonolobus edulis and Gonolobus taylorianus are known by the popular name of cuayote. The fruit of both species is traditionally used for food purposes. A medicinal use of the plant and the fruit have also been reported for the treatment of warts and prostate. The fruit characterization revealed, through a phytochemical screening, the presence of important compounds such as flavonoids, steroids, triterpenes, carbohydrates and cardiotonic glycosides UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

The aim of this study is to determine the impact caused by direct compression on the crystalline state of two prototypes of Rupatadine fumarate 10 mg tablets. The tablets were manufactured through direct compression. Five grams powdered tablets samples were taken randomly for analysis through DSC, TGA and XRD. The results were analyzed by making a comparison between their crystalline characterization and the one shown by the active pharmaceutical ingredient, excipients, the placebo and the powdered formula before compression. The active pharmaceutical ingredient showed a melting point at 201.38 °C, which decreased 2 – 3 °C in the tablets’ thermograms. Placebos presented an endotherm at 228 °C characteristic of amorphous lactose’s melting point. The only thermal change presented between the tablets and the other samples is the crystallization of amorphous lactose around 172 – 176 °C. X-ray diffractograms showed an increased intensity for the peaks of α - lactose monohydrate after compression and no changes regarding the active pharmaceutical ingredient. The comparison done between the analyses, confirmed that compression didn’t impact the crystalline state of Rupatadine fumarate. However mechanical treatment and the influence of the excipients caused the fusion peak to shift towards lower temperatures. Lactose’s crystal lattice suffered the greatest impact caused by compression, which generated the crystallization of the amorphous region present in that raw material. Nevertheless, such modification doesn’t alter the prototypes’ aptitude for being developed into a final solid pharmaceutical form and it is not a situation that affects the product’s quality. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

The present study was carried out with the purpose of validating an analytical method for the quantification of the immediate release of tablets of chlorpheniramine maleate 4 mg and the determination or the dissolved percentage of them in three buffers, using a UV-Vis spectrophotometer for the analysis of these data. The analytical results show that the method complies with the parameters of linearity, precision and accuracy. The calibration curve of each medium was carried out in a concentration range of 2-14 μg / mL, linearity was demonstrated in each medium, considering the following criteria: homoscedasticity, variance analysis, correlation coefficient and random distribution data; precision was evaluated in terms of repeatability and intermediate precision; and finally, the accuracy was evaluated by the determination of recovery percentage. Therefore, the methodology complies with the specifications established by USP 40. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

Bactris gasipaes es una palmera de la cual se obtiene una fruta conocida comúnmente en Costa Rica como Pejibaye, es autóctona de América Central, muy común en la alimentación de Costa Rica, por su alto contenido de almidón en su fruto. La semilla es un producto de desecho industrial. El presente estudio busca caracterizar la composición de la misma para analizar sus aplicaciones farmacéuticas. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

El objetivo de este artículo es describir los resultados obtenidos de la implementación de un modelo socio-económico que permite gestionar la innovación en empresas artesanales a través de la articulación de sectores sociales, la Universidad de Costa Rica, la Facultad de Farmacia y el Instituto de Investigaciones Farmacéuticas. Se describen los principios del modelo, la caracterización y clasificación de las empresas, así como las acciones realizadas. La metodología empleada fue un análisis observacional, mediante la recolección, revisión y análisis prospectivo por triangulación de las acciones tomadas sobre variables tales como: tipos de actividad económica, puntos de venta, productos de las empresas, interrelaciones comerciales, sociales y de innovación, entre otros. Se demostró que la aplicación del modelo permitió el incremento de los indicadores mencionados, la generación de nuevos proyectos de investigación-desarrollo-innovación, así como el acceso a fondos y al fortalecimiento de la colaboración entre estudiantes, investigadores y las empresas artesanales. The objective of this paper is to describe the results obtained from the implementation of a socioeconomic model that allows managing innovation in artisanal companies through the articulation of social sectors, the University of Costa Rica, the Faculty of Pharmacy and the Institute of Pharmaceutical Research. The principles of the model, the characterization and classification of the companies, as well as the actions carried will be described. The methodology used was an observational analysis, through the collection, review and prospective analysis by triangulation of the actions taken after variables such as: types of economic activity, number of: points of sale, products of the companies, commercial, social and innovation interrelations, among others. It has been fully demonstrated that the application of the model allowed the increase of the aforementioned indicators, the generation of new research-development-innovation projects, as well as access to funds and to the strengthening of collaboration among students, researchers and artisan businesses. UCR::Vicerrectoría de Docencia::Salud::Facultad de Farmacia

The Bactris gasipaes is a native palm from Central America which its fruit is known as pejibaye, its wood is also used for the manufacture of various utensils, the marrow of its tender stems is edible and it is called palmetto, it is used in the preparation of salads and other dishes. The pejibaye is cultivated in Costa Rica and part of the diet, this due to its high content of starch and mainly by content of antioxidant substances. The objective of the present study is to identify the main phytochemical groups and quantify the main markers in order to associate them with cosmetic or medicinal functions in pharmaceutical products. Materials and Methods: The mature fruits of Bactris gasipaes were peeled and separated the seeds of the mesocarp, were dried, milled and subdivisions were made with low, medium and high polarity solvents, then a phytochemical screening was carried out according to the Guidelines for the Quality Control of Products of Natural Origin of the World Health Organization, additionally the antioxidant properties were evaluated, the concentration of total phenols, total carotenoids content, the content and type of saturated and unsaturated fatty acids and the physicochemical properties of the aqueous extract were determined. The study found a low concentration of phenolic compounds such as condensed and non-condensed tannins and the main phytochemical groups such as: carotenoids, terpenes, fats, carbohydrates and alkaloids and the absence of Anthocyanins. The antioxidant power that was 45.56 ± 1.96 g/mol Trolox Eq/g dry fruit, an EC 50 0.293 mg/Lfor the mesocarp oil, the total phenols found are 0.628 ± 0.12 mg/Gof dry sample (equivalents of Gallic acid), which shows that the main antioxidant components are lipophilic, so they can be useful in formulations such as emollients, anti-aging effect, anti-wrinkle, nourishing and moisturizing for the skin, and as a sunscreen. The mesocarp oil contains unsaturated fats (78.6% ± 1.2 µg/g): oleic, linoleic and Palmitoleic and Palmitic acid, respectively 58.3 ± 1.8, 14.5 ± 1.2, 4.5 ± 0.3 and 20.8 ± 1.4 µg/g. The acidity index is 4.32 ± 0.10 which is beneficial to maintain the cutaneous acid mantle and thus favor the normal flora of the skin, although this property represents a challenge in the formulation of Carbomer-based gels. The aqueous extract is hyperosmotic, 2333 ± 9.54 mOs/kg, and has a high electrical conductivity (1492 ± 5.56 S/cm) due to the presence of polyelectrolytes and a high concentration of reducing sugars according to the obtained brix degrees (13.45 ± 0.01), finally mesocarp oil at 0.1% w/w shows an absorption of ultraviolet radiation of 25% at wavelengths between 260 nm and 400 nm, which could also be useful for formulating compositions for sun protection UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

The absence of a consolidated definition of the term “natural product” is a problem to establish a relationship between this concept and intellectual property. The intellectual property includes many different categories, such as distinctive signs, invention patents, author rights, plant variety rights and other categories not recognize by all entities and countries denominated sui generis, for example, test data, traditional knowledge and the access to genetic and biologic resources. The objective of this study is to analyze with a diagnostic approach the added value that natural products have received through different types of intellectual property. Methods: The present study is a diagnostic and descriptive analysis of the relationships between natural products and the different types of intellectual property. A search using the World Health Organizations databases about intellectual property and the web pages of the world most important offices of intellectual property was used. Finally, a triangulation of the consulted information was carried out. Results and Conclusions: An increase of protected natural products was detected. The intellectual property identified categories were invention patents, plant variety rights, and distinctive signs. It is in consequence to the increase in national laws related to intellectual property that responds to the trades treaties present in some regions, for example, Latin America. However, there are two phenomena related to natural products. In first place, the natural products with some type of protection are concentrated in developed countries and multinational corporations, and in second place, a lot of natural products in Latin America do not have intellectual protection, usually due to the absence of the most beneficial categories of intellectual protection in the trades treaties or because these categories are not recognized by the States or international organizations. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR) UCR::Vicerrectoría de Docencia::Salud::Facultad de Microbiología

Polymorphism analysis of pharmaceutical raw materials is considered one of the most relevant evaluations that should be done. As we know, different crystal forms from the same molecule have differences in terms of their physicochemical properties. According to the crystal form used, researchers can obtain benefits for the development of a new product or it can also imply a disadvantage for the formulation of the product. The present study focuses on the identification of crystalline forms in Rupatadine Fumarate raw material samples. The active pharmaceutical ingredient is an antihistaminic, classified as a second-generation selective H1 receptor, which shows advantages in terms of solubility in contrast with the free base and the trichloride form. Analytical techniques employed were: X ray diffraction, differential scanning calorimetry, thermogravimetric analysis, and infrared spectroscopy. The results were analyzed all together and compared with the information found in literature. Based on the results obtained, it was demonstrated that the analyzed drug samples don´t present any other polymorphic form besides A form, which is the only one reported in literature. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

Liposomal vesicles are used as a strategy to enhance the stability and bioavailability of its bioactive components. Large part of its characteristics can be attributed to the likeness between the liposomal and biological membranes, given both are formed by amphiphilic molecules. Since they have a vesicular shape, liposomes have the particularity to encapsulate bioactive molecules. This way certain physicochemical and pharma-kinetic characteristics can be enhanced and optimized. Curcumin is a polyphenolic compound with a high therapeutic potential. However, its bioavailability, stability and solubility are relatively low. Due to this, alternatives have been explored, such as liposomes to enhance the aforementioned properties. This investigation yielded a characterization of the physicochemical properties of a nutritious product using curcumin as a bioactive component. Brix levels, pH levels, specific gravity, refraction index and conductivity were measured. Additionally, liposomal vesicles were observed through optical microscopy to recognize structure, size (diameter) and membrane width. Physicochemical characterization indicates that the formula is stable. Also, they can be utilized as quality control for the product and represent a starting point to accomplish possible formula enhancements and optimization. The microscopic observation indicates that liposomes are multi-vesicular and multi-layered structures. This fact indicates that liposomal vesicles are more stable which results favorable for successful formulation. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

The study of has increased in the last decades. One of the mechanisms that has acquired great relevance is to formulate using liposomal vesicles. Liposomes are structures that enh and transport of active compounds, which is reflected by an increase in the bioactivity of the encapsulated molecules. The guarana extract has proven to be rich in methylxanthines and phenolic compounds. These metabolites are exert a stimulating effect. For this reason, it has become popular in nutritional products. was characterized physicochemically a nutritional product based on guarana, vitamins In this product the active components were encapsulated in liposomal vesicles, which were analyzed to know their structure, size (diameter) and membrane thickness. liposomes are multivesicular and multilam greater stability of the vesicles, which represents a favorable aspect for the formulation. hand, the data obtained from the physicochemical characterization can be used as part of control performed on the formulation. Additionally, they represent a starting point for improvements and optimization of this nutritional product. Copyright©2017, Madrigal-Redondo et al. This is an open access article distributed under the use, distribution, and reproduction in any medium, provided the original work is properly cited UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR) UCR::Vicerrectoría de Docencia::Salud::Facultad de Farmacia

There are more than 700 species of the genus Rubus, popularly known as Mora (tropical highland blackberry). In Costa Rica, the species Rubus adenotrichus has been characterized by its high content of antioxidant substances, becoming one of the most cultivated species and that may have characteristics to be used in cosmetics or medicine. The objective of the present study is to identify the main phytochemical groups and to quantify the main markers in order to associate them with cosmetic or medicinal functions in pharmaceutical products. Ripe fruits of Rubus adenotrichius were fractionated with solvents of low, medium and high polarity, followed by a phytochemical screening according to the World Health Organization Guidelines for the Control of Quality of Products of Natural Origin. The antioxidant properties were evaluated by means of the H-ORAC and DPPH test; the concentration of total phenols by Folin-Ciocalteau and antocinanins by differential pH was determined. Finally, the physicochemical properties of the aqueous extract, such as pH, specific gravity, Brix grades, conductivity, and osmolarity was determined and an absorption spectrum from 260 to 700 nm was obtained. Phenolic compounds were found as condensed and non-condensed tannins, anthocyanins, flavonoids, terpenes, and alkaloids as major phytochemical groups, a high antioxidant power measured in H-ORAC 311 ± 7.63 μg/mol Trolox Equivalent/g of dry fruit, and EC 50 118.46 mg/L for the aqueous extract. The total phenols found was 20.85 ± 0.27 mg/g of dry sample of gallic acid equivalents which makes the Rubus adenotrichus fruit an excellent component for bacteriostatic, anti-aging, anti-wrinkle, nourishing and moisturizing formulations, and the astringent effect also allows its application to small superficial wounds on the skin. Likewise, the acidic pH of 3.55 ± 0.1 is beneficial for maintaining the cutaneous acid mantle thereby favoring the normal flora of the skin, but may be a problem for the formulation of carbomer-based gels or the incorporation of preservatives. The aqueous extract is hyperosmotic (559.66 ± 3.21 mOs/kg) and has a high electrical conductivity (285 ± 2 μS/cm) due to the presence of electrolytes and a considerable amount of sugars, according to Brix degrees (7.543° ± 0.005°). Finally, the 4% w/w aqueous extract shows an absorption of ultraviolet radiation of 25% in the wavelengths from 260 to 400nm, by which it also could be useful for formulating compositions for sun protection. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

The determination of the spatial configuration of the compounds structures used in the production of drugs is of utmost importance due to the different physical characteristics that each have in their solid state and therefore the different qualities of each one for its use as pharmaceutical raw material. This study aimed to identify the polymorphic crystalline form of Etoricoxib raw material, a non-steroidal anti-inflammatory drug (NSAIDs) selective inhibitor of cyclooxygenase 2 (COX2) enzyme widely used in the present, which was done through four different instrumental analytical techniques: X-ray diffractometry, differential scanning calorimetry, thermogravimetry and infrared spectroscopy, comparing and studying the results obtained from the analysis with those found in the literature. Using the data obtained with these four techniques it was demonstrated that the study sample exists predominantly in the 1 anhydrous Etoricoxib form. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR) UCR::Vicerrectoría de Docencia::Salud::Facultad de Farmacia

Ginger is a medicinal plant native to India. Their potential use in cosmetics, medicines and natural productshas been reported, however depending on crop conditions,the medicinal components of the different parts of the plantmaynot only go through changes in concentration but in composition, what modifies its medicinal potential. The aim of this study was to characterizeby the chemical composition of essential oil obtained from rhizomes of Zingiber officinalegrown in the area of San Carlos, Costa Rica,in order to standardize future hydroponic cultivations of the plant and validate their subsequent pharmacological or cosmetic effects.The rhizomes of the plant were used, the active principles were extracted by ethanolic extraction with Soxleth and distillation by entrainment with vapor, analysis was performed by using a qualitative phytochemical profile for the ethanolic extract, and the composition of the essential oil was studied by gas chromatography coupled to mass spectrometry detector (GC-MS). Thepresence of flavonoids, alkaloids, saponins, tannins and triterpenes in the ethanolic extract was qualitatively determined. In characterizing the essential oil by GC-MS we identified as lead compounds geranialdehyde (27.42%), neral (20.11%), 1.8-cineole (13.35%), camphene (4.65%) and E-geraniol (3.92%). The composition we obtained presenteda clear difference with those reported in other studies, allowing the prediction of an antimicrobial behavior unlike most traditional essential oils of the rhizomes. Universidad Nacional de Costa Rica/[]/UNA/Costa Rica Universidad de Costa Rica/[]/UCR/Costa Rica UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

Determining the spatial configuration of the structures of compounds used in the production of medicines is extremely important due to the different characteristics of each of them in its solid state and therefore its different qualities of each for use as pharmaceutical raw material. This study aimed to identify the phase of the solid state of Atorvastatin hemi-dihydrate, a lipid-lowering medication HMG-CoA reductase widely use in the present and their characterization by four different instrumental analytical techniques: X-ray diffractometry, differential scanning calorimetry, thermogravimetry and infrared spectroscopy, comparing the obtained analytical results with those found in the literature. Using data obtained from these four techniques are able to show that the study sample exists predominantly in the 27 form of amorphic hemi-dihydrate calcic atorvastatin. Universidad de Costa Rica/[]/UCR/Costa Rica UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

La información de patentes es una fuente de información técnica indispensable para el desarrollo científico-tecnológico. Esta información debe ser analizada, filtrada, sintetizada y agrupada para que pueda ser de utilidad en el campo farmacéutico. Los sistemas coloidales (mesofases) son uno de los temas más importantes para el desarrollo de la nanotecnología, de nuevas formas farmacéuticas y tratamientos, así como para lograr el aumento de la biodisponibilidad y estabilidad de productos farmacéuticos, cosméticos, suplementos nutricionales, entre otros, ya que por su tamaño de partícula se caracterizan por tener propiedades fisicoquímicas de la física clásica y de la física cuántica. El presente trabajo tiene como objetivo establecer prioridades para el desarrollo de sistemas coloidales para la industria farmacéutica, cosméticas y otras, a partir de la tendencia existente en ese campo identificado a partir de los estudios de patentabilidad de microemulsiones. Las principales variables utilizadas en el presente estudio son el número de patentes solicitadas y concedidas, principales inventores y solicitantes o titulares, así como las principales aplicaciones. Se utilizó la base de datos PatentScope®. Se realizó la correlación de variables mediante un muestreo aleatorio de la población total de solicitudes de patentes evaluadas Entre los resultados del estudio se determinó que existe una tendencia al aumento del número de patentes solicitadas y concedidas relacionadas con las microemulsiones en el período seleccionado. El estudio permitió la gestión de una estrategia de desarrollo tecnológico de microemulsiones en el campo farmacéutico. Patent information is an indispensable source of scientific and technical information technological development. This information must be analyzed, filtered, summarized and grouped so that it can be useful in the pharmaceutical field. Colloidal systems (mesophases), are one of the most important for the development of nanotechnology, new formulations and treatments as well as to achieve increased bioavailability and stability of pharmaceuticals, cosmetics, nutritional supplements topics including because its particle size is characterized by physicochemical properties of classical physics and quantum physics. This paper aims to set priorities for the development of colloidal systems for the pharmaceutical, cosmetic and other industries, from the trend in this area identified from patentability studies of microemulsions. The main variables used in this study are the number of patents filed and granted, principal inventors and applicants or holders and key applications. Patentscope® data base was used. The correlation of variables was performed using a random sample of the total population of evaluated applications between the findings patents was determined that there is an upward trend in the number of requested and granted microemulsions related patents in the selected period. The study allowed the management of a strategy of technological development in the pharmaceutical field microemulsions. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

Introduction: Since 2009 the University of Costa Rica, through the Faculty of Pharmacy, is dedicated to promote a model of development in cosmetics in small and medium industries in rural or poorest areas of Costa Rica, in which female heads of household are leading the company,. aA successful example of this model is microenterprise Biosphere, located in the province of Alajuela, canton of San Carlos, District Fortune, which produces cosmetics based on hot springs and peloids obtained in the surroundings of the Arenal Volcano, which are characterized and formulated at the Institute of Pharmaceutical Research (INIFAR). Objective: Formulate a cream based on hot springs with renewable natural resources, cosmetic features, and high in content of minerals and high in content of minerals and not physicochemically unstable due to this composition. Methods: the raw materials and formulations were characterized by physicochemical tests such as pH, rheology, density, and organoleptic tests, and a formula were selected due to this characterized attributes. Results and conclusions: an stable formulation at high mineral content, HLB 6.82 , thixotropic adequate bed-wetting characteristics, pH 5.0 -7.0 , and without overheating with the friction, useful as the base was obtained for massage spas were obtain. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

Called pharmaceutical polymorphism to change of the crystal structure of a substance when it is in its solid state, this has generated a controversy over whether or not to enjoy protection for patents for invention, and that it could limit or delay the access of generic drugs to health care centers, or services, this study aims to define the main technical characteristics of pharmaceutical polymorphs and determine its patentability under Costa Rican law, such legislation also compared with the doctrine poured into other countries, mainly the United States of America. Methodology: Written information sources and electronic media since 1850 to February 2014 were revised, data were collected and information was placed in an instrument that selects the main themes. Then it was analyzed by triangulation and conclusions were made by technical and legal criteria. Results: Among the main results the eligibility of patentable matter was determined against the non-patentable, the main technical criteria of pharmaceutical polymorphs for a prior art study were established and the differences between the US and Costa Rican law doctrine on the subject of polymorphism and patents was determined. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR) UCR::Vicerrectoría de Docencia::Salud::Facultad de Farmacia

Costa Rica is a volcanic country, containing a variety of peloids with different physicochemical properties; also its main source of income is the tourism. Most of their abundant natural resources have not been characterized and even used yet, this need offer the opportunity to study the physicochemical characteristics of peloids near the Arenal Volcano which may be related to its therapeutic properties, despite of this is a tourist attraction area characterized by hot springs, hotels and spas, it has a low socioeconomic and industrial development, and industrialization of products would create new jobs, and promote the health and wellness tourism, producing a productive linkage. Objective The physicochemical characterization of the Peloids near the Arenal Volcano Costa Rica and relate them to their therapeutic properties. Methods Peloids were characterized by tests such as pH, rheology, density, DSC, X-ray diffraction and thermal conductivity. Results and conclusions Peloids where characterized primarily as kandites billaminars, with a thixotropic flow, high in Fe2O3 , Al2O3, SIO2, Na2O, TiO2, ZrO2 minerals, an acid 4,70 pH, allowing them for the formulation of masks and other anti-psoriasis and anti-acne pharmaceutical forms. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR) UCR::Vicerrectoría de Docencia::Salud::Facultad de Farmacia

A problem of rural women in Latin America is the poor access to economic resources; a solution we propose is to implement a collaborative model, where are used natural resources in the area for production of value added products such as cosmetics products,to improve their living conditions. Objective: This paper concerns the evaluation of the physicochemical stability of hair cosmetics based on natural resources of the Costa Rican flora. Methodology: cosmetic products were developed based on Carica papaya,Ananascomosus, and others from the area, equally developed stability testing at 25 ° C and 40 ° C for six months following the guidelines of ANVISA, and quality control which were adapted for reproduction on the production site. Results: Formulations designed contain at least 80% of natural excipients, but preservatives exclude parabens derivatives or other similar substances, also were quantified their physicochemical properties such as viscosity, specific gravity and pH, in different storage conditions during the time of the present study.Using ANOVA,was analyzed thedata. Conclusions: the study revealed that the formulations are stable for at least one year under the conditions of no more than 30°C and protected from light packaging, and achieved the respective health registry that allowed the marketing of the product. Universidad de Costa Rica/[]/UCR/Costa Rica UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

Desde el año 2009 la Universidad de Costa Rica por medio de la Facultad de Farmacia se ha dedicado a promover un modelo de desarrollo en la pequeña y mediana industria cosmética, para las zonas rurales o más pobres de Costa Rica, en la que las mujeres jefas de hogar lideran la empresa. Un ejemplo exitoso de este modelo es la microempresa Ditutto S.A, de las montañas de Acosta, la cual produce cosméticos a base de leche de cabra, en coordinación con el Instituto de Investigaciones Farmacéuticas, donde son evaluados y formulados. Este modelo ha hecho que la empresa genere empleo local, aumente su producción y ventas, y exporte a países como Canadá. Se plantea el modelo socioeconómico empleado y los resultados del mismo, entre los años 2009 al 2013, como un ejemplo del vínculo Empresa-Universidad-Sociedad. Universidad de Costa Rica/[]/UCR/Costa Rica UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)

Trabajo final de graduación de 217 páginas en formato pdf La propiedad intelectual ha generado una serie de polémicas en Costa Rica, en los últimos años, esta se define como la protección de bienes intangibles producidos por el intelecto, en especial la protección de la propiedad industrial se debatió con mucha fuerza, por sus implicaciones en afectaciones socioeconómicas, las patentes de invención forman parte de la propiedad industrial. El polimorfismo farmacéutico en materia de patentes de invención, en especial se ha convertido en un punto de discordia entre las distintas doctrinas y legislaciones a nivel mundial ya que involucra criterios muy técnicos y especializados que al mismo tiempo se puede ver afectados por condiciones socioeconómicas de la población en general, en particular a nivel de la salud humana y animal. Es por esta razón, que este estudio pretendió analizar la situación actual del fenómeno del polimorfismo farmacéutico en materia de patentes de invención en Costa Rica mediante un diagnóstico cualitativo de la situación actual, utilizando como principal fuente de información grupos de personas expertas nacionales, de los cuales se compararon sus principales criterios relacionados con el tema obtenidos por medio de una entrevista semiestructurada, con los establecidos en la doctrina y literatura en general sobre este tópico. Se logró mediante la triangulación de la información analizar la situación actual del polimorfismo farmacéutico en materia de patentes de invención, cumpliendo con esto con el objetivo general de la investigación, y las pregunta principal de investigación planteada, se logró determinar mediante los criterios de personas expertas los cuatro conceptos fundamentales que definen la situación actual del fenómeno polimorfismo farmacéutico en materia de patentes de invención en Costa Rica, entre ellos están la definición de polimorfismo farmacéutico, las ventajas y desventajas del fenómeno a nivel socioeconómico, la opinión sobre la patentabilidad de polimorfos farmacéuticos en Costa Rica y la situación actual del fenómeno en Costa Rica, con esto logró cumplir con los objetivos específicos del trabajo y se contestaron las preguntas secundarias de investigación. Al final del trabajo se realizan las principales conclusiones del estudio, junto con una serie de recomendaciones para futuros estudios sobre el tema. Universidad Estatal a Distancia de Costa Rica

El presente trabajo corresponde a un estudio in vitro de equivalencia terapéutica e intercambiabilidad de tres medicamentos multiorigen de tabletas de liberación inmediata de levofloxacino del mercado costarricense. Método: Se siguieron los criterios del informe 7 de la Organización Mundial de la Salud (OMS). Los medicamentos se analizaron mediante un método de espectroscopía ultravioleta desarrollado y validado en nuestro laboratorio. Resultados: Se demostró que los productos analizados de dos laboratorios, designados por A y B, se comportaron con una muy rápida disolución (no menos de un 85 % disuelto del etiquetado en 15 minutos) En cambio, un tercer producto de un laboratorio, denominado C, mostró una rápida disolución (no menos del 85 % disuelto del etiquetado a los 30 minutos). Conclusiones: y por tanto podrían declararse intercambiables con el medicamento de referencia Elequine®, mientras que C no es comparable con el de referencia y por tanto no puede demostrarse su intercambiabilidad in vitro, sino que se requiere un estudio in vivo. Universidad de Costa Rica/[]/UCR/Costa Rica UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)