A New Journal in the Field of Pharmaceutical Technology Is Born

International audience

Development of Vegetable Oil Emulsions with Lamellar Liquid-Crystalline Structures

Emulsions containing vegetable oils and anisotropic phases have especially attractive properties in pharmaceutical technology. They are use as vehicle for different kind of drugs, especially those of topical application. Apart from that, many vegetable oil have pharmacological activity, increasing the necessity for the development of new delivery systems for them. We developed emulsions with vegetable oils at a fixed surfactant ratio and observed the formation of liquid crystalline phases. Nine vegetable oils: Andiroba, Apricot, Avocado, Brazil Nut, Buriti, Cupuassu, Marigold, Passion Fruit and Pequi and mineral oil were tested. Surfactant system was consisted by Steareth-2 and Ceteareth-5. Emulsions were prepared by the emulsion phase inversion (EPI) method, presenting high stability independent on the HLB value. Results indicate that this method could be employed to attain stable emulsions, even if the required HLB value is not known.

A new approach to the granulation of beta-cyclodextrin inclusion complexes

Cyclodextrins (CDs) are annular oligosaccharides containing 6-12 glucose unities joined together by alpha-1,4 bonds. They have a conical-truncated shape with a lipophilic cavity in which different molecules can be included resulting in a stable inclusion complex. The cyclodextrins have been widely applied in pharmaceutical technology with the objective of increasing the solubility, stability and bioavailability of drugs in different pharmaceutical dosage forms, such as tablets. In order to obtain beta-CD tablets, liquid dispersions of drug/beta-CD are usually submitted to different drying processes, like spray-drying, freeze-drying or slow evaporation, being this dry material added to a number of excipients. However, such drying processes can generate particulate materials showing problems of flow and compressibility, needing their conversion into granulates by means of wetting with granulation liquid followed by additional drying. In this work, the main objective was to evaluate the preparation of tablets without the need of this additional drying step. For this purpose an aqueous dispersion containing acetaminophen/beta-CD complex and cornstarch was dried using a spouted bed and the obtained granules were compressed in tablets. Acetaminophen was used as model drug due to its low water solubility and the inexpensive and widely available cornstarch was chosen as excipient. Acetaminophen powder was added into a beta-cyclodextrin solution prepared in distilled water at 70 degrees C. Stirring was kept until this dispersion cooled to room temperature. Then cornstarch was added and the resulting dispersion was dried in spouted bed equipment. This material was compressed into tablets using an Erweka Korsh EKO tablet machine. This innovative approach allowed the tablets preparation process to be carried out with fewer steps and represents a technological reliable strategy to produce beta-cyclodextrin inclusion complexes tablets. (C) 2010 Elsevier By. All rights reserved.

Colloidal systems for the delivery of cyclosporin A to the anterior segment of the eye.

Due to the eye's specific anatomical and physiological conformation, the treatment of eye diseases is a real challenge for pharmaceutical therapy. The presence of efficient protective barriers (i.e., the conjunctival and corneal membranes) and protective mechanisms (i.e., blinking and nasolachrymal drainage) makes this organ particularly impervious to local drug therapy. To overcome these issues, numerous strategies have been envisioned using pharmaceutical technology. Many formulations currently on the market or still under development are emulsions or colloidal systems intended to enhance precorneal residence time and corneal penetration, causing a consequent increase in drug bioavailability after instillation. After a review of some recent developments in the field of cyclosporin A formulations for the eye, a novel micellar formulation of cyclosporine A based on a diblock methoxy-poly(ethylene glycol)-hexysubstituted poly(lactides) (MPEG-hexPLA) is described.

Ocular biocompatibility of novel Cyclosporin A formulations based on methoxy poly(ethylene glycol)-hexylsubstituted poly(lactide) micelle carriers.

Topical ocular drug delivery has always been a challenge for pharmaceutical technology scientists. In the last two decades, many nano-systems have been studied to find ways to overcome the typical problems of topical ocular therapy, such as difficult corneal penetration and poor drug availability. In this study, methoxy poly(ethylene glycol)-hexylsubstituted poly(lactides) (MPEG-hexPLA) micelle formulations, which are promising nanocarriers for poorly water soluble drugs, were investigated for the delivery of Cyclosporin A (CsA) to the eye. As a new possible pharmaceutical excipient, the ocular compatibility of MPEG-hexPLA micelle formulations was evaluated. An in vitro biocompatibility assessment on human corneal epithelial cells was carried out using different tests. Cytotoxicity was studied by using the [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide] (MTT), and clonogenic tests and revealed that the CsA formulations and copolymer solutions were not toxic. After incubation with MPEG-hexPLA micelle formulations, the activation of caspase-dependent and -independent apoptosis as well as autophagy was evaluated using immunohistochemistry by analyzing the localization of four antibodies: (1) anti-caspase 3; (2) anti-apoptotic inducing factor (AIF); (3) anti-IL-Dnase II and (4) anti-microtubule-associated protein 1 light chain 3 (LC3). No apoptosis was induced when the cells were treated with the micelle solutions that were either unloaded or loaded with CsA. The ocular tolerance was assessed in vivo on rabbit eyes by Confocal Laser Scanning Ophthalmoscopy (CLSO), and very good tolerability was seen. The observed corneal surface was comparable to a control surface that was treated with a 0.9% NaCl solution. In conclusion, these results demonstrate that MPEG-hexPLA micelles are promising drug carriers for ocular diseases involving the activation of cytokines, such as dry eye syndrome and autoimmune uveitis, or for the prevention of corneal graft rejection.

Technological, biopharmaceutical and pharmacokinetic advances: new formulations of application on the skin and oral mucosa

Currently a growing interest to improve the pharmacological therapy exists, not only by the production and the appearance of new drugs, but guaranteeing that the uses of those which already exist, become more effective. In fact, the conventional pharmaceutical formulations of different drugs present a few secondary effects due to oral administration. In order to avoid these undesired side effects, the purpose of current therapeutic is the development and research of formulations as an alternative to others routes of administration. Therefore, in spite of the undoubtedly complete parenteral absorption, the transdermal and transbuccal routes appear to be a rather attractive alternative to provide an efficient absorption. In this chapter a new technological, biopharmaceutical and pharmacokinetic approach of strategies for application on skin and buccal mucosa are reported. In the future new transdermal drug delivery systems will emerge to be more effective, equipped with an improved aesthetic appearance, better adherence and greater diffusion. But to reach these aims, it is necessary previous knowledge of histology and physiology of skin, and factors involved in the penetration of drugs through it.

Introducción a la farmacia galénica: un reto en primer año de farmacia

[spa] Este curso académico 2009-2010 se implanta el nuevo plan de estudios de Farmacia en la Universidad de Barcelona, diseñado según los planteamientos del EEES. Como consecuencia, y por primera vez en la historia de la Facultad de Farmacia de la UB, se imparte una asignatura troncal de cariz galénico en el primer año de la carrera. Esto constituye un nuevo reto para el Grupo de Innovación Docente de Tecnología Farmacéutica (GIDTF), dado que la asignatura Introducción a la Farmacia Galénica se ha de impartir a grandes grupos de estudiantes, al inicio de su carrera, mediante sesiones teóricas de 1,5 h. Excepcionalmente en este curso académico, la asignatura se imparte en el primer semestre y se repite en el segundo. En este trabajo se presenta el planteamiento metodológico presencial diseñado para esta asignatura, apoyado en estrategias no presenciales como foro de debate, recursos on-line, cuestionarios y tareas de autoevaluación a través de la plataforma Moodle del Campus Virtual de la UB, puesto que el equipo docente considera prioritario iniciar al estudiante en el uso de la misma en el primer año de carrera. Se han efectuado encuestas de satisfacción a los estudiantes que se han evaluado, así también como los resultados académicos obtenidos. En el análisis de los puntos fuertes y débiles de la metodología empleada, se han detectado evaluaciones positivas y también aspectos que podrían mejorarse, estableciendo las medidas correctoras adecuadas. En cuanto a los resultados académicos, han sido muy satisfactorios. [eng] This academic year 2009-2010, the new curriculum of Pharmacy according to the premises of the EHEA is started at the University of Barcelona. As a result, for the first time in the history of the Faculty of Pharmacy of UB, an obligatory galenic subject will be given during the first year of the career. This is a new challenge for Teaching Innovation Group of Pharmaceutical Technology (GIDTF), as the subject Introduction to Galenic Pharmacy is given by a team of teachers to large groups of students who began its career, through theoretical sessions of 1.5 h. The subject will be taught exceptionally this academic year in the first semester and repeated in the second. In this paper we present the methodological approach designed to face this subject, supported by virtual strategies as discussion forum, online resources, self-assessment test and work through the platform Moodle of the Virtual Campus UB, as the team considers it a priority to initiate the student in using it in the first year of pharmacy study. Were carried out satisfaction surveys to students and we have evaluated them, as well as academic performance. Through the analysis of the methodology, we detected positive evaluations and areas for improvement that have been used to establish appropriate corrective measures. Academic results have been very satisfactory.

The use of the SeDeM diagram expert system for the formulation of Captopril SR matrix tablets by direct compression

The SeDeM Diagram Expert System has been used to study excipients, Captopril and designed formulations for their galenic characterization and to ascertain the critical points of the formula affecting product quality to obtain suitable formulations of Captopril Direct Compression SR Matrix Tablets. The application of the Sedem Diagram Expert System enables selecting excipients with in order to optimize the formula in the preformulation and formulation studies. The methodology is based on the implementation of ICH Q8, establishing the design space of the formula with the use of experiment design, using the parameters of the SeDeM Diagram Expert System as system responses.

Valoración experiencial del aprendizaje tras formación virtual.

[eng] An observable study on the behaviour in the laboratory of Pharmaceutical Technology II (pharmaceutical pilot plant), with two groups of students of 3rd course (proactive aptitude and valuation of the"knowledge to do acquired") is carried out. The variable between groups is that one has realised a training (by means of self-study of an interactive application multimedia, especially designed), without tutorship on behalf the teacher in front of the other group that carried out the same training with the same material but with the guide of the teacher in the computer lab. On the one hand it is valued if there is some effect differentiator between both types of training, by means of the accounting of the correct results obtained in a previous test to the entrance in the pilot plant and by another one the valuation that the professors made responsible for the groups of practices in situ. The results demonstrate the previous hypothesis that there must not be significant differences between the groups, beyond the inherent ones to personality of the students itself (interest and personal implication by the subject). On the other hand the test for the observation in the laboratory did not facilitate the distinction of objective differences. [spa] Se lleva a cabo un estudio observacional sobre el comportamiento de los estudiantes (aptitud pro-activa y valoración del “saber hacer adquirido”) en el laboratorio de Tecnología Farmacéutica II (planta piloto farmacéutica) de dos grupos de estudiantes de 3er curso. La variable entre los dos grupos es que uno ha realizado una formación no presencial (mediante el autoestudio de una aplicación interactiva multimedia, especialmente diseñada), sin tutoría por parte del profesor, frente al otro grupo que llevó a cabo la misma formación con el mismo material pero con la guía del profesor en el aula de informática. Por una parte se valora si hay algún efecto diferenciador entre ambos tipos de formación, mediante la contabilización de los resultados correctos obtenidos en un test previo a la entrada en la planta piloto y por otro la valoración que hicieron los profesores responsables de los grupos de prácticas in situ. Los resultados demuestran la hipótesis previa de que no debían existir diferencias significativas entre los grupos, más allá de las inherentes a la propia personalidad de los estudiantes (interés e implicación personal por el tema). Por otra parte el test para la observación en el laboratorio no facilitó la distinción de diferencias objetivas.

Innovar, renovar, avaluar

[eng] The new educational context in which we are involved and the facilities of the TIC (Communication Information Technologies) have led to the necessary modification of didactic approach that during years has been used for Pharmaceutical Technology teaching. However, changes/updating and innovation require a simultaneous reflection in order to avoid excessive dispersion of the approach and to channel adequately the pedagogic and didactic effort. On the other hand, it is necessary to evaluate the above initiatives to determinate if these one are on the right track. The Pharmaceutical Technology Teaching Innovation Group of the University of Barcelona has been formed and consolidated in this point of view. In this work, a review of studies carried on by the group, in the exposed purposes, from the beginning of their activities is presented. [spa] El nuevo contexto docente en el que estamos inmersos así como las posibilidades de las TIC (Tecnologías de la Información y de la Comunicación) han conllevado la necesaria modificación de los planteamientos didácticos que durante años han servido de base para las enseñanzas de la Tecnología Farmacéutica. Sin embargo, la renovación/actualización e innovación precisan de una simultánea reflexión a fin de evitar una excesiva dispersión del enfoque y para encauzar adecuadamente el esfuerzo pedagógico y didáctico. Por otra parte, es necesario evaluar dichas iniciativas para determinar si están bien encaminadas. El Grupo de Innovación Docente de Tecnología Farmacéutica de la Universidad de Barcelona se ha creado y consolidado desde esta óptica. En este trabajo se presentan un conjunto de estudios que el grupo ha llevado a cabo, con los fines expuestos, desde el comienzo de sus actividades.

Autoevaluación intercativa y lúdica de Tecnología Farmacéutica

[eng] The individual work of the student, in the European space for higher education, takes a particular relevance. At the same time, in this context, a complex challenge is presented to the professors, in the educational and formative work aimed at the students as well as in the organization of educational plans. Among the different activities that the system of ECTS comprises, we can highlight the preparation and accomplishment of examinations. This fact means to integrate into the learning process the individual and autonomous work that the students have to carry out to acquire the knowledge and to surpass the evaluation test. To achieve this objective, a database including multiple choice questions with three possible answers has been developed (similar to those composing part of the Pharmaceutical Technology test). This database has a design that facilitates its use by professors and students interested in this area and allows as the interactive evaluation of obligatory and optional subjects from the formal point of view, as a corporate recreational environment to make their employment more attractive for the students. The edition of the Web page of the Pharmaceutical Technology Teaching Innovation Group of the UB has been used to place this database within everybody"s reach. [spa] El trabajo individual del alumno adquiere, dentro del marco europeo de educación superior, una particular relevancia. Al mismo tiempo, en este contexto, a los profesores se nos presenta un reto complejo, tanto en nuestra labor docente y formativa del alumno, como en la organización de los planes docentes. De las distintas actividades que engloba el crédito europeo podemos destacar la preparación y realización de exámenes, hecho que supone integrar en el proceso de aprendizaje el trabajo individual y autónomo que realiza el estudiante para adquirir los conocimientos y superar las pruebas de evaluación. Para conseguir este objetivo se ha planteado la elaboración de una base de preguntas con tres respuestas posibles (del tipo de las que componen parte de los exámenes de Tecnología Farmacéutica), en forma de base de datos con un formato que facilite su utilización por parte de profesores y alumnos interesados en este ámbito y que permita tanto la evaluación interactiva de las asignaturas troncales y optativas desde el punto de vista formal, como su aplicación en un entorno lúdico corporativo para hacer más atrayente su empleo por los estudiantes. Se ha aprovechado la edición de la página Web del Grupo de Innovación Docente de Tecnología Farmacéutica de la UB para ponerlo al alcance de todos.

Reflexiones en torno a la "infantilización" del alumno universitario: el canal Youtube Officinalis.com

No son pocos los profesores que piensan que con la llegada de los planes de estudios adaptados a Bolonia ha bajado la exigencia personal frente a la propia responsabilidad de los estudiantes ante su aprendizaje. El uso, más o menos extendido, de materiales didácticos fácilmente 'digeribles'...

Reflexiones en torno a la "infantilización" del alumno universitario: el canal Youtube Officinalis.com

No son pocos los profesores que piensan que con la llegada de los planes de estudios adaptados a Bolonia ha bajado la exigencia personal frente a la propia responsabilidad de los estudiantes ante su aprendizaje. El uso, más o menos extendido, de materiales didácticos fácilmente 'digeribles'...

Valoración experiencial del aprendizaje tras formación virtual.

[eng] An observable study on the behaviour in the laboratory of Pharmaceutical Technology II (pharmaceutical pilot plant), with two groups of students of 3rd course (proactive aptitude and valuation of the"knowledge to do acquired") is carried out. The variable between groups is that one has realised a training (by means of self-study of an interactive application multimedia, especially designed), without tutorship on behalf the teacher in front of the other group that carried out the same training with the same material but with the guide of the teacher in the computer lab. On the one hand it is valued if there is some effect differentiator between both types of training, by means of the accounting of the correct results obtained in a previous test to the entrance in the pilot plant and by another one the valuation that the professors made responsible for the groups of practices in situ. The results demonstrate the previous hypothesis that there must not be significant differences between the groups, beyond the inherent ones to personality of the students itself (interest and personal implication by the subject). On the other hand the test for the observation in the laboratory did not facilitate the distinction of objective differences. [spa] Se lleva a cabo un estudio observacional sobre el comportamiento de los estudiantes (aptitud pro-activa y valoración del “saber hacer adquirido”) en el laboratorio de Tecnología Farmacéutica II (planta piloto farmacéutica) de dos grupos de estudiantes de 3er curso. La variable entre los dos grupos es que uno ha realizado una formación no presencial (mediante el autoestudio de una aplicación interactiva multimedia, especialmente diseñada), sin tutoría por parte del profesor, frente al otro grupo que llevó a cabo la misma formación con el mismo material pero con la guía del profesor en el aula de informática. Por una parte se valora si hay algún efecto diferenciador entre ambos tipos de formación, mediante la contabilización de los resultados correctos obtenidos en un test previo a la entrada en la planta piloto y por otro la valoración que hicieron los profesores responsables de los grupos de prácticas in situ. Los resultados demuestran la hipótesis previa de que no debían existir diferencias significativas entre los grupos, más allá de las inherentes a la propia personalidad de los estudiantes (interés e implicación personal por el tema). Por otra parte el test para la observación en el laboratorio no facilitó la distinción de diferencias objetivas.