APh, vol. 52(3)

Utilización terapéutica de los anticuerpos monoclonales

2021-06-15T16:44:10Z

Utilización terapéutica de los anticuerpos monoclonales García-Ramos, Silvia E.; García-Poza, Patricia; Ramos-Díaz, Francisco La utilización de terapias basadas en anticuerpos monoclonales ha supuesto un gran avance en la práctica clínica. Tienen un ámbito de utilización muy diverso, incluyendo aplicaciones diagnósticas y terapéuticas principalmente. En cuanto a su uso como tratamiento, las áreas más beneficiadas con su descubrimiento han sido la oncología y las enfermedades del sistema inmune. Se trata de un área en continuo crecimiento, tanto por la aparición de nuevos fármacos, como por la ampliación de indicaciones de los ya existentes. Esta revisión resume las características farmacológicas más importantes de los anticuerpos monoclonales comercializados en nuestro país. Se centra principalmente en la utilidad terapeútica, dosificación, eventos adversos de gran relevancia clínica y consideraciones importantes para su correcta administración. También se realiza un breve apunte de las indicaciones de los anticuerpos monoclonales autorizados por la agencia europea del medicamento (EMEA) y que se encuentran en distintas fases del proceso de comercialización.; The utilization of therapies based on monoclonal antibodies has supposed a great advance in the clinical practice. They have a diverse field of use, including diagnostic and therapeutic applications. As treatment, the most benefited has been the oncology and immune system diseases. This is an area in continuous growth, so much for the appearance of new medicaments, since for the extension of indications of the already existing ones. This review summarizes the most important pharmacological characteristics of the monoclonal antibodies commercialized in our country. It centres principally on the authorized indications, dosing, adverse events of great clinical relevancy and important considerations for his correct administration. Also there is realized a brief note of the indications of the monoclonal antibodies authorized by the European agency of the medicine (EMEA) and that are in different phases of the process of commercialization.

Categorización de las farmacias españolas según la teoría de difusión de las innovaciones de Rogers en relacion a la práctica del seguimiento farmacoterapéutico

2022-07-08T08:30:54Z

Categorización de las farmacias españolas según la teoría de difusión de las innovaciones de Rogers en relacion a la práctica del seguimiento farmacoterapéutico Casado de Amezúa, María José; Martínez Martínez, Fernando; Feletto, E.; Cardero, Manuel; Gastelurrutia, Miguel Ángel Introduccion: El presente estudio pretende categorizar las farmacias españolas en función de su situación en el proceso de decisión-innovación de Rogers en relación a la provisión del Seguimiento Farmacoterapéutico (SFT). Metodo: Se empleó un cuestionario, no validado, previamente utilizado con el mismo objetivo, mediante la técnica de CATI. Las variables dependientes fueron las cinco fases del proceso de implantación/adopción de Rogers [Conocimiento (F-C); Persuasión (F-P); Decisión (F-D); Implantación (F-I); Mantenimiento (F-M)], a las que se sumó la fase previa al conocimiento (No conocen). Las farmacias en F-M se sub-categorizaron en función del número de pacientes en Seguimiento, siempre que éste fuera superior a 1: (F-M1) de 2 a 5 pacientes; (F-M2) 6 a 10 pacientes; (F-M3) 11 a 25 pacientes; (F-M4) 26 a 50; (F-M5) 51 a 100 y (F-M6) 101 ó más pacientes. Las farmacias con un único paciente se incluyeron en F-I. Resultados: Se obtuvieron 1.135 respuestas (tasa de respuesta = 54%). Su distribución según el proceso de decisión/innovación de Rogers es la siguiente: No conocen (353; 31,1%); F-C (351; 30,9%); F-P (145; 12,8%); F-D (129; 11,4%); F-I (100; 8,8%); F-M (57; 5,0%). Las subcategorías en la F-M son: F-M1(15; 26,3%); F-M2 (12; 21,1%); F-M3 (10; 17,5%) F-M4 (10; 17,5%); F-M5 (4; 7,0%). Hay grandes diferencias entre las distintas CCAA siendo Aragón la que tiene mayor porcentaje de farmacias en F-I y F-M mientras que Cantabria es la que mayor desconocimiento refleja (50,0%) con un 0% en las F-I y F-M. También se observa un 0% en F-M en La Rioja, Canarias y Asturias. La existencia de una ZAP se muestra como un facilitador para la realización del servicio y la presencia de un responsable del SFT parece que es importante para conseguir su mantenimiento una vez implantado el mismo. Conclusiones: A pesar de los esfuerzos realizados por diferentes organizaciones e instituciones para impulsar la implantación y sostenibilidad del SFT, de acuerdo con los datos obtenidos es posible afirmar que este servicio se encuentra muy poco implantado en España. El hecho de que en la farmacia exista una zona de atención personalizada (ZAP) se muestra como un elemento que facilita la implantación del SFT. Por otra parte, la existencia de un farmacéutico responsable del servicio aparece como un elemento que permite la sostenibilidad del mismo una vez implantado. Es necesario modificar los objetivos de la formación postgrado de los farmacéuticos. Esta debe estar menos orientada a aumentar el conocimiento y más orientada a mejorar las habilidades y competencias, es decir, debe estar encaminada al cambio de comportamiento.; Introduction: The aim of the study is to categorize Spanish Community Pharmacies in relation to their position in the innovation-decision process by Rogers, in relation to the provision of Medication Review with follow up. Methods: A non validated questionnaire, previously used with the same objective, was used through a CATI methodology. The dependent variables were the five different innovation/decision phases defined by Rogers [Knowledge (F-C); Persuasion (F-P); Decision (F-D); Implementation (F-I); Maintenance (F-M). Another further phase was added including pharmacists in a phase previous to knowledge (No knowledge). Pharmacies in F-M were sub categorized in relation to the number of patients receiving the service: (F-M1) from 2 to 5 patients; (F-M2) 6 to 10 patients; (F-M3) 11 to 25 patients; (F-M4) 26 to 50 patients); (F-M5) 51 to 100 and (F-M6) 101 or more patients. Pharmacies with only one patient were included in F-I. Results: 1135 answers were received (response rate = 54%). Their distribution, according to the innovation/decision process by Rogers, was as follows: No knowledge (353; 31.1%); F-C (351; 30.9%); F-P (145; 12.8%); F-D (129; 11.4%); F-I (100; 8.8%); F-M (57; 5.0%). The F-M sub categories were: F-M1 (15; 26.3%); F-M2 (12; 21.1%); F-M3 (10; 17.5%) F-M4 (10; 17.5%); F-M5 (4; 7.0%). There are huge differences among Autonomous Communities, being Aragon the one with more pharmacies located in F-I and F-M, while Cantabria shows the most high level of no-knowledge (50.0%) having a 0.0% in F-I and F-M. A 0% in F-M is also shown in La Rioja, Canarias and Asturias. The existence of a private consultation room (ZAP) is shown as a facilitator for the provision of the service, and the existence of a responsible for the service seems to be very important to the sustainability of the service after it implementation. Conclusions: However the great efforts already done by different organizations and institutions to promote the implementation and sustainability of Medication Review with follow up, according to the data obtained in this study is possible to affirm that so far this service is poorly implemented in Spain. The existence of a private consultation room (ZAP) is shown as a facilitator for the implementation of Medication Review with follow up. On the other hand the existence of a pharmacist being the responsible for the service is shown as a support to the sustainability of the service, once this has been implemented. It seems necessary to change post degree educational programs. These shouldn’t be directed only to improve knowledge, but to develop skills and competencies, what means that these programs should try to change behaviours.

Rapidly disintegrating tablets of metoclopramide hydrochloride using novel chemically modified cellulose

2021-06-15T16:44:15Z

Rapidly disintegrating tablets of metoclopramide hydrochloride using novel chemically modified cellulose Aloorkar, N.H.; Bhatia, M.S. The purpose of the study was to modify cellulose using hydrochloride salt of 2-aminoethanoyl chloride with optimum hydrophilic and hydrophobic properties to impart it a superdisintegrant activity and also to formulate and evaluate rapidly disintegrating tablets of metoclopramide hydrochloride using this novel chemically modified cellulose. A novel polymer, chemically modified cellulose was synthesized by chemically modifying microcrystalline cellulose with hydrochloride salt of 2-aminoethanoyl chloride. The formation of novel polymer was confirmed by Fourier Transform Infrared (FTIR) and Nuclear Magnetic Resonance (NMR) spectroscopy and by differential scanning calorimetric (DSC) and elemental analysis. The toxicity study proved the novel modified cellulose to be non toxic. Rapidly disintegrating tablets of metoclopramide hydrochloride were prepared using novel modified cellulose and compared for the release of drug with control formulation, prepared using non modified microcrystalline cellulose. The tests like wetting time, water absorption ratio and in vitro disintegration time were carried out to elucidate the relationship between them. The study revealed that novel modified cellulose in a concentration of 2% released the drug faster than at a concentration higher than that. Hence it could be concluded that microcrystalline cellulose, a polymer which is devoid of superdisintegrant activity, can suitably be modified by controlled chemical modification of it with hydrochloride salt of 2-aminoethanoyl chloride or similar groups with optimum hydrophilicity and hydrophobicity to convert it into a superdisintegrant material. It can also be concluded that rapidly disintegrating tablets of metoclopramide hydrochloride can suitably be developed for the efficient management of emesis

Hydrophilic polymers as release modifiers for primaquine phosphate: effect of polymeric dispersion

2021-06-15T16:44:14Z

Hydrophilic polymers as release modifiers for primaquine phosphate: effect of polymeric dispersion Sant, S.; Swati, S.; Awadhesh, K.; Sajid, M.A.; Pattnaik, G.D.; Tahir, M.A:; Farheen, S. Primaquine (PQ), a synthetic compound with potent antimalarial activity is characterized by low plasma half life, requiring frequent administration leading to several undesired side effects, patient incompliance. The objective of the present study was to design an extended release formulation incorporating PQ in hydrophillic matrix composed of HPMC,Sodium CMC, Sodium alginate. Effects of polymeric dispersions of ethyl cellulose (EC) and polyvinylpyrrolidone (PVP) was also studied. Tablets were prepared by wet granulation method. The results of angle of repose (<30) and compressiblity index (upto 15%) indicate good flow properties. Tablets were subjected to weight variation, hardness, friability and drug content tests. The swelling and drug release profile were investigated under dissolution condition. The result showed that the swelling index & release retarding capacity follows HPMC>Sodium CMC>Sodium alginate, which was further sustained by polymeric dispersions of EC and PVP. The kinetics of drugs showed extended release of up to 20 hrs (F3) following non fickian diffusion (0.45

Simultaneous RP-HPLC method for the stress degradation studies of atorvastatin calcium and ezetimibe in multicomponent dosage form

2021-06-15T16:44:10Z

Simultaneous RP-HPLC method for the stress degradation studies of atorvastatin calcium and ezetimibe in multicomponent dosage form Rajasekaran, A.; Sasikumar, R.; Dharuman, J. A stability-indicating reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous estimation of atorvastatin calcium and ezetimibe for their multicomponent dosage form. The proposed RP-HPLC method utilizes a 125 mm x 4.6 mm i.d 5 μm Phenomenex C-18 column at ambient temperature; the optimum mobile phase consists of acetonitrile and 0.4% v/v triethylamine (pH adjusted to 5.5 with ortho-phosphoric acid) in the ratio of 55:45, v/v respectively, flow rate of 1.0 ml/min. Measurements were made at a wavelength of 231 nm. Multicomponent dosage form was exposed to thermal, photolytic, hydrolytic and oxidative stress. No co eluting, interfering peaks from excipients, impurities were observed for the degradation products and hence the method was found to be specific. The method was linear in the range of 5-25 μg/ml for atorvastatin calcium and ezetimibe. The mean recoveries were 98.82% and 98.72% for atorvastatin calcium and ezetimibe respectively. The method was validated for linearity, range, precision, accuracy, specificity, selectivity, intermediate precision, ruggedness, robustness, solution stability and suitability.; Se desarrolló y validó un método estable de cromatografía líquida de alta eficacia de fase reversa (RP-HPLC) para la estimación simultánea de atorvastatina de calcio y ezetimiba en su forma de dosificación multicomponente. El método RP-HPLC propuesto utiliza, a temperatura ambiente, una columna C-18 Phenomenex de 125 mm x 4,6 mm y d.i de 5 μm; la fase móvil óptima consta de acetonitrilo y 0,4% v/v de trietilamina (pH ajustado a 5,5 con ácido ortofosfórico) en una proporción de 55:45, v/v, respectivamente, y una velocidad de flujo de 1,0 ml/min. Las medidas se realizaron a una longitud de onda de 231 nm. La forma de dosificación multicomponente se expuso a estrés oxidativo, hidrolítico, fotolítico y térmico. No se observaron, en la degradación de productos, ni impurezas ni picos de coelución o interferencia por excipientes, y, además, el método resultó ser específico. El método fue linear, en el rango de 5-25 μg/ml para atorvastatina de calcio y ezetimiba. Las recuperaciones medias fueron del 98,82% y 98,72% para atorvastatina de calcio y ezetimiba, respectivamente. El método se validó para linealidad, rango, precisión, exactitud, especificidad, selectividad, precisión intermedia, dureza, robustez, estabilidad de la disolución e idoneidad.