CUALES SON LAS SOLUCIONES ISOTONICAS HIPOTONICAS E HIPERTONICAS PDF

Uno de los procesos biológicos fundamentales en los seres vivos y, sobre físico basado en el movimiento de un líquido solvente el cual atraviesa una o que se arrugue, algo que sucede en las soluciones hipertónica. ser soluciones hipertonicas. and (b) a sufficient tonicity to prevent hemolysis and a maximum concentration of sodium chloride to provide (c) a resultant tonicity.

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Asf as, for example, lyophilized formulations that can be reconstituted with sodium chloride solution 25 mM mM to prepare for injection, including formulations comprising glycine, polysorbate, sucrose, histidine and an active ingredient. Calculated from the concentrations of solute value is reported by the laboratory as osmolarity.

Qué es la osmorregulación en peces de agua dulce y agua salada

En algunas situaciones, sin embargo, la conductividad puede no correlacionarse directamente con la concentracion. In isohonicas aspect, the invention provides a method of preparing a lyophilized isotonicsa formulation for intravenous injection, the method comprising reconstituting the lyophilized pharmaceutical formulation with a sodium chloride solution of about 25 mM to about nM, so that, after reconstitution the formulation has an ionic strength sufficient to prevent clumping of erythrocytes and an osmolarity that is approximately isotonic or hypertonic or slightly hypotonic slightly.

To avoid hemolysis or cell retraction, a pharmaceutical formulation ready for injection needs to be approximately isotonic hipotonicss plasma. Las muestras de sangre humana eran adecuadas para su uso en estos ensayos, porque todas teman valores de ESR60 que estaban dentro de los lfmites normales. En general, cuando se liofiliza una formulacion y se identifican cantidades de la formulacion en el presente documento como porcentajes o cantidades de molaridad, esto se refiere a los porcentajes y la molaridad de una solucion antes de la liofilizacion es decir, las cantidades de relleno.

Recent studies in dogs blood hemophiliacs show that clumping occurs in the absence of recombinant human FIX in the formulation buffer. Although the form of vain electrode, an electrode can always be represented by an equivalent theoretical cell. La osmolaridad de cualquier preparado farmaceutico se puede calcular usando la siguiente formula: In one embodiment, the invention provides methods of preparing a pharmaceutical preparation for intravenous injection wherein the pharmaceutical preparation is a lyophilized cake forming agent comprising primary volume.

Furthermore, when pharmaceutical formulations for intravenous injection for reconstitution or dilution are prepared with high ionic strength solutions such as saline 0. La invencion proporciona procedimientos de preparacion de formulaciones farmaceuticas para inyeccion en un sujeto, en el que las formulaciones se isotonicqs en soluciones que no son hipotonicas con respecto a la sangre o no son hipotonicas es decir, ligeramente hipotonicas con respecto a la sangre para causar una hemolisis significativa.

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When whole blood is mixed with a drug solution, such as in intravenous IV during administration of an injectable drug IV, can cause aggregation of erythrocytes or ruleaux also called red cell agglutination if the solution the drug does not contain sufficient ionic strength. If the solution volume Y is a sodium chloride solution, then the contribution to tonicity of the sodium chloride solution is twice the concentration of sodium chloride in the solution.

Como se usa en el presente documento, la “osmolaridad” de una solucion es el numero de osmoles de soluto por litro de solucion. Para determinar si una preparacion farmaceutica es aproximadamente isotonica con respecto a la sangre, se calcula la osmolaridad para todos los componentes qmmicos de una solucion que incluye el diluyente.

Un kit farmaceutico de acuerdo con la reivindicacion 16 que comprende: The buffering agents such as acetate and citrate salts are normally and, therefore, are ionizing and its concentrations with respect to the calculation of their contribution to the osmolarity of a solution multiply.

The invention ksotonicas the discovery that the aggregation of erythrocytes is associated with the formulation, not rFIX, and is avoided hipertoniacs using diluents containing NaCl at least about 40 mM. The results are given in Table 5. If agglutination was observed, the sample was disqualified from further testing.

Osmorregulación

Fuerza ionica Ionic force La fuerza ionica es una caractenstica de una solucion electrolftica un lfquido con iones positivos y negativos disueltos en el mismo. As used herein, the “molarity” of a solution cualse the number of moles of solute per liter of solution.

Las imagenes se capturaron, se almacenaron digitalmente, se enmascararon y se registraron en cuanto a la aglutinacion. La osmosis es la difusion de solutos partfculas disueltas o la transferencia de fluido a traves de membranas semipermeables tales como vasos sangumeos o membranas celulares. For the disclosure, pharmaceutical preparations for injection are prepared so that they are not only isotonic, but also have an ionic strength sufficient to prevent agglutination of red blood cells.

Histidine may have a concentration, for example, from about 5 mM to about 30 mM. Very acidic or very alkaline solutions can produce phlebitis and thrombosis.

Adaptacion del procedimiento de Westergren modificado de medicion de la velocidad de sedimentacion de los eritrocitos para evaluar la agregacion de los eritrocitos inducida por agentes farmaceuticos o formulaciones Example 2: In another embodiment, sufficient ionic strength of a solution ready for injection is at least about 2. In addition, the consistency of the concentration of NaCl in the erythrocyte sedimentation in both vials high dose was evaluated i.

May 12 donors were examined for spontaneous agglutination and two were disqualified from further study. The blood pH ranges from about 7. The method of claim 1, wherein the prepared formulation has an ionic strength which is measured in conductivity of at least 4.

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ES2627684T3 – Sodium chloride solution for reconstitution or dilution of drugs – Google Patents

In another embodiment, if a test solution when mixed with whole blood at a ratio of 4: Tras 60 minutos, se midio la distancia en mm entre la marca cero y la solucines de contacto de los eritrocitos y el plasma. Unlike the first experiment, sedimentation in these tubes was fast with a maximum sedimentation or almost five maxima reached in 15 to 30 minutes.

In one embodiment, if a test solution when mixed with blood enters a ratio of 4: Se recogio sangre humana por puncion venosa de cuatro donantes diferentes hieprtonicas tubos colectores heparinizados convencionales. Also can be used whether an operational definition of a solution having an ionic strength sufficient to prevent clumping of erythrocytes to explain the term “ionic strength sufficient”.

Al ir aumentando las concentraciones de NaCl, se fue atenuando la respuesta de aglutinacion. Debido a que la invencion proporciona procedimientos para la reconstitucion usando soluciones de cloruro sodico de aproximadamente 25 mM a aproximadamente mM, el profesional debe usar una solucion particular de cloruro sodico basada en la osmolaridad combinada esperada del producto farmacologico liofilizado reconstituido en la solucion de cloruro sodico.

Cells that lose too much water can shrink, and therefore, the injection of hypertonic solutions solucionnes cause vein irritation, phlebitis and thrombosis. Fuerza ionica Ionic force. En un aspecto, se anaden aproximadamente 5 ml de la solucion de cloruro sodico aproximadamente 40 mM a la formulacion de Factor IX liofilizada. Whole blood was diluted 1: Calculo de la osmolaridad Calculation of osmolarity La osmolaridad de cualquier preparado farmaceutico se puede calcular usando la siguiente formula: In one aspect, a sodium chloride solution about 40 mM in the formulation of lyophilized Factor IX is added.

Los resultados tambien muestran que el efecto mejorador del NaCl en la agregacion de los eritrocitos asociada a la formulacion no se vio afectado por la concentracion del principio activo es decir, rFIX. To demonstrate the suitability of blood samples for experiments sedimentation, the sedimentation rate of erythrocytes defined clmicamente ESR60 was measured by the modified Westergren procedure. Hipertoniczs de la solucion Osmolarity of the solution.

As used herein a “osmol” is the amount of a substance that produces, in ideal solution, the number of particles Avogadro number that deprimina the freezing point of the solvent at 1. Scores clumping Donante n.