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Bases para supositorios y sus requisitos

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Bases para supositorios y sus requisitos

From the physicochemical point of view suppositories are considered as disperse systems consisting of disperse medium, represented by the base of the disperse phase, in the role of which act as medecine substances. Depending on the properties of medecine substances dispersed systems of suppositories can be both homogeneous and heterogeneous. Homogeneous systems are formed in those cases where the medecine substance is dissolved in the base. Heterogeneous systems are formed in the case of introduction of medecine into the base of the type of emulsion or suspension. In the structure of suppositories distinguish the main (medecine substances) and auxiliary (carriers or base) components. To suppository bases are a number of requirements: bases should retain sufficient hardness at room temperature, the melting (dissolution) temperature of the base should be close to the human body temperature, bases should not irritate the rectal mucosa or cause undesirable phenomena, ie should be physiologically indifferent, suppository bases should not interfere with the release and therapeutic effect of the medecine substance, bases should not interact with the medecine substances introduced into the suppository.

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  • Información actualizada : 07 / 11 / 2024
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  • Fabricante : 1 año para Bases para supositorios y sus requisitos

Modelo: Requirements for suppository bases

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Abroad, polyethylene glycol bases are known as «Carbovax» (USA), «Scourol» (France), «Postonal», «Suppopharm» (Germany and Scandinavian countries). This group of bases is able to dissolve in the secretions of mucous membranes, fully release medecine substances without irritating the mucosa. These bases have a long shelf life, high physiologic indifference and relatively affordable cost. Gelatin-glycerin and soap-glycerin bases are much less frequently used in the manufacture of suppositories, although they are included in the pharmacopoeias of a number of countries around the world. The following requirements are imposed on hydrophilic suppository bases: to dissolve quickly and completely in the secretions of mucous membranes; not to irritate the mucosa; to mix with hydrophobic medecine substances or absorb them; to be chemically and pharmacologically indifferent.
For suppositories made on hydrophilic bases, determine the dissolution time. To do this, one suppository is placed at the bottom of a vessel with a capacity of 100 ml, containing 50 ml of water with a temperature of (37±1) °C. Every 5 min the vessel is shaken so that the liquid and the sample acquire rotational motion. The suppository should dissolve within 1h. To ensure optimal structural and mechanical characteristics of suppository bases to them add stearates of aluminum, magnesium and other salts of fatty acids, as well as emulsifiers T-1, T-2 and №1, bentonite, glucose, starch, aerosil and other auxiliary substances approved for medical use.

Glosario Farmacéutico

Analizador de Fusión  — Un tipo de equipo de laboratorio para determinar el punto de fusión de medicamentos, impurezas y colorantes utilizados en la producción de medicamentos farmacéuticos. La temperatura del punto de fusión de una sustancia se controla cuando se convierte a un estado líquido a partir de un estado sólido. Tales pruebas son una forma convincente de detectar impurezas en una sustancia.
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Especificaciones técnicas

Closely related to these general requirements and technological requirements for bases, which should: show chemical and physical stability in the process of manufacture and storage of suppositories, easily molded and retain the necessary hardness during insertion, have the ability to emulsify the required amount of solutions, have a certain plasticity, viscosity, deformation time and structural and mechanical properties. These technological requirements are met by lipophilic, hydrophilic bases and their mixtures used in the pharmaceutical industry in different countries of the world. As lipophilic suppository bases State Pharmacopoeia USSR XI recommends using cocoa butter, its alloys with paraffin and hydro-genated fats, vegetable and animal fats, solid fat, lanol, alloys of fats with wax and solid paraffin. Currently, cocoa butter remains the official pharmacopoeial base in the pharmacopoeias of a number of countries. Lipophilic bases should meet the following requirements: quickly melt in the rectum, have a melting point not higher than 37 ° C, have sufficient hardness and a small difference between the melting and solidification temperatures, have sufficient viscosity, absorb liquids well, be stable during storage.

Información adicional

Due to the fact that the melting points of the base components fluctuate within a fairly wide range (hydrofat – from 28 to 37 ° C, paraffin – from 50 to 57 ° C, cocoa butter – from 30 to 34 ° C), the actual melting point of the resulting alloy may be slightly higher or lower than the specified temperature. In this case, paraffin or hydrofat is added to the base in the amounts necessary to bring the melting temperature of the mixture to the specified value. In this case, use the «table of additives». In addition to the required melting point, suppository base should also have appropriate structural and mechanical properties. They can be judged by the time of total deformation of the suppository prepared from this base. Determination of the time of full deformation is carried out at a temperature of 37 ° C on the device Kruvchinsky. In the composition of bases are often introduced surfactants, which not only improve the structural and mechanical properties, but also affect the kinetics of release and absorption of medecine. Hydrophilic suppository bases are mainly represented by polyethylene glycols (polyethylene oxides) – condensed polymers of ethylene oxide and water. Domestic industry produces polyethylene glycols differing in molecular weight: PEO-400, PEO-1500, PEO-2000, PEO-4000 and PEO-6000.

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