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Estandarización de ungüentos en producción.

  • Standardization of ointments in production
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Estandarización de ungüentos en producción.

In-house control of ointments is carried out practically at every stage of production and especially before packing of the drug. The final conclusion on all quality indicators of the finished product is given by the quality control department of the plant. In the conditions of industrial production testing is carried out in accordance with the requirements of the general article of the State Pharmacopoeia (GF) for ointments, as well as the requirements included in the articles of the GF for individual names of ointments. Ointment is standardized for appearance, homogeneity, drug content, pH value, degree of dispersibility of solids, colloidal stability and thermostability. The company controls the appearance, odor and characteristic organoleptic properties (if any) of ointments and other soft medicines. They should not have a rancid odor, as well as (unless otherwise specified in private articles) signs of physical instability (aggregation of particles, coalescence, coagulation and stratification). The amount of drug substances in ointments are determined according to the methods given in private pharmacopoeial articles on the ointment under test. Standardization of ointments and therapeutic creams for qualitative and quantitative content of medicinal substances or determination of authenticity is carried out visually by appearance and organoleptic characteristics, as well as by qualitative reactions to the medicinal substances included in their composition. The permissible deviation in the content of the medicinal substance in ointments, liniments, pastes and therapeutic creams shall not exceed ±5%. If necessary, determine the authenticity of excipients and type of base. Ointments should be homogeneous. Homogeneity of ointments are determined taking into account the properties of a particular drug by appearance or by the following methodology. Take 4 samples of the drug at 20-30 mg each, place 2 samples on a slide, cover with a second slide and tightly press until the formation of spots with a diameter of about 2 cm. On examination of the obtained samples with the naked eye (at a distance of about 30 cm from the eye), all four samples shall be free from inclusions and (unless otherwise specified in the private article) from signs of physical instability: aggregation and coalescence of particles, coagulation, stratification. If visible foreign matter is present in one of the samples, the determination shall be made on eight additional samples. All additional samples shall be free of foreign matter. The degree of dispersibility of particles of ointments and creams are determined using an electron microscope with an ocular micrometer. For suspension ointments dispersibility of solid particles is determined according to the methodology of the State Pharmacopoeia. The standards for the degree of dispersibility of particles are individual for each ointment and should be specified in the private articles of the pharmacopoeia.

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  • Información actualizada : 07 / 11 / 2024
  • En stock
  • Fabricante : 1 año para Estandarización de ungüentos en producción.

Modelo: Standardization of ointments in production

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The application of the sample is repeated until the filter paper disks applied to the test area no longer absorb the ointment. Then the amount of unresorbed drug contained in the paper is determined. The amount of drug that has penetrated the skin is determined by the remaining difference. Histologic studies with the help of a microscope allow to determine which layer of the skin the preparation has reached. The ointment is applied to a depilated area of the animal’s skin, then, after slaughtering it, histologic sections are made, which may be longitudinal (to determine the depth of penetration) or transverse (to evaluate the area of ointment distribution). Determination of drugs resorbed in blood, organs and tissues, secretions, or exhaled air after topical application of the ointment.
4Registration of biological or toxic reactions caused by the drug (pupil reaction, change in pain sensation, heart rate, onset of convulsions or death, etc.).
Radioisotope method using labeled drugs. Both in vitro and in vivo methods give relative results. While the former should be viewed critically on the grounds that they do not take into account the physiological functions of the skin, the latter give only approximate results, since human skin both in terms of function and structure differs significantly from animal skin. Only clinical tests can give the final assessment of the ointment. In addition to the above-described quality indicators of ointments, which are controlled before packing, after the completion of the entire production process should control the mass of the contents of the package, which should not be less than the mass indicated on the label. Deviation in the mass of ointments or creams, packaged in tubes or jars, checked by weighing ten samples. For sterile and non-sterile ointments, creams and other soft drugs should be carried out to determine the tightness of packaging in accordance with the following methodology. Take 10 tubes with the drug and thoroughly wipe their outer surfaces with filter paper. The tubes in a horizontal position are placed on a sheet of filter paper and kept in the thermostat at a temperature of 60±3 ° C for 8 hours. There should be no drips of drug from any tube on the filter paper, ignoring any traces of drug initially on the threads of the cap and tube. If leakage is observed from only one tube, the test shall be carried out with an additional 20 tubes. The results of the test shall be considered satisfactory if no leakage is observed from the first ten tubes or if leakage is observed for only one of the thirty tubes.

Glosario Farmacéutico

Almacenamiento de ungüentos  — Los términos y condiciones de almacenamiento de ungüentos se especifican en la documentación técnica.
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Especificaciones técnicas

The degree of dispersibility in emulsion ointments and creams is determined under the condition of coloration of the dispersed phase. The diameter of 1000 droplets is determined and then the percentage of droplets of different sizes is calculated. The method is easy to perform, but quality standards for emulsion creams and ointments are not yet specified in any pharmacopoeia. Determination of pH of ointments is necessary to monitor the behavior of drug substance and base during storage. A shift in pH indicates a change in their physicochemical properties. To determine the pH of ointments and creams suspended product poured 50 ml of distilled water with a temperature of 50-60 «C and shaken on a vibrator for 30 minutes. The resulting extract is filtered and conducted potentiometric titration according to the method of GF. All ointments produced by pharmaceutical companies, have a guaranteed shelf life, during which, if properly stored, they should remain stable. The stability of ointments is determined by the unchanged content of drug substances (within the established tolerance), structural properties and the rate of release of drugs. Stability testing of ointments is particularly essential if they are emulsion systems. One acceptable technique for testing the stability of such ointments is the colloidal stability methodology. Assessment of colloidal stability of a cream or ointment is carried out on a centrifuge at a speed of 6000 rpm for 5 min. Under the influence of centrifugal force, the emulsion breaks down the faster; the less stable it is. The absence of stratification of the product sample indicates the stability of the composition. Thermal stability of the product is determined by heating the ointment or cream in a desiccator at 60 ° C for 1 h. If the product is qualitative, the sample should remain homogeneous without stratification. Sometimes in ointments and creams it is necessary to determine the structural and mechanical properties (ultimate shear stress, which characterizes the strength of the structure and consistency of ointments, and plastic viscosity, which characterizes the flow of the system with a destroyed structure), the degree of release of drug substances from the preparation and the stability of the product under different storage conditions. These determinations are usually made when developing new ointments and creams or improving existing ones. The consistency of ointments and ointment bases requires objective evaluation, as it affects the processes of their preparation and packaging, the ease of application of ointments to the skin and the release of drug substances from them. One of the main factors on which the consistency of ointments depends is the ultimate shear stress. It characterizes the ability of ointments to provide some resistance to smearing, the ability to squeeze out of tubes, dispensers, etc. The ultimate (or critical) shear stress is the force in dynes acting on an area of 1 cm2 tangentially to the plane of displacement and causing irreversible deformation of the system.

Información adicional

The ultimate shear stress is also called the flow point, meaning the stress required for the system to start flowing (for irreversible deformation). The higher the value of this value, the more difficult the ointment is to spread. This is an important characteristic of ointments and ointment bases because it determines the ease of application of ointments. Usually a Volarovich rotary viscometer or a conical plastometer is used to determine the ultimate shear stress. Plastic viscosity, another important rheological characteristic of ointments and ointment bases, is determined on a Volarovich rotary viscometer RV-8. The degree of release of drug substances is a criterion for assessing the quality of ointments, which should become the main criterion for standardization and rejection (verification of compliance of the product quality with the requirements of the standard) of ointments. Methods for determining the degree of drug release in vitro and in vivo have been developed. In vitro methods. The technical performance of experiments by in vitro method can be different and is mainly determined by the properties of the included drugs. Direct diffusion method. In this case, the ointment sample must be in direct contact with the medium into which the drug substance diffuses. Method of diffusion through the membrane. The essence of the method is that the ointment under study is separated from the aqueous medium by a semipermeable membrane. This can be cellophane or lipoid membranes of animal origin, such as egg shells, a section of intestine or animal skin. The dialysis media are aqueous solutions or water. The apparatus design of these studies can vary. In recent years, there have been many installations that maximally approximate the conditions of experience to the conditions of a living organism. Most often these are two-chamber installations separated by membranes or membrane systems. One of the chambers contains the ointment and the other contains the dialysis medium. Despite the design differences, the setups obey the same principle and reflect the same dependencies. In vivo methods. In contrast to in vitro methods, these methods allow two processes to be assessed at once: the ability of the ointment base to release the active ingredients and the degree of resorption of the active ingredients through the skin. In vivo methods include the following studies: Determination of the resorbed amount of drugs by the difference between the applied ointment sample and the non-absorbed portion of the ointment. Such evaluation is acceptable on both animal and human skin. A certain amount of ointment is applied and rubbed evenly on a strictly limited area of skin using a template. A pressure of 100 mmHg is applied to this area using a cuff.

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