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Catalog / Pharmaceutical Technology / Production of suppositories in production / Suppository bases and requirements for them

Suppository bases and requirements for them

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  • Types of Suppositories
  • Suppository form
  • Suppositories for the pharmaceutical business
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  • Types of Suppositories
  • Suppository form
  • Suppositories for the pharmaceutical business
  • Suppositories of industrial production

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Catalog / Pharmaceutical Technology / Production of suppositories in production / Suppository bases and requirements for them

Suppository bases and requirements for them

From the physicochemical point of view, suppositories are considered as dispersed systems consisting of a dispersion medium represented by the basis of the Dispersed phase, in the role of which are medicinal substances. Depending on the properties of drugs, dispersed suppository systems can be either homogeneous or heterogeneous. Homogeneous systems are formed in those cases when the drug substance is dissolved in the base. Heterogeneous systems are formed in the case of the introduction of drugs into the base as an emulsion or suspension. In the structure of suppositories, the main (medicinal substances) and auxiliary (carriers or base) components are distinguished. A number of requirements are imposed on suppository bases: the bases must maintain sufficient hardness at room temperature; the melting temperature (dissolution) of the base should be close to the temperature of the human body; the bases should not irritate the rectal mucosa or cause undesirable effects, i.e. should be physiologically indifferent; suppository bases should not interfere with the release and therapeutic effect of the drug substance; the bases should not interact with medicinal substances introduced into the suppository mass.

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  • Updated: 08/10/2019
  • Pharmaceutical equipment in stock and on order
  • Warranty: 1 year for equipment for the production of suppository bases

Model: Suppository Foundation Requirements

  • Marked as: Melting analyzer Business Business plan The blog Investments Innovation Equipment catalog Commerce Company Buy a business Medication Medicinal substances New Preparation of suppository base Production Suppository Production Startup Articles Suppository line Suppository base Suppository Foundation Requirements Pharmaceutical equipment Suppository molding

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Abroad, polyethylene glycol bases are known under the name Carbovax (USA), Skurol (France), Postonal, Suppofarm (Germany and the Scandinavian countries). This group of bases is able to dissolve in the secrets of the mucous membranes, completely release medicinal substances without irritating the mucous membrane. These bases have a long shelf life, high physiological indifference, and relatively affordable cost. Gelatin-glycerin and soap-glycerin bases are much less commonly used in the production of suppositories, although they are included in the pharmacopeias of several countries of the world. The following requirements are imposed on hydrophilic suppository bases: quickly and completely dissolve in the secrets of the mucous membranes; do not irritate the mucous membrane; mix with hydrophobic medicinal substances or absorb them; be chemically and pharmacologically indifferent.
For suppositories made on hydrophilic bases, the dissolution time is determined. For this, one suppository is placed on the bottom of a vessel with a capacity of 100 ml, containing 50 ml of water with a temperature of (37 ± 1) ° С. Every 5 minutes, the vessel is shaken so that the liquid and the sample become rotational. The suppository should dissolve within 1 hour. To ensure optimal structural and mechanical characteristics of suppository bases, they are added aluminum stearates, magnesium and other salts of fatty acids, as well as emulsifiers T-1, T-2 and No. 1, bentonite, glucose, starch, aerosil and other auxiliary substances approved for medical use.

Specifications

Closely related to these general requirements are the technological requirements for the basics, which should: show chemical and physical stability during the manufacture and storage of suppositories; easy to form and maintain the necessary hardness upon insertion; have the ability to emulsify the required number of solutions; to have certain ductility, viscosity, deformation time and structural and mechanical properties. The listed technological requirements are met by lipophilic, hydrophilic bases and their mixtures used in the pharmaceutical industry around the world. As the lipophilic suppository bases, the State Pharmacopoeia of the USSR XI recommends the use of cocoa butter, its alloys with paraffin and hydro-genetized fats, vegetable and animal fats, hard fat, lanol, fat alloys with wax and hard paraffin. Currently, in the pharmacopeias of several countries, cocoa butter remains the official pharmacopeia base. Lipophilic bases must 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 pour points; have sufficient viscosity; well absorb liquids; be stable during storage.

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Due to the fact that the melting temperature of the components of the base varies quite widely (hydro fat - from 28 to 37 ° C, paraffin - from 50 to 57 ° C, cocoa butter - from 30 to 34 ° C), the actual melting temperature of the resulting alloy can be slightly higher or lower than the specified. In this case, paraffin or hydro fat is added to the base in the amounts necessary to bring the melting temperature of the mixture to a predetermined value. At the same time, they use the “supplement table”. In addition to the required melting point, the suppository base must also have the appropriate structural and mechanical properties. You can judge them by the time of complete deformation of the suppository prepared from this base. Determination of the time of complete deformation is carried out at a temperature of 37 ° C on a Kruvchinsky instrument. Surfactants are often introduced into the composition of the bases, which not only improve the structural and mechanical properties, but also affect the kinetics of the release and absorption of drugs. Hydrophilic suppository bases are mainly represented by polyethylene glycols (polyethylene oxides) - condensed polymers of ethylene oxide and water. Domestic industry produces polyethylene glycols that differ in molecular weight: PEO-400, PEO-1500, PEO-2000, PEO-4000 and PEO-6000.

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