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Standardization of suppositories in the pharmaceutical industry

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СATALOGUE / PHARMACEUTICAL PRODUCTION TECHNOLOGIES / MAKING SUPPOSITORIES IN PRODUCTION / Standardization of suppositories in the pharmaceutical industry

Standardization of suppositories in the pharmaceutical industry

All manufactured suppositories must meet the requirements of the State Pharmacopoeia XI: Suppositories must have a homogeneous mass. Homogeneity of suppository is checked visually on a longitudinal slice for the presence or absence of inclusions, pieces” of the basis, particles of different colors, other inclusions, while the presence of air rod is allowed. Deviations in the mass of suppositories are allowed within 5%. Suppositories should have the correct uniform shape. In suppositories, the drug substances must be accurately dosed. The suppositories must have a hardness that makes them easy to use.

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  • Information updated : 07 / 01 / 2026
  • In stock
  • Manufacturer : 1 year for Standardization of suppositories in the pharmaceutical industry

Model: Standardization of suppositories in the pharmaceutical industry

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The release of drugs from hydrophobic bases is slower.
When making suppositories, it should be remembered that the drug substances introduced into the composition of these dosage forms in the form of aqueous solutions, absorbed much easier and faster have a local effect than the drug substances introduced in dry form. In terms of microbiological purity of preparations for rectal administration are classified by the State Pharmacopoeia to category IIIA, ie in 1 g or 1 ml of the drug should contain no more than 1000 aerobic bacteria and 100 fungi in the absence of Escherichia coli.

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Technical specifications

All suppositories (especially rectal and urethral) must have sufficient hardness to overcome the resistance of tissues and sphincters, otherwise the suppositories are deformed and their use becomes impossible. The melting point determined for lipophilic suppositories should not exceed 37 °C. Moreover, it is necessary that their melting occurred in a short temperature range (1-2 ° C). If the definition of melting temperature causes difficulties, then set the time of full deformation, which should be no less than 3 and no more than 15 min. For suppositories made on hydrophilic bases, determine the time of dissolution in water, which should not exceed 1 h.

Additional information

The liquid mass formed after melting or dissolution of suppositories should spontaneously spread over the mucous membrane, forming a uniform layer. This condition is necessary to ensure close contact of the drug substance with tissues and its proper absorption. Suppositories should easily release the drug substances included in them. This quality depends both on the properties of the base used for the preparation of suppositories, and on the method of introduction of drugs into the base. Hydrophilic bases (except polyethylene oxides) easily release active substances, as they are able to dissolve in the secretions of mucous membranes.

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