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GPM.1.4.1.0014.15 Suspensions

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

GENERAL MONOGRAPH

Suspensions GPM.1.4.1.0014.15

Supersedes the XI Monograph of the State Pharmacopoeia

Suspension is a liquid dosage form, which is a heterogeneous dispersed system containing one or more solid active ingredients distributed in a liquid dispersion medium.

Suspensions may be ready-to-use and also prepared immediately before use from powders, granules, tablets and water or other suitable liquid as specified in the monograph or regulatory documentation.

Suspensions are used for oral administration, inhalation, external use, topical and parenteral administration.

Powders, granules and tablets for suspensions should comply with the requirements of the GM «Powders», «Granules» or «Tablets», respectively. Suspensions for parenteral administration should comply with the requirements of the GM «Parenteral dosage forms». Suspensions for inhalation should comply with the requirements of the GM «Dosage forms for inhalation». Suspensions in the form of eye drops should comply with the requirements of the GM «Ophthalmic dosage forms».

TECHNOLOGY CHARACTERISTICS

Buffer solutions, stabilizers (substances that increase the viscosity of the dispersion medium, surface active substances, etc.), flavoring agents can be used as excipients in suspensions.

preservatives, antioxidants, colorants and other substances approved for medical use.

TESTING

Description. After shaking, suspension should be a liquid with particles uniformly distributed in it; the color and the odor, if necessary, are specified.

pH. It is determined if specified in the monograph or regulatory documentation. The test is carried out by a potentiometric method in accordance with the requirements of the GM «Ionometry».

Particle size. Determination of a particle size in suspensions is carried out by optical microscopy (the GM «Optical Microscopy») and laser diffraction (the GM «Determination of particle size distribution by laser diffraction method «).

The particle size is determined by optical microscopy according to the following procedure.

A certain amount of suspension, corresponding to 10 μg of solid medicinal substance, is introduced into a counting chamber or, with a micropipette, applied to a glass slide and the entire area of a sample is viewed under a microscope. First, scan a sample at a small magnification (for example, 50*), identifying particles with a maximum size of more than 25 μm. Then, measure these particles at a larger magnification (for example, from 200* to 500*).

Presence of particles with a maximum size of more than 100 μm is not allowed, unless otherwise specified in the monograph or regulatory documentation.

For eye drops of suspension type containing 10 μg of solid active ingredient, there should be not more than 20 particles with a maximum size of more than 25 μm, with therefrom not more than 2 particles with a maximum size of more than 50 μm; presence of particles with a maximum size of more than 90 μm is not allowed.

Syringeability. The determination is carried out in suspensions for parenteral administration according to the procedure specified in the monograph or regulatory documentation. The suspension should pass into the syringe freely through a 0.8 * 40 needle, unless otherwise specified in the monograph or regulatory documentation.

Sedimentation stability. The determination is carried out according to the following procedure. The pharmaceutical product is shaken carefully and transferred from a vial (or other package specified in the monograph or regulatory documentation) to a graduated cylinder or glass tube. The vial (or other appropriate package) is also inspected. To inspect the polymer vial, it is cut into sections. At the bottom and on the walls of the vial (package), aggregates and agglomerates of dispersed phase particles should not be observed.

For suspensions for parenteral administration and oral administration, the time for resuspension should not be more than 1 minute, for eye drops the recommended time for resuspension is not more than 30 seconds.

There should be no signs of sedimentation and the formation of aggregates and agglomerates for the time needed to administer a pharmaceutical product. Generally, for suspensions for parenteral and oral administration, eye drops of suspension type it should be at least 2-3 minutes.

Viscosity. It is determined, if specified in the monograph or regulatory documentation, in accordance with the requirements of the GM «Viscosity» by rotational viscometry at 25 °C. Determination of viscosity should be provided for suspensions if they contain substances that increase viscosity.

PACKAGING

In accordance with the requirements of the GM «Dosage forms». Suspensions are available both in multi-dose and unit-dose containers, with a device, if necessary, to ensure the convenience of use and dosage of a medicinal product.

As a means for measuring a prescribed dose, a dosing spoon or a cup, a dropper, etc. may be provided in a package.

Suspensions for parenteral administration, eye drops and suspensions for application to damaged skin are available in sterile airtight containers.

LABELLING

In accordance with the requirements of the GM «Dosage forms». The cautionary warning «Shake before use» should be provided on the label.

STORAGE CONDITIONS

In accordance with the requirements of the GM «Storage of medicinal products». In a package that provides stability during the indicated shelf life of the medicinal product, in a dark place at a temperature of 8 to 15 °C, unless otherwise specified in the monograph or regulatory documentation.

 

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