Powders GPM.1.4.1.0010.15

Supersedes the XI Monograph of the State Pharmacopoeia

Powders are a dosage form consisting of solid, separate, dry particles of different dispersion, possessing the flow property.

Powders should be homogeneous when viewed with the naked eye and have a particle size of no more than 160 μm, unless otherwise specified in the monograph or regulatory documentation.

Powders may be a dosage or non-dosage form containing one or more active ingredients or mixtures thereof with excipients.

Depending on the route of administration, there are following types of powders:

powders for external use;
powders for topical application;
powders for solutions or suspensions for external use;
powders for solutions or suspensions for topical application;
powders for solutions or suspensions for parenteral administration;
powders for eye drops (and eye lotions);
powders for oral administration;
powders for solutions, drops or suspensions for oral administration. There are also “effervescent” powders. “Effervescent” powders are intended to be dissolved in water before use;
powders for inhalation.

TECHNOLOGY CHARACTERISTICS

The process of producing powders consists of the following stages:

grinding of starting materials;
producing homogeneous powder (sieving);
intermixing;
pre-packaging, packaging, labelling.

Vehicles, solubilizers, flavoring agents, coloring agents, preservatives approved for medical use are used as excipients in powders.

Powders may contain excipients that provide dissolution or dispersion, prevent caking, reduce hygroscopicity, regulate or stabilize pH, or stabilize pharmaceutical ingredient, etc.

“Effervescent” powders for oral administration mainly contain substances of acidic and basic nature, which in the presence of water react rapidly with the release of carbon dioxide. Powders for inhalation contain one or more finely-dispersed pharmaceutical ingredients together with inert excipients – “carriers” (generally, lactose) or without them.

Depending on a dosage form and route of administration, powders are presented with different dispersion requirements. Powder dispersion is characterized by the size of the sieve opening through which powder passes. The particle size of powder is expressed in microns. When producing powders for external use, topical application and/or for suspensions for external use, topical application it is necessary to provide an appropriate particle size with its mentioning in the monograph or regulatory documentation.

When producing polycomponent powders, each ingredient is ground separately and sieved through a suitable sieve in accordance with the requirements of the GM “Sieve analysis”. Pharmaceutical ingredients in powders for inhalations are micronized (ground in special micronizing devices).

Toxic and superpotent ingredients in amounts less than 0.05 g per the whole mass are used in the form of trituration – mixtures with lactose sugar or other excipients approved for medical use (1: 100 or 1:10).

TESTING

Description. Powders should be homogeneous when viewed with the naked eye and have a particle size of no more than 160 μm, unless otherwise specified in the monograph or regulatory documentation.

Loss on drying or Water. The determination is made in accordance with the GM “Loss on drying” or “Determination of water”.

Particle size. The particle size of powders for external use is determined by a sieve test in accordance with the requirements of the GM “Sieve test” or by other validated method.

Assay. For assay a weight of not less than 10 g of powder should be taken.

For powders for solutions, dissolution and pH of ready solutions is additionally controlled, if necessary.

The content of the ingredients to be determined is expressed in mg or U in a single dose for metered-dose powders or in 1 g of the drug for not metered-dose powders, unless otherwise specified in the monograph or regulatory documentation.

Metered-dose powders should comply with the requirements of the GM “Uniformity of dosage units” and the GM “Uniformity of weight of dosage forms”.

FEATURES OF INDIVIDUAL DOSAGE FORM TESTING

Powders for topical application and/or for solutions or suspensions for topical application. Powders for topical application, as well as solutions or suspensions made from them, for use on open wounds or on damaged skin should be sterile.

Powders for solutions or suspensions for parenteral administrations should be sterile and comply with the requirements of the GM “Parenteral dosage forms”.

Powders for the eye drops should comply with the requirements of the GM “Ophthalmic dosage forms”.

Powders for suspensions for oral administration. For powders used for suspensions for oral administration, the control of the resulting suspension according to the “Particle size” and “Sedimentation stability” parameters should be additionally provided in accordance with the requirements of the GM “Suspensions”.

Powders for inhalation. The test for uniformity of dosage units of powders for inhalations is carried out in accordance with the requirements of the GM “Dosage forms for inhalation”.

For metered-dose powders for inhalation, the content of the fine particle fraction in a single dose of powder is additionally determined in accordance with the GM “Aerodynamic distribution of finely dispersed particles” and the quantity of doses in accordance with the GM “Dosage forms for inhalation”.

PACKAGING

In accordance with the requirements of the GM “Dosage forms”. Each dose of metered-dose powders is packaged in an individual package or several doses per package with a special device for dosing an individual dose.

Packaging for metered-dose powders for inhalation is an individual inhaler: capsular (spinhaler, rotahaler, diskhaler), reservoir (turbuhaler, cyclohaler, isihaler), multi-dose (multi-disk) providing dosing and administration of the active ingredient into the respiratory tract.

LABELLING

In accordance with the requirements of the GM “Dosage forms”.

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.