Nasal preparations monograph Flashcards
Nasal spray preparations may contain excipients, for example to
adjust the tonicity or viscosity of the preparation, to adjust or stabilise the pH, to increase the solubility of the active substances, to stabilise the preparation or to provide adequate antimicrobial properties.
The excipients do not adversely affect the intended medicinal action of the preparation or, at the concentrations used, cause toxicity or undue local irritation.
When would a multi use nasal spray not need a preservative to be present in its preparation
Where the preparation itself has adequate antimicrobial properties.
Preparations for administration to the injured nose, particularly when the mucosa is damaged, or prior to surgery are sterile and, unless otherwise justified and authorised, free from preservatives and supplied in single-dose containers.
Several categories of nasal preparations may be distinguished?
— nasal drops;
— nasal sprays;
— nasal powders;
— semi-solid nasal preparations;
— nasal washes;
— nasal sticks.
What is important in the manufacture of nasal sprays?
During the development of nasal preparations whose formulation contains a preservative, the need for and the efficacy of the chosen preservative shall be demonstrated to the satisfaction of the competent authority.
In the manufacture, packaging, storage and distribution of nasal preparations, suitable measures are taken to ensure their microbial quality.
Sterile nasal preparations are prepared using materials and methods designed to ensure sterility and to avoid the introduction of contaminants and the growth of micro-organisms.
In the manufacture of nasal preparations containing dispersed particles, measures are taken to ensure a suitable and controlled particle size with regard to the intended use.
During manufacture of metered-dose nasal sprays and metered-dose nasal powders supplied in multidose containers, the uniformity of delivered dose must be ensured within a container (intra-container) and between containers (inter-container).
Nasal preparation monograph - Labelling
The label states:
— the name of any added preservative;
— where applicable, that the preparation is sterile;
— for multidose containers:
— the period within which the preparation is to be used after opening;
— where applicable, the number of deliveries per container;
— where applicable, the delivered dose or, if justified and authorised (e.g. where the dose has been established as a metered dose or as a pre-metered dose), the metered dose or the pre-metered dose.
Nasal preparation - tests
Uniformity of dosage units
Uniformity of mass
Uniformity of content
Nasal sprays - tests
Uniformity of delivered dose
Uniformity of delivered mass
Number of deliveries per container
Leak rate
