Tonicity formulation property

Tonicity agents are added to injectable preparations to prevent osmotic shock at the site of injection upon administration, and thereby reduce local irritation. Typical excipients used for tonicity adjustment include saline, glycerin, mannitol, dextrose, and trehalose. Tonicity is a colligative property that depends primarily on the number of dissolved particles in solution. Hence, the amount of tonicity agent to be added depends on the specific formulation. Typically, osmolality of 280 to 320mOsm is considered iso-osmotic. 

The user enters all known data on the solubility (aqueous and non-aqueous), stability in specified solutions, compatibility, pAia, and molecular properties of the active ingredient (molecular weight, log/, etc.). As with the system for tablet formulation, the data may be numerical or symbolic. All relevant properties of additives used in parenteral formulation (e.g., buffers, antioxidants, chelating agents, antimicrobials, and tonicity adjusters) are present in the knowledge base. 

The four colligative properties that are of importance are 1) the vapor pressure lowering 2) the elevation of boiling point 3) the freezing-point depression and 4) the osmotic pressure. An attempt is made below to describe qualitatively and quantitatively each colligative property of solutions, with an emphasis on their interrelationship and their application later in measurement and adjustment of the tonicity of solutions, with particular reference to parenteral formulations. Although theoretical derivations based on thermodynamics can be used to show how each of the colligative properties of solution arises and relate to each other, textbooks on physical chemistry for theoretical derivations are recommended. 

From the theoretical background presented above, one can easily devise his or her own methods to adjust tonicity of solutions using the principles of colligative properties. However, in the practice of pharmacy, a number of simple methods to adjust tonicity of formulation in a prescription order on an extemporaneous basis were developed to help the pharmacist. The methods of adjusting tonicity could be classified into... 

Extracts are quite extensively used in tonics (especially those for female ailments). Also used in diuretic, laxative, and antismoking preparations as well as in cosmetic and toiletry formulations, presumably for their tonic properties. In Germany, the root is used for disturbances in bile flow, as diuretic, and as an appetite stimulant. The herb is used for appetite and dyspeptic disorders, such as abdominal fullness and flatulence. Products are contraindicated in obstruction of bile ducts. 

Uses Surfactant for cleansers, electroplating baths Rapidaminreserve CL [Clariant/Functional Chems.j Chem. Descrip. Cresol-formaldehyde condensation prod., sodium salt tonic Nature Anionic Uses Dispersant for crop formulations Regulatory EINECS listed Properties Liq. = 35% act. 

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