Suppository Bases, Hard Fat

Synonyms: Adeps neutralis; adeps solidus; Akosoft; Akosol; Cremao CS-34; Cremao CS-36; hydrogenated vegetable glycerides; Massa Estarinum; Massupol; Novata; semisynthetic glycerides; Suppocire; Wecobee; Witepsol

Description: A white or almost white, practically odorless, waxy, brittle mass. When heated to 50C it melts to give a colorless or slightly yellowish liquid.

Chemical Name: Hard fat triglyceride esters

Suppository base.

• The primary application of hard fat suppository bases, or semisynthetic glycerides, is as a vehicle for the rectal or vaginal administration of a variety of drugs, either to exert local effects or to achieve systemic absorption
• Selection of a suppository base cannot usually be made in the absence of knowledge of the physicochemical properties and intrinsic thermodynamic activity of the drug substance.
• Other drug-related factors that can affect release and absorption and which must therefore be considered are the particle size distribution of insoluble solids, the oil : water partition coefficient, and the dissociation constant.
• The displacement value should also be known, as well as the ratio of drug to base.
• Properties of the suppository base that may or may not be modified by the drug, or that can influence drug release, are the melting characteristics, chemical reactivity, and rheology.
• The presence of additives in the base can also affect performance.

Incompatibilities with suppository bases are not now extensively reported in the literature. The occurrence of a chemical reaction between a hard fat suppository base and a drug is relatively rare, but any potential for such a reaction may be indicated by the magnitude of the hydroxyl value of the base. The risk of hydrolysis of aspirin, for example, may be reduced by the use of a base with a low hydroxyl value (<5) and, additionally, by minimization of the water content of both the base and the aspirin.>

Suppository bases are generally regarded as nontoxic and nonirritant materials when used in rectal formulations. However, animal studies have suggested that some bases, particularly those types with a high hydroxyl value, may be irritant to the rectal mucosa

Observe normal precautions appropriate to the circumstances and quantity of material handled. There is a slight fire hazard on exposure to heat or flame.

Glycerin; medium-chain triglycerides; polyethylene glycol; theobroma oil.