Solid rectal suppositories

Rectal Administration. The administration of drugs by a solid rectal dosage form (i.e., suppositories) results in a wide variability in the rate and extent of absorption in children [79]. This fact, coupled with the inflexibility of a fixed dose, makes this a route that should not be promoted for pediatric patients. At least one death involving a 7-month-old infant can be directly attributed to the use of solid rectal dosage form of a therapeutic dose of morphine [80]. 

A change in the container closure system of unit dose packaging (e.g., blister packs) for nonsterile solid dosage fonn products, as long as the new package provides the same or better protective properties and any new primary packaging component materials have been used in and been in contact with CDER-approved products of the same type (e.g., solid oral dosage form, rectal suppository). 

Suppository is solid-like preparation made from drug and suitable bases for cavity administration. When inserted into cavities, they melt or soften, after which drug dissolution and absorption result in local or systemic effect. Whin rectal suppository is a common form which is usually used as laxatives. Administrated by rectum mucosa, suppositories possess many advantages compared with oral route. Firstly, it is a convenient administration way for infants or patients suffering from vomiting or gastrointestinal disturbances. 

H. Suppositories Solid preparations which melt at body temperature delivering medication for at-site treatment or for absorption at that point (usually rectal, vaginal, or urethral). Excipients include cocoa butter, waxy fatty acids, and derivatives, polyethylene glycol, theobroma oil, as well as many ingredients found in G. 

FIGURE 40.9 Irritation effects of single or repeated administration (four times, 12-h intervals) of EBA or its (3-CyD complexes as suppositories (lOmg/kg as EBA) on rectal mucosa in rats. Open bars, EBA alone hatched bars, (3-CyD complex tinted bars, DM-(3-CyD complex solid bars, HP-(3-CyD complex. Each value represents the mean SE of five rats. 

Suppositories are solid bodies of various weights and shapes intended for introduction into various body orifices (rectal, vaginal, or urethral) where they soften or melt, release their medication, and exert their therapeutic effect. These effects include the promotion of laxation (glycerin), the relief of discomfort (pain or hemorrhoids) from inflamed tissue, or the promotion of systemic effects (analgesic or antifebrile) in infants, children, and adults. 

For rectal administration an active substance can be formulated into a suppository (solid dosage form) or in an enema (liquid dosage form). The desired miset of action is important for the choice. For a rapid onset an enema is preferable, because a suppository base has to melt or to dissolve first. A suppository may be preferred because its use is easier and more patient-friendly. An enema is the best choice when a local effect over a large surface is desired, for instance in the treatment of ulcerative colitis. From a practical viewpoint an enema can be prepared faster, but is more sensitive to chemical degradation, due to the presence of water. 

Suppositories are solid, single-dose preparations. Their shape, volume and consistency make them suitable for rectal administration. They contain one or more active substances dispersed or dissolved in a suitable basis that may be soluble or dispersible in water or may melt at body temperature. Excipients such as diluents, adsorbents, surface-active agents, lubricants, antimicrobial preservatives and colotulng matter, authorised by the competent authority, may be added if necessary (Ph. Eur.). 

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