A suppositories is a medicated solid dosage from generally intended for us in the rectum, vagina and to a lesser extent the urethra. Suppositories usually employ vehicles that melt or soften at body temperature. Rectal suppositories for adults weigh about 2g and usually tapered to resemble a torpedo shape children suppositories weigh about 1g

A suppository may be used for either local or for systemic effects 1.Babies or old people who cannot swallow oralmedication 2.Bed ridden people 3.Post operative people who cannot be administered oral medication 4.People suffering from severe nausea or vomiting 5.People suffering from some obstruction in the intestine Applications:

1.Physiological factors 2.Physico chemical characters of drug 3.Physico chemical characters of base Factors affecting drug absorption from suppositories:

The ideal suppository base may be described as follows- The base is Nontoxic and Nonirritant Compatible with wide variety of drugs The water number is high It is stable on storage It can be manufactured by molding by either hand machine The acid value is below 0.2 Iodine Value is less than 7 The Ideal Suppository Base:

Saponification value ranges from 200 to 245. Melt at or just below body temperature Solidify quickly after melting Be easily moulded and removed from the mould Solid fat curve should be sharp The Ideal Suppository Base (continued):

3.1. Solid-Fat Index (SFI): From the graph of % of solids versus temperature one can determine the solidification and melting ranges of fatty bases. A base with a sharp drop in solids over a short temperature span proves brittle if molded for quickly. 3.Physico chemical characters of base

3.3. Iodine Value: This value expresses the number of gm of Iodine that reacts with 100g of fat.The possibility of decomposition by moisture, acids and Oxygen increases with high Iodine values. 3.Physico chemical characters of base(continued)

3.4. Water Number: The amount of water in gms That can be incorporated in 100g of fat is expressed by this value. Its water no. should be high so that it dissolve easily. It indicates tendency of dissolution of the base. 3.Physico chemical characters of base(continued)

3.5. Acid Value: the number of mgs of KOH required to neutralize the free acid in 1g of substance is expressed by this value. Low acid value or complete absence of acid are important for good suppository base. Free acids complicate formulation work because they react with other ingredients and can also cause irritation 3.Physico chemical characters of base(continued)

a) Typical Vegetable Oils : 1. Theobroma oil/ Cocoa butter is the fat obtained from the roasted seeds of Theobroma cocoa *Melting point is °C / °F Types of Suppository Bases

2. Coconut or Palm Kernel oil : Modified by esterification, Hydrogenation and fractionation at different melting ranges to obtain desired product. b) Hydrophilic Suppository Bases 1. Glycerin Suppositories: 2. The Polyethylene Glycols(PEG): Types of Suppository Bases

1.melting of the vehicle 2.mixing of the drug and the molten vehicle 3.dispensing in a former 4.cooling to solidify 5.packing in final container or with PVC ot al foil pack Manufacture of Suppositories:

Water in suppositories Hygroscopicity Incompatibilities Viscosity Brittleness Density Volume Contraction Rancidity Specific Problems In Formulating Suppositories: Details from Lachman page 583

Quality control procedures listed in the USP 26-NF 21 for manufactures suppositories include; Melting range test Liquefaction or softening time test Breaking test Dissolution testing Testing of Suppositories :

References Remington-The Science and Practice of Pharmacy, 21st Edition 2005, Ch No. 44, Page No.883. ANSEL’s Pharmaceutical Dosage Forms and Drug Delivery System, Edition 8th, Ch. No. 12, Page No. 316 to 335. Leon Lachman’s The Theory and Practice of Industrial Pharmacy, 3rd Edition, Section III, Ch. No. 19, Page 582,83,84. for Images.