Transcript The Ideal Suppository Base


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
Applications:
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
Factors affecting drug absorption from suppositories:
1.Physiological factors
2.Physico chemical characters of drug
3.Physico chemical characters of base
The Ideal Suppository Base:
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 (continued):





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
3.Physico chemical characters of base
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(continued)
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
Types of Suppository Bases
a) Typical Vegetable Oils :
 1. Theobroma oil/ Cocoa butter is the fat
obtained from the roasted seeds of
Theobroma cocoa
*Melting point is 30-36 °C / 86-97 °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):
Manufacture of Suppositories:






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
Specific Problems In Formulating Suppositories:
Details from Lachman page 583








Water in suppositories
Hygroscopicity
Incompatibilities
Viscosity
Brittleness
Density
Volume Contraction
Rancidity
Testing of Suppositories:
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




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.
www.google.com for Images.