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A. Oleaginous Bases:: (I) Glycero - Gelatin
A. Oleaginous Bases:: (I) Glycero - Gelatin
A. Oleaginous Bases:: (I) Glycero - Gelatin
A. Oleaginous bases:
Theobroma oil or cocoa butter was introduced as base in 1852 and has been one of the most widely
used bases. It satisfies most of the criteria of an ideal suppository base but it melts at 32°C i.e.,
below the body temperature.
Overheating alters its physical characteristics and it has a tendency to adhere to the mold when
solidified. It may exist in 4 crystalline states.
α Form : This form is obtained by suddenly cooling the melted mass to 0 °C. Its melting point is
24°C. .
β Form : This form is obtained when cocoa butter is melted at 35 to 36°C and slowly cooled. It
melts at 18 to 23°C.
γ Form : It is obtained by pouring a cool (20°C) cocoa butter into a container before it is solidified
and cooled at deep freeze temperature. It melts at 18°C.
All the four forms are unstable and are converted to stable form over a period of several days. Thus
extreme care should be exercised while melting and cooling cocoa butter. As a general rule, the
minimal use of heat during the melting process is recommended.
Cocoa butter can take up to 20 to 30g of water per 100 g. The incorporation of emulsifiers such as
Tween 61 (5 to 10%) increases the water absorption capacity of cocoa butter.
Drugs like volatile oils, cresol, phenol and chloral hydrate lower the melting point of cocoa butter
considerably and hence some wax and spermaceti can be used to correct such a problem.
To overcome drawbacks of cocoa butter, hydrogenated palm kernel and soyabean oils have been
suggested. Palm kernel oil is particularly suggested for use in tropical countries. Completely or
partially hydrogenated cottonseed oil such as 'Cotoflakes' and 'Cotomar' together with hexanediol
has also been suggested.
Edible hydrogenated vegetable oil in combination with some waxes has been worked out in India.
Pas a major constituent of the official suppository bases.
B. Aqueous bases
(i) Glycero - gelatin:
It is a mixture of glycerin and water made into a stiff jell by the addition of gelatin. The proportion
of gelatin can be varied according to the intended use of the preparation.
Gelato-glycerin bases dissolve in the body fluids liberating contained medicaments Gelato-glycerin
Mass BP contains 14% gelatin, 70% glycerin and water. USP formula contains 20% gelatin together
with 70% of glycerin.
For dispensing purposes, good quality powdered gelatin should be used. In order to control the
consistency, glycerin can be partially or wholly substituted by propylene glycol and polyethylene
glycols. The incompatibility of some medicaments can be avoided by the use of either Pharmagel
A (cationic) or Pharmagel B (anionic). Glycerin suppositories being liable to mould growth,
preservatives should be added.
Different mixtures of polyethylene glycols are marketed under the trade names of Postonals, Carbo
waxes and Macrogols.
Most of the drugs commonly administered in suppository form are compatible with these bases.
Polyethylene glycols are however incompatible with phenols and reduce the antiseptic effects of
quaternary ammonium compounds.
C. Emulsifying bases:
Massa Esterinum, Witepsol and Massupol are the trade names under which the emulsifying bases
are marketed. Massa Esterinum is a mixture of the mono-, di- and tri-glycerides of the fatty acids
having the formula C11H23COOH to C17H35COOH. Witepsol bases consist of hydrogenated
triglycerides of lauric acid with added monoglycerides. These are available in 9 grades. Massupol
consists of glyceryl esters namely of lauric acid and addition of very small quantity of glyceryl
monostearate.
All these bases are free from the drawbacks of cocoa butter and don't require any mold lubricant.
Water-dispersible bases essentially consist of surfactants. They melt at body temperature. Some
formulae of dispersible bases containing surfactants are outlined below.