الفهرس 
INTRODUCTIONOnly 14 pages are availabe for public view
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Abstract
Rectal administration of drugs for systemic action may be particularly
important, especially when the drug cannot be tolerated orally, where
patient suffer from nausea or vomiting. In addition, rectal
administration is preferred in case of infants. Furthermore, rectally
administered drugs are absorbed directly into the general circulation,
bypass the liver which may bring about a faster onset of action than
after oral administration and avoid enzymatic decomposition.
It is well known that therapeutic effectiveness of the final
pharmaceutical dosage forms depends on the medicament and the
excipients used.
The objective of the present work was to formulate and characterize
diclofenac sodium in a rectal dosage form. Further to investigate the
physical stability of the proposed dosage forms.
These investigations together with the obtained results and the attained
conclusions can be summarized as follows:
The rectal dosage form is a promising method towards non-steroidal
anti-inflammatory drugs, especially when these drugs are major factors
in gastric irritation and bleeding.
The suppositories of diclofenac sodium were prepared by fusion
method with several bases including cocoa butler, witepsol H15,
witepsol W25, Witepsol W35 and Witepsol E75. Release rate of the
drug from these suppositories was dependent on the nature of base
employed and quantitatively release was in the order Cocoa butter >
Witepsol H15 > witepsol W25 > witepsol W35 > witepsol E75.
Formulation of polyethylene glycol suppositories indicated slow and
insufficient release.
Abstract
iii
The softening point, liquefaction point and flow point of diclofenac
sodium suppositories formulated with fatty bases is not affected by
either the nature of the base, incorporated medicament or upon
aging.
The softening point, liquefaction point and flow point of diclofenac
sodium suppositories formulated with polyethylene glycol base
decrease upon incorporation of the medicament. Aging has no effect on
these parameters.
Disintegration time of diclofenac sodium suppositories formulated with
fatty bases decreases upon incorporation of the medicament, while, the
nature of the base and aging have no effect.
Dissolution time of diclofenac sodium suppositories formulated with
polyethylene glycol base increases upon incorporation of the
medicament or increasing the medicament concentration and is not
affected by aging.
The hardness of diclofenac sodium suppositories formulated with
polyethylene glycol base is higher than that of those formulated with
fatty bases
Neither color change nor crystal growth is observed on the surface of
diclofenac sodium suppositories formulated with all tested bases.
There is no change in the in vitro release profile of diclofenac sodium
suppositories formulated with fatty bases after a period of one-year
storage, while, a relative lowering with those formulated with
polyethylene glycol base