الفهرس 
IntroductionOnly 14 pages are availabe for public view
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Abstract
Phenytoin is a remarkable multipurpose, commonly prescribed anticonvulsant drug. It is still the most efficacious, cost effective and widely prescribed for the treatment for epilepsy particularly in countries with limited financial resources.
Wide variations in the in vitro performance of various Phcnytoin sodium solid dosage forms were reported in different countries and were reflected on its bioavailability and clinical performance.
Despite the relatively high water solubility of phenytoin sodium, variations in the dissolution rate of its solid dosage forms, and even failure of some phenytoin sodium capsules to comply with the USP dissolution requirements were reported as shown previously. This presents a serious practical problem, in view of the narrow therapeutic index (10-20 igIrnl) of phenytoin.
The main problem of variations in the release of Phenytoin sodium from preparations is its stability. Phenytoin sodium is a hygroscopic powder, which is converted to the practically insoluble acid form. resulting in incomplete drug release.
Poor in vitro performance of solid dosage forms of phenytoin sodium products can, therefore, be attributed to poor storage conditions.
Part one
Assess the quality of locally manufactured capsules containing phenytoin sodium in order to improve their performance, through the assessment of the in-vitro performance of locally manufactured capsules containing phenytoin sodium in comparison with standard phenytoin sodium capsules (Phenytoin sodium, Parke Davis).
It also identify the factors involved in the fluctuations of pharmaceutical quality of the locally manufactured capsules as physicochemical properties of the drug, formulation factors, manufacturing methods, Packaging, and storage conditions of the raw material and the finished product. The study included measuring the dissolution stability of the test and standard capsules either packed in the container of marketed Epanutin capsules (packed) or removed from their outer pack (unpacked) under various stress humidity(60%,75%, and 90% RH).
The obtained data indicates that humidity has a detrimental effect on the properties and performance of phenytoin sodium capsules of both the standard and the test products. This point to the great influence of storage conditions on the pharmaceutical quality of phenytoin sodium capsules during their shelf life.
Furthermore, the pack of the standard Phenytoin sodium product (plastic box) obviously provides greater protection against humidity compared to that of the locally manufactured product (at um i num strip).