Studies on Pseudomonas Cepacia Isolated from Cystic Fibrosis patients Natural& Soures

Gram-negative rod Burkholderia cepacia is an oprtunistic pathogen and it is considered the major pathogen in patients with cystic fibrosis (CF). Immunocomprimised patients can acquire infection with B. cepacia. B. cepacia can be isolated from environment and from different sources. B. cepacia is actually a cluster of at nine closely related genomic species (or genomovars) which constitute B. cepacia complex. This work aimed mainly to study the B. cepacia behavior, in addition to find out the differences between environmental and pathogenic isolates.2- Among the investigated water-soluble based pessaries, formula No. 18 (PEG 1500: PEG 400; 90:10 weight ratio.) gives the heighest drug release. whereas, formula No. 3 (Suppocire AM) gives the heighest drug release among the prepared fatty-based pessaries.3- Incorporation of ketoconazole in the form of inclusion complex with -CD in both binary and ternary systems improves the drug release from water-soluble suppository bases than from fatty suppository bases.4- The heighest drug release is achieved from the formulated pessaries with PEG 1500: PEG 400 (90:10 weight ratio) containing the coground mixture of ketoconazole/-CD/PVP 40000 ternary system (Formula No. 31).Selected suppository formulations were subjected to shelf-storage stability studies. Accordingly, the selected formulae were stored in amber colored closed glass containers at ambient conditions and on the shelf of refrigerator for 6 months. Samples were subjected to re-evaluation study to test the drug content remained, physical characteristics as well as the dissolution characteristics.The obtained results revealed that ketoconazole vaginal pessaries are physically stable under ambient conditions and in general these pessaries should be stored in a cool place in closed containers.Chapter 2Clinical evaluation of the prepared ketoconazole vaginal pessariesThis study was conducted in Out patient Gynecological Clinic of Assiut University Hospital.Thirty women were selected for this study and randomly assigned to one of the three studied groups. Group (1), which received ketoconazole vaginal pessaries containing 200 mg of the drug alone. Group (2), that received ketoconazole vaginal pessaries containing ketoconazole/-CD/PVP 40000 coground mixture equivalent to 50 mg of the drug. The last group was the control group whose patients received 200 mg miconazole vaginal suppositories (GynozoleTM).Two vaginal swabs were taken from each women diagnosed to have Vulvovaginal Candidiasis (VVC), one swab after enrollment and the second after one week from the beginning of the treatment.The results of clinical examination, microbiological evaluation and patient complaints were recorded in an evaluation sheet for each patient.Percent reduction in candida albicans (C. albicans) colonies count after treatment was calculated for each woman in each group.The results of the clinical and microbiological evaluations revealed that:1- The best clinical and microbiological responses are obtained in patients of group (2), receiving ketoconazole vaginal pessaries containing ketoconazole/-CD/PVP 40000 coground mixture equivalent to 50 mg of the drug.2- There is a statistically significance difference between the percent reduction in C. albicans colonies count in patients of group (2) and that in patient of the control group.Therefore, from this study it could be concluded that ketoconazole can be formulated into vaginal pessaries in which the dose of ketoconazole can be reduced to one quarter as compared to the oral effective dose of ketoconazole.