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The bioequivalence of two brands of lisinopril 20 mg tablets was demonstrated in 28 healthy human volunteers after a single oral dose in a randomized cross-over study, conducted at ACDIMA Center for Bioequivalence and Pharmaceutical Studies, Amman, Jordan. Reference (Zestril, AstraZeneca, UK) and test (Lisotec, Julphar, UAE) products were administered to fasting volunteers on 2 treatment days separated by a 2-week washout period; blood samples were collected at specified time intervals, and the plasma was separated and analysed for lisinopril using a validated LC-MS/MS method at ACDIMA Laboratory. The pharmacokinetic parameters AUC(0-t), AUC(0- proportional), C(MAX), T(MAX), T(1/2) and the elimination rate constant were determined from the plasma concentration-time profiles for both formulations and were compared statistically to evaluate bioequivalence between the two brands, using the statistical modules recommended by the FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals fell within the acceptable range for bioequivalence. Based on these statistical inferences it was concluded that the two brands exhibited comparable pharmacokinetic profiles and that Julphar's Lisotec is bioequivalent to Zestril of AstraZeneca, UK.

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A bioequivalence study of two oral formulations of 20 mg fluoxetine was carried out in 24 healthy volunteers following a single dose, two-sequence, crossover randomized design at International Pharmaceutical Research Centre (IPRC), Amman, Jordan. The two formulations were Flutin capsules (Julphar, UAE) as test and Prozac capsules (Eli Lilly, UK) as reference product. Test and reference capsules were administered to each subject after an overnight fasting on two treatment days separated by a 28 day washout period. After dosing, serial blood samples were collected for a period of 360 h. Plasma harvested from blood was analysed for fluoxetine by a sensitive, reproducible and accurate LC-MS method. Various pharmacokinetic parameters including AUC(0-t), AUC(0-infinity), C(max), T(max), T(1/2), and lambda(Z) were determined from plasma concentrations for both formulations and found to be in good agreement with reported values. AUC(0-t), AUC(0-infinity) and C(max) were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval (94.60%-106.41% for AUC(0-t), 94.6%-108.14% for AUC(0-infinity); 91.88%-103.65% for C(max)) for test/reference ratio of these parameters were found within FDA acceptance range of 80%-125%. Based on these statistical inferences, it was concluded that Flutin is bioequivalent to Prozac and can be used interchangeably in medical practice.

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The pharmacokinetic profiles of two brands of losartan 50 mg tablets were compared in 24 healthy adult volunteers after a single oral dose in a randomized cross-over study. The study was conducted at the ACDIMA Center for Bioequivalence & Pharmaceutical Studies, Amman, Jordan. The reference (Cozaar, MSD, The Netherlands) and test (Blosart, Julphar, UAE) products were administered to fasting volunteers. Blood samples were collected at specified time intervals, and the plasma separated and analysed for losartan and its active metabolite (losartan carboxylic acid) using a validated HPLC method with fluorescence detection. Pharmacokinetic parameters AUC(0-t), AUC(0-alpha), C(max), T(max), T(1/2), elimination rate constant, MRT, Cl/F and Vss/F were determined from plasma concentration-time profiles of both formulations and found to be in good agreement with reported values. Three parameters (AUC(0-t), AUC(0-alpha), and C(max)) were compared statistically to evaluate the bioequivalence between the two brands, using statistical modules recommended by the FDA. Analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals fell within the acceptable range (80%-125%) for bioequivalence. Based on these statistical inferences it was concluded that the two formulations exhibited comparable pharmacokinetic profiles and that Julphar's Blosart is bioequivalent to Cozaar of MSD, The Netherlands.

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Two studies were performed to assess the relative bioavailability of Lovrak (Julphar, UAE) compared with Zovirax (Glaxo Wellcome, UK) at the International Pharmaceutical Research Center (IPRC), Amman, Jordan. One study involved acyclovir tablets and the other acyclovir suspension. Each study enrolled 24 volunteers and in both studies, after an overnight fasting, the two brands of acyclovir were administered as a single dose on 2 treatment days separated by 1 week washout period. After dosing, serial blood samples were collected for a period of 16 h. Plasma harvested from blood, was analysed for acyclovir by an HPLC method with UV detection. Various pharmacokinetic parameters including AUC0-t, AUC0-infinity, Cmax, Tmax, T1/2 and Kelm were determined from plasma concentrations for both formulations and found to be in good agreement with the reported values. AUC0-t, AUC(0-proportional to), and Cmax were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence intervals for the test/reference ratio of these parameters were found within the bioequivalence acceptance range 80%-125%. Based on these statistical inferences it was concluded that a Lovrak tablet is bioequivalent to a Zovirax tablet and that Lovrak suspension is bioequivalent to Zovirax suspension.

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A bioequivalence study of two oral formulations of 100 mg atenolol was carried out in 24 healthy volunteers following a single dose, two-sequence, cross-over randomized design at the International Pharmaceutical Research Centre (IPRC), as a joint venture with Al-Mowasah Hospital, Amman, Jordan. The two formulations were Tensotin (Julphar, UAE) as test and Tenormin (Zeneca, UK) as reference product. Both test and reference tablets were administered with 240 ml of water to each subject after an overnight fast on 2 treatment days separated by a 1 week washout period. After dosing, serial blood samples were collected for a period of 36 h. Whole blood was analysed for atenolol by a sensitive, reproducible and accurate HPLC method with fluorescence detection capable of detecting atenolol in the range of 20-1600 ng/ml with a limit of quantitation of 20 ng/ml. Various pharmacokinetic parameters including AUC0-t, AUC0-proportional to), Cmax, Tmax, T1/2 and lambdaZ were determined from blood concentrations of both formulations and found to be in good agreement with reported values. AUC0-t, AUC0-proportional to), and Cmax were tested for bioequivalence after log-transformation of data using ANOVA and 90% confidence interval and were found within the acceptable range of 80%-125%. Based on these statistical inferences, it was concluded that Tensotin is bioequivalent to Tenormin.

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A randomized, two-way, crossover, bioequivalence study in 24 fasting, healthy, male volunteers was conducted to compare two brands of aceclofenac 100 mg tablets, Aceclofar (Julphar, UAE) as test and Bristaflam (Bristol Myers Squibb, Egypt) as the reference product. The drug was administered with 240 ml of water after a 10 h overnight fast on two treatment days separated by 1 week washout period. After dosing, serial blood samples were collected for a period of 24 h. Plasma harvested from blood was analysed for aceclofenac by a validated HPLC method with UV-visible detection capable of detecting aceclofenac in the range 0.2-8.0 microg/ml with the limit of quantitation as 0.2 microg/ml. Various pharmacokinetic parameters including AUC(0-t), AUC(0- infinity ), C(max), T(max), T(1/2), and lambda(Z) were determined from plasma concentrations for both formulations and found to be in good agreement with reported values. AUC(0-t), AUC(0- infinity), and C(max) were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval (100.0%-106.4% for AUC(0-t), 100.2%-106.8% for AUC(0- infinity ); 83.3%-102.8% for C(max)) of test/reference ratio for these parameters were found to be within the bioequivalence acceptance range of 80%-125%. Based on these statistical inferences, it was concluded that Aceclofar is bioequivalent to Bristaflam.

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BACKGROUND: Laser resurfacing has now become an accepted and important component of facial rejuvenation. With the introduction of computerized scanning systems, the actual laser resurfacing technique has been greatly simplified; however, the final outcome still depends to a large extent on the efficiency of the postlaser wound care in promoting wound healing and preventing early and late complications. It has been repeatedly confirmed that a moist environment is the single most important external factor affecting the rate of re-epithelialization. Occlusive moisture-retentive dressings, however, are difficult to apply and maintain in position and may as well be complicated by serious infections. OBJECTIVE: Moist exposed burn ointment has been shown to maintain adequate moisture for optimal healing by frequent ointment application without the need for a secondary overlying dressing. It would be ideal for postoperative laser care. METHODS: Twenty-eight consecutive patients treated with coherent ultrapulse CO2 laser in Toulouse, France, were included in the trial. Moisture-retentive ointment was applied over the treated areas every 4 to 6 hours. Healing was assessed clinically and with repeated transepidermal water loss measurements. Swab cultures were taken, and pain was evaluated with a visual analog scale. Colorimetric analysis of pictures taken was statistically compared with picture analysis of 20 patients treated earlier with an occlusive dressing. RESULTS: Uneventful timely healing occurred in all patients with minimal pain and discomfort. Healing with moist exposed therapy resulted in faster recovery of cutaneous erythema, as evidenced by colorometry. CONCLUSION: Moist exposed burn ointment application can be safely considered a good and valid alternative to occlusive dressings for postoperative laser care.

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The bioequivalence of two brands of enalapril 20 mg tablets was demonstrated in 24 healthy human volunteers after a single oral dose in a randomized cross-over study, conducted at IPRC, Amman, Jordan. Reference (Renitec, MSD, Netherlands) and test (Narapril, Julphar, UAE) products were administered to fasted male volunteers; blood samples were collected at specified time intervals, plasma separated and analysed for enalapril and its active metabolite (enalaprilat) using a validated LC-MS/MS method at Cartesius Analytical Unit, Institute of Biomedical Sciences, USP, Sao Paulo, Brazil. The pharmacokinetic parameters AUC(0-t), AUC(0-infinity), Cmax, Tmax, T(1/2) and elimination rate constant were determined from plasma concentration-time profile for both formulations and were compared statistically to evaluate bioequivalence between the two brands, using the statistical modules recommended by FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals fell within the acceptable range for bioequivalence. Based on these statistical inferences it was concluded that the two brands exhibited comparable pharmacokinetic profiles and that Julphar's Narapril is bioequivalent to Renitec of MSD, Netherlands.

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A randomized, two-way, crossover, bioequivalence study was conducted in 24 fasting, healthy, male volunteers to compare two brands of furosemide 40 mg tablets, Salurin (Julphar, UAE) as test and Lasix (Hoechst AG, Germany) as reference product. The study was performed at the International Pharmaceutical Research Centre (IPRC), in a joint venture with Al-Mowasah Hospital, Amman, Jordan. One tablet of either formulation was administered with 240 ml of water after a 10 h overnight fast. After dosing, serial blood samples were collected for a period of 12 h. Plasma harvested from blood was analysed for furosemide by a validated HPLC method. Various pharmacokinetic parameters including AUC(0-t), AUC(0-infinity), C(max), T(max), T(1/2), and elimination rate constant were determined from plasma concentrations of both formulations. Statistical modules (ANOVA and 90% confidence intervals) were applied to AUC(0-t), AUC(0-infinity), and C(max) to assess the bioequivalence of the two brands which revealed no significant difference between them, and 90% CI fell within the US FDA accepted bioequivalence range of 80%-125%. Based on these statistical inferences, Salurin was found to be bioequivalent to Lasix.

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The pharmacokinetics of two brands of simvastatin 40 mg tablets were compared in 24 healthy human volunteers after a single oral dose in a randomized cross-over study, conducted at IPRC, Amman, Jordan. Reference (Zocor, MSD, Netherlands) and test (Simvast, Julphar, UAE) products were administered to fasted volunteers; blood samples were collected at specified time intervals, plasma separated and analyzed for simvastatin and its active metabolite (beta-hydoxy acid) using a validated LC-MS/MS method at Cartesius Analytical Unit, Institute of Biomedical Sciences - USP, Sao Paulo, Brazil. The pharmacokinetic parameters AUC(0-t), AUC(0-variant), C(MAX), T(MAX), T(1/2) and elimination rate constant were determined from plasma concentration-time profile for both formulations and were compared statistically to evaluate bioequivalence between the two brands, using the statistical modules recommended by FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals fell within the acceptable range for bioequivalence. Based on these statistical inferences it was concluded that the two brands exhibited comparable pharmacokinetic profiles and that Julphar's Simvast is bioequivalent to Zocor of MSD, Netherlands.

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Toxic epidermal necrolysis (TEN) is a rare condition that was described by Lyell in 1956. It is a severe, acute, adverse, primarily drug-induced, potentially fatal, cutaneous reaction that is characterized by large areas of skin desquamation and sloughing, similar in many aspects to second-degree burns. The treatment of cutaneous drug reactions rests essentially on immediate diagnosis and recognition of the disease process, accurate history, thorough physical examination, prompt discontinuation of the offending drug, and supportive care. TEN patients are best managed in specialized burn units. Nevertheless, the management remains very much individualized, based on the clinical setting. Topical wound care remains an essential factor in the treatment of burn-like syndromes and is a main determining parameter for morbidity and mortality. As the value of moist environment in wound healing is being fully appreciated, we report on the use of a newly introduced ointment, the Moist Exposed Burn Ointment (Julphar; Gulf Pharmaceutical industries, Ras El-Khaymah, United Arab of Emirutes), a moisture-retentive ointment, in the successful management of a case of TEN.

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BACKGROUND: There is growing evidence of improved healing of full- and partial-thickness cutaneous wounds in wet and moist environments. Retention of biologic fluids over the wound prevents desiccation of denuded dermis or deeper tissues and allows faster and unimpeded migration of keratinocytes over the wound surface. It allows also the naturally occurring cytokines and growth factors to exert their beneficial effect on wound contracture and re-epithelialization. Despite all of these documented benefits, applying the moist healing principles to large surface areas, in particular to large burns, is hindered by the major technical handicap of creating and maintaining a sealed moist environment over these areas. METHODS: From January to September 2001, healing of partial-thickness skin graft donor sites was studied in a prospective comparative study of two types of moist dressings, Tegaderm (3M Health Care, St. Paul, MN), a semipermeable membrane occlusive dressing, and moist exposed burn ointment (MEBO) (Julphar; Gulf Pharmaceutical Industries, United Arab of Emirates), an ointment that can provide a moist environment without the need of an overlying occlusive dressing. Healing was assessed both clinically and with serial measurements of transepidermal water loss (TEWL) and moisture. Following healing, scar quality was evaluated by two members of the team separately using a visual analog scale. Results were statistically analyzed. RESULTS: Faster healing was observed clinically with MEBO application. Physiologic healing as determined by TEWL measurements occurred at an extremely significant earlier stage for MEBO, and this was associated with better scar quality, demonstrating a positive relationship between function and cosmetic appearance. Moreover, the ointment is definitely easier to apply than the occlusive self-adhesive membrane, which requires some degree of dexterity and expertise. CONCLUSION: MEBO application is an effective and valid alternative to conventional occlusive dressings. Moreover, the observed improved anatomic and physiologic healing indicates that MEBO may have a positive effect on healing more that the mere fact of passive moisture retention.

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A study was conducted to establish bioequivalence between two oral cyclosporine 100 mg capsules, Sigmasporin Microoral (Gulf Pharmaceutical Industries - Julphar, United Arab Emirates, under technical co-operation with Sigma Pharma, Brazil) and Sandimmun Neoral (Novartis, Switzerland), in a Middle Eastern population, even though both formulations were found to be bioequivalent earlier in a Brazilian population (data on file). It was designed as a randomized, open label, two-way crossover study in which 30 fasting, healthy male volunteers received a single 100 mg cyclosporine dose with 240 ml of water on two treatment days separated by a 1 week washout period. After dosing, serial blood samples were collected for a period of 24 h. Plasma was analyzed for cyclosporine A by a sensitive, reproducible and accurate HPLC method with MS detection capable of detecting cyclosporine A in the range of 5-400 ng/ml with a limit of quantitation of 5 ng/ml. Various pharmacokinetic parameters including AUC(0-t), AUC(0- proportional, variant ), C(max), T(max), T(1/2), and lambda(Z) were determined from plasma concentrations of both formulations. AUC(0-t), AUC(0- proportional, variant ), and C(max) were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence intervals (82.98-110.57% for AUC(0-t), 81.57-124.71% for AUC(0- proportional, variant ), 80.15-98.91% for C(max)) for these parameters were found to be within the bioequivalence acceptance range of 80-125%. Based on these statistical inferences, it was concluded that Sigmasporin Microoral is bioequivalent to Sandimmun Neoral.

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Burn injury is one of the most devastating injuries that may affect a patient. Even in economically deprived areas, burn care is largely driven by relatively plentiful resources equating quality of care with generous monitoring and clinical attention with little concern to management cost. Burn care costs have been the subject of very few investigations and are among the least studied by health services researchers. Nevertheless, it can be stated that local care of burn wounds accounts for a large proportion of the cost per day for treating patients. As economic times are changing and as market penetration of managed care contracts and stiff competition in the health care industry gains momentum, ways to reduce expenditures without adversely affecting the quality of care have become of primary importance. We report a randomized prospective comparative study analyzing the benefit-cost value of moist exposed burn ointment (MEBO) application, an exposed method for burn wound care without the need for a secondary covering dressing, as compared to conventional closed methods.

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A randomized, two-way, crossover study was conducted in 24 fasting, healthy, male volunteers to compare the bioavailability of two brands of metformin 500 mg tablets; Dialon (Julphar, UAE) as test and Glucophage (Lipha Pharmaceutical Industries, France) as reference product. The study was performed at the International Pharmaceutical Research Centre (IPRC), in joint venture with Al-Mowasah Hospital, Amman, Jordan. The drug was administered with 240 ml of water after a 10-h overnight fasting on two treatment days separated by 1-week washout period. After dosing, serial blood samples were collected for a period of 30 h. Plasma harvested from blood was analyzed for metformin by validated HPLC method with UV-visible detector capable to detect metformin in the range of 0.05-5.0 microg/ml with limit of quantitation of 0.05 microg/ml. Various pharmacokinetic parameters including AUC(0-t), AUC(0-proportional to), C(max), T(max), T(1/2), and lambda(Z) were determined from plasma concentrations of both formulations and found to be in good agreement with reported values. AUC(0-t), AUC(0-proportional to) and C(max) were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval (97.9-110.8% for AUC(0-t), 97.4-110.7% for AUC(0-proportional to); 95.3-110.5% for C(max)) of test/reference ratio for these parameters were found within bioequivalence acceptance range of 80-125%. Based on these statistical inferences, it was concluded that Dialon is bioequivalent to Glucophage.

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A randomized, two-way, crossover, bioequivalence study in 24 fasting, healthy, male volunteers was conducted to compare two brands of gliclazide 80 mg tablets, Glyzide (Julphar, UAE) as test and Diamicron (Servier Industries, France) as reference product. The study was performed at the International Pharmaceutical Research Centre (IPRC), in joint venture with Speciality Hospital, Amman, Jordan. The drug was administered with 240 ml of 20% glucose solution after a 10 h overnight fasting. After dosing, serial blood samples were collected for a period of 48 h. Plasma harvested from blood was analyzed for gliclazide by validated HPLC method. Various pharmacokinetic parameters including AUC(0-t), AUC(0- proportional, variant), C(max), T(max), T(1/2), and elimination rate constant were determined from plasma concentrations of both formulations. Statistical modules (ANOVA and 90% confidence intervals) were applied to AUC(0-t), AUC(0- proportional, variant), and C(max) for bioequivalence evaluation of the two brands which revealed no significant difference between them, and 90% CI fell within US FDA accepted bioequivalence range of 80-125%. Based on these statistical inferences, Glyzide was judged bioequivalent to Diamicron.

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Following traumatic or surgical injury to the skin, wounds do not heal by tissue regeneration but rather by scar formation. Though healing is definitely a welcomed event, the resultant scar, very often, is not aesthetically pleasing, and not infrequently, may be pathologic causing serious deformities and contractures. Management of problematic scars continues to be a frustrating endeavor with less than optimal results. Prophylactic methods of wound management to minimize serious scarring are being developed. In a previously published study, we have demonstrated improved healing of split thickness skin graft donor sites following treatment with Moist Exposed Burn Ointment (MEBO, Julphar Gulf Pharmaceutical Industries, Ras Al-Khaimah, UAE). At present, we are reporting the results of a comparative clinical prospective study evaluating scar quality following primary healing of elective surgical and traumatic facial wounds with prophylactic MEBO application, topical antibiotic ointment application, and no topical therapy at all. Scars were evaluated according to the Visual Analogue Scale for scar assessment. Statistical analysis of scar assessment scores demonstrated marked prevention of unfavorable scars with improved cosmetic results following MEBO prophylactic therapy.

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