An in vitro isolated human skin technique with known reliable predictive value for in vivo performance was used to compare the skin penetration of the proprietary ibuprofen gel formulation, IbugelTM, with five other commercially available topical formulations containing ibuprofen 5%: IbusprayTM, IbumousseTM, Proflex CreamTM, Fenbid GelTM and Deep Relief GelTM. There was a marked difference between some formulations in the percentage of applied ibuprofen penetrating the skin samples, with IbusprayTM, IbugelTM and IbumousseTM showing the most efficient penetration. The percentage of applied ibuprofen penetrating the skin samples from these formulations was significantly greater (p < 0.05) at all sampling intervals when compared with Proflex CreamTM, Fenbid GelTM or Deep Relief GelTM. By 48 h, the percentage of applied ibuprofen that had penetrated through the skin samples from IbusprayTM, IbugelTM and IbumousseTM was approximately 2.5 times greater than that from Deep Relief GelTM, 3 times greater than that from Proflex CreamTM and 5 times greater than that from Fenbid GelTM. The data demonstrate that, with topically applied preparations, the composition of the vehicle can have a significant impact on the percutaneous penetration of the active medicament. The possible reasons for this are discussed in terms of partition and diffusion phenomena. Different topical presentations of the same drug substance – especially agents like ibuprofen which are intended for subcutaneous action – cannot be assumed to be pharmaceutically and clinically equivalent or indeed interchangeable.
BackgroundFew studies have directly compared the effectiveness of different emollients in vivo, and the important matter of patient preference is generally overlooked.MethodsWe report the results of an assessor-blinded, bilateral, concurrent comparison of two emollient pharmaceutical presentations, ie, Doublebase gel (DB) and Aqueous cream BP (AC), applied by 20 participants three times daily for 7 consecutive days. The primary efficacy endpoint was cumulative improvement in skin hydration measured by corneometry on days 1, 3, and 5 immediately before the first application and approximately 2 hours after the third application of the day. Secondary endpoints were investigator assessment of skin condition at these time points and participant assessment of product acceptability at the end of the study.ResultsBoth products increased skin hydration, but the effect of AC was relatively modest, with morning values readily returning to pretreatment levels. Hydration levels were higher for DB gel, maintained at all time points, and showed stepwise, cumulative increases over the 7 days of use. Overall patient satisfaction scores were higher for DB gel, and especially for “consistency,” “ease of use,” and “ease of absorption into the skin.” Eighty-five percent of participants expressed a desire to use DB gel again as compared with 40% for AC.
Objective: The aim of this study was to compare the moisturising efficacy and acceptability of physical characteristics of two commonly prescribed emollients licenced in the UK, Doublebase Dayleve gel (DELP) and Diprobase cream (DIPC). Methods: The study was a double-blind, concurrent bi-lateral comparison in female eczema subjects with dry skin. Results: In Part 1, comparing the area under the curve (AUC) change from baseline corneometer readings over 24 h following single applications of the emollients to the volar forearms of 34 subjects, the AUC for DELP was more than three times that seen for DIPC (p < 0.0001). In Part 2, comparing the same outcome measured over 5 days of twice daily applications to the lower legs in 36 subjects, the AUC for DELP was approximately five times that for DIPC (p < 0.0001). 69% of subjects “Like Slightly” or “Like Strongly” DELP compared to 33% for DIPC (p = 0.025). 72% indicated they would use DELP again compared to 33% for DIPC (p = 0.033). 75% of subjects preferred DELP, 17% preferred DIPC and 8% expressed no preference (p = 0.0004).
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