In Vivo Evaluation of Stable Cream Containing Flavonoids on Hydration and TEWL of Human Skin

Antioxidants contribute to endogenous photoprotection and are important for the maintenance of skin health. The study was carried out to compare the skin hydration and transepidermal water loss (TEWL) effects of a stable cosmetic preparation containing flavonoids, following two applications a day over a period of tenth week. The skin trans-epidermal water loss and skin hydration effect was measured at the beginning and up to the end of study period of ten weeks. Any effect produced was measured by Corneometer and TEWA meter (Non-invasive probe). Two formulations were developed for this study design. Formulation one the control formulation in which no apple juice extract( Flavonoids) was incorporated while second one was the active formulation in which the apple juice extract (3%) containing flavonoids was incorporated into water in oil emulsion using Abil EM 90 as an emulsifier. Stable formulations (control and Active) were applied on human cheeks (n = 12) for a study period of 10 weeks. Result of each volunteer of skin hydration and TEWL was measured by corneometer and TEWA meter. By using ANOVA and Paired sample t test as a statistical evaluation, result of both base and formulation were compared. Statistical significant results (p≤0.05) were observed regarding skin hydration and TEWL when two creams, control and Formulation were compared. It showed that desired formulation (Active) may have interesting application as an active moisturizing cream on healthy skin.

New Simultaneous High Performance Liquid Chromatographic Method for Determination of NSAIDs and Opioid Analgesics in Advanced Drug Delivery Systems and Human Plasma

A new and cost effective RP-HPLC method was developed and validated for simultaneous analysis of non steroidal anti inflammatory dugs Diclofenac sodium (DFS), Flurbiprofen (FLP) and an opioid analgesic Tramadol (TMD) in advanced drug delivery systems (Liposome and Microcapsules), marketed brands and human plasma. Isocratic system was employed for the flow of mobile phase consisting of 10 mM sodium dihydrogen phosphate buffer and acetonitrile in molar ratio of 67: 33 with adjusted pH of 3.2. The stationary phase was hypersil ODS column (C18, 250×4.6 mm i.d., 5 μm) with controlled temperature of 30 C°. DFS in liposomes, microcapsules and marketed drug products was determined in range of 99.76-99.84%. FLP and TMD in microcapsules and brands formulation were 99.78 - 99.94 % and 99.80 - 99.82 %, respectively. Single step liquid-liquid extraction procedure using combination of acetonitrile and trichloroacetic acid (TCA) as protein precipitating agent was employed. The detection limits (at S/N ratio 3) of quality control solutions and plasma samples were 10, 20, and 20 ng/ml for DFS, FLP and TMD, respectively. The Assay was acceptable in linear dynamic range. All other validation parameters were found in limits of FDA and ICH method validation guidelines. The proposed method is sensitive, accurate and precise and could be applicable for routine analysis in pharmaceutical industry as well as in human plasma samples for bioequivalence and pharmacokinetics studies.

Pharmaceutical Microencapsulation Technology for Development of Controlled Release Drug Delivery systems

This article demonstrated development of controlled release system of an NSAID drug, Diclofenac sodium employing different ratios of Ethyl cellulose. Diclofenac sodium and ethyl cellulose in different proportions were processed by microencapsulation based on phase separation technique to formulate microcapsules. The prepared microcapsules were then compressed into tablets to obtain controlled release oral formulations. In-vitro evaluation was performed by dissolution test of each preparation was conducted in 900 ml of phosphate buffer solution of pH 7.2 maintained at 37 ± 0.5 °C and stirred at 50 rpm. At predetermined time intervals (0, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hrs). The drug concentration in the collected samples was determined by UV spectrophotometer at 276 nm. The physical characteristics of diclofenac sodium microcapsules were according to accepted range. These were off-white, free flowing and spherical in shape. The release profile of diclofenac sodium from microcapsules was found to be directly proportional to the proportion of ethylcellulose and coat thickness. The in-vitro release pattern showed that with ratio of 1:1 and 1:2 (drug: polymer), the percentage release of drug at first hour was 16.91 and 11.52 %, respectively as compared to 1:3 which is only 6.87 % with in this time. The release mechanism followed higuchi model for its release pattern. Tablet Formulation (F2) of present study was found comparable in release profile the marketed brand Phlogin-SR, microcapsules showed an extended release beyond 24 h. Further, a good correlation was found between drug release and proportion of ethylcellulose in the microcapsules. Microencapsulation based on coacervation found as good technique to control release of diclofenac sodium for making the controlled release formulations.