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      • KCI등재

        Physicochemical and toxicological characterization of sucrosebound polynuclear iron oxyhydroxide formulations

        Bhavesh S. Barot,Punit B. Parejiya,Pragna K. Shelat,Gaurang B. Shah,Dharmik M. Mehta,Trupti V. Pathak 한국약제학회 2015 Journal of Pharmaceutical Investigation Vol.45 No.1

        Intravenous iron formulations comprising ofiron/iron–oxyhydroxide–carbohydrate complex are anestablished therapy for the treatment of iron deficiency anemia. These preparations should be subjected to exhaustive physicochemical and toxicological studies in order to establish their safety and efficacy. Following VenoferⓇ (innovator iron–sucrose formulation), variousiron sucrose similar have entered into the market with equivalent physicochemical and toxicological profile. This report describes the physicochemical and toxicological studies of a novel iron sucrose injection (IS-Claris). IS-Claris and VenoferⓇ were subjected to various physicochemical studies such as elemental and chemical analysis;X-ray diffraction; particle size and distribution; labile iron detection, Mo¨ssbauer and Raman spectroscopy. The presenceof iron oxides in IS-Claris and VenoferⓇ could be confirmed by the major peaks at 24.65˚ (2θ) and 38.2˚ (2θ). The iron sucrose samples demonstrated similar reduction peaks of Fe(III) to Fe in their respective polarograms. The average diameter of the core of IS-Claris and VenoferⓇ was estimated to be 2.92 ± 0.01 and 2.77 ± 0.63 nm, respectively. The Mo¨ssbauer spectra of IS-Claris and VenoferⓇ showed a doublet with an isomer shift δ = 0.43 ± 0.01 mm/s. Moreover, the other physicochemical specifications of IS-Claris were comparable to VenoferⓇ. The toxicological studies demonstrated that IS-Claris safety profile is equivalent to VenoferⓇ. It could be concluded that IS-Claris could be used as a potential alternative to VenoferⓇ with similar clinical implications.

      • KCI등재

        Formulation, optimization and evaluation of microemulsion based gel of Butenafine Hydrochloride for topical delivery by using simplex lattice mixture design

        Shruti Rao,Tularam Barot,K. S. Rajesh,Lalit Lata Jha 한국약제학회 2016 Journal of Pharmaceutical Investigation Vol.46 No.1

        The aim of the present investigation was to develop and evaluate Butenafine Hydrochloride loaded microemulsion based gel for treatment of fungal infection. Pseudo ternary phase diagrams were constructed for different microemulsion formulations composed of Capmul MCM as oil, Cremophor RH 40 as surfactant and Transcutol HP as co-surfactant. Composition of microemulsion system was optimized using simplex lattice mixture design including the concentration of oil, Surfactant co-surfactant ratio (Smix) and water (independent variables) and the % transmittance and globule size of microemulsion (response variables). The physicochemical properties of the optimized microemulsion were investigated. Microemulsion was incorporated into 1 % carbopol 934P gel and the ex vivo drug permeation of gel was also investigated. The results showed that the optimized microemulsion formulation was composed of Capmul MCM oil (5 %, w/w), Cremophor RH 40/Transcutol HP (43.333 %, w/w) and water (51.667 %, w/w). The mean globule diameter was 108.8 nm. The conclusion was that the release controlling ability of microemulsion containing gel formulation was significantly improved in comparison to commercial cream. Skin irritation study was also performed and it shows no irritation on rat skin after 24 h of application. Microbiological assay of Butenafine Hydrochloride was performed where it shows better zone of inhibition than marketed formulation.

      • KCI등재

        Release modulation of highly water soluble drug using solid dispersion: impact of dispersion and its compressed unit

        Punit B. Parejiya,Bhavesh S. Barot,Hetal K. Patel,Dharmik M. Mehta,Pragna K. Shelat,Arunkumar Shukla 한국약제학회 2014 Journal of Pharmaceutical Investigation Vol.44 No.3

        In present day, availability of various carriers,innovative techniques of production and plenty of solventssupport the growth of solid dispersion (SD) technology inpharmaceutical industries to overcome many issues. Thepresent study was aimed to develop SD based sustainedrelease system of Milnacipran HCl (MH). The SD containingethyl cellulose, Eudragit RLPO and Eudragit RSPOat drug–polymer ratios of 1:1, 1:2, and 1:3 were developedusing solvent evaporation technique and different waxes atratio of 1:1, 1:1.25, 1:1.5 and 1:1.75 with drug weredeveloped by melting method. The physicochemicalproperties of SD were evaluated using Fourier transforminfrared spectroscopy (FTIR), differential scanning calorimetry(DSC) and X-ray diffraction (XRD). The desiredSD batch was further compressed into tablet unit to achievepredetermined once a day drug release. Tablets preparedwere evaluated for physicochemical parameters, in vitrodrug release, drug release kinetics and scanning electronmicroscopy. Out of selected carriers, bees wax had shownmaximum release retardation. The results of FTIR, DSCand XRD studies exhibited poor interaction amongst MH–bees wax and retention of crystalline state of MH in SDsystem. The presence of Benecel (HPMC K 200 M;75 mg) in tablets comprising SD (1:1.25, MH:bees wax)revealed remarkable drug release extension and it wasconsidered an optimal. The later was submitted to shortterm stability study and its results indicated the stablecharacteristic of system. Drug release from optimizedformulation fitted well into Higuchi model with anomalousdiffusion. The compressed unit of SD system of highlywater soluble drug can be successful single day regimen.

      • KCI등재

        Quick dissolving films of nebivolol hydrochloride: formulation and optimization by a simplex lattice design

        Punit B. Parejiya,Rakshit C. Patel,Dharmik M. Mehta,Pragna K. Shelat,Bhavesh S. Barot 한국약제학회 2013 Journal of Pharmaceutical Investigation Vol.43 No.4

        Present study aims at formulation and development of quick dissolving film of nebivolol hydrochloride applying simple lattice experimental design using three hetero polymers hydroxypropyl methylcellulose, pullulan and polyvinyl pyrrolidone. Films were prepared using solvent casting technique and optimized formulation was derived by desirability function. Regression equations and contour plots were executed to narrate dependent variables,i.e. percentage drug release in 30 s (Y30), tensile strength,elastic modulus, percentage elongation and load at yield, to independent variables. Results of the experimental design revealed that the independent factors hydroxypropyl methylcellulose and pullulan significantly influenced the mechanical properties and percentage drug release from the film which was ultimately reflect in the formulation of optimized batch. The high % drug release of the film in simulated saliva and simulated gastric fluid indicated that it can be successfully used in drug delivery systems for drugs with high first-pass metabolism.

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