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Intravenous polynuclear iron formulations are vital components in the treatment of iron deficiency anemia associated with chronic kidney disease as well as other diseases associated with gastro-intestinal and cardio-vascular system. Intravenous iron preparations consist of iron-carbohydrate nanoparticles with iron-oxyhydroxide as a core covered by carbohydrate shell. These preparations should be very well characterized in terms of their physicochemical properties and pharmacological profile in order to establish safety and efficacy. The present research work was aimed to physicochemically characterize a new generic iron-sucrose preparation (IS-Claris) and establish its equivalency with the reference product (Venofer®). Various analytical techniques including gel permeation chromatography (GPC), mass spectroscopy (MALDI-TOF), absorption spectroscopy, X-ray diffraction analysis (XRD), nuclear magnetic resonance spectroscopy (proton and 13C NMR), Fourier transform infrared spectroscopy (FTIR) and thermal gravimetric analysis (TGA) were employed. It was observed that the specifications of IS-Claris obtained through these analyses reflect those of Venofer® and hence the two formulations were considered comparable. [ABSTRACT FROM AUTHOR]

The study was aimed toward development of modified release oral drug delivery system for highly water soluble drug, Milnacipran HCl (MH). Novel Tablet in Tablet system (TITs) comprising immediate and extended release dose of MH in different parts was fabricated. The outer shell was composed of admixture of MH, lactose and novel herbal disintegrant obtained from seeds of Lepidium sativum. In the inner core, MH was matrixed with blend of hydrophilic (Benecel®) and hydrophobic (Compritol®) polymers. 32 full factorial design and an artificial neuron network (ANN) were employed for correlating effect of independent variables on dependent variables. The TITs were characterized for pharmacopoeial specifications, in vitro drug release, SEM, drug release kinetics and FTIR study. The release pattern of MH from batch A10 containing 25.17% w/w Benecel® and 8.21% w/w of Compritol® exhibited drug release pattern close proximal to the ideal theoretical profile (t50% = 5.92 h, t75% = 11.9 h, t90% = 18.11 h). The phenomenon of drug release was further explained by concept of percolation and the role of Benecel® and Compritol® in drug release retardation was studied. The normalized error obtained from ANN was less, compared with the multiple regression analysis, and exhibits the higher accuracy in prediction. The results of short-term stability study revealed stable chataracteristics of TITs. SEM study of TITs at different dissolution time points confirmed both diffusion and erosion mechanisms to be operative during drug release from the batch A10. Novel TITs can be a succesful once a day delivery system for highly water soluble drugs. [ABSTRACT FROM AUTHOR]

Incorporation of weakly basic drugs, exhibiting pH dependent solubility, into oral sustained release delivery systems shows pH dependent release profiles. The strongly inhibited drug release in basic media can be raised by creating acidic microenvironment using acidic excipients, which was explored by incorporating fumaric acid and citric acid as acidifiers in present study. A 32 full factorial design was applied to study effects of different ratios of acidifiers and optimization of cinnarizine matrix tablets. Drug dissolution study was performed using modified flow through cell, fabricated to maintain sink condition throughout the study. Presence of acidifiers was checked by measuring tablet surface pH. Citric acid could effectively overcome pH dependent solubility compared to fumaric acid but it quickly depleted from the matrix, while fumaric acid could retain into the matrix for longer time but it showed lower acidifying capacity. Hence, proper selection of acidifiers may give pH independent release profiles of weakly basic drugs like cinnarizine. [ABSTRACT FROM AUTHOR]

Milnacipran is an antidepressant drug belonging to the class of serotonin and noradrenaline reuptake hibitors. A new, rapid, simple and sensitive spectrophotometric method has been developed for the determination of milnacipran in bulk and pharmaceutical formulations. The linearity was observed in -1 e concentration range of 2-45 µg mL-1. The method is based on spectrophotometric determinaiton. Absorbance of milnacipran was determined at 220 nm wavelength. The method was validated in terms of accuracy and precision (intra and interday variations). This method is extended to pharmaceutical preparations. Results of the analysis were validated statistically and by recovery studies. The proposed method was found accurate, reproducible and economical for the routine analysis of milnacipran in bulk and pharmaceutical formulation. [ABSTRACT FROM AUTHOR]