• Chronic Arsenic Toxicity and Cancer

      Arsenic pollution in ground water has been envisaged as a problem of Global concern. Chronic arsenic toxicity (arsenicosis) due to drinking of arsenic contaminated ground water is a major environmental health hazard throughout the world including India and Bangladesh. Chronic exposure to arsenic in drinking water can cause increased risk of skin, lung, kidney, bladder cancer, liver disease and chronic respiratory problems. The exact molecular mechanism of arsenic induced carcinogenesis is still less understood. Both arsenite and its metabolites can have a variety of genotoxic effects, which may be mediated by oxidants or free radical species. All of these species also have effects on signaling pathways leading to proliferative responses. There are interesting differences in the activities of inorganic and organic species both in terms of target organ carcinogenicity and genotoxic and toxic mechanisms. A scientific consensus has not yet been reached on the many suggested modes of arsenic carcinogenesis that exist in the literature. These include modes that are predominately genotoxic (i.e.,chromosomal abnormalities, oxidative stress, and gene amplification) vs. more nongenotoxic (i.e., altered growth factors, enhanced cell proliferation and promotion of carcinogenesis, and altered DNA repair). Likewise, the dose-response relationship at low arsenic concentrations for any of these suggested modes is not known. Download
    • Extraction and Encapsulation of Beetroot (Beta Vulgaris.L) Extract Using Spray Dryer

      This study aims to obtain encapsulated beetroot extract in a powder form using spray drying technology. The beetroot extract, as core material was obtained using aqueous extraction method. The encapsulated beetroot extract powder was produced by spray drying process using the combination of maltodextrin and gum arabic as wall material in the ratio of 1:2 (core material : wall material), and drying inlet air temperatures at 120°C, 140°C and 160°C as independent parameters. Thus the effect on spray drying inlet air temperatures on encapsulation efficiency, moisture content and betanin content of encapsulated beetroot extract powder was evaluated. Download
    • Forced Degradation Study for Assay Method of Rifampicin, Isoniazid and Pyrazinamide in Combined Pharmaceutical Dosage Form

      As HPLC method is time consuming, very accurate and precise method was developed for simultaneous estimation of Rifampicin, Isoniazid and Pyrazinamide from Rifampicin, Isoniazid, Pyrazinamide and Ethambutol dosage form by UPLC. Forced degradation study was performed on this method to establish the method is stability indicating. The liquid forced degradation and solid degradation study was carried out on Acquity UPLC @BEH C18, (100 mm x 2.1 mm), 1.7 µm column using the gradient composition of mixture of phosphate buffer pH 6.8 and acetonitrile in ratio of 96:4 v/v as mobile phase A and mixture of phosphate buffer pH 6.8 and acetonitrile in ratio of 45:55 v/v used as mobile phase B at flow rate 0.25 mL/min and detection wavelength 238 nm. Download
    • A Short Review on the Anti-Cancer Activities of Natural Polyphenols

      Cancer continues worldwide disease taking the life of individuals irrespective of their age. There are various types of cancer detected by the doctors worldwide. Cancer is a group of diseases caused by loss of cell cycle control. Cancer is associated with abnormal uncontrolled cell growth. The cause of cancer can be external and internal. It can affect any organs of the human being. Plant derived polyphenols plays a vital role in protecting humans from cancerous diseases. Polyphenols play a major role as a powerful natural anti oxidant which can protect the cells. The review focuses on the role of natural polyphenols as an anti cancer agent. Download
    • Development and Validation RP-HPLC Method For Simultaneous Estimation of Cefuroxime Axetil and Linezolid In Combined Dosage Form

      A simple, specific and accurate Reverse Phase High Performance Liquid Chromatography Method was developed for the simultaneous determination of Cefuroxime Axetil and Linezolid in combined dosage form. The using Kromasil C-8 (250×4.6 mm, 5 μm) column in Isocratic mode, with Mobile Phase Acetonitrile : Phosphate buffer, pH=4.0 (60:40 % v/v) (pH 4.0 adjusted with Orthophosphoric acid). The Flow Rate was 0.9 ml/min and effluents were monitored at 268 nm. The Retention Time of were found to be Linezolid and Cefuroxime Axetil 6.860 min and 8.840 min respectively. The Linearity for Cefuroxime Axetil and Linezolid were found to be 2.5-12.5 µg/ml and 3-15 µg/ml respectively. The Recoveries of Cefuroxime Axetil and Linezolid were found to be 101.66 – 101.90% and 98.14 - 101.15 % respectively. The proposed method was validated and successfully applied for the estimation of Cefuroxime Axetil and Linezolid in combined dosage form. Download
    • Current Scenario in Indian Regulatory Update: September 2015 – December 2015

      India has been a hub for conducting various multi centre trials. The conduct of clinical trials in India has been critically reviewed at national and international platforms. While it is imperative that the number of clinical trials increase, the Government is also trying to ensure that the rights and safety of the subjects are protected and the quality of the trials performed in India improve to international standards. The regulatory guidelines in terms of serious adverse events (SAEs) reporting, informed consent, compensation in case of injury or death in clinical trials have been recently modified. It is essential that now all clinical trials conducted in India should as per the International conference of Harmonization-Good Clinical Practices Guidelines (ICH-GCP) for clinical trials and follow the recently amended Schedule Y of the Drugs and Cosmetics Act. This article provides an insight into the recent changes with respect to the regulations of clinical trials and its impact on the clinical research industry in India. Download
    • Development of a Thin Layer Chromatography Method for the Estimation of Quinine and Ciprofloxacin

      A new, rapid, and specific thin layer chromatographic method was developed for the estimation of quinine and ciprofloxacin. Separation was achieved in chromatographic tank by using adsorbent material as silica gel which was applied on glass plate and mobile phase as acetonitrile: methanol: 0.1% triethylamine in water: (1:6:3 v/v/v) was found to resolve quinine and ciprofloxacin. Detection was achieved by using iodine flakes. The selected chromatographic conditions effectively separated quinine and ciprofloxacin with the distance travelled by quinine and ciprofloxacin 2.6 cm and 1.9 cm with the distance travelled by solvent 5 cm. This gives R f value 0.52 and 0.38 for quinine and ciprofloxacin respectively. The developed method was completely novel, reproducible and specific. Download
    • Quantitative Analysis of Almotriptan Malate by UV Spectrophotometric Method Development

      Aim/background: A simple, rapid, precise, and economical spectrophotometric method has been developed for the quantitative estimation of Almotriptan Malate in pharmaceutical formulation Materials and Methods: The simple, precise, economical and rapid method was developed and validated for the estimation of Almotriptan Malate using 0.1N HCl as a solvent. The stock solution of Almotriptan Malate was prepared and subsequent suitable dilution was prepared in 0.1N HCl to obtained standard curve. The standard solution of Almotriptan Malate showed two absorption maxima, one at 283.000 nm and another at 283.00 nm. Results: The drug obeyed beer lambert’s law in the concentration range of 10-100 µg/ mL with regression 0.9998 at 283.00 nm. The overall % recovery was found to be 99.82% which reflects that the method is free from interference of the impurities and other additives used in formulation. The low value of % RSD was indicative of accuracy and reproducibility of the method. The %RSD for interday and intraday precision was found to be 0.1874 and 0.3612, respectively which is <2% hence proved that method is precise. Conclusions: The results of analysis have been validated as per ICH guidelines. The developed method can be adopted in routine analysis of Almotriptan Malate in tablet dosage form as well bulk dosage form Download
    • Development and Evaluation of Oral Floatable In situ Gel Containing Ranolazine

      The aim of the present study is to develop and evaluate stomach specific oral floatable in situ gel of Ranolazine using pH triggered mechanism. The in situ gel is developed using gellan gum as gelling agent and HPMC K 100M as drug release retarding polymer. Calcium chloride is added as source of Ca2+ ion required for gelation. The different batches of gels were prepared and in vitro release study for the same is carried out by USP dissolution test apparatus using 900 ml of 0.1N HCl, at temperature at 37 °C. Developed in situ gelling solutions were evaluated for pH measurement, viscosity determination, in vitro gelling studies, in vitro buoyancy studies, drug content, in vitro release study and stability studies were done according to ICH guidelines. FTIR study revealed no interaction between drug and selected polymer. pH of gels were neutral in nature. Viscosity of F8 (optimized formulation) was in acceptable range and possess enough gelling capacity. Viscosity of solutions and gel strength were increased with increase in the concentration of polymers. The F8 showed an increased floating time upto 14 hrs and drug content 92±0.23%. The in vitro release data revealed that 91.23 % of drug released over the period of 12 hrs. FT-IR and DSC studies revealed that there was no significant drug-excipient interaction and degradation. The drug release was sustained as the polymer concentration increased in the formulae. Stability study showed no remarkable changes in drug content, viscosity and other evaluation parameters. The results suggested that developed floating in situ gel could perform better than conventional dosage forms leading to improved efficacy and better patient compliance. Download
    • Formulation and Evaluation of Cefpodoxime Proxetil Solid Dispersion: An Approach for Dissolution Enhancement of Cephalosporin

      Cefpodoxime Proxetil is an broad spectrum, third generation cephalosporin drug used in the treatment of skin infections, upper respiratory tract and urinary tract infections. Furthermore it shows low aqueous solubility, poor dissolution and hence low oral bioavailability. In present study an attempt has been made to enhance the aqueous solubility of Cefpodoxime Proxetil and hence its availability in aqueous media. Solid dispersion (SD) of Cefpodoxime Proxetil using soluplus as carrier was prepared by solvent evaporation method. The prepared solid dispersion was characterized using FTIR, SEM, DSC and evaluated for In vitro drug release. FTIR and DSC results indicated chemical compatibility between drug and carrier. Moreover DSC thermogram of SD and pure drug suggested the change in crystallinity of Cefpodoxime Proxetil. SEM showed that the physical structure of Cefpodoxime Proxetil was modified from crystalline to amorphous. Dissolution rate of Cefpodoxime Proxetil, physical mixture and SD were found 46.3%, 65.04% and 91.04 % respectively Which concluded a significant improvement in in vitro drug release profile. Solid dispersion of Cefpodoxime Proxetil and soluplus prepared in 1:10 ratio by solvent evaporation method resulted in enhancement of aqueous solubility of Cefpodoxime Proxetil and hence improved dissolution. Download
    • Influence of Tamarind Seed Gum and Chitosan on Sustained Release Tablets of Ropinirole Hydrochloride

      The objective of the present study was to develop the oral sustained release matrix tablets of Ropinirole HCl by using Tamarind seed gum in different Drug:Gum ratios (i.e.1:1, 1:2, 1:3 and 1:4) and comparative studies were carried out by taking any other natural gum in different Drug:Gum ratios (i.e.1:1, 1:2, 1:3 and 1:4). In this work other Gum choosen for comparison is Chitosan. Ropinirole HCl is used in treatment of idiopathic Parkinson disease and also in treatment of moderate to severe primary RLS. Its biological half life was found to be 6 hours. Sustained release formulations of Ropirinole HCl (6mg) were prepared by direct compression method. The tablets were subjected to physicochemical, in vitro drug release and stability studies. Optimization of the formulation was done by studying, effect of different drug:polymer ratio on drug release. FTIR studies indicated absence of any interaction between Ropinirole HCl and polymers. The Pre-compression and post compression parameters of all the formulations were found to be within the limits. In-vitro dissolution studies results elicited that by increasing Drug:Gum ratios, the drug release was found to be retarded and F4 formulation(Drug:TSG in 1:4) was found to be the optimized formulation with 99.32% CDR for a period of 12 hrs. Download
    • Influence of Tamarind Seed Gum and Carrageenan On Sustained Release Tablets of Ropinirole Hydrochloride

      The objective of the present study was to develop the oral sustained release matrix tablets of Ropinirole HCl by using Tamarind seed gum and carrageenan in different Drug:Gum ratios (i.e.1:1, 1:2, 1:3 and 1:4). Ropinirole HCl is used in treatment of idiopathic Parkinson disease and also in treatment of moderate to severe primary Restless leg syndrome(RLS). Its biological half life was found to be 6 hours. Sustained release formulations of Ropirinole HCl (6mg) were prepared by direct compression method and the tablets were subjected to physicochemical, in-vitro drug release and stability studies. FTIR studies indicated absence of any interaction between Ropinirole HCl and polymers used. The Pre-compression and post compression parameters of all the formulations were found to be within the limits. In-vitro dissolution studies results elicited that, by increasing Drug:Gum ratio, the drug release was found to be retarded and F4 formulation (Drug:TSG in 1:4) was found to be the optimized formulation with 99.32% CDR for a period of 12 hrs. The drug release data was fit well to the zero order. Korsmeyer’s plot indicated that the drug release mechanism from the matrix tablet followed Anomalous(non-Fickian) diffusion. Stability studies showed that no change in physical appearance, drug content or dissolution pattern of optimized formulation F4 after storage at 40°C temperature and relative humidity 75% RH for 90 days. Download
    • Chemoprevention of Oral Cancer by Saudi Arabian Propolis: An Overview

      Propolis is a resinous substance collected by worker honeybees from tree buds, sap flows, or other botanical sources. The bees pack propolis on their hind legs, carry it to their colony, and use it as a sterilant & sealant for unwanted open spaces in the hive. It is one of the oldest known therapeutic agents that are used even today in traditional medicines. Saudi Propolis has numerous therapeutic properties like antibacterial, antifungal, anticancer, anti-inflammatory etc. Although numerous researchers have been reported the antimicrobial activity of propolis from different countries and geographical regions but information about Saudi Arabian Propolis are still limited. The composition of propolis can vary according to the geographic locations from where the bees obtained the ingredients. Main chemicals constituents of Saudi propolis have been identified as caffeic acid phenethyl ester (CAPE) and artepillin C, galangin, xanthomicrol, chrysin. CAPE or chrysin are the active ingredients having anti proliferative property. The anti proliferative (anti cancer) effects of CAPE or chrysin in cancer cells are the result of the suppression of complexes of cyclins, as well as cell cycle arrest. The results of in vitro and in vivo studies suggest that CAPE and chrysin may inhibit tumor cell progression and may be useful as potential chemotherapeutic or chemopreventive anti cancer drugs. Oral cancer represents 3rd most common malignancy after lymphoma and leukemia of all cancers in the Saudi Arabia. In addition to high rates of recurrence of head and neck squamous cell carcinoma because of frequent formation of second primary tumor in 3% to 7% per year, among the highest for any malignancy. Chemopreventive agents can serve as an appropriate therapy for patients with a premalignant lesion or patients who have had head and neck squamous cell carcinoma. Also, excellent candidate of cancer for assessment of chemoprevention is Squamous cell carcinoma (SCC) of the oral mucosa because lesions are amenable to oral delivery of chemopreventive agents. We assume that either dietary administration or intralesional injection of ’propolis’ would inhibit the occurrence and progression of malignant oral lesions. The effects can be visually monitored during treatment, and modulation or inhibition of genes or gene products involved in oral SCC constitute molecular targets against which chemopreventive approaches can be tested and validated. Download