• Review on Technology Transfer as a Regulatory Aspect with Inclusion of ICH Guidelines

      Technology transfer in simple terms transfer of the technology in the form of idea, innovation and process etc. for successful technology transfer there is an involvement of the two sites together with its documentation. Here this review paper describes various models proposed for the technology transfer such as qualitative model and quantitative models and there requirements, and it also includes basic principle and goals for the technology transfer. Download
    • Review on Technology Transfer as a Regulatory Aspect with Inclusion of ICH Guidelines

      Technology transfer in simple terms transfer of the technology in the form of idea, innovation and process etc. for successful technology transfer there is an involvement of the two sites together with its documentation. Here this review paper describes various models proposed for the technology transfer such as qualitative model and quantitative models and there requirements, and it also includes basic principle and goals for the technology transfer. Download
    • Stability Indicating UV Spectrophotometric Assay Method Development for Simultaneous Determination of Ranitidine and Dicyclomine in Bulk and Pharmaceutical Dosage Form

      A simple, accurate, economic and reproducible ultraviolet spectrophotometric method for the simultaneous estimation of ranitidine and dicyclomine has been developed and validated. The method was involved the measurement of absorbance at two wavelengths 325 nm and 218 nm for ranitidine and dicyclomine respectively by using methanol as solvent. The method was found to be linear in the range of 3-18 µg/ml for ranitidine and 1-6 µg/ml for dicyclomine respectively. The method was validated in terms of linearity, accuracy, precision, limit of detection and limit of quantitation as per ICH guidelines. The method has good reproducibility with % RSD less than two. Thus, proposed method can be successfully applied for ranitidine and dicyclomine in routine analysis work. Download
    • Extracellular Synthesis of Silver Nanoparticles Using Actinomycetes and their Antibacterial Activity

      In the present study, isolate and identify the pigment producing actinomycetes, to identify the bioactive compounds and biologically synthesis silver nanoparticles against pathogenic bacteria. A total of seven actinomycetes were isolated from soil samples and tested against pathogenic bacteria. Out of seven isolates, three isolates [A1, A3 and A7] showed better result against pathogenic bacteria by primary screening. Out of three isolates, A1 and A7 were subjected to secondary screening, identification, growth study (temperature and pH), mass multiplication and synthesis of silver nanoparticles methods. The potential isolates was identified by morphological and biochemical tests (Streptomyces sp.). The optimum temperature as room temperature 28oC and favorable pH was 7. The cell free extract of potential isolate was assessed for the synthesis of silver nanoparticles. The biologically synthesized silver nanoparticles showed major peak at 420 nm. Synthesized nanoparticles also exhibited antibacterial activity against bacterial pathogens. Download
    • Endometriosis –A New Age Disease

      Endometriosis is the biological complication that occurs when the lining of the uterus called endometrium grows outside the uterine cavity. It affects females in their reproductive years, and is an estrogen-dependent condition. In US about 5 million women have endometriosis with different symptoms. Endometriosis is known to occur when the lining of the uterus called the endometrium, grows in other places such as fallopian tubes, ovaries or along the pelvis .The major issues that limit the currently available endometriosis treatment are lack of awareness, delay in diagnosis, high cost, long-term treatment and recurrence. The impact includes fertility, sexuality and ability to work, play and personal relationships. Treatment for endometriosis involves pain medication, hormone therapy, surgery, or a combination of both. However to avoid recurrence hysterectomy or total removal of the uterus may be a 'last resort' option. Download
    • Needs and Necessity of Polyploidy in Medicinal Plants

      Polyploids are organisms with multiple sets of chromosomes in excess of the diploid number. Polyploidy is common in nature and provides a major mechanism for adaptation and speciation. Approximately 50-70% of angiosperms, which include many crop plants, have undergone polyploidy during their evolutionary process. Flowering plants form polyploids at a significantly high frequency of 1 in every 100,000 plants. Many studies have been carried out to understand the nature of polyploidism. The polyploid condition may bring about several advantages compared to the diploid state. Polyploids often show phenotypes that are not present in their diploid progenitors or exceed the range of the contributing species. Some of these traits may play a role in heterosis or could favor adaptation to new ecological niches. Advances in genomics and sequencing technology may create unprecedented opportunities for discovering and monitoring the molecular effects of polyploidization. Through this review, we provide an overview of technologies and strategies that may allow an in-depth analysis of polyploid genomes. After introducing some basic aspects on the origin and genetics of polyploids, we highlight the main tools available for genome and gene expression analysis and summarize major findings. In the last part of this review, the implications of next generation sequencing are briefly discussed. The accumulation of knowledge on polyploid formation, maintenance, and divergence at whole-genome and subgenome levels will not only help plant biologists to understand how plants have evolved and diversified, but also assist plant breeders in designing new strategies for crop improvement. Download
    • Assessment of Serum Paraoxonase Levels In Patients Fatty Liver Disease

      The liver plays a key role in the synthesis of serum Paraoxonase (PON). It is circulating enzyme in the serum and bound to HDL. PON has function as an anti-oxidant effective of protecting low density lipoproteins against peroxidative reactions. PON1 levels have been reported in a variety of diseases along with the liver diseases. The study was planned with the aim of ascertaining the diagnostic use of level of the PON in various diseases. The two group of patients were selected based as Fatty Liver disease patients and control group patients. The blood samples were withdrawn from the patients. The various biochemical parameters such as fasting blood glucose, lipid profiles, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma glutamyl transferase (GGT) levels were reposted in the two groups of the patients. The study has established PON levels were declined in patients with fatty liver disease. With the specificity and sensitivity of this enzyme being high, it could emerge as a parameter to assess liver function. Download
    • Development and Validation of Spectrophotometric Method for Analysis of Topiramate

      Selective, inexpensive and validated method was developed and optimized for determination of antiepileptic drug, Topiramate in drug substance and drug product as well as in the presence of pyridine. The method is based on the reaction of the primary amino group of Topiramate with Ninhydrin reagent in ethanolic medium in the presence of 10% pyridine solution. The colored product was measured at 568 nm. The linearity range was found to be 50 – 300 μg mL-1 with mean recovery 98-102%. All variables affecting the reaction conditions were thoroughly studied. The results were found to agree statistically, the method was validated according to the ICH guidelines. The proposed method is practical and valuable for their in quality control laboratories for analysis of Topiramate. Download
    • Formulation and In-Vitro Evaluation of Modified Release Delivery of Trazodone Hydrochloride Tablets

      The objective behind this study was to formulate and evaluate Modified release tablet of Trazodone hydrochloride by using different hydrophilic and hydrophobic polymers by Wet granulation technology and to study the effect of different concentrations of polymers on release rate from tablet. Tablets were prepared using carnauba wax as extra fine powder (8.5-28%), hydroxypropyl methylcellulose (HPMC) (2-14.5%), and polyvinyl pyrollidone (PVP K-30) (8.5-30%) as release retardant polymers. The FTIR and DSC analysis does not show any interaction of drug with Excipients. The formulation was optimized on the basis of acceptable pre and post compressional parameters and in-vitro drug release. The resulting formulations produced monolithic tablets with optimum hardness, consistent weight uniformity and low friability. The results of dissolution studies indicated that Batch F8 exhibited drug release of 99% at the end of 12h to provide sufficient concentration for achieving satisfactory therapeutic value for extended period of time. The drug release from Batch F8 formulation was sustained up to 12 h. Fitting in-vitro drug release data from optimized matrix formulation to first order followed by Korsmeyer’s-Peppas indicated that diffusion could be mechanism of drug release. Download
    • A Comparative Study on Different Methods of Granulation on Tablet Properties

      The active ingredient in a formulation represents a very small portion of the overall tablet, then the challenge is to ensure that each tablet has the same amount of active ingredient. Sometimes, blending the ingredients is not enough. The active ingredient may segregate from the other ingredients in the blending process. The ingredients may be incompatible because of particle size, particle density, flow characteristics, compressibility, and moisture content. These incompatibilities can cause problems such as segregation during blending or during transfer of the product to the press as well as separation of the active on the tablet press. Granulating the active ingredient by itself and then blending it with the rest of the ingredients is one solution to the segregation problem. Otherwise, all or most of the ingredients could be granulated together. The best course of action to ensure that each tablet contains the correct amount of active ingredient, especially if the active ingredient is only a small percentage of the tablet ingredients, is to mix the active ingredient thoroughly with some or most of the other ingredients and then granulate the blend (i.e., form the blend into granules). Each granule would contain a little of each of the ingredients, and the active ingredient would be distributed evenly. Different granulation techniques include Wet granulation, Dry granulation and Direct Compression. The method of granulation is chosen based on the ingredient’s individual characteristics and ability to flow, compress, eject, and disintegrate. Choosing a method requires thorough investigation of each ingredient in the formula, the combination of ingredients, and how they work with each other. Then, the proper granulation process can be applied. In this study, work was done to evaluate the different process of granulation techniques for the preparation of tablets. Download
    • Oil Extraction from Matured Seeds of Cassia Tora and its Nutritional, Antioxidative Properties

      The matured seed of Cassia tora was analyzed to extract oil content to determine nutritional and antioxidant properties. The seed oil extracted by the steam distillation method, the nutritional profile, free radical scavenging and phosphomolybdenum reduction assay were also determined. The seed derived extracted oil (41.8%) contained free fatty acids 22.15±1.71%, total amino acids 21.09±1.69%, unsaturated fatty acids of oleic acid (13.31±1.72%), linoleic acid (11.25±1.13%), palmitic acid (12.78±1.21%) and total amino acid. The seed oil possessed significant free radical scavenging activity of IC50 (28.78±0.69) and phosphomolybdenum reduction (52.4±4.32), which was equal to that of rutin (31.56±0.81) as synthetic antioxidant drug. The result of this study revealed that the oil extracted from matured seeds possess reduced fatty acids, higher unsaturated fatty acids, more content of amino acids, free radical scavenging ability and phosphomolybdenum reduced properties. In conclusion, the Cassia tora seed oil may be used as edible in human health and also used for various treatments of rheumatoid, cardiovascular disease and nutritional deficiency. Download
    • A Novel RP HPLC Method for Development and Validation of Cilnidipine In Bulk and Pharmaceutical Dosage Form

      A simple, Precise, accurate RP-HPLC method was developed and validated for the estimation of cilnidipine in pharmaceutical dosage forms. separation was achieved on Symmetry C18 column (4.6 x 150mm), with mobile phase consisting of ortho phosphoric acid buffer pH 4 and Acetonitrile in 60:40, V/V. The flow rate was maintained at 1 ml/min and the analyte was monitored at 240nm wavelength. The retention time for cilnidipine was found to be 2.35 min. The linearity of the method was observed in the concentration range of 5-25ppm and correlation coefficient was found to be 0.999. The percentage assay of Cilnidipine was found to be 98.733%. The method was robust and rugged as observed from insignificant variation in the results of analysis by changes in flow rate and analysis being performed on different days. The method was validated for its accuracy, precision and system suitability. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the routine estimation of Cilnidipine in pharmaceutical dosage forms. Download
    • A Descriptive Study of Childhood Malignancies: A Ten Year Study (1999-2008) In Regional Cancer Centre Kidwai Memorial Institute of Oncology, Bangalore

      Objective: The objective of this study was to find out the profile of childhood cancers in kidwai Memorial Institute of Oncology (KMIO), Regional Cancer Centre Karnataka, India during 1999 to 2008. Methodology: It was a retrospective study using hospital based cancer registry records from January 1999 to December 2008. All the children below 15 years with confirmed diagnosis of cancer by means of Clinical, Imaging techniques, histological and cytological examinations were included in this study. Results: There were 79909 new confirmed cases attended outpatient department of KMIO during these 10 years. Among which 3879 were below 15 years of age. An average 388 cases attended per year. Overall pediatric tumors were 4.9% of total cancers. The frequency of cancer was found to be higher among boys (64%) than girls (36%) with a ratio of 1.6:1. Majority of the children were from Karnataka stae (81%) compared to (19%) from others area of India. The results showed that Leukemia (42.9%), Lymphoma (14.1%) and CNS (12.1%) were the commonly found childhood cancers among the children attended at KMIO, Bangalore during data collection period. Other commonly found tumor was bone tumour (5.2%), renal tumour (4.6%). Conclusion:, leukemia, Lymphoma and CNS commonly found in Male children same pattern also observed in females children also from 0-15 ages below 5 years in contradiction to retinoblastoma, hepatic tumour neuroblastoma and renal tumour which were prevalent in children less than 5 years of age. Download
    • Development and Validation of HPLC Method for the Simultaneous Estimation of Levosulpiride and Esomeprazole in their Combined Pharmaceutical Dosage Formulation

      A simple, efficient, and reproducible HPLC method for the simultaneous estimation of Levosulpiride (LEVO) and Esomeprazole magnesium trihydrate (ESO) in their combined pharmaceutical formulations has been developed and validated. The separation was carried out on HYPERSIL ODS (C18), 250 x 4.6 mm (5 µm) column using Methanol: Water: Trietylamine in the ratio (50:50:0.1, v/v/v) as mobile phase. The flow rate was 1 ml/min and effluent was detected at 224 nm. The retention time of LEVO and ESO were 2.51min and 4.52 min. respectively. The linear range was 15-75 μg/ml and 8-40 μg/ml for LEVO and ESO, respectively. Percentage recoveries for LEVO and ESO were 98.30 - 100.6% and 99.5 - 101.25% respectively. All the analytical validation parameters were determined and found in the limit as per ICH guidelines, which indicates the validity of the method. The developed method is also found to be precise and robust for the simultaneous determination of LEVO and ESO in their pharmaceutical formulation. Download
    • Ion Chromatography with UV Detection as Sensitive Method for Bromate Determination in Bread

      Bromate is well known as a harmful inorganic disinfection by-product arising during water ozonation. Anyway, it is not the only source of that toxic compound for people. Another example is using a potassium bromate as an oxidant in flour doughs and in bakery industry. It is used as a flour improver that acts as a maturing agent. In the work a method with post-column Derivatization with triiodide and UV detection at 352 was is applied for the determination of bromate in selected breads, rolls, croissants and baguettes bought at Polish supermarkets. Method detection limit is on the level of 0.32 µg L-1, and spiked recovery for bromate was in the range of 96%-104%. The results of this study show that in most of analysed samples there is no bromate or the concentration is very low. Download