Current Issue : July - September Volume : 2012 Issue Number : 3 Articles : 7 Articles
Till the date a limited number of peptides and proteins have been used therapeutically. However, this number is growing rapidly. Because of this study of the stability problems related to the proteins and peptides are to be carried out. Many scientists have studied to solve the problems related to the drug delivery system as like current approaches towards formulation and developments are given in this review. An important goal of molecular medicine is the identification of proteins whose presence, absence, or deficiency is associated with specific physiologic states or diseases. The primary sequence of a protein provides both a molecular fingerprint for its identification and information about it. This may be evaluated in advance studies....
The antimicrobial peptide dermaseptin 01 (DS 01), from the skin secretion of Phyllomedusa hypochondrialis frogs, was immobilized\r\nin nanostructured layered films in conjunction with nickel tetrasulfonated phthalocyanines (NiTsPc), widely used in electronic\r\ndevices, using layer-by-layer technique. The films were used as a biosensor to detect the presence of dopamine (DA), a\r\nneurotransmitter associated with diseases such as Alzheimer�s and Parkinson�s, with detection limits in the order of 10-6 mol L-1.\r\nThe use of DS 01 in LbL film generated selectivity in the detection of DA despite the presence of ascorbic acid found in biological\r\nfluids. This work is the first to report that the antimicrobial peptide and NiTsPc LbL film exhibits electroanalytical activity to\r\nDA oxidation. The selectivity in the detection of DA is a fundamental aspect for the development of electrochemical sensors with\r\npotential applications in the biomedical and pharmaceutical industries....
Delignified cellulosic material has shown a significant promotional effect on the alcoholic fermentation as yeast\r\nimmobilization support. However, its potential for further biotechnological development is unexploited. This study reports\r\nthe characterization of this tubular/porous cellulosic material, which was done by SEM, porosimetry and X-ray powder\r\ndiffractometry. The results showed that the structure of nano-tubular cellulose (NC) justifies its suitability for use in ââ?¬Ë?ââ?¬Ë?cold\r\npasteurizationââ?¬â?¢Ã¢â?¬â?¢ processes and its promoting activity in bioprocessing (fermentation). The last was explained by a glucose\r\npump theory. Also, it was demonstrated that crystallization of viscous invert sugar solutions during freeze drying could not\r\nbe otherwise achieved unless NC was present. This effect as well as the feasibility of extremely low temperature\r\nfermentation are due to reduction of the activation energy, and have facilitated the development of technologies such as\r\nwine fermentations at home scale (in a domestic refrigerator). Moreover, NC may lead to new perspectives in research such\r\nas the development of new composites, templates for cylindrical nano-particles, etc....
Packing of the drug product is highly important in order to protect it from the surroundings. When there is any change in the packing material, it is highly important to validate the packing process as it may have effect on the product quality and also to have evidence that the packaging process is robust and reproducible. For this purpose, the packaging process was carried out at different speed of the machine and sealing temperature. Various parameters were observed and assay was performed to verify no effect on the product quality due to sealing temperature. The packaging process carried out at lowest speed and highest temperature showed assay results within the limit indicating the packaging process at highest sealing temperature can be carried out....
The number of drugs coming from synthesis and being poorly soluble is steadily increasing. At present about 40% of the drugs in the development pipelines and approximately 60% of the drugs coming directly from synthesis are poorly soluble. For many new chemical entities of very low solubility oral bioavailability enhancement by micronisation is not sufficient, the next step taken was nanonisation. The production of drug nanocrystals by bottom up techniques (precipitation) is briefly described, main focus is given on particle diminution by high pressure homogenisation. Homogenisation can be performed in water (DissoCubes) or alternatively in non-aqueous media or water-reduced media (Nanopure). There is also a combination process of precipitation followed by a second high energy step, e.g. homogenisation (NANOEDGE). The result is a suspension of drug nanocrystals in a liquid, the so-called nanosuspension. As an important point the transfer of the liquid nanosuspensions to patient convenient oral dosage form such as tablets is described....
Researchers often identify robust design, based on the concept of building quality into products\r\nor processes, as one of the most important systems engineering design concepts for quality\r\nimprovement and process optimization. Traditional robust design principles have often been\r\napplied to situations in which the quality characteristics of interest are typically time-insensitive.\r\nIn pharmaceutical manufacturing processes, time-oriented quality characteristics, such as the\r\ndegradation of a drug, are often of interest. As a result, current robust design models for\r\nquality improvement which have been studied in the literature may not be effective in finding\r\nrobust design solutions. In this paper, we show how the robust design concepts can be applied\r\nto the pharmaceutical production research and development by proposing experimental and\r\noptimization models which should be able to handle the time-oriented characteristics. This is\r\nperhaps the first attempt in the robust design field. An example is given, and comparative studies\r\nare discussed for model verification....
Background: Lamivudine (3TC), Zidovudine (AZT) and Nevirapine (NVP) are the common antiretrovirals prescribed in resource limited countries due to its cost effectiveness compared to other newer antiretrovirals. Monitoring quality of such generic versions of the dosage forms is a crucial aspect. The main aim of the study is to develop a simple reversed phase (RP) HPLC-UV method to determine 3TC, AZT, NVP with some of its degradation products cytosine and thymine that can be applied in monitoring the quality of such products.\r\nMethods: A RP gradient HPLC method was developed using following chromatographic conditions: LunaC18 150 x 4.6mm column; 50mM ammonium acetate buffer (pH = 6.8) and methanol as mobile phase; Gradient mode of elution with 0- 35%v/v methanol for first 10 minutes increased to 50%v/v till 12 minutes and isocratic to 18minutes, return to initial at 20min; sample injection volume 50�µl; detection wavelength 265nm. Calibration ((n= 6) and validation samples (n=3) were prepared in triplicate for analysis and validated for specificity, linearity, range, accuracy and precision. The method was used in dissolution studies of the fixed dose combination tablets of AZT/3TC/NVP using USP Type I method.\r\nResults: No interference between the analytes was observed. The method was found to be linear over the following concentration range for the five analytes: Cytosine and thymine (0.5-8�µg/ml), 3TC (1- 50�µg/ml), AZT and NVP (1-80�µg/ml) with coefficient of determination (R2) value > 0â�¢9997. Accuracy in terms of mean percent recovery for the five analytes was found to in the range of (Mean Recovery �± S.D) 101.26�± 1.27%. Intra-day and Inter-day precision (%RSD) was found to be 0.49�± 0.28% and 2.24 �± 0.26% respectively. There were no significant differences in the mean recovery of the APIs between the days as analyzed by two-way ANOVA at p >0â�¢05. No matrix effect due to the presence of other excipients in the formulation was observed in the chromatograms of the dissolution samples. \r\nConclusion: The method developed was specific, accurate, reliable and can be applied during routine pharmaceutical analyses such as drug content analysis, dissolution studies and stability of the fixed dose combination product of AZT/3TC/NVP....
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