iosr-JPBS   Volume-9 ~ Issue-1 ~ Jan-Feb 2014

Abstract: The purpose of this effort is to provide an introduction and overview of the process validation of the production of pharmaceutical manufacturing process especially tablet with particular attention to the U.S. Food and Drug Administration requirements (FDA). Quality is always a prerequisite when looking at a product. Therefore, drugs must be manufactured to the highest quality standards. In the context of one of the types of process validation, retrospective validation are used for the facilities , processes and process controls in use that have not been subjected to a documented formal process validation (prospective, concurrent ) . The validation of these facilities , processes and process controls can use historical data to provide the necessary evidence that the process does what it is supposed to do provide the source of data for this study include , but are not limited to processing batch records and packing , process control charts , logs, maintenance records personnel changes , process capability studies , final data, including trend cards and storage stability validation results. Retrospective validation is the starting point for the non-regulated or Sami-regulated toward the compliance of cGMP and is less expensive exercise to evaluate and demonstrate the product quality. Application of statistical and quality control will give a strength, confidence and reliability to demonstrate the retrospective process validation.
Keywords: Retrospective, Statistical Tool, Quality Control Tool, Validation, Process Validation.

Abstract: Trial Design: Observational study
Methods
Inclusion criteria: All In-patients who were treated with AEDs admitted in different units of Medicine Department.
Exclusion Criteria: All pregnant women who are on AEDs.
Sample size: 35
Objective: The chief objective behind this project was to observe the various therapy of AED used in epilepsy and in some co-morbid condition and to observe the patient condition.
Outcome
 A total of 35 patients data were recorded in the study for 1 month.
 In the study percentage of men suffering from epilepsy was 45.71% (16) and Female was 54.24 %( 19).
 The study shows that most of the patients 14 (40%) were from the age group of 31-60 years; followed by 14 (40%) of patients in the age group of 61-90 years and 7 (20%) patients were in the group of 10-30 year.
 Most commonly prescribed drug concluded is phenytoin which accounts for 30 (85.30%) in both the genders, followed by phenobarbitone 11 (31.18%) and levitracetam usage was 11 (31.18%)
 Monotherapy is the type of therapy most frequently used in 23 patients (65.71%).
 Dual therapy is used in 6 patient (17.14%).Triple therapy is used in 5 patient (14.28%).
Conclusion: The most frequently prescribed AED in the study was Phenytoin followed by Phenobarbital and levitracetam.

Abstract: The present study was undertaken with the aim to find prevalence of biofilm forming ability among Pseudomonas aeruginosa clinical isolates. A total of 129 clinical isolates were identified from clinical specimens by standard microbiological techniques. Biofilm formation ability among these isolates was studied using in vitro bifilm formation assay. Minimum inhibitory concentration (MIC) and minimum biofilm eradication concentration (MBEC) were studied using procedure as described in Clinical and Laboratory Standards Institute. Among 129 isolates, the prevalence of aminoglycoside resistance was 75.2 % out of which 70.1% were found to be biofilm producers. The MIC for Tobracef in aminoglycoside resistant strains ranged from 8 to 16 μg/ml and for other antibacterial drugs it ranged from 16 to 256 μg/ml. The MBEC for Tobracef in biofilm producing isolates was ranged from 32 to 64 μg/ml and for other antibacterial agents, it ranged from 1024 to 8292 μg/ml. When the effect of half of MBEC of drugs were evaluated on preformed biofilms, Tobracef significantly reduced viable counts of bacterial cells presented in biofilms of P. aeruginosa with log reduction values ranging 5.17 to 5.46 logs. Our data showed that Tobracef has significantlly enhanced activity against aminoglycoside resistance biofilm producing isolates. Therefore, use of this antibiotic should be considered to treat the infections caused by aminoglycoside resistant biofilm producing isolates.
Keywords: Bifilm, Clinical isolate, MIC, MBEC,Tobracef.

Abstract: Acinetobacter baumannii (A. baumannii) is a pathogenic bacterium that can cause nosocomial infection in hospitalized patients with many kinds of manifestations. All bacterial infection is initiated by adhesion of bacterium to host cells through certain virulence factor which are called adhesin proteins. The purposes of this study were to isolate the pili subunit hemagglutinin (HA) protein of A. baumannii and to prove whether it functioned as adhesin protein and could activate the production of s-IgA. Isolation of pili subunit protein, was done using SDS-PAGE to get the molecular weight (MW) of pili subunit protein and then hemagglutinated. Adhesion test was conducted using pili subunit HA protein which had the highest titer of hemagglutination test, then coated on enterocyte cells of mice at the doses of 400 μg, 200 μg, 100 μg, 50 μg, 25 μg, 12.5 μg, 0 μg (control), respectively.
Keywords: Acinetobacter baumannii, pili, hemagglutinin, adhesin protein, s-IgA.

Abstract: The possibility of upgrading spent sorghum grains to chicken feed through microbial processing was investigated. Spent sorghum grains (SSG) were fermented for a period of 21 days at 25 ± 2 oC using a consortium of A. niger, C. globosum and S. cerevisiae. The effects of microbial processing on the nutrient composition of the SSG were assessed and the nutrient composition of the microbe-processed product was compared with the nutrient requirements of chicken. Fermentation led to increases in the contents of crude protein (56%), crude fat (59.65%) and ash (38%). Crude fibre and NFE contents were decreased by 24.84% and 35.43% respectively. Energy content increased by 7.8%. The percent dry matter values of fifteen amino acids ( lysine, histidine, arginine, aspartic acid, glutamic acid, proline, glycine, alanine, cystine, valine, methionine, isoleucine, leucine tyrosine and phenylalanine) were found to increase. Elemental analysis revealed increases in the values of calcium, phosphorus, potassium and iron, and decreases in the values of magnesium, manganese, copper and zinc. Microbial processing with the test organisms generally enhanced the nutritional quality of SSG, but for it to be used as chicken feed, there is need for further fibre reduction, energy enhancement and mineral supplementation.
Keywords: chicken, feed, microbial, processing, spent sorghum grains.

Abstract: The objective of the present investigation was to prepare bilayer tablets of Glimepride and Metformin HCL in combination. Metformin hydrochloride and Glimepiride are oral hypoglycemic drug and effectively used in treatment of diabetes mellitus (type-2 diabetes). The main aim of the present study was to formulate Metformin hydrochloride sustained release and Glimepride immediate release matrix tablets as a dosage form by different polymers such as HPMC, Povidone, Lactose Monohydrate, Ethylcellulose, Microcrystalline Cellulose and study the invitro release patterns of the drug. In the present study bilayer tablets Glimepride prepared by direct compression method and Metformin prepared by wet granulation technology.
Keywords: Glimepiride, Metformin HCL, Oral controlled release drug delivery system, HPMC.

Abstract: Various lipid classes and compounds were monitored during the period of leaf emergence to leaf drop of Rauwolfia serpentina. The expansion to early maturation phase was accompanied by cellular buildup of all major lipid classes, whilst aging and senescence were characterized by their significant turn down, except for the neutral lipids; the leaf monogalactosyl diglyceride/digalactosyl diglyceride ratio decreased from 4.6 (complete maturity) to 2.5 (abscised stage). The early maturation stage was the earliest stage when substantial amounts of free sterols and fatty acids could be pragmatic. The unsaturated/saturated fatty acid ratio was far lesser in the senescent leaf as compared to that of the fully expanded leaf. The specific changes in lipid composition may be evocative of simultaneous alterations in membrane ultrastructure and functions, putatively leading to perturbation of indole alkaloid impounding potential of the tissues of a pharmaceutically significant species.
Key words: Glycolipids, leaf development, phospholipids, Rauwolfia serpentina, senescence, sterol.

Abstract: An amperometric biosensor based on catalase enzyme was developed for the investigation of the effect of calcium ions on the activity of the enzyme. Calcium plays an activator role for the catalase enzyme that catalysis the degradation of hydrogen peroxide to O2 and H2O. Determination method of the effect of calcium ion on the activity of the enzyme was based on the assay of the differences on the responses of the biosensor in the absence and the presence of calcium in the reaction medium. The biosensor had a linear relation to calcium concentrations and good measurement correlation between 0.05 and 15 mM with 3 min response time. PPB–HCl buffer (pH 6.8; 20 mM) and 37ºC were obtained as the optimum working conditions. In the application studies, the biosensor was used determination of calcium level of real samples such as cow milk, Aavin (green) and MD water. In the characterization studies of the biosensor some parameters such as reproducibility, substrate specificity, operational and storage stability were carried out. Finally, by using the biosensor developed and enzymatic-spectrophotometric method alcohol concentrations of some alcoholic drinks were determined and results were compared.
Keywords: Acinetobacter calcoaceticus, Ganoderma lucidum, Catalase, Biosensor, Milk and calcium.

Abstract: A bacterium was detached from the "rhizosphere" part of tea plant from a tea garden of Barak Valley, Assam (India). The bacterial isolate was separated on an "N-free medium" and it was identified on the basis of its "external attributes". The "Gram staining" and "molecular features" were also conceded in. Further the molecular work through"16SrDNA scrutiny" of the isolate was decided out and on the foundation of that; "species level" identification of that bacterium was made. The "evolutionary tree" was constructed by taking the concerned bacterial isolate that was marked as "Azo-4"with taking ten other close strains that were available in the "NCBI" GenBank nucleotide database.
Key words: external attributes, detached, 16SrDNA scrutiny, species level.

Abstract: The paper deals with 25 major ethno-botanically important Non Timber Forest Produces (NTFPs) of South West Bengal forest at Jamboni community development block (JCDB). It reflects source and sink relation of the products in the said forest ecosystem. It also broadcasts the proper conservation measures of plant species. The products of plants includegreen leaves, fruits, twigs, unwanted timber as fuel, litter, brumes, fiber and flosses, sticks, barks from roots and stems, seeds, basket making stem, medicinal plants, plant material for local use like mushrooms, kendu fruits, baichi, tasar, lac, kurkut(eggs of red ant) etc. for different purposes. All the products are seasonally collected from forests by local people of the said area but most of the ethnic groups use these products luxuriantly to earn money from market for their own need. For the collection of minor forest produces, forest department have no rigidity thereby. Collectors of JCDB may be the inhabitants of the area or under the group as members of Forest Protection Committees (FPCs). The local markets are the nodal area for the sale of the products where they can sale freely and easily, and buyers can purchase these NTFPs for the big markets to earn maximum profit in later stage. By and large, they collect huge amount of NTFPs from the forest which need conservation to protect the species from the loss of abundance of species and to protect it in near future either locally or by scientific way.
Keywords: Jamboni Block, NTFPs, Ethnobotany, Marketing, Sustainable management.

Abstract: This study based on such concepts and provides an overview of the quality tools such as cause & effect analysis, process capabilities and other quality tools like normality plots histograms. Box plots and other statistical techniques and a step-by-step approach for determining process capability. Which ultimately leads to overall process improvement and validation of that tablets. Which were manufactured at industrial lab. Faculty of pharmacy Hamdard university. The above approach is illustrated in present study. As part of a process validation, A 5 mg tablet was evaluated for content and dosage uniformity. The specifications were 85-115%. Three batches were made and sampled. Thirty tablets were taken throughout the production run for each batch and thus represented the entire batch. The sample size is selected to conform to USP chapter <905>, Uniformity of dosage unit. The overall results in different interpretation were satisfactory as per normality plots histograms. Box plots and other statistical techniques .Furthermore over all process capability Cpk was found with 1.206. Which is acceptable indicator of process capability
Keywords: Process validation, Quality tools, Statistical techniques, Content Uniformity, Process capabilities.

Abstract: The objective of this research project is to analyze the gaps and improve process of a packaging process and managing operations of a pharmaceutical company to carry out with the help of a quality and sigma tools. Analysis gives the effect of material inventory, planning and productivity improvement. The research also aims to find out and eliminate the bottleneck in packaging operations. Our proposed changing in the material inventory and aggregate planning has been drawn in by the industry which optimized their productivity and customer demand by zero production orders delay. Introduction to scrape factor in bill of packaging material and preventive maintenance is found significant increase in productivity of a product and machine efficiency. It results in improvement of the productivity and improves the lead time of a product to prevent any loss which may be customer or financial.
Keywords: Blister, Granulation, Production Orders, Scrape Factor, SPC.

Abstract: In total world population, most of the people depend on rice as a staple food because it gives proper amount of nutrition, which help to people in leading healthy life mainly in the developing countries of Asia. This valuable plant is attacked by various types of micro-organism like bacteria. Under the pseaudomonas species, pseaudomonas fulva 12-x is one of the strain, contain receiver domain include regulator protein, which ultimately help them to maintain signal transduction pathway.so the aim is to find out new target site in this hazardous bacteria to develop a potential medicine that help in saving our crops without using fertilizer because fertilizer causes various types of environmental problem. Very little amount of information is known about the structural biology of pseaudomonas fulva 12-x,so using homology modeling of bioinformatics approach the tertiary structure of response receiver regulator protein of pseaudomonas fulva 12-x has determined.

Abstract: In the present study evaluation of synergistic antimicrobial activity and antioxidant activity of blend of essential oil contains cardamom, coriander, fennel, caraway and ajowan were carried out. The essential oil was extracted from dried seed of cardamom, Coriander, Fennel, caraway and Ajowan were blend in sunflower oil used as base. The antibacterial activity and minimum inhibitory concentration (MIC) of essential oil against several pathogens was evaluated. The minimum inhibitory concentration (MIC) values of oils were determined by micro broth dilution assay. The results showed that the gram positive and gram negative strains of bacteria had different sensitivities to essential oils. The potential synergetic effect of blend of essential oil with a common antibacterial, Ciprofloxacin, was also studied. Ciprofloxacin and extracted essential oil in combination inhibited the growth of gram positive and gram negative bacteria. Extracted essential oil showed synergistic activity with ciprofloxacin against test strains. Antioxidant activity of the essential oils extracted were carried out using DPPH, H2O2 and Nitric oxide scavenging assay at 100 μg/mL and 200 μg/mL and compared with the standard Ascorbic acid. In the present study, extract blend of essential oil showed a significant effect in inhibiting DPPH, reaching up to 76.84% at concentration of 200 μg/mL. The blend of extract showed a significant effect in inhibiting H2O2, reaching up to 70.04 % at concentration of 200 μg/mL. The extract showed maximum activity of 72.80 % at 200 μg/mL, where as ascorbic acid at the same concentration exhibited 94.96% inhibition in Nitric oxide scavenging assay.
Keywords: Essential oil, antibacterial activity, MIC, antioxidant activity and synergistic activity.

Abstract: The purpose of Quality Risk Management is to illustrate practical ways to analyze the risks to quality system, providing guidance along the way to achieving effective and efficient quality management and compliance. In the pharmaceutical manufacturing every product and every process associated with risks. To maintain product quality throughout the product life cycle, too much time and resources are allocated. Risk is described in -recent guidance as a combination of the probability of occurrence of harm and the severity of that harm. The Quality Risk Management (QRM) approach initiated by regulatory agencies with recognized management tools along with support of statistical tools in combination allows for a risk-based approach to quality management, thus ensuring that resources are deployed in a timely and expeditious manner to areas that need them most and proactive approach to compliance of good manufacturing practices (GMP).
Keywords: FMEA , HACCP ICH Pharmaceutical Industry, Quality Risk Management, Risk Assessment, Risk Control, Risk Identification, WHO. Gezt Pharma.

Abstract: A good flow ability of granules or powder ensures efficient mixing, uniform dose as well as weight distribution in solid dosage form. Reformulation of product done for use of excipients that would aid in manufacturing of large, uniform, spherical & dense granules then redesign of manufacturing techniques. Series of trials conducted to select most appropriate excipients and their optimum ratios, and techniques, subsequently evaluating and identifying parameters obtained from angle of repose, carr's index & Hausner Ratio. The project is designed to facilitate, improve the process of granules or powder filling in capsules (flow ability), reduction of weight variation of capsules and also cut down the number of workers utilization for the capsule manufacturing process, which is based on herbal formulation that is phytopharmaceutical health care products, in which the Active is derived/extracted from the herbs and that is in large quantities and semisolid in nature, as compared to the Allopathic medicines where API's are in limited quantity and are mostly in the form of powder which can be easily mixed with other excipients and diluents to achieve uniform capsule filling.
Keywords: Angle of Repose, Bulk Density, Flowability, Tapped Density, Thick Extract.

Abstract: Metabolic syndrome is a multiplex risk factor arising from abdominal obesity, insulin resistance and dyslipidemia. It increases the risk for cardiovascular complications, fatty liver disease and cognitive dysfunction. The prevalence is rampantly increasing among all age groups worldwide due to nutrition excess, physical inactivity and increased stress. Despite its epidemiological nature, treatment is limited to lifestyle changes and lifelong medical intervention. This may be due to incomplete knowledge of the etiology of the syndrome. The present study is aimed at developing an animal model using male C57BL/6J mice and studying the biochemical profile during the onset and progression of the syndrome. Test group was fed with High Fat Simple Carbohydrate (HFSC) diet and the Control group was fed with standard diet for a period of 5 months. Body weight and biochemical profile was analyzed on a monthly basis. Oral Glucose tolerance test (OGTT) was performed following a glucose load of 1g/kg body weight at 143rd day. The syndrome was successfully induced in male C57BL/6J mice within a period of 5 months with perturbed lipid profile and insulin resistance.
Keywords: C57BL/6J, Metabolic Syndrome, High Fat Simple Carbohydrate (HFSC) Diet.

Abstract: A simple, selective and precise RP-HPLC method was developed for the simultaneous estimation of Aliskiren Hemifumarate, amlodipine besylate and hydrochlorothiazide in the Bulk and Pharmaceutical Dosage Forms using losartan as an internal standard. The chromatographic separation of the three drugs was achieved on a reverse phase Inertsil-ODS, C18, 100X 4.6 mm, 5μm column using 0.1 M Ammonium acetate buffer (pH adjusted to 5 using formic acid) and Acetonitrile in the ratio of 65:35 v/v with flow rate of 1.0 ml/min with injection volume 20 μL and the detection was carried out at 232 nm. The retention time of aliskiren hemifumarate (ALSK), amlodipine besylate (AMLO) and hydrochlorothiazide (HCT) were found to be 3.90, 5.22 and 1.91 min respectively. The drug products were subjected to stress conditions of acidic, alkaline, oxidation, UV and Thermal conditions. The degradation products were well resolved from ALSK, AMLO and HCT peaks, thus indicating the stability-indicating nature of the method. The linear regression analysis data for the calibration plots showed good linear relationship in the concentration range of 37.5-225.00 μg/ml for aliskiren hemifumarate, 3.125-18.75 μg/ml for hydrochlorothiazide and 1.25-7.50 μg/ml for amlodipine besylate. The developed method was successfully validated in accordance to ICH guidelines. Hence, this method can be conveniently adopted for the routine analysis in quality control laboratories.

Key words: Aliskiren hemifumarate, Amlodipine besylate, Hydrochlorothiazide, RP-HPLC

Abstract: A simple, selective and precise Stability indicating RP-HPLC method was developed for the simultaneous estimation of Metformin Hydrochloride, Pioglitazone Hydrochloride and Glibenclamide in the Bulk and Pharmaceutical Dosage Forms using glimepiride as an internal standard. The chromatographic separation of the three drugs was achieved on a reverse phase Inertsil-ODS, C18, 100X 4.6 mm, 5μm column using 0.1 M Ammonium acetate buffer (pH 4.5adjusted by using formic acid) and Acetonitrile in the ratio of 45:55 v/v with flow rate of 0.8 ml/min with injection volume 20 μL and the detection was carried out at 254 nm. The retention time of metformin hydrochloride, pioglitazone hydrochloride and glibenclamide and glimepiride were found to be 1.1, 4.5, 5.9, 6.5min respectively. The drug products were subjected to stress conditions of acidic, alkaline, oxidation, UV and Thermal conditions. The degradation products were well resolved from Metformin Hydrochloride, Pioglitazone Hydrochloride and Glibenclamide peaks, thus indicating the stabilityindicating nature of the method. The linear regression analysis data for the calibration plots showed good linear relationship in the concentration range of 62.5-375.00 μg/ml for metformin hydrochloride, 3.75-22.5 μg/ml for pioglitazone hydrochloride and 1.25-7.50 μg/ml for glibenclamide. The developed method was successfully validated in accordance to ICH guidelines. Hence, this method can be conveniently adopted for the routine analysis in quality control laboratories.
Key words: Metformin Hydrochloride, Pioglitazone Hydrochloride, Glibenclamide, RP-HPLC.

Abstract: Hepatitis B virus infection (HBV) is common among prisoners suggesting them as one of the main infection source in the community; Hence in this study, we evaluated the sero-prevalence of this infection among jail inmates in Bali prison, Taraba State Nigeria between August and November 2013. The sero-prevalence of Hepatitis B among the random population of sentenced prison inmates was investigated. We examined a total of fifty (50) inmates (49 males and 1 female). All collected blood samples were tested for Hepatitis B surface Antigen antibodies using rapid test strip (Global). An overall prevalence rate of 18% ( 9 positive inmates) was observed. Male inmates were mostly infected while the only female inmate was not. Inmates between the age group 20 – 29 years had higher infection rate. There was significant association (p<0.01) between age, sex and HBsAg sero-positivity in this study. This study confirms the presence of HBsAg among jailed inmates in Bali prison. Regular testing for hepatitis B virus antibodies in prisons is necessary to identify those already infected and those in need of specific health care to help limit further transmission of the disease within and outside the prison. Furthermore, introduction of effective preventive measures is recommended and uninfected inmates should be vaccinated as this will reduce the spread of the disease.
Key words: Inmates, HBsAg, Bali prison, Survey, Sero-positivity.

Abstract: In this study, RNA isolated from sera of Egyptian HCV-patients was used to amplify a fragment of a M. wt. of ~800pb corresponding to a partial sequence of the HCV-E2 encoding gene. The amplified fragment was cloned, sequenced and the nucleotide blast analysis of our sequence revealed partial homology with previously published E2-genes of viral isolates from different locations; the highest match (88%) was annotated with a Japanese isolate suggesting that our herein characterized HCV-E2 partial sequence is a novel one. The impact of HCV-E2 sequence variability will be discussed.