Formulation and Evaluation of Liquisolid Compacts of Zotepine

The aim of present research work is to formulation and evaluates Liquisolid Compacts of Zotepine to improve solubility and dissolution rate of drug. Solubility and dissolution rate of Zotepine was increased by preparing Liquisolid Compacts of Zotepine using PEG as vehicle, Aerosil as coating agent and Avicel as adsorbent and sodium starch glycolate as super disintegrant. FTIR study was checked for possible drug excipient interaction. The hardness of all formulation was found good enough to pass the friability criteria. Hence the friability of the formulation is well within the acceptance criteria. The friability was found less than 1 in all formulations. Further, the drug content of the formulation batches F1-F8 found within acceptance range. The disintegration time of the F1-F8 batches was found less the 60 seconds. It was found that the amount of SSG is directly affecting to DT time of formulation. The F8 formulation was found stable for 1 month during stability study. Liquisolid Compacts of Zotepine were successfully developed by using PEG as vehicle, Aerosil as coating agent and Avicel as adsorbent and sodium starch glycolate as super disintegrant.

Professor Endrenyi’s Legacy: An Evaluation of the Regulatory Requirement “Fixed Effects, Rather Than Random Effects, Should Be Used for All Terms”

Purpose: In the latest revision of the guideline for evaluation of bioequivalence (BE), European regulators introduced the requirement for using subjects as fixed factors in the underlying statistical models, even in replicate and semi-replicate studies. The implication was that estimates of within-subject variability were derived with a linear model rather than with a mixed model based on restricted maximum likelihood (REML). While REML-based methods are generally thought to give rise to less biased estimates of variance components, there have been no studies that compared the quality of REML-based estimates and estimates derived via linear models. Methods: A publication by Endrenyi and Tothfalusi from 1999 described simulations in a fashion that is useful for testing the European Medicines Agency’s (EMA) requirement. This study defines 7 scenarios within which 10,000 individual 2-sequence, 2-treatment, 4-period trials are simulated and makes a comparison of the quality of estimates. Results: It is concluded that estimates based on REML are closer to the true values than estimates based on linear models, but significant differences are only shown in two of the seven scenarios tested. REML-based estimators have less variability. Both types of estimates appear negatively biased and will therefore decrease the width of the acceptance range.

Perancangan sistem informasi inventarisasi aset berbasis web menggunakan metode waterfall

Perkembangan ilmu pengetahuan terutama sistem infomasi dari tahun ke tahun sangat pesat dan dengan adanya kebutuhan penyelesaian pekerjaan semakin meningkat, sehingga sistem Inventaris Aset SDN Rawamangun 09 mengalami kemunduran kualitas laporan yang masih menggunakan sistem manual. Bagi sekolah dasar yang berorientasi pada bidang Pendidikan, aset ini di harapkan menjadi sarana dan prasarana sekolah yang dapat dipergunakan dan di jaga di masa yang akan datang. Selama ini untuk pengolahan data aset masih dilakukan secara manual oleh pengurus barang yaitu untuk pendataan barang yang dibeli dengan dana Bantuan Operasional Sekolah ( BOS) maupun bantuan Aset yang di peroleh dari Dinas Pendidikan Provinsi DKI Jakarta. Dimulai dengan mencatat Kartu Inventaris Barang ( KIB ) lalu di salin di komputer , pada saat arsip aset di sekolah di perlukan sewaktu – waktu mengakibatkan lamanya waktu pencarian dan kurang lengkap nya data yang disajikan. Untuk menanggulangi permasalahan dan memenuhi serta mencapai efisiensi data pada SDN Rawamangun 09. Oleh karena itu penulisan sistem informasi inventaris aset berbasis web ini dapat memudahkan sistem kerja di mulai dari penginputan melalui web sampai dengan hasil laporan dalam bentuk pdf , selain data tercatat dengan rapih dan efisien kekeliruan pencatatan inventaris dapat berkurang . Kata kunci: Maksimum 5 kata kunci dipisahkan dengan tanda koma, harus spesifik, hindari singkatan (sesuai dengan ruang lingkup artikel dan jurnal).. Currently the internet has become one of the cheapest communication infrastructure and has a wide and unlimited acceptance range, so the internet is often used as an alternative medium for running a business or business.For elementary schools that are oriented towards the field of education, these assets are expected to become school facilities and infrastructure that can be used and protected in the future. So far, asset data processing is still done manually by the goods manager, namely for data collection of goods purchased with School Operational Assistance (BOS) funds and asset assistance obtained from the DKI Jakarta Provincial Education Office. Starting with recording the Goods Inventory Card (KIB) and then copying it on the computer, when the asset archive at school is needed at any time it results in a long search time and incomplete data presented.To overcome problems and fulfill and achieve data efficiency at SDN Rawamangun 09. Therefore, writing a web-based asset inventory information system can facilitate the work system starting from input via the web to reporting results in pdf format, in addition to the data being recorded neatly and efficiently.

A VALIDATED RP-HPLC METHOD FOR IMPURITY PROFILING OF SODIUM NITROPRUSSIDE IN INJECTION DOSAGE FORM

Objective: The main objective of this research work is to develop and validate a single reverse-phase high-performance liquid chromatography (RP-HPLC) method. This method should becapable of quantifying all the known, as well as other possible degradation impurities of sodium nitroprusside (SNP) in its injection formulation. Methods: Of allmethod development trails, we have observed better separations between known and degradation impuritiesin Inert sustain C18, (250 x 4.6) mm, 5 µm column at 30 °C temperature. Isocratic elution was carried out by using pH 8.6 phosphate buffer and acetonitrile in the ratio of 65:35 %v/v with a flow rate of 0.8 ml/min. The detection was carried out at 220 nm, with an injection volume of 10 µl. Results: In the proposed method, SNP was eluted at 22.5 min. Nitrite, nitrate, and ferrocyanide were linear from 0.25 to 37 μg/ml, ferricyanide was linear from 1.0 to 37 μg/ml, and SNP was linear from 0.75 to 37 μg/ml. The % RSD for six spiked samples (precision)was found to be less than 0.5 %. Accuracy was performed for known impurities from LOQ to 150 % for a 0.5 % specification level. The resultswere found to be in the acceptance range of 90-110 %. The LOQ concentration of nitrite, nitrate, and ferrocyanide was 0.25 μg/ml each,LOQ offerricyanide and SNP was found to be 1.0 μg/ml and 0.75 μg/ml, respectively. The SNP injection samples were exposed to different degradation conditions, and the results were found specific in the proposed methodology. Conclusion: The proposed RP-HPLC method is specific, precise, accurate, linear, stable, and robust for quantification of known and other possible degradation impurities in SNP injection formulation.

Wind Farming Feasibility Assessment in 16 Locations of Nepal

The paper assesses the feasibility of wind farming at the 16 sites scattered in different ecological regions of Nepal. The wind speed, the hourly and seasonal variation of wind, the wind-rose, the wind turbulence rate, the wind power density, the Weibull probability distribution and the frequency of the wind speed above cut in speed were computed. The average wind speed at all the sites was found to be higher during the dry season from March to May. The wind speed of the modern turbine for power generation at eight sites was found to be above cut-in speed. However, the wind power density was found to be good only at the two sites and fairly good at the six sites. More than 50 % time of a year at these eight sites had over 3.5 m/s wind speed. However, the turbulence rate at all the studied sites was found to be above the acceptance range of 25 %. Among the study sites, Kagbeni, Thini, Jumla, Ramechhap, Vorleni, Patan west, Hansapur and Baddanda were found to be technically feasible sites for wind energy generation in Nepal.

PREPARATION OF POLYHERBAL DISPERSIBLE TABLET AND EVALUATION BY RP-HPLC

The aim of the present study was to convert an Ayurvedic formulation, “trikatu churna”, into a polyherbal dispersible tablet. Standardization parameters were performed for raw materials, trikatu churna and its extract. The standardized extract was further used for formulation of the dispersible tablet. The evaluation of raw materials, trikatu churna, trikatu extract and dispersible tablet was done using preliminary phytochemical and physico-chemical tests. The pre- and post-compression parameters for polyherbal dispersible tablet formulation were within the acceptance range. The piperine content in Piper nigrum, Piper longum, trikatu extract and formulation was found to be 2.884mg/mL, 0.515mg/gm, 0.303mg/gm and 0.357mg/gm, respectively. The developed RP-HPLC method was found to be precise, accurate and reproducible for the estimation of piperine in raw materials and dispersible tablet. It can be concluded that the prepared dispersible tablet has overcome the disadvantages of churna, such as poor patient compliance and pungent taste, without altering its dose and chemical properties.

Elaboration and physical-chemical, microbiological and sensorial characterization of sweet gluten-free cookies prepared with babassu mesocarp flour and rice flour

Cookies, in general, are well accepted by all audiences, and research and investments in this type of product are of great importance to meet market demands. There are few product options for people with gluten intolerance on the market, and rice flour and babassu fruit mesocarp flour are good options for the development of new products for this audience. The objective of the present work was to prepare a gluten-free sweet biscuit with high nutritional value, based on babassu mesocarp flour with partial replacement by rice flour, to carry out the physical-chemical, microbiological characterization, sensory acceptance, and purchase intention of consumers. Three different formulations were studied, with 50, 75 and 100% babassu fruit mesocarp flour. Physical-chemical analyzes of moisture, water activity, ash, lipids, proteins and carbohydrates (by difference) were carried out, the microbiological quality was also evaluated according to the legislation and sensory acceptability through a questionnaire with 80 untrained tasters, as for the appearance, color, aroma, texture, sweetness, flavor, global impression and purchase intention attributes. The results showed that the cookies with variations of babassu fruit mesocarp flour and rice flour are comparable to other studies found in the literature, in terms of physical-chemical and microbiological characteristics. In the sensory evaluation, the cookies received grades in the acceptance range for all formulations, demonstrating that the product has the potential to be in the market.

Inter-Laboratory Validation of 4-(Dimethylamino) Cinnamaldehyde (DMAC) Assay Using Cranberry Proanthocyanidin Standard for Quantification of Soluble Proanthocyanidins in Cranberry Foods and Dietary Supplements, First Action Official MethodSM: 2019.06

Background Proanthocyanidins (PAC) are oligomers and polymers of flavan-3-ols with putative health benefits. PAC are prevalent in a wide variety of natural products and dietary supplements. Objective An inter-laboratory study was conducted to validate the 4-(dimethylamino)cinnamaldehyde (DMAC) colorimetric assay using a 96-well plate spectrophotometer for the accurate quantification of PAC in cranberry products and to evaluate the comparison of the procyanidin A2 (ProA2) dimer and cranberry PAC (c-PAC) reference standards. Methods Four test materials analyzed in this study included cranberry fiber powder, cranberry extract powder, concentrated cranberry juice, and a solution of cranberry PAC (30%, w/v). The samples were homogenized, extracted, sonicated, centrifuged, and analyzed using a 96-well plate spectrophotometer. Results Linearity for both the ProA2 and c-PAC standards was determined from 4.053 to 50.666 µg/mL and from 13.520 to 135.95 µg/mL, respectively. The relative standard deviation of repeatability (RSDr) values for the four materials analyzed, using both ProA2 and c-PAC standards, met the Standard Method Performance Requirements (SMPR®). Inter-laboratory precision using Horwitz ratio (HorRat) values for the four materials analyzed, using both ProA2 and c-PAC standards, satisfies the acceptance range in Appendix K of the Official Methods of Analysis (2003): Guidelines for Dietary Supplements and Botanicals. The limit of quantification (LOQ) was estimated to be 3.16 µg/mL. Conclusions The results produced from this study demonstrate the utility of the c-PAC standard over the ProA2 standard and the advantages of using a 96-well plate spectrophotometer for the accurate quantification of PAC. Highlights The use of a 96-well plate reader and c-PAC reference standard in the DMAC method improves accuracy and percision for quantification of soluble proanthocyanidins in cranberry foods and dietary supplements.

Bioequivalence study of two oral lincomycin formulations (lincopharm 800® and lincoyosr®) in broiler chickens

The present study was designed to assess the comparative bio-equivalence of Lincopharm 800® and Lincoyosr® in healthy broiler chicken after oral administration of both products in a dose of 20 mg lincomycin base/kg b.wt. Twenty four broiler chickens were divided into two groups. The first group was designed to study the pharmacokinetics of Lincopharm 800®, while the 2nd group was designed to study the pharmacokinetics of Lincoyosr®. Each broiler chicken in both groups was orally administered with 20 mg lincomycin base/kg b.wt. Blood samples were obtained from the wing vein and collected immediately before and at 0.08, 0.16, 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after a single oral administration. The disposition kinetics of Lincopharm 800® and Lincoyosr® following oral administration of 20 mg lincomycin base /kg b.wt, revealed that the maximum blood concentration of lincomycin [Cmax] were 4.81 and 4.62 μg/ml and attained at [tmax] of 1.36 and 1.35 hours, respectively. In conclusion: Lincoyosr® is bioequivalent to Lincopharm 800® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) was 0.96, 0.92 and 0.91 respectively. These are within the bioequivalence acceptance range. Lincoyosr® and Lincopharm 800® are therefore bioequivalent and interchangeable.