Analytical method development and validation of a combination formulation

This project report is submitted in a partial fulfillment of the requirements for the degree of Bachelor of Pharmacy, 2015.Cataloged from PDF version of Internship report.Includes bibliographical references (page 83-88).Hypertension and dyslipidemia may frequently coexist, and together have an increase in coronary heart disease related events. Combination therapy of rosuvastatin calcium and amlodipine besylate, effective for the control of hypertension by substantially reducing blood pressure and cholesterol levels, can improve its control rates to well above 80% rather than a single pill for hypertension which will control no more than 50% of a hypertensive population. The objective of the present study was to develop and validate a simple, selective and reproducible RP-HPLC method according to the ICH guidelines for the simultaneous estimation of rosuvastatin calcium and amlodipine besylate in their combined dosage forms and for drug dissolution studies. The method involves gradient elution of drugs in a stationary phase of Luna 5μ C18 column (250 mm x 4.60 mm) using a mobile phase mixture of acetonitrile and phosphate buffer of pH 2.5 in the ratio 45:55 % v/v, with a flow rate of 1.5 ml/min in ambient temperature for separation and quantification of the drugs. The injection volume was 10μl and ultraviolet detector was set at 240 nm. Total runtime was less than 9 minutes. Under the above mentioned conditions, the system was found to elute rosuvastatin calcium at approximately 6.08 mins (Assay), 6.17 mins (dissolution) and amlodipine besylate at approximately 2.5 min (dissolution), 2.7 min (assay). Linear regression analysis data for the calibration plots showed good linear relationship with r2= 0.993 with respect to peak area in the concentration range 8 -1.2 μg/ml for rosuvastatin and r2= 0.996 with respect to peak area in the concentration range 4-6 μg/ml concentration of amlodipine. The percent of recovery was found to be in the range of 98-102% for both the drugs. The developed and validated assay method was found to be accurate, precise, robust and specific which allows its adoption for the routine quality control in-vitro dissolution studies of both the pure drug and the combination formulation.Noshin MubtasimB. Pharmac

PENERAPAN PENDEKATAN ANDRAGOGI MELALUI METODE DEMONSTRASI PADA PEMBELAJARAN LIFE SKILL MENJAHIT PROGRAM PAKET C

Tujuan dari penelitian ini adalah mengetahui penerapan metode demonstrasi pada pembelajaran life skill menjahit program paket C di UPTD SKB Susukan Kabupaten Semarang. Mengetahui kendala-kendala yang dihadapi dalam metode demonstrasi pada pembelajaran life skill menjahit program paket C di UPTD SKB Susukan Kabupaten Semarang. Mengetahui upaya-upaya untuk mengatasi kendala dalam metode demonstrasi pada pembelajaran life skill menjahit program paket C di UPTD SKB Susukan Kabupaten Semarang. Penelitian ini menggunakan metode deskriptif kualitatif sedangkan subjek penelitian adalah 3 warga belajar 1 tutor dan 1 kepala UPTD SKB Susukan. Berdasarkan analisis menggunakan teknik triangulasi sumber dapat diketahui bahwa penerapan metode demonstrasi menjahit kejar paket C di UPTD SKB Susukan yaitu Identifikasi kebutuhan warga belajar, mempersiapkan demonstrator, ruangan yang yang digunakan cukup memadai, persiapkan tutor dalam memberikan materi sudah baik, mempersiapkan warga belajar, terjadinya tanya jawab, dan publikasi hasil demontrasi menjahit dilakukan pada even karnaval, pameran maupun kepada pengunjung di UPTD SKB Susukan. Kendala yang hadapi diantarannya kurangnya perhatian dan konsentrasi beberapa warga belajar pada pelaksanaan demonstrasi menjahit,  terdapat mesin jahit yang rusak belum diperbaiki sehingga warga belajar harus bergantian dalam praktek menjahit dan ruangan yang kurang memadahi. Solusi untuk mengatasi kendala tersebut dengan melengkapi dan memperbaiki  peralatan yang kurang memadai. Menyajikan pembelajaran semenarik mungkin sehingga perhatian dan konsentrasi warga belajar bisa terfokus pada pembelajaran

The Pivotal Role of Regionally-Embedded Innovation Systems for Inclusive and Sustainable Development in Manufacturing Industries

of the developed world, attributed to increased merger activity, outsourcing and automation, have created socio-economic rifts in communities once reliant on the sector. Local innovation systems often perpetuate these issues through path-dependence on international business trends that prioritize global markets above regional ones, leaving regional actors deficient in their ability to harness the unique “socio-cultural capital” of their locality for business success. This paper proposes that bottom-up “regionally- embedded” innovation systems are better poised to sustain regional employment than manufacturing clusters that excessively rely on external sources of product and process innovation. Using furniture manufacturing as a case-study, the regionally-embedded innovation system of the Amish community in Holmes County, Ohio is compared with the nationally and internationally-embedded system of West Jutland, Denmark. Despite significant technological constraints, the Amish were able to match the productivity of industry peers through utilizing strong linkages with the local labor force, suppliers and financiers based on networks with high levels of regional trust. This allowed for process innovations such as trade shows and apprenticeship pipelines to organically arise from the bottom-up. Capitalizing on the wider curiosity associated with the Amish name, the Amish of Holmes County created a brand for their product offerings and a booming local tourism industry that fed into their existing furniture manufacturing cluster, thereby benefiting from economies of scope. This product innovation enabled Holmes County’s furniture cluster to create a competitive advantage for itself that cushioned them from the shocks faced by the manufacturing industry. In contrast, West Jutland’s furniture cluster, dependent on extraterritorial innovation from the national and international level, succumbed to these shocks in the absence of the innovation system factors that aided Holmes Country. The resulting effect is a cluster that employs and contributes much less to the locality than it once did

Investigations into the use of enzyme inhibitors to control drug release for overdose prevention

Pharmaceutical pain killers, particularly opioids, have seen a rise in misuse and accidental overdoses. This thesis provides a new method in creating these medications in attempt to combat this issue. New formulations termed inhibitor controlled-release (ICR) were created which have the ability to prevent drug release as more doses are consumed, thereby lowering the chance of an accidental overdose. This new approach has laid the foundation for further research which has the ability to save many lives and could reduce the risks linked with some pharmaceutical medications

The Complex Biology of the Obesity-Induced, Metastasis-Promoting Tumor Microenvironment in Breast Cancer

Breast cancer is one of the most prevalent cancers in women contributing to cancer-related death in the advanced world. Apart from the menopausal status, the trigger for developing breast cancer may vary widely from race to lifestyle factors. Epidemiological studies refer to obesity-associated metabolic changes as a critical risk factor behind the progression of breast cancer. The plethora of signals arising due to obesity-induced changes in adipocytes present in breast tumor microenvironment, significantly affect the behavior of adjacent breast cells. Adipocytes from white adipose tissue are currently recognized as an active endocrine organ secreting different bioactive compounds. However, due to excess energy intake and increased fat accumulation, there are morphological followed by secretory changes in adipocytes, which make the breast microenvironment proinflammatory. This proinflammatory milieu not only increases the risk of breast cancer development through hormone conversion, but it also plays a role in breast cancer progression through the activation of effector proteins responsible for the biological phenomenon of metastasis. The aim of this review is to present a comprehensive picture of the complex biology of obesity-induced changes in white adipocytes and demonstrate the relationship between obesity and breast cancer progression to metastasis

A pragmatic approach to the analysis of a combination formulation

The aim of the paper was to formulate a combined oral dosage form of rosuvastatin calcium and amlodipine besylate and to develop and validate an analytical method to be adopted for both routine quality control assay and in vitro dissolution studies of the formulation. The proposed combination formulation has shown compatibility with the chosen excipients, verified through FT-IR study. A novel gradient RP-HPLC method was developed and validated according to the ICH guideline which was found to be suitable for the simultaneous estimation of rosuvastatin calcium and amlodipine besylate from the formulation. The retention time of 2.7 and 6.08 min allows the analysis of large amount of samples with less mobile phase which makes the method economic. The dissolution profiles of both the drugs in different dissolution medium were encouraging which makes the combination formulation of rosuvastatin calcium and amlodipine besylate superior and effective in achieving patient compliance

Attention-Driven Multi-Modal Fusion: Enhancing Sign Language Recognition and Translation

In this paper, we devise a mechanism for the addition of multi-modal information with an existing pipeline for continuous sign language recognition and translation. In our procedure, we have incorporated optical flow information with RGB images to enrich the features with movement-related information. This work studies the feasibility of such modality inclusion using a cross-modal encoder. The plugin we have used is very lightweight and doesn't need to include a separate feature extractor for the new modality in an end-to-end manner. We have applied the changes in both sign language recognition and translation, improving the result in each case. We have evaluated the performance on the RWTH-PHOENIX-2014 dataset for sign language recognition and the RWTH-PHOENIX-2014T dataset for translation. On the recognition task, our approach reduced the WER by 0.9, and on the translation task, our approach increased most of the BLEU scores by ~0.6 on the test set.Comment: This version has some errors. Our schedule is packed, so we don't have enough time to correct it. We will share another work when we have time to fix thi

Plant–water relations in subtropical maize fields under mulching and organic fertilization

The plant–water relationship of maize under conservation practices needs to be assessed to quantify the effectiveness of the practices in conserving soil water for crop production. This study evaluated in three trials how straw and plastic film mulching and organic manure application could potentially change water fluxes in the root zone and increase maize yield. A mathematical model HYDRUS-1D was calibrated against the observed soil water content and drainage data to predict the water fluxes in the root zone soil. The model simulated soil water dynamics in the root zone with satisfactory performance (RMSE of 0.6–2.3%, CD of 0.37–1.41, NSE of 0.18–0.88, and R2 of 0.62–0.91) during both the calibration and validation periods. The model predicted the observed drainage in a lysimeter with only a 5.5–11.7% bias and actual evapotranspiration (ETc) with a 2.6–6.7% bias for the control conditions in all three trials when the model was provided with measured plant growth, soil properties, and weather data. Both measurement and modeling confirmed that mulching augmented soil water storage by reducing ETc, i.e., 0.24–0.37 mm d-1 by straw mulching and 0.05–0.24 mm d-1 by plastic mulching during the trials. Manure application did not affect the ETc rate and resulted in the highest grain yield (6.8–8.3 Mg ha˗1) followed by plastic mulching (6.1–8.1 Mg ha˗1) and straw mulching (5.3–7.5 Mg ha˗1). Manure application increased the harvest index by optimally allocating biomass because of a steady supply of water and nutrients. The straw mulch, plastic mulch, and manure treatments increased grain yield by 13%, 24%, and 35%, respectively, compared to the control condition. Large-scale implementation of these practices would lessen blue water scarcity in agriculture

Multi-sample deformability cytometry of cancer cells

There is growing recognition that cell deformability can play an important role in cancer metastasis and diagnostics. Advancement of methods to characterize cell deformability in a high throughput manner and the capacity to process numerous samples can impact cancer-related applications ranging from analysis of patient samples to discovery of anti-cancer compounds to screening of oncogenes. In this study, we report a microfluidic technique called multi-sample deformability cytometry (MS-DC) that allows simultaneous measurement of flow-induced deformation of cells in multiple samples at single-cell resolution using a combination of on-chip reservoirs, distributed pressure control, and data analysis system. Cells are introduced at rates of O(100) cells per second with a data processing speed of 10 min per sample. To validate MS-DC, we tested more than 50 cell-samples that include cancer cell lines with different metastatic potential and cells treated with several cytoskeletal-intervention drugs. Results from MS-DC show that (i) the cell deformability correlates with metastatic potential for both breast and prostate cancer cells but not with their molecular histotype, (ii) the strongly metastatic breast cancer cells have higher deformability than the weakly metastatic ones; however, the strongly metastatic prostate cancer cells have lower deformability than the weakly metastatic counterparts, and (iii) drug-induced disruption of the actin network, microtubule network, and actomyosin contractility increased cancer cell deformability, but stabilization of the cytoskeletal proteins does not alter deformability significantly. Our study demonstrates the capacity of MS-DC to mechanically phenotype tumor cells simultaneously in many samples for cancer research