Sustainable Stabilizer-Free Nanoparticle Formulations of Valsartan Using Eudragit® RLPO

The bioavailability of the antihypertensive drug valsartan can be enhanced by various microencapsulation methods. In the present investigation, valsartan-loaded polymeric nanoparticles were manufactured from Eudragit® RLPO using an emulsion–solvent evaporation method. Polyvinyl alcohol (PVA) was found to be a suitable stabilizer for the nanoparticles, resulting in a monodisperse colloid system ranging in size between 148 nm and 162 nm. Additionally, a high encapsulation efficiency (96.4%) was observed. However, due to the quaternary ammonium groups of Eudragit® RLPO, the stabilization of the dispersion could be achieved in the absence of PVA as well. The nanoparticles were reduced in size (by 22%) and exhibited similar encapsulation efficiencies (96.4%). This more cost-effective and sustainable production method reduces the use of excipients and their expected emission into the environment. The drug release from valsartan-loaded nanoparticles was evaluated in a two-stage biorelevant dissolution set-up, leading to the rapid dissolution of valsartan in a simulated intestinal medium. In silico simulations using a model validated previously indicate a potential dose reduction of 60–70% compared to existing drug products. This further reduces the expected emission of the ecotoxic compound into the environment.

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DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE

International Journal of Drug Regulatory Affairs ◽

10.22270/ijdra.v3i2.12 ◽

2015 ◽

Vol 3 (2) ◽

pp. 1-7 ◽

Cited By ~ 1

Author(s):

Achin Jain ◽

M P Venkatesh M P ◽

Pramod T.M. Kumar

Keyword(s):

Quality Control ◽

Medical Devices ◽

Emerging Market ◽

Well Being ◽

New Drugs ◽

Regulatory Body ◽

Herbal Drugs ◽

Drug Products ◽

Set Up

In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality,safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuringsafety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms.The guidelines laid by TFDA have also emanated from commitment to democracy and gives strong emphasis to thefulfilment of the needs of the less privileged rural population.Tanzania is an emerging market; the pharmaceutical market is valued at over US$250 million, and is growing at anannual rate of around 16.5% and is expected to reach approximately US$550 billion in 2020. Currently, the market ishighly dependent on imports, which account for around 75% of the total pharmaceutical market.The procedures and approval requirements of new drugs, variations, import, export and disposal have been set up bythe TFDA, which help in maintaining quality of the drug products that are imported as well being produced locally

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Innovating on Inhaled Bioequivalence: A Critical Analysis of the Current Limitations, Potential Solutions and Stakeholders of the Process

Pharmaceutics ◽

10.3390/pharmaceutics13071051 ◽

2021 ◽

Vol 13 (7) ◽

pp. 1051

Author(s):

Jonattan Gallegos-Catalán ◽

Zachary Warnken ◽

Tania F. Bahamondez-Canas ◽

Daniel Moraga-Espinoza

Keyword(s):

New Technologies ◽

Innovation Process ◽

Cost Effective ◽

Regulatory Agencies ◽

Drug Products ◽

Effective Strategies ◽

Rate Analysis ◽

Orally Inhaled Drug Products ◽

Next Generation Impactor ◽

First Time

Orally inhaled drug products (OIDPs) are an important group of medicines traditionally used to treat pulmonary diseases. Over the past decade, this trend has broadened, increasing their use in other conditions such as diabetes, expanding the interest in this administration route. Thus, the bioequivalence of OIDPs is more important than ever, aiming to increase access to affordable, safe and effective medicines, which translates into better public health policies. However, regulatory agencies leading the bioequivalence process are still deciding the best approach for ensuring a proposed inhalable product is bioequivalent. This lack of agreement translates into less cost-effective strategies to determine bioequivalence, discouraging innovation in this field. The Next-Generation Impactor (NGI) is an example of the slow pace at which the inhalation field evolves. The NGI was officially implemented in 2003, being the last equipment innovation for OIDP characterization. Even though it was a breakthrough in the field, it did not solve other deficiencies of the BE process such as dissolution rate analysis on physiologically relevant conditions, being the last attempt of transferring technology into the field. This review aims to reveal the steps required for innovation in the regulations defining the bioequivalence of OIDPs, elucidating the pitfalls of implementing new technologies in the current standards. To do so, we collected the opinion of experts from the literature to explain these trends, showing, for the first time, the stakeholders of the OIDP market. This review analyzes the stakeholders involved in the development, improvement and implementation of methodologies that can help assess bioequivalence between OIDPs. Additionally, it presents a list of methods potentially useful to overcome some of the current limitations of the bioequivalence standard methodologies. Finally, we review one of the most revolutionary approaches, the inhaled Biopharmaceutical Classification System (IBCs), which can help establish priorities and order in both the innovation process and in regulations for OIDPs.

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Fabrication of a liquid cell for in situ transmission electron microscopy

Microscopy ◽

10.1093/jmicro/dfaa076 ◽

2020 ◽

Author(s):

Xiaoguang Li ◽

Kazutaka Mitsuishi ◽

Masaki Takeguchi

Keyword(s):

Electron Microscopy ◽

Transmission Electron Microscopy ◽

Cost Effective ◽

Production Method ◽

Microscopy Imaging ◽

Transmission Electron ◽

In Situ Electron Microscopy ◽

Liquid Cell ◽

Si Wafer

Abstract Liquid cell transmission electron microscopy (LCTEM) enables imaging of dynamic processes in liquid with high spatial and temporal resolution. The widely used liquid cell (LC) consists of two stacking microchips with a thin wet sample sandwiched between them. The vertically overlapped electron-transparent membrane windows on the microchips provide passage for the electron beam. However, microchips with imprecise dimensions usually cause poor alignment of the windows and difficulty in acquiring high-quality images. In this study, we developed a new and efficient microchip fabrication process for LCTEM with a large viewing area (180 µm × 40 µm) and evaluated the resultant LC. The new positioning reference marks on the surface of the Si wafer dramatically improve the precision of dicing the wafer, making it possible to accurately align the windows on two stacking microchips. The precise alignment led to a liquid thickness of 125.6 nm close to the edge of the viewing area. The performance of our LC was demonstrated by in situ transmission electron microscopy imaging of the dynamic motions of 2-nm Pt particles. This versatile and cost-effective microchip production method can be used to fabricate other types of microchips for in situ electron microscopy.

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Environmental Engineering Techniques to Restore Degraded Posidonia oceanica Meadows

Water ◽

10.3390/w13050661 ◽

2021 ◽

Vol 13 (5) ◽

pp. 661

Author(s):

Luigi Piazzi ◽

Stefano Acunto ◽

Francesca Frau ◽

Fabrizio Atzori ◽

Maria Francesca Cinti ◽

...

Keyword(s):

Large Scale ◽

Natural Habitat ◽

Cost Benefit ◽

Cost Effective ◽

Posidonia Oceanica ◽

Environmental Engineering ◽

Bottom Surface ◽

Sessile Invertebrates ◽

Set Up ◽

Short Time

Seagrass planting techniques have shown to be an effective tool for restoring degraded meadows and ecosystem function. In the Mediterranean Sea, most restoration efforts have been addressed to the endemic seagrass Posidonia oceanica, but cost-benefit analyses have shown unpromising results. This study aimed at evaluating the effectiveness of environmental engineering techniques generally employed in terrestrial systems to restore the P. oceanica meadows: two different restoration efforts were considered, either exploring non-degradable mats or, for the first time, degradable mats. Both of them provided encouraging results, as the loss of transplanting plots was null or very low and the survival of cuttings stabilized to about 50%. Data collected are to be considered positive as the survived cuttings are enough to allow the future spread of the patches. The utilized techniques provided a cost-effective restoration tool likely affordable for large-scale projects, as the methods allowed to set up a wide bottom surface to restore in a relatively short time without any particular expensive device. Moreover, the mats, comparing with other anchoring methods, enhanced the colonization of other organisms such as macroalgae and sessile invertebrates, contributing to generate a natural habitat.

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K-seq, an affordable, reliable, and open Klenow NGS-based genotyping technology

Plant Methods ◽

10.1186/s13007-021-00733-6 ◽

2021 ◽

Vol 17 (1) ◽

Author(s):

Peio Ziarsolo ◽

Tomas Hasing ◽

Rebeca Hilario ◽

Victor Garcia-Carpintero ◽

Jose Blanca ◽

...

Keyword(s):

Cost Effective ◽

Genetic Distances ◽

Set Design ◽

Special Equipment ◽

Genetic Studies ◽

Set Up ◽

Genomic Regions ◽

Biology Laboratory ◽

Genotyping Technology ◽

Genetic Results

Abstract Background K-seq, a new genotyping methodology based on the amplification of genomic regions using two steps of Klenow amplification with short oligonucleotides, followed by standard PCR and Illumina sequencing, is presented. The protocol was accompanied by software developed to aid with primer set design. Results As the first examples, K-seq in species as diverse as tomato, dog and wheat was developed. K-seq provided genetic distances similar to those based on WGS in dogs. Experiments comparing K-seq and GBS in tomato showed similar genetic results, although K-seq had the advantage of finding more SNPs for the same number of Illumina reads. The technology reproducibility was tested with two independent runs of the tomato samples, and the correlation coefficient of the SNP coverages between samples was 0.8 and the genotype match was above 94%. K-seq also proved to be useful in polyploid species. The wheat samples generated specific markers for all subgenomes, and the SNPs generated from the diploid ancestors were located in the expected subgenome with accuracies greater than 80%. Conclusion K-seq is an open, patent-unencumbered, easy-to-set-up, cost-effective and reliable technology ready to be used by any molecular biology laboratory without special equipment in many genetic studies.

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Sustainable Ventilation Strategies for a Medium-Sized Space with Regional Effect

Sustainability ◽

10.3390/su13094651 ◽

2021 ◽

Vol 13 (9) ◽

pp. 4651

Author(s):

Ming-Lun Alan Fong

Keyword(s):

Life Cycle ◽

Life Cycle Cost ◽

Co2 Emission ◽

High Efficiency ◽

Regional Climate ◽

Cost Effective ◽

Regional Effect ◽

Climate Conditions ◽

Ventilation Strategies ◽

Set Up

The analysis of ventilation strategies is fundamentally affected by regional climate conditions and local cost databases, in terms of energy consumption, CO2 emission and cost-effective analysis. A systematic approach is covered in this paper to estimate a local economic and environmental impact on a medium-sized space located in two regions during supply-and-installation and operation phases. Three ventilation strategies, including mixing ventilation (MV), displacement ventilation (DV) and stratum ventilation (SV) were applied to medium-sized air-conditioned space with this approach. The trend of the results for three ventilation systems in the life cycle assessment (LCA) and life cycle cost (LCC) analysis is SV < DV < MV. The result of CO2 emission and regional LCC shows that SV is the lowest one in both regional studies. In comparison with the Hong Kong Special Administrative Region (HKSAR) during 20 Service years, the case analysis demonstrates that the percentage differences in LCC analysis of MV, DV & SV in Guangdong are less than 20.5%, 19.4% and 18.82% respectively. Their CO2 emission of MV, DV and SV in Guangdong are more than HKSAR in 10.69%, 11.22% and 12.05%, respectively. The present study could provide information about regional effects in the LCA and LCC analysis of three ventilation strategies emissions, and thereby help set up models for decision-making on high efficiency and cost-effective ventilation strategy plans.

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Cost Effective Swath Bathymetry

Marine Technology Society Journal ◽

10.4031/002533201788057982 ◽

2001 ◽

Vol 35 (4) ◽

pp. 33-45 ◽

Cited By ~ 3

Author(s):

Peter Hogarth

Keyword(s):

Processing Time ◽

Cost Effective ◽

High Accuracy ◽

High Coverage ◽

Swath Bathymetry ◽

World Survey ◽

Set Up ◽

Very High ◽

Harbor Area ◽

Wide Swath

Between 23rd and 25th July 2001 GeoSwath, a high specification shallow water wide swath bathymetry system, was used to survey the entire Portsmouth NH Harbor area. This paper deals with the results of this survey, illustrating the potential for significant reductions in the high costs, which have prevented widespread proliferation of Swath Bathymetry systems to date. Data, including a complete DTM gridded to 1 m resolution, will be presented and discussed in detail. These results show that the system is very easy to set up and use, requires greatly reduced boat and processing time, whilst offering high accuracy and very high coverage and resolution when used in a real-world survey of a dynamic harbor environment.

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Innovation Pathways in the NHS: An Introductory Review

Therapeutic Innovation & Regulatory Science ◽

10.1007/s43441-021-00304-w ◽

2021 ◽

Author(s):

Anmol Arora ◽

Andrew Wright ◽

Mark Cheng ◽

Zahra Khwaja ◽

Matthew Seah

Keyword(s):

Health Care ◽

National Health ◽

Health Care Professionals ◽

New Technologies ◽

Care Delivery ◽

Cost Effective ◽

Care Models ◽

Set Up ◽

The Uk ◽

Introductory Review

AbstractHealthcare as an industry is recognised as one of the most innovative. Despite heavy regulation, there is substantial scope for new technologies and care models to not only boost patient outcomes but to do so at reduced cost to healthcare systems and consumers. Promoting innovation within national health systems such as the National Health Service (NHS) in the United Kingdom (UK) has been set as a key target for health care professionals and policy makers. However, while the UK has a world-class biomedical research industry, several reports in the last twenty years have highlighted the difficulties faced by the NHS in encouraging and adopting innovations, with the journey from idea to implementation of health technology often taking years and being very expensive, with a high failure rate. This has led to the establishment of several innovation pathways within and around the NHS, to encourage the invention, development and implementation of cost-effective technologies that improve health care delivery. These pathways span local, regional and national health infrastructure. They operate at different stages of the innovation pipeline, with their scope and work defined by location, technology area or industry sector, based on the specific problem identified when they were set up. In this introductory review, we outline each of the major innovation pathways operating at local, regional and national levels across the NHS, including their history, governance, operating procedures and areas of expertise. The extent to which innovation pathways address current challenges faced by innovators is discussed, as well as areas for improvement and future study.

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Dual Drug Delivery of Sorafenib and Doxorubicin from PLGA and PEG-PLGA Polymeric Nanoparticles

Polymers ◽

10.3390/polym10080895 ◽

2018 ◽

Vol 10 (8) ◽

pp. 895 ◽

Cited By ~ 18

Author(s):

György Babos ◽

Emese Biró ◽

Mónika Meiczinger ◽

Tivadar Feczkó

Keyword(s):

Drug Delivery ◽

Polymeric Nanoparticles ◽

Single Agent ◽

Double Emulsion ◽

Controlled Drug Release ◽

Chemical Characteristics ◽

Solvent Evaporation Method ◽

Polymeric Carrier ◽

Sustained Drug Delivery ◽

Dual Drug

Combinatorial drug delivery is a way of advanced cancer treatment that at present represents a challenge for researchers. Here, we report the efficient entrapment of two clinically used single-agent drugs, doxorubicin and sorafenib, against hepatocellular carcinoma. Biocompatible and biodegradable polymeric nanoparticles provide a promising approach for controlled drug release. In this study, doxorubicin and sorafenib with completely different chemical characteristics were simultaneously entrapped by the same polymeric carrier, namely poly(d,l-lactide-co-glycolide) (PLGA) and polyethylene glycol-poly(d,l-lactide-co-glycolide) (PEG-PLGA), respectively, using the double emulsion solvent evaporation method. The typical mean diameters of the nanopharmaceuticals were 142 and 177 nm, respectively. The PLGA and PEG-PLGA polymers encapsulated doxorubicin with efficiencies of 52% and 69%, respectively, while these values for sorafenib were 55% and 88%, respectively. Sustained drug delivery under biorelevant conditions was found for doxorubicin, while sorafenib was released quickly from the PLGA-doxorubicin-sorafenib and PEG-PLGA-doxorubicin-sorafenib nanotherapeutics.

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How to Implement Safe, Efficient and Cost-Effective SARS-CoV-2 Testing in Urban and Rural Schools within One Month

COVID ◽

10.3390/covid1040057 ◽

2021 ◽

Vol 1 (4) ◽

pp. 717-727

Author(s):

Parastoo Kheiroddin ◽

Magdalena Gründl ◽

Michael Althammer ◽

Patricia Schöberl ◽

Linda Plail ◽

...

Keyword(s):

Data Transfer ◽

Cost Effective ◽

Testing System ◽

Successful Implementation ◽

Rural And Urban ◽

Local Involvement ◽

Working Day ◽

Set Up ◽

The Individual ◽

Time Required

(1) Background: With vaccination and new variants of SARS-CoV-2 on the horizon, efficient testing in schools may enable prevention of mass infection outbreaks, keeping schools safe places and buying time until decisions on feasibility and the necessity of vaccination in children and youth are made. We established, in the course of the WICOVIR (Where Is the COrona VIRus) study, that gargle-based pool-PCR testing offers a feasible, efficient, and safe testing system for schools in Germany when applied by central university laboratories. (2) Objectives: We evaluated whether this approach can be implemented in different rural and urban settings. (3) Methods: We assessed the arrangements required for successful implementation of the WICOVIR approach in a variety of settings in terms of transport logistics, data transfer and pre-existing laboratory set-up, as well as the time required to establish the set-up. (4) Results: We found that once regulatory issues have been overcome, all challenges pertaining to logistics, data transfer, and laboratory testing on different platforms can be solved within one month. Pooling and depooling of samples down to the individual test result were achievable within one working day in all settings. Local involvement of the community and decentralized set-ups were keys for success. (5) Conclusion: The WICOVIR gargle-based pool-PCR system is so robust and simple that it can be implemented within one month in all settings now or in future pandemics.

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