scholarly journals Solubility Enhancement of Antihyperlipidemic Drug by Solvent Diffusion Technique

2021 ◽  
Vol 10 (5) ◽  
Author(s):  
Anjli Chauhan ◽  
Gaurav Gupta ◽  
Pratyush Jain ◽  
Alok Pal Jain
Keyword(s):  
Development Process ◽  
Critical Factor ◽  
Aqueous Solubility ◽  
New Drugs ◽  
Limiting Factor ◽  
Pharmaceutical Development ◽  
Solvent Diffusion ◽  
Diffusion Technique ◽  
Successful Launch ◽  
Spherical Agglomerates

Poor aqueous solubility of drugs is major limiting factor with many new drugs in their successful launch in market in spite of their potential pharmacokinetic activity. Therefore, poor solubility is critical factor if the molecule is to survive the pharmaceutical development process. In the current work, it was planned to enhance the solubility of antihyperlipidemic drug by solvent diffusion technique. For this the drug clofibrate and excipients were procured and spherical agglomerates were prepared and evaluated. The findings of the study states the novelty the hypothesis. Keywords: Solubility, Diffusion, Agglomerates

Pharmaceutical Development Process

2019 ◽  
pp. 133-157
Author(s):  
Yaashikaa Ponnambalam Ragini
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Drug Development ◽  
Development Process ◽  
Human Life ◽  
Drug Application ◽  
New Drugs ◽  
Pharmaceutical Drug ◽  
Pharmaceutical Development

The most significant attribute of the pharmaceutical industry is its creations and advancements. The innovation of new drugs is necessary for improving the quality of human life and duration. Pharmaceutical drug development is a time-consuming, costly, and crucial process. The essential goal of drug development is to discover a dosage or dosage scale of a drug application that is both efficient in curing the desired disease and safe. Clinical trials including newly developed drugs that are directed in a progression of successive steps called stages to decide the security and efficacy of the new drug moreover the viability against the targeted diseases. There are four phases through which clinical trials are conducted. An investigational item can be assessed in more than one stage all the while in various clinical trials, and some clinical trials may cover two unique stages.

scholarly journals Comparative Analysis of the QbD Approach in the Pharmaceutical Industry

2019 ◽  
Vol 8 (4) ◽  
pp. 20-26 ◽  
Author(s):  
S. A. Rozhnova ◽  
A. V. Tsypkina
Keyword(s):  
Comparative Analysis ◽  
Drug Development ◽  
Systematic Approach ◽  
New Drugs ◽  
Pharmaceutical Development ◽  
Drug Products ◽  
New Drug ◽  
Eurasian Economic Union ◽  
Pharmaceutical Manufacturers ◽  
Economic Union

Introduction. In the development and introduction of medicines into production, the aim of pharmaceutical manufacturers is to comply with the principle of «Quality-by-Design» (QbD). The International Council for Harmonisation (ICH) has created a number of GxP standards, which have become the regulatory framework for the development of documentation regulating the requirements for the development and production of drug products for countries focused on bringing their products to the world pharmaceutical market. The analysis of the system of regulation of pharmaceutical stages of development of new drugs in the territory of the Eurasian Economic Union was not considered, but for the formation of a systematic approach to the management of the process of pharmaceutical development it is necessary to describe them.Aim. To analyze the possibility of applying the QbD principle to the process of drug development at domestic pharmaceutical enterprises.Materials and methods. Content analysis of scientific publications, system and comparative analysis, sociological methods of research in the field of pharmaceutical development.Results and discussions. Regulatory state requirements to the organization and conduct of drug development procedures are analyzed and described. A number of systemic and sectoral problems typical for domestic pharmaceutical manufacturers in the organization of the development and implementation of new drug products. It is established that one of the main problems for Russian enterprises was the organization of the process as a whole and its individual procedures. To solve the problem of organization of procedures for the development and implementation of new medicines, we formed a methodological support, developed on the basis of a systematic approach and international requirements from the quality system.Conclusion. The main problem identified by the manufacturers is the lack of methodological support for the organization of the processes of pharmaceutical development and the introduction of new drugs in the part of research going to the stage of preclinical and clinical development. The decisions adopted by the Eurasian Economic Union do not affect such aspects of pharmaceutical development regulation as the organization of processes, their management and methodological support aimed at the implementation of the QbD principle. To solve this problem, we have developed guidelines for the implementation of the processes of pharmaceutical development and the introduction of new drug products, which allowed us to apply unified and formalized approaches to their organization. 

Antimetastatic Potential of Quercetin Analogues with Improved Pharmacokinetic Profile: Pharmacoinformatic Preliminary Study

2021 ◽  
Vol 21 ◽  
Author(s):  
Nebojša Pavlović ◽  
Nastasija Milošević ◽  
Maja Đjanić ◽  
Svetlana Goločorbin-Kon ◽  
Bojan Stanimirov ◽  
...  
Keyword(s):  
Membrane Permeability ◽  
Anticancer Agents ◽  
Inhibitory Activity ◽  
Computational Models ◽  
Aqueous Solubility ◽  
Pharmacokinetic Profile ◽  
Limiting Factor ◽  
Hydroxyl Groups ◽  
Molegro Virtual Docker ◽  
Upa Receptor

Background: Urokinase-type plasminogen activator (uPA) system is a crucial pathway for tumor invasion and metastasis. Recently, multiple anticancer effects of quercetin have been described, including inhibitory activity against uPA. However, the clinical use of this flavonoid has been limited due to its low oral bioavailability. Objective: The objectives of the study were to assess the antimetastatic potential of quercetin analogues by analyzing their binding affinity for uPA and to select the compounds with improved pharmacological profiles. Methods: Binding affinities of structural analogues of quercetin to uPA receptor were determined by molecular docking analysis using Molegro Virtual Docker software, and molecular descriptors relevant for estimating pharmacological profile were calculated from ligand structures using computational models. Results: Among 44 quercetin analogues, only one quercetin analogue (3,6,2’,4’,5’-pentahydroxyflavone) was found to possess both higher aqueous solubility and membrane permeability, and a stronger affinity for uPA than quercetin, which makes it the potential lead compound for anticancer drug development. Like quercetin, this compound has five hydroxyl groups but is arranged differently, which contributes to the higher aqueous solubility and higher amphiphilic moment compared to quercetin. Since membrane permeability is not recognized as the limiting factor for quercetin absorption, analogues with higher aqueous solubility and retained or stronger uPA inhibitory activity should also be further experimentally validated for potential therapeutic use. Conclusion: Identified quercetin analogues with better physicochemical and pharmacological properties have a high potential to succeed in later stages of research in biological systems as potential anticancer agents with antimetastatic activity.

Preparation of Zaleplon Microparticles Using Emulsion Solvent Diffusion Technique

2012 ◽  
Vol 01 (03) ◽  
Author(s):  
Ahmed Abd El-Bary ◽  
Omaima El-Gazayerly ◽  
Arwa El-Hagrasy ◽  
Ibtehal Salah Ad-din
Keyword(s):  
Solvent Diffusion ◽  
Diffusion Technique

Marketing and Pharmaceutical Development

1992 ◽  
Vol 22 (2) ◽  
pp. 221-234
Author(s):  
Maven J. Myers
Keyword(s):  
Cumulative Effect ◽  
Basic Research ◽  
Decision Processes ◽  
New Drugs ◽  
The Political ◽  
Market Demand ◽  
Pharmaceutical Development ◽  
New Drug ◽  
The Cost ◽  
Political Decisions

New pharmaceuticals are developed in response to therapeutic need, scientific feasibility, and market demand. As research and development (R&D) decision processes becomes more sophisticated, marketing input plays a greater role in these decisions. Industry-financed R&D is dependent on basic research financed by government. The political decisions which determine government-financed research are significant determinants of the scientific feasibility of a new drug. Many new drugs offer only minor advantages over existing therapies. The cumulative effect of these minor improvements are significant. In addition, new drugs often increase competition in a market. The Orphan Drug Act has contributed to the marketing of drugs where sufficient market demand may not otherwise exist. While some portion of R&D funds are spent on imitative drugs, the incentive for this use of R&D funds decreases as buyers become more sophisticated and as the cost of marketing a new drug increases.

A new double emulsion solvent diffusion technique for encapsulating hydrophilic molecules in PLGA nanoparticles

2009 ◽  
Vol 133 (2) ◽  
pp. 90-95 ◽  
Author(s):  
Einat Cohen-Sela ◽  
Michael Chorny ◽  
Nickolay Koroukhov ◽  
Haim D. Danenberg ◽  
Gershon Golomb
Keyword(s):  
Double Emulsion ◽  
Plga Nanoparticles ◽  
Solvent Diffusion ◽  
Diffusion Technique

scholarly journals Evaluation of molecular assays to detect Leishmania donovani in Phlebotomus argentipes fed on post-kala-azar dermal leishmaniasis patients

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Md Anik Ashfaq Khan ◽  
Khaledul Faisal ◽  
Rajashree Chowdhury ◽  
Rupen Nath ◽  
Prakash Ghosh ◽  
...  
Keyword(s):  
Leishmania Donovani ◽  
Control Strategies ◽  
Reference Method ◽  
Critical Factor ◽  
Sand Fly ◽  
Accurate Estimation ◽  
Limiting Factor ◽  
Sand Flies ◽  
Real Time Quantitative Pcr ◽  
Kala Azar

Abstract Background Post-kala-azar dermal leishmaniasis (PKDL) caused by Leishmania donovani (LD) is a skin disorder that often appears after treatment of visceral leishmaniasis (VL) patients. PKDL patients are potential reservoirs of LD parasites, which can initiate a new epidemic of anthroponotic VL. Therefore, host infectiousness to its sand fly vector is a critical factor for transmission, and its accurate estimation can facilitate control strategies. At present, conventional microscopy serves as the reference method to detect parasites in its vector. However, low sensitivity of microscopy can be a limiting factor. Methods In this study, real-time quantitative PCR (LD-qPCR) and recombinase polymerase amplification (LD-RPA) assays were evaluated against microscopy for the detection of LD DNA extracted from live sand flies five days after controlled feeding on PKDL cases. Results The sensitivity of LD-qPCR and LD-RPA assays were found to be 96.43 and 100%, respectively, against microscopy for the selected fed sand flies (n = 28), and an absolute specificity of both molecular tools for apparently unfed sand flies (n = 30). While the proportion of infectious cases among 47 PKDL patients was estimated as 46.81% as defined by microscopic detection of LD in at least one fed sand fly per case, LD-RPA assay evaluation of only the microscopy negative sand flies fed to those 47 PKDL cases estimated an even greater proportion of infectious cases (51.06%). In overall estimation of the infectious cases in retrospective manner, discordance in positivity rate was observed (p < 0.05) between LD-RPA (59.57%) assay and microscopy (46.81%), while LD-RPA had slightly better positivity rate than LD-qPCR (55.32%) as well. Conclusions Considering the sensitivity, cost, detection time, and field applicability, RPA assay can be considered as a promising single molecular detection tool for investigations pertaining to LD infections in sand flies and/or host infectiousness in PKDL, while it can also be useful in confirmation of microscopy negative sand fly samples. Graphical abstract

scholarly journals OSTEOPOROSIS: CELLULAR AND MOLECULAR MECHANISMS OF DEVELOPMENT AND TARGET MOLECULES IN SEARCH FOR NEW TREATMENTS OF THE DISEASE

2012 ◽  
Vol 15 (1) ◽  
pp. 15-22
Author(s):  
S Sagalovski
Keyword(s):  
Bone Formation ◽  
Signaling Pathway ◽  
Molecular Mechanism ◽  
Development Process ◽  
Molecular Mechanisms ◽  
New Drugs ◽  
Review Of The Literature ◽  
Target Molecules ◽  
Mechanisms Of Development ◽  
New Treatments

In a review of the literature reflects the modern understanding of the cellular-molecular mechanism development of osteoporosis. Reflects the importance of cytokine RANKL-RANK-OPG sistem and Wnt/β-catenin signaling pathway in the development process of osteoblasto- and osteoclastogenesis. Noting the key role in the process of bone formation a number of molecules of cell signaling pathway and their antagonists are of interest as a target molecule to search for new drugs treatment for osteoporosis.

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