Raman spectroscopy in pharmaceutical research and industry

2018 ◽  
Vol 3 (8) ◽  
Author(s):  
Nathalie Jung ◽  
Maike Windbergs
Keyword(s):  
Drug Delivery ◽  
Raman Spectroscopy ◽  
Quality Control ◽  
Drug Delivery Systems ◽  
Large Scale ◽  
Pharmaceutical Research ◽  
Delivery Systems ◽  
Scale Production ◽  
Non Invasive ◽  
Large Scale Production

Abstract In the fast-developing fields of pharmaceutical research and industry, the implementation of Raman spectroscopy and related technologies has been very well received due to the combination of chemical selectivity and the option for non-invasive analysis of samples. This chapter explores established and potential applications of Raman spectroscopy, confocal Raman microscopy and related techniques from the early stages of drug development research up to the implementation of these techniques in process analytical technology (PAT) concepts for large-scale production in the pharmaceutical industry. Within this chapter, the implementation of Raman spectroscopy in the process of selection and optimisation of active pharmaceutical ingredients (APIs) and investigation of the interaction with excipients is described. Going beyond the scope of early drug development, the reader is introduced to the use of Raman techniques for the characterization of complex drug delivery systems, highlighting the technical requirements and describing the analysis of qualitative and quantitative composition as well as spatial component distribution within these pharmaceutical systems. Further, the reader is introduced to the application of Raman techniques for performance testing of drug delivery systems addressing drug release kinetics and interactions with biological systems ranging from single cells up to complex tissues. In the last part of this chapter, the advantages and recent developments of integrating Raman technologies into PAT processes for solid drug delivery systems and biologically derived pharmaceutics are discussed, demonstrating the impact of the technique on current quality control standards in industrial production and providing good prospects for future developments in the field of quality control at the terminal part of the supply chain and various other fields like individualized medicine. On the way from the active drug molecule (API) in the research laboratory to the marketed medicine in the pharmacy, therapeutic efficacy of the active molecule and safety of the final medicine for the patient are of utmost importance. For each step, strict regulatory requirements apply which demand for suitable analytical techniques to acquire robust data to understand and control design, manufacturing and industrial large-scale production of medicines. In this context, Raman spectroscopy has come to the fore due to the combination of chemical selectivity and the option for non-invasive analysis of samples. Following the technical advancements in Raman equipment and analysis software, Raman spectroscopy and microscopy proofed to be valuable methods with versatile applications in pharmaceutical research and industry, starting from the analysis of single drug molecules as well as complex multi-component formulations up to automatized quality control during industrial production.

scholarly journals Extracellular Vesicles as Drug Delivery Systems in Cancer

Pharmaceutics ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 1146
Author(s):  
Laia Hernandez-Oller ◽  
Joaquin Seras-Franzoso ◽  
Fernanda Andrade ◽  
Diana Rafael ◽  
Ibane Abasolo ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Extracellular Vesicles ◽  
Drug Delivery Systems ◽  
Large Scale ◽  
Delivery Systems ◽  
Biological Behavior ◽  
Scale Production ◽  
Cancer Resistance ◽  
Large Scale Production ◽  
Transport Complex

Within tumors, Cancer Stem Cell (CSC) subpopulation has an important role in maintaining growth and dissemination while preserving high resistance against current treatments. It has been shown that, when CSCs are eliminated, the surrounding Differentiated Cancer Cells (DCCs) may reverse their phenotype and gain CSC-like features to preserve tumor progression and ensure tumor survival. This strongly suggests the existence of paracrine communication within tumor cells. It is evidenced that the molecular crosstalk is at least partly mediated by Extracellular Vesicles (EVs), which are cell-derived membranous nanoparticles that contain and transport complex molecules that can affect and modify the biological behavior of distal cells and their molecular background. This ability of directional transport of small molecules prospects EVs as natural Drug Delivery Systems (DDS). EVs present inherent homing abilities and are less immunogenic than synthetic nanoparticles, in general. Currently, strong efforts are focused into the development and improvement of EV-based DDS. Even though EV-DDS have already reached early phases in clinical trials, their clinical application is still far from commercialization since protocols for EVs loading, modification and isolation need to be standardized for large-scale production. Here, we summarized recent knowledge regarding the use of EVs as natural DDS against CSCs and cancer resistance.

scholarly journals A Comprehensive Review on Self-Nano Emulsifying Drug Delivery Systems: Advancements & Applications

2020 ◽  
pp. 576-583
Author(s):  
Srikanth Reddy Sokkula ◽  
Suresh Gande
Keyword(s):  
Drug Delivery ◽  
Drug Delivery Systems ◽  
Large Scale ◽  
Antihypertensive Drugs ◽  
Drug Loading ◽  
Delivery Systems ◽  
Water Soluble ◽  
Scale Production ◽  
Advantages And Disadvantages ◽  
Water Soluble Drugs

Lipid-based drug delivery systems are extensively reported in literature for enhancing the drug solubility, permeability and bioavailability. These systems include   simple oil solutions, coarse, multiple and dry emulsions, complex self-emulsifying, microemulsifying or nanoemulsifying drug delivery systems. Self-emulsifying systems are further classified as self-microemulsifying drug delivery systems (SMEDDS) and self-nanoemulsifying drug delivery systems (SNEDDS) are most prevailing and commercially viable oil based approach for drugs that exhibit low dissolution rate and inadequate absorption. Ever since the progress of SNEDDS, they drew the interest of researchers in order to deal with the challenges of poorly water-soluble drugs. SNEDDS is a proven method for enhancing solubility and bioavailability of lipophilic compounds. Considering the ease of large-scale production and the robustness of SNEDDS, several formulations techniques are commercially available. The stability of SNEDDS can be further enhanced by solidifying liquid SNEDDS. Controlled release and supersaturated SNEDDS received patient compliance with larger drug loading. Presence of biodegradable ingredients and ‘drug-targeting opportunities’ facilitate SNEDDS a clear merit and distinction amongst available solubility enhancement techniques. In this article attempt was made to present an overview of SNEDDS, their mechanism, formulation excipients and potentials of SNEDDS, recent advancements, advantages and disadvantages of SNEDDS formulations. The article also focuses on reviewing the application of SNEDDS in enhancing bioavailability of antihypertensive drugs.

The Research of Production Process Statistical Steady-State Based on the Hypothesis Test

2011 ◽  
Vol 314-316 ◽  
pp. 2433-2438
Author(s):  
Wei Zhi Wang
Keyword(s):  
Quality Control ◽  
Steady State ◽  
Production Process ◽  
Quantitative Method ◽  
Large Scale ◽  
Hypothesis Test ◽  
Influence Factors ◽  
Normal Operation ◽  
Scale Production ◽  
Large Scale Production

By only applying a after the event exam in the quality control of the batch production is not enough to meet the needs of modern large-scale production. To a certain extent, modern quality control is a dynamic process of the steady-state judge and adjustment. A simple and reliable steady-state judge rule and method is the premise to guarantee the normal operation. This paper provides a quantitative method to evaluate production process steady-state by analyzing influence factors based on mathematical statistics. The method is both suitable for simple production process and complex production process with sub-processes.

Liposomes

2017 ◽  
pp. 52-87
Author(s):  
Mangal Shailesh Nagarsenker ◽  
Megha Sunil Marwah
Keyword(s):  
Quality Control ◽  
Large Scale ◽  
Clinical Success ◽  
Scale Production ◽  
Large Scale Production ◽  
Diagnostic Applications ◽  
Set Up ◽  
Insight Into ◽  
Characterisation Techniques

The science of liposomes has expanded in ambit from bench to clinic through industrial production in thirty years since the naissance of the concept. This chapter makes an attempt to bring to light the impregnable contributions of great researchers in the field of liposomology that has witnessed clinical success in the recent times. The journey which began in 1965 with the observations of Bangham and further advances made en route (targeting/stealthing of liposomes) along with alternative and potential liposome forming amphiphiles has been highlighted in this chapter. The authors have also summarised the conventional and novel industrially feasible methods used to formulate liposomes in addition to characterisation techniques which have been used to set up quality control standards for large scale production. Besides, the authors have provided with an overview of primary therapeutic and diagnostic applications and a brief insight into the in vivo behaviour of liposomes.

A Non-Invasive, Low-Cost Study Design to Determine the Release Profile of Colon Drug Delivery Systems: A Feasibility Study

2012 ◽  
Vol 29 (8) ◽  
pp. 2070-2078 ◽  
Author(s):  
Marina J. M. Maurer ◽  
Reinout C. A. Schellekens ◽  
Klaus D. Wutzke ◽  
Gerard Dijkstra ◽  
Herman J. Woerdenbag ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Feasibility Study ◽  
Study Design ◽  
Drug Delivery Systems ◽  
Low Cost ◽  
Delivery Systems ◽  
Release Profile ◽  
Cost Study ◽  
Non Invasive ◽  
Colon Drug Delivery

scholarly journals Review on Transferosomes and Transferosomal Gels

2021 ◽  
pp. 114-126
Author(s):  
P. Kranthi Kumar ◽  
R. Santosh Kumar
Keyword(s):  
Drug Delivery ◽  
Transdermal Drug Delivery ◽  
Drug Delivery Systems ◽  
First Generation ◽  
Delivery Systems ◽  
Non Invasive ◽  
Transdermal Drug Delivery Systems ◽  
First Pass Metabolism ◽  
Pharmaceutical Uses ◽  
Pass Metabolism

Transdermal drug delivery systems (TDDS), which are self-administrable and non-invasive, can improve bioavailability and patient compliance by bypassing first-pass metabolism. Vesicular-based TDDS have attracted a lot of attention in recent years because they're designed for controlled, efficient, and targeted drug delivery. One of these delivery technologies, transferosomal-based formulations, has grown in popularity due to its ability to achieve all of the desired criteria and quality qualities. Transferosomes combine the characteristics of liposomes and niosomes because they contain both liposomes (phospholipids and cholesterols) and niosomes as components (nonionic surfactants; edge activators). as a result, they are referred to as the first generation of elastic liposomes. However transdermal drug delivery is difficult due to the presence of the skin's protective barrier, transferosomal drug delivery overcomes all obstacles due to its unique characteristics, such as its ultradeformable vesicular nature. The benefits, limitations, modes of penetration, formulations, production and assessment methodologies, and pharmaceutical uses of transferosomal drug delivery systems are discussed in this paper. Conclusion: Transferosomes have several importance over other vesicular systems, including greater deformability, greater penetration power across skin, the ability to deliver systemic drugs, and higher stability.

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