scholarly journals Spectroscopic Analysis of Melatonin in the Terahertz Frequency Range

Sensors ◽  
2018 ◽  
Vol 18 (12) ◽  
pp. 4098 ◽  
Author(s):  
Uroš Puc ◽  
Andreja Abina ◽  
Anton Jeglič ◽  
Aleksander Zidanšek ◽  
Irmantas Kašalynas ◽  
...  
Keyword(s):  
Spectroscopic Analysis ◽  
Active Pharmaceutical Ingredient ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Thz Spectroscopy ◽  
Terahertz Frequency ◽  
Thz Imaging ◽  
Pharmaceutical Ingredients ◽  
Indispensable Tool ◽  
First Time

There is a need for fast and reliable quality and authenticity control tools of pharmaceutical ingredients. Among others, hormone containing drugs and foods are subject to scrutiny. In this study, terahertz (THz) spectroscopy and THz imaging are applied for the first time to analyze melatonin and its pharmaceutical product Circadin. Melatonin is a hormone found naturally in the human body, which is responsible for the regulation of sleep-wake cycles. In the THz frequency region between 1.5 THz and 4.5 THz, characteristic melatonin spectral features at 3.21 THz, and a weaker one at 4.20 THz, are observed allowing for a quantitative analysis within the final products. Spectroscopic THz imaging of different concentrations of Circadin and melatonin as an active pharmaceutical ingredient in prepared pellets is also performed, which permits spatial recognition of these different substances. These results indicate that THz spectroscopy and imaging can be an indispensable tool, complementing Raman and Fourier transform infrared spectroscopies, in order to provide quality control of dietary supplements and other pharmaceutical products.

scholarly journals Stability of Pharmaceutical Co-Crystals at Humid Conditions Can Be Predicted

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 433
Author(s):  
Heiner Veith ◽  
Maximilian Zaeh ◽  
Christian Luebbert ◽  
Naír Rodríguez-Hornedo ◽  
Gabriele Sadowski
Keyword(s):  
Pharmaceutical Formulations ◽  
Active Pharmaceutical Ingredient ◽  
Storage Conditions ◽  
Pharmaceutical Products ◽  
Active Pharmaceutical Ingredients ◽  
Statistical Associating Fluid Theory ◽  
Pharmaceutical Ingredients ◽  
Soluble Solid ◽  
Fluid Theory ◽  
The Stability

Knowledge of the stability of pharmaceutical formulations against relative humidity (RH) is essential if they are to become pharmaceutical products. The increasing interest in formulating active pharmaceutical ingredients as stable co-crystals (CCs) triggers the need for fast and reliable in-silico predictions of CC stability as a function of RH. CC storage at elevated RH can lead to deliquescence, which leads to CC dissolution and possible transformation to less soluble solid-state forms. In this work, the deliquescence RHs of the CCs succinic acid/nicotinamide, carbamazepine/nicotinamide, theophylline/citric acid, and urea/glutaric acid were predicted using the Perturbed-Chain Statistical Associating Fluid Theory (PC-SAFT). These deliquescence RH values together with predicted phase diagrams of CCs in water were used to determine critical storage conditions, that could lead to CC instability, that is, CC dissolution and precipitation of its components. The importance of CC phase purity on RH conditions for CC stability is demonstrated, where trace levels of a separate phase of active pharmaceutical ingredient or of coformer can significantly decrease the deliquescence RH. The use of additional excipients such as fructose or xylitol was predicted to decrease the deliquescence RH even further. All predictions were successfully validated by stability measurements at 58%, 76%, 86%, 93%, and 98% RH and 25 °C.

scholarly journals Regulatory Aspects of Cleaning and Cleaning Validation in Active Pharmaceutical Ingredients

2018 ◽  
Vol 6 (3) ◽  
pp. 69-74
Author(s):  
Priyanka D Debaje ◽  
Gurmeet S. Chhabra ◽  
Nayan Gujarathi
Keyword(s):  
Raw Materials ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Cleaning Validation ◽  
Cleaning Agents ◽  
Predetermined Level ◽  
Extraneous Material

 Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particles, dust,  lubricants, raw materials,  intermediates, etc. In the manufacturing of the pharmaceutical products, it is a must to reproduce consistently the desired quality of product. Residual material from the previous batch of the same product or from different product may be carried to the next batch of the product, which in turn may alter the quality of the subjected product. An effective cleaning shall be in place to provide documented evidence that the cleaning method employed within a facility consistently controls potential carryover of product including intermediates and impurities, cleaning agents and extraneous material into subsequent product to a level which is below predetermined level The purpose of this review is to provide information about importance of cleaning validation of API in pharmaceutical industry and this information is in accordance with the regulatory guidelines

The Influence of TRIPS Compliant Patent Laws on Indian Pharmaceutical Industry

2014 ◽  
Vol 4 (1) ◽  
Author(s):  
Rupesh Rastogi ◽  
Virendra Kumar
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Protection ◽  
Uruguay Round ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Patent Law ◽  
Patent Laws ◽  
The Impact ◽  
First Time ◽  
Indian Pharmaceutical Industry

The first legislation in India relating to patents was the Act VI of 1856. The Indian Patents and Design Act, 1911 (Act II of 1911) replaced all the previous Acts. The Act brought patent administration under the management of Controller of Patents for the first time. After Independence, it was felt that the Indian Patents & Designs Act, 1911 was not fulfilling its objective. Various comities were constituted to recommend, framing a patent law which can fulfill the requirement of Indian Industry and people. The Indian Patent Act of 1970 was enacted to achieve the above objectives. The major provisions of the act, provided for process, not the product patents in food, medicines, chemicals with a term of 14 years and 5-7 for chemicals and drugs. The Act enabled Indian citizens to access cheapest medicines in the world and paved a way for exponential growth of Indian Pharmaceutical Industry. TRIPS agreement, which is one of the important results of the Uruguay Round, mandated strong patent protection, especially for pharmaceutical products, thereby allowing the patenting of NCEs, compounds and processes. India is thereby required to meet the minimum standards under the TRIPS Agreement in relation to patents and the pharmaceutical industry. India’s patent legislation must now include provisions for availability of patents for both pharmaceutical products and processes inventions. The present paper examines the impact of change in Indian Patent law on Pharmaceutical Industry.

US trade policy is putting at risk the sustainability of the generic/biosimilar industry and the drug supply chain

2021 ◽  
pp. 174113432199431
Author(s):  
María Fabiana Jorge
Keyword(s):  
Supply Chain ◽  
Trade Policy ◽  
Pharmaceutical Products ◽  
Drug Supply ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Us Trade Policy ◽  
Drug Supply Chain ◽  
Security Concern ◽  
The U.S

With the outbreak of the Coronavirus there is a new realization of the vulnerabilities of the U.S. drug supply chain. However, while such concerns may have been amplified by the pandemic, they preceded Covid-19 and were well documented before 2020. Indeed, in past years the U.S. Congress held several hearings addressing potential vulnerabilities in the U.S. drug supply chain, in part due to the increasing dependency on China as a dominant supplier of active pharmaceutical ingredients (APIs) and some finished pharmaceutical products. These vulnerabilities go well beyond health policy and constitute a national security concern. The article addresses how U.S. trade policy plays a significant role in shaping the pharmaceutical industry at home and abroad and is in part responsible for some of the current vulnerabilities of the U.S. drug supply chain.

scholarly journals Shell-crossing in a ΛCDM Universe

2020 ◽  
Vol 501 (1) ◽  
pp. L71-L75
Author(s):  
Cornelius Rampf ◽  
Oliver Hahn
Keyword(s):  
Dark Matter ◽  
Perturbation Theory ◽  
Large Scale ◽  
Cold Dark Matter ◽  
Three Dimensional ◽  
Random Initial Data ◽  
Recursion Relations ◽  
Indispensable Tool ◽  
First Time ◽  
Very High

ABSTRACT Perturbation theory is an indispensable tool for studying the cosmic large-scale structure, and establishing its limits is therefore of utmost importance. One crucial limitation of perturbation theory is shell-crossing, which is the instance when cold-dark-matter trajectories intersect for the first time. We investigate Lagrangian perturbation theory (LPT) at very high orders in the vicinity of the first shell-crossing for random initial data in a realistic three-dimensional Universe. For this, we have numerically implemented the all-order recursion relations for the matter trajectories, from which the convergence of the LPT series at shell-crossing is established. Convergence studies performed at large orders reveal the nature of the convergence-limiting singularities. These singularities are not the well-known density singularities at shell-crossing but occur at later times when LPT already ceased to provide physically meaningful results.

scholarly journals Continuous-Wave THz Imaging for Biomedical Samples

2020 ◽  
Vol 11 (1) ◽  
pp. 71
Author(s):  
Yaya Zhang ◽  
Chuting Wang ◽  
Bingxin Huai ◽  
Shiyu Wang ◽  
Yating Zhang ◽  
...  
Keyword(s):  
Medical Imaging ◽  
Biomedical Imaging ◽  
Continuous Wave ◽  
Biological Tissues ◽  
Thz Spectroscopy ◽  
Label Free ◽  
Thz Imaging ◽  
Malignant Tumours ◽  
Advantages And Disadvantages ◽  
Imaging Application

In the past few decades, the applications of terahertz (THz) spectroscopy and imaging technology have seen significant developments in the fields of biology, medical diagnosis, food safety, and nondestructive testing. Label-free diagnosis of malignant tumours has been obtained and also achieved significant development in THz biomedical imaging. This review mainly presents the research status and prospects of several common continuous-wave (CW) THz medical imaging systems and applications of THz medical imaging in biological tissues. Here, we first introduce the properties of THz waves and how these properties play a role in biomedical imaging. Then, we analyse both the advantages and disadvantages of the CW THz imaging methods and the progress of these methods in THz biomedical imaging in recent ten years. Finally, we summarise the obstacles in the way of the application of THz bio-imaging application technology in clinical detection, which need to be investigated and overcome in the future.

A New Macrocyclic γ-Pyrone From a Southern Australian Marine Red Alga

1995 ◽  
Vol 48 (8) ◽  
pp. 1485 ◽  
Author(s):  
L Murray ◽  
G Currie ◽  
RJ Capon
Keyword(s):  
Spectroscopic Analysis ◽  
Red Alga ◽  
First Time

A new macrocyclic γ- pyrone (10) and two known γ- pyrones (2) and (6) have been isolated from a Victorian collection of Phacelocarpus peperocarpos. The Z geometry about ∆17,18 in (2) has been established for the first time. All structure elucidations were supported by detailed spectroscopic analysis.

scholarly journals Membrane Distillation for the Production of Pharmaceutical-Grade Water—Investigation into the Application of AGMD and VMD

2021 ◽  
Vol 18 (11) ◽  
pp. 6058
Author(s):  
Cornelius Nellessen ◽  
Thomas Klein ◽  
Hans-Jürgen Rapp ◽  
Frank Rögener
Keyword(s):  
Energy Demand ◽  
Tap Water ◽  
Membrane Distillation ◽  
Pharmaceutical Products ◽  
Optimum Process ◽  
The European Union ◽  
Pharmaceutical Ingredients ◽  
Multi Stage ◽  
One Step ◽  
Selection Of

The production of pharmaceutical ingredients, intermediates and final products strongly depends on the utilization of water. Water is also required for the purification and preparation of reagents. Each specific application determines the respective water quality. In the European Union, the European Pharmacopeia (Ph. Eur.) contains the official standards that assure quality control of pharmaceutical products during their life cycle. According to this, the production of water for pharmaceutical use is mainly based on multi-stage distillation and membrane processes, especially, reverse osmosis. Membrane distillation (MD) could be an alternative process to these classical methods. It offers advantages in terms of energy demand and a compact apparatus design. In the following study, the preparation of pharmaceutical-grade water from tap water in a one-step process using MD is presented. Special emphasis is placed on the performance of two different module designs and on the selection of optimum process parameters.

Polymorphism control of active pharmaceutical ingredients

2021 ◽  
pp. 37-54
Author(s):  
Roman Petrovich Terekhov ◽  
Denis Igorevich Pankov ◽  
Ekaterina Aleksandrovna Anfinogenova ◽  
Irina Anatolievna Selivanova
Keyword(s):  
Active Pharmaceutical Ingredient ◽  
Development Stage ◽  
Poor Quality ◽  
Polymorphic Modification ◽  
High Tech ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Medicinal Substances ◽  
The Usa ◽  
Economic Union

Рolymorphism is receiving increasing attention due to its influence on the physicochemical and pharmacological properties of the active pharmaceutical ingredients (API) while maintaining the molecular structure. This review is devoted to the problem of APIs phase state control both at the development stage and during the circulation of the drug. The term «polymorphism» has different definitions depending on the branch of science. There is no unambiguous solution to this issue in the regulatory documentation of pharmaceutical industry either. Based on the analysis of literary sources, the article presents a comparison of pharmacopeia methods, recommended in Russian and foreign regulatory documents for the analysis of polymorphism of medicinal substances, including state pharmacopeias of Russia, Belarus, Kazakhstan, the USA, and Japan, as well as international pharmacopeias of the European Economic Union and the Eurasian Economic Union. The trend on using a complex of high-tech equipment is revealed. A systematic approach to analysis based on X-ray diffraction, thermal, spectral, microscopic, biological, and physical methods for determining constants makes it possible not only to identify the polymorphic modification of API, but also to characterize its structure, morphology, physicochemical properties and pharmacological activity. In the Russian Federation, the phenomenon of polymorphism is being studied especially intensively, and some control methods, such as biological methods, are validated only in Russian pharmacopeia. A promising direction for further research is the improvement and harmonization of regulatory documentation within the framework of this chemical and technological field of pharmacy. A global approach will help to reduce not only the probability of poor-quality products entering the market, but also the costs of establishing the authenticity of the active pharmaceutical ingredient produced.

scholarly journals A National Survey of Community Pharmacists on Smoking Cessation Services in Thailand

Pharmacy ◽  
2018 ◽  
Vol 6 (3) ◽  
pp. 101 ◽  
Author(s):  
Surarong Chinwong ◽  
Dujrudee Chinwong
Keyword(s):  
Smoking Cessation ◽  
Community Pharmacists ◽  
Cross Sectional Study ◽  
Postal Questionnaire ◽  
Pharmaceutical Product ◽  
Perceived Barriers ◽  
Cross Sectional ◽  
Smoking Cessation Services ◽  
First Time

Providing smoking cessation services is one role of community pharmacists in Thailand. This cross-sectional study aimed to investigate activities and barriers related to smoking cessation services provided in community pharmacies in Thailand, as well as to compare these activities and barriers between those pharmacists providing and those not providing smoking cessation services. A postal questionnaire was conducted to collect information from community pharmacists across Thailand. In all, 413 valid responses were received from 5235 questionnaires, giving a 7.9% response rate. Of the 413 respondents, 152 (37%) pharmacists provided smoking cessation services in their pharmacy. The activities of smoking cessation services varied. Time for counseling each smoker varied, a mean of 15.1 ± 10.9 min (range 1–60) per person for the first time, and 8.9 ± 6.7 min (range 1–30) for each follow-up visit. Community pharmacists, providing smoking cessation services, were more likely to have pharmacist assistants, be a member of the Thai Pharmacy Network for Tobacco Control, and have more than 1 pharmacist on duty. The most dispensed pharmaceutical product for smoking cessation was nicotine gum. Their most perceived barriers were being unable to follow-up and inadequate staff. In conclusion, only a minority of community pharmacists in Thailand are engaged in smoking cessation activities, even though some perceived barriers existed.

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