scholarly journals Indian Active Pharmaceutical Ingredient (API) Industry- An overview on Challenges, Opportunities & Regulatory prerequisites

2021 ◽  
Vol 9 (2) ◽  
pp. 66-76
Author(s):  
Shefali Singh ◽  
Harvinder Popli
Keyword(s):  
Raw Materials ◽  
Pharmaceutical Medicine ◽  
Active Pharmaceutical Ingredient ◽  
Point Of View ◽  
Raw Material ◽  
Manufacturing Cost ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Self Sufficiency ◽  
History Of

Active pharmaceutical ingredient is a chemical compound which is most important raw material to formulate a finished pharmaceutical medicine and has a pharmacological effect.  India has a long history of being heavily dependent for these raw materials on China due to one major reason i.e. Low manufacturing cost. But overdependence of APIs imports from China brought various liabilities to India including supply chain disruption and price hikes during pandemic, leading to shortage of various important APIs/KSMs. This COVID 19 widespread has solidly put the center of our country on being “Atma Nirbhar”. And this activity had brought out the strengths, market patterns and opportunities in five divisions counting Healthcare, which are basic from country’s point of view. In view of changing geo-political situation and recalibrated trade arrangement, it is crucial that India become self-reliant within the generation of APIs and KSMs, which is why decreasing the Import reliance for Active pharmaceutical ingredients (APIs) & Key starting materials (KSMs) particularly from china has been focused upon with the assistance of productive linked incentive scheme (PLIS) passed by Department of pharmaceuticals, Government of India to thrive Indian API industry. Hence, this review highlights the current state of Indian API industry, evaluates challenges, opportunities give suggestions for moving forward for self-sufficiency of APIs as well as centers on current regulatory prerequisites for Active pharmaceutical Ingredients.

scholarly journals SELF-SUFFICIENCY IN MANUFACTURE OF APIS AND INTERMEDIATES IS A NECESSITY FOR THE INDIAN PHARMACEUTICAL INDUSTRY

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (04) ◽  
pp. 5-6
Author(s):  
Shreerang Joshi ◽  
Keyword(s):  
Pharmaceutical Industry ◽  
Raw Materials ◽  
Building Blocks ◽  
Dosage Forms ◽  
Considerable Extent ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Self Sufficiency ◽  
Dear Reader ◽  
Indian Pharmaceutical Industry

Dear Reader, Active Pharmaceutical Ingredients (APIs) are key raw materials to produce pharmaceutical finished dosage forms like tablets, capsules, syrups, ointments etc. Swift growth in new innovations is prodding the interest for generic active pharmaceutical ingredients manufacturers worldwide with the expanded import of key starting materials (KSMs) and building blocks from the emerging markets. The focus of Indian pharmaceutical industry in last two decades has moved towards finished formulations, ignoring in-house manufacture of APIs to a considerable extent.

Calculation of the Glaze Recipe for Porcelain Feldspar Products Based on their Molecular Formula Rationalization

2008 ◽  
Vol 59 (2) ◽  
pp. 129-134
Author(s):  
Ion Teoreanu ◽  
Roxana Lucia Dumitrache ◽  
Stefania Stoleriu
Keyword(s):  
Raw Materials ◽  
Computer Programs ◽  
Point Of View ◽  
Raw Material ◽  
Easy Access ◽  
Molecular Formula ◽  
Design Equation ◽  
Material Sources

Any change of the raw material sources for glazes, economically, ecologically motivated, and also from the glaze quality point of view, is conditioned by the molecular formula rationalization and by the variation limits of the molecular formula, respectively. The proper glaze compositions are placed within their limit variation intervals with optimized processing and utilization properties. For this purpose, the rationalization criteria and procedures of molecular formulas are summarized in the present paper, as well as the results referring to their rationalization obtained in the authors� previous work. Thus, one starts from a base of raw materials that are selected, usable and also accessible for the design and producing of the glazes. On these bases the groundwork and the design equation for the glaze recipes are developed, exemplified for a single glaze. For an easy access to results, computer programs are used for an easy access to results.

scholarly journals Encapsulation of Active Pharmaceutical Ingredients in Lipid Micro/Nanoparticles for Oral Administration by Spray-Cooling

Pharmaceutics ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1186
Author(s):  
Carmen S. Favaro-Trindade ◽  
Fernando E. de Matos Junior ◽  
Paula K. Okuro ◽  
João Dias-Ferreira ◽  
Amanda Cano ◽  
...  
Keyword(s):  
Oral Administration ◽  
Raw Materials ◽  
Low Cost ◽  
Pharmaceutical Formulations ◽  
Spray Cooling ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Taste And Odor ◽  
Cooling Technology ◽  
Simple Technology

Nanoencapsulation via spray cooling (also known as spray chilling and spray congealing) has been used with the aim to improve the functionality, solubility, and protection of drugs; as well as to reduce hygroscopicity; to modify taste and odor to enable oral administration; and many times to achieve a controlled release profile. It is a relatively simple technology, it does not require the use of low-cost solvents (mostly associated to toxicological risk), and it can be applied for lipid raw materials as excipients of oral pharmaceutical formulations. The objective of this work was to revise and discuss the advances of spray cooling technology, with a greater emphasis on the development of lipid micro/nanoparticles to the load of active pharmaceutical ingredients for oral administration.

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.

Study of Phyto-ingredients of Wild Berry Juice

2021 ◽  
pp. 47-50
Author(s):  
Антонина Григорьевна Чернобровина ◽  
Наталья Николаевна Роева ◽  
Наталия Евгеньевна Куликова ◽  
Ольга Юрьевна Попова
Keyword(s):  
Raw Materials ◽  
Antioxidant Properties ◽  
Point Of View ◽  
Natural Dyes ◽  
Raw Material ◽  
Protective Properties ◽  
Enzyme Preparations ◽  
Other Substances ◽  
Ingredient Composition ◽  
Functional Components

В настоящее время к одним из наиболее приоритетных направлений пищевой промышленности относят разработку функциональных продуктов питания на основе экологически чистого сырья естественного происхождения, в том числе ягодного. При разработке новых продуктов с защитными свойствами важно учитывать ингредиентный состав сырья, оказывающий лечебно-профилактический эффект, и с этой точки зрения ягоды малины и брусники заслуживают особого внимания. С целью максимального извлечения и сохранения природных, физиологически-функциональных компонентов дикорастущих ягод (витаминов, микро- и макроэлементов, фенольных, пектиновых соединений и др.) были разработаны и созданы мультиэнзимные композиции для предобработки ягод брусники (МЭКб) и малины (МЭКм). Большой интерес вызывали исследования состава и содержания красящих веществ в исследуемых образцах. В качестве структурных элементов антоцианов в соке малины и брусники, а также в их ферментативных соках установлены дисахариды, основной структурный компонент которых - цианидин. Количественное содержание антоцианов в соке брусники и малины составило 305,4 и 106,2 мг/дм3, а в ферментативном соке брусники (БФС) и малины (МФС) - 553,7 и 146,4 мг/дм3, соответственно. Высокое содержание красящих веществ - важный критерий для использования БФС и МФС в качестве источника натуральных красителей. Установлена более высокая антиоксидантная активность в БФС и МФС (соответственно в 1,3 и 1,5 раза) по сравнению с соком, полученным без применения ферментных препаратов. Следовательно, ферментативный сок ягод обладает высокими антиоксидантными свойствами и служит источником натуральных красителей, поэтому его можно рассматривать как перспективный сырьевой полуфабрикат при производстве продуктов питания функциональной направленности, оказывающих благотворное регулирующее действие на организм человека. Currently, one of the priority areas of the food industry is the development of functional food products based on environmentally friendly raw materials of natural origin, including berry. When developing new products with protective properties, it is important to take into account the ingredient composition of the raw materials, which has a therapeutic and prophylactic effect, and from this point of view, raspberries and lingonberries deserve special attention. In order to maximize the preservation and extraction of natural, physiologically functional components of wild berries (vitamins, micro - and macroelements, phenolic compounds, pectin and other substances) were developed and created multienzymatic compositions for the pretreatment of lingonberry (MEKb) and raspberry (MEKm). Of great interest were studies on the characterization and content of dyes in the samples being studied. As structural elements of anthocyanins in raspberry and lingonberry juice, as well as in their enzymatic juices, disaccharides were established, the main structural component of which is cyanidine, and the quantitative content of anthocyanins (mg/dm3) in the juice of lingonberry and raspberry, corresponded - 305.40 and 106.20, and in the enzymatic juice of lingonberry and raspberry - 553.70 and 146.40. The high content of dyes is an important criterion for the use of BFS and MFS as a source of natural dyes. A higher antioxidant activity was found in BFS and MFS (1.3 and 1.5 times, respectively) compared with juice obtained without the use of enzyme preparations. Therefore, the enzymatic juice of berries has high antioxidant properties and is a source of natural dyes, so it can be considered as a promising raw material in the production of functional foods that have a beneficial regulatory effect on the human body.

scholarly journals Carbonate complexes underlying Flysch belt and subsurface Neogene volcanic in the NE part of Slovakia – a potential for geothermal energy and raw materials

2012 ◽  
Vol 42 (4) ◽  
pp. 283-294
Author(s):  
Ľudovít Kucharič ◽  
Vladimír Bezák ◽  
Dušan Majcin ◽  
Ján Vozár
Keyword(s):  
Gravity Anomaly ◽  
Magnetic Measurements ◽  
Slovak Republic ◽  
Raw Materials ◽  
Point Of View ◽  
Raw Material ◽  
Geothermal Potential ◽  
Two Factors ◽  
New Perspective ◽  
Carbonate Complexes

Abstract A positive gravity anomaly was observed in the Flysch belt realm. Based on this fact and available geological knowledge we suppose that the source of gravity anomaly might be carbonate rocks lying perhaps in the footwall of Flysch sediments. The carbonates belong perhaps to the Penninic crust cover (a part of Klippen belt), or to lower structural stage of the Flysch belt. Besides this it is interpreted more volume of Neogene subvolcanic bodies in the frame of the Flysch belt based on the results of the newest magnetic measurements in the NE part of Slovakia (Kucharič et. al., in press). These are accompanied by increasing heat flow and hydrothermal alteration within neighbouring rocks what may eventuate into creation of raw materials. These two factors - carbonates and subvolcanic bodies - are important items for appraisal of new perspective in this area not only from hydrocarbon occurrences point of view (a primary intend within this area) but also for enhancement of geothermal potential of Slovak Republic and opening possibilities for prognosis of raw material occurrences as well.

New Development in Rubber Reclaiming

1941 ◽  
Vol 14 (3) ◽  
pp. 717-723
Author(s):  
W. G. Essex
Keyword(s):  
Carbon Black ◽  
Milling Time ◽  
Steam Pressure ◽  
Raw Material ◽  
Manufacturing Cost ◽  
Pneumatic Motor ◽  
Vulcanized Rubber ◽  
New Development ◽  
History Of ◽  
Free Sulfur

Abstract The history of rubber reclaiming has been given by Alexander, and it is therefore intended only to make a brief reference to the well-known acid and alkali processes, the latter having proved to be by far the most successful method of reclaiming vulcanized rubber. The alkali process, introduced by Marks in 1899 had the outstanding advantage of simultaneously removing, from the waste, free sulfur, of which from 3 to 5 per cent was present, of destroying the fabric and of plasticizing the waste, this being accomplished by heating in a closed vessel under steam pressure with caustic soda. The acid process destroyed only the fabric, and plasticization by heat was performed in another operation in a separate vessel: by this method little or no free sulfur was removed from the waste. This latter disadvantage has since disappeared, for, with modern rubber compounding, there is little free sulfur left in vulcanized rubber. In recent years there have been widespread changes in the manufacture of rubber goods, particularly in the case of pneumatic motor tires, which are now the main source of raw material for reclaimed rubber. Organic accelerators, anti-oxidants and carbon black have made vulcanized rubber a very tough, resilient article, extremely resistant to aging and to heat, one of the chief agents used in rubber reclaiming. For example, modern motor tire treads, which are heavily reinforced with carbon black, are not so amenable to alkali and heat treatment, and tire treads reclaimed by this process have finally to be plasticized and made homogeneous by a much longer mechanical milling and refining treatment than was formerly necessary; in spite of this the treads still produce a proportion of rough, unrefinable material which has to be separated and rejected from the final reclaim. This increase in milling time, combined with lower finished production due to rejected unrefinable material, has had the effect of greatly increasing the manufacturing cost of the reclaim. Research was therefore started with the object of evolving a process which would successfully offset these difficulties caused by the changes in the properties and characteristics of the initial waste. The result of this work has been the creation of reclaimed rubber from which the disadvantages mentioned have been largely eliminated.

scholarly journals Investigations of quartz raw materials from the locality of Rekovac muncipality

2019 ◽  
Vol 73 (4) ◽  
pp. 265-274
Author(s):  
Slavica Mihajlovic ◽  
Zivko Sekulic ◽  
Jovica Stojanovic ◽  
Vladan Kasic ◽  
Iroslav Sokic ◽  
...  
Keyword(s):  
Chemical Composition ◽  
Physical Properties ◽  
Quartz Sand ◽  
Raw Materials ◽  
Construction Materials ◽  
Size Fraction ◽  
Point Of View ◽  
Raw Material ◽  
Potential Applications

Quality of raw materials, including quartz sand and quartzite, varies from one deposit to another. Furthermore, the material quality determines in which industrial branches it can be used after certain preparation processes. Potential applications of quartz raw materials are: in the construction and refractory industry, ceramics and glass industry, then in metallurgy, foundry and also in production of water treatment filters. Geological investigations of the central Serbia region, in the Rekovac municipality, resulted in identification of occurrence of quartz sand ("Ursula") and quartzite ("Velika Krusevica"). Preliminary laboratory tests and characterization of the quartz sand size fraction -0.63+0.1 mm confirmed the possibility of applying this size fraction in the construction materials industry, while the quartzite can be used in refractory, glass and metallurgy industries. After determining the geological reserve of quartz sand "Ursula" and quartzite "Velika Krusevica", detailed investigations are required. Quality conditions from the aspect of chemical composition and physical properties of quartz sand and quartzite are mostly clearly defined by a special standard for this purpose. On the other hand, there are also application areas where standards does not exist, but users define their quality conditions. This example is with the application of quartz sand in the production of water glass. Chemical composition as well is not always the determining factor for the application of quartz raw material. For example, for quartz sand used for sandblasting, grain form is essential. From the economic analysis point of view, the prices of quartz raw materials vary depending on their chemical and physical properties. After all, what needs to be pointed out is the fact that these raw materials are very widespread in nature and that their exploitation is quite simple. After the raw material is excavated, it is stored and further sieved, washed, dried and processed according to customer requirements. All of these processes are cheaper than preparing, for example, limestone, and significaly cheaper than preparation of metal ores.

scholarly journals Urban metabolism and river systems: an historical perspective – Paris and the Seine, 1790–1970

2007 ◽  
Vol 4 (3) ◽  
pp. 1845-1878 ◽  
Author(s):  
S. Barles
Keyword(s):  
Water Supply ◽  
Rural Areas ◽  
Industrial Ecology ◽  
Raw Materials ◽  
Local History ◽  
Raw Material ◽  
Domestic Water ◽  
History Of ◽  
Growth Changes ◽  
Domestic Water Supply

Abstract. The aim of this paper is to analyse interaction between Paris and the Seine during the industrial era, 1790–1970, a period marked by strong population growth, changes in techniques, and the absence of specific legislation on environmental issues. The viewpoint focuses on exchanges of waters and wastes between city and river, quantifying them and tracing evolution in the light of the strategies implemented by the stakeholders in charge. The study combines industrial ecology, local history and the history of technology. From 1790 to 1850, waste matters, and especially excreta, were considered as raw materials, not refuse: they generated real profits. The removal of human excreta aimed not only at improving urban hygiene, but at producing the fertilizers needed in rural areas. Discharging them into the river was out of the question. But after the 1860s, several factors upset this exploitation, notably domestic water supply. Even so, Parisian engineers continued to process sewage using techniques that would not only ensure hygiene but also conciliate economic and agricultural interests. Both of these early periods are thus noteworthy for a relative limitation of the river's deterioration by urban wastes. Not until the 1920s, when domestic water supply had become the rule and excreta came to be considered as worthless waste, was the principle of valorisation abandoned. This led to important and long-lasting pollution of the Seine, aggravating the industrial pollution that had been in evidence since the 1840s. Analysing the priorities that led to the adoption of one principle or another in matters of urban hygiene and techniques, with the causes and consequences of such changes, enables us to understand the complex relations between Paris and the Seine. From raw material to waste matter, from river to drain, the concept of quality in environment remains the underlying theme.

scholarly journals Expedient behaviour and predetermination at the Ciota Ciara cave (north-western Italy) during Middle Palaeolithic.

2020 ◽  
Author(s):  
Sara Daffara ◽  
Gabriele L.F. Berruti ◽  
Marta Arzarello
Keyword(s):  
Raw Materials ◽  
Point Of View ◽  
Raw Material ◽  
Functional Study ◽  
Middle Palaeolithic ◽  
General Behaviour ◽  
Stratigraphic Sequence ◽  
Hunter Gatherers ◽  
Functional Studies ◽  
North Western

The Ciota Ciara cave is a Middle Palaeolithic site located in Piedmont (north-western Italy) and it is the only one systematically investigated in the region. It opens at 670 m a.s.l. on the west side of Monte Fenera and its archaeological deposit has a stratigraphic sequence documenting several and repeated human frequentations. Four archaeological layers have been identified (13, 14, 15 and 103) and are characterized by lithic assemblages where vein quartz is the main exploited raw material. The upper level (13), was already subject to technological and functional studies but the enlargement of the excavated area made necessary a completion of the technological data. The aim of this work is to deal with a complete technological and functional study of the lithic assemblage of the four archaeological layers of the Ciota Ciara cave to face the issues of predetermination and adaptation of the reduction sequences to the raw materials features. The technological analysis is based on the concept of chaîne opératoire and refers to the classical definitions of the S.S.D.A., discoid and Levallois methods for the identification of the different exploitation strategies. The concepts of curated and expedient technology are also applied to the present study. We finally refer to the huge debate concerning the concept of predetermination related to cores that show reduced or none phases of core configuration for the analysis and interpretation of the considered lithic assemblage.The results obtained show that the general behaviour can be interpreted as expedient, both from a technological and a functional point of view. The Middle Palaeolithic hunter-gatherers of the Ciota Ciara cave adapted their “technological background” to the resources available and put into action flexible adaptation strategies. Even in the shortness or absence of phases of core configuration, predetermination can be observed in the adaptation of Levallois and discoid concepts to the natural constraints of the pebbles chosen as cores. The natural convexities are exploited to obtain Levallois and discoid flakes after an intentional choice made by the knappers. In order to deeply investigate the characteristics of the technological behaviour of the hunter-gatherers that inhabited the site, the use-wear analysis is a fundamental additional source of information and it is here aimed to understand if there is or not a differential use of the lithic artefacts according to their typology and/or to the knapping method.

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