Process Analytical Technology for Crystallization of Active Pharmaceutical Ingredients

Background: Pharmaceutical industry is witnessing increased pressure to introduce innovative and efficient processes for manufacturing Active Pharmaceutical Ingredients (APIs) in order to be competitive as well as to meet the stringent product quality requirements set by regulatory authorities. Crystallization with its ability to engineer the final product to the desired qualities such as purity, polymorphic form, particle size and shape is one of the most important steps involved in the manufacturing of APIs. Therefore, development of crystallization processes with better understanding of process parameters and their impact on quality of APIs and subsequently the drug products assume great significance for the pharmaceutical industry. Methods: This review paper focuses on the application of PAT tools, an integral part of Quality by Design (QbD) approach, for better understanding, control, and design of crystallization processes in the manufacturing of APIs. Results: Firstly, various steps involved in the drug development process are introduced briefly with emphasis on crystallization as one of the most important steps in manufacturing of drug products. Secondly, Critical Quality Attributes (CQAs) of drug products, their dependence on material attributes of APIs and role of crystallization in manipulating material attributes of APIs has been discussed. Finally, application of PAT tools such as advanced process analyzers for continuous monitoring, chemometric methods for multivariate data analysis, and control strategy for APIs crystallization processes has been reviewed along with some examples. Conclusion: Application of PAT in crystallization of APIs facilitates development of robust processes that works within the design space to produce the drug products of consistent quality. Furthermore, it opens up the opportunities for continuous improvement of the process by generating knowledge base of existing processes.

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The role of degradant profiling in active pharmaceutical ingredients and drug products☆

Advanced Drug Delivery Reviews ◽

10.1016/j.addr.2006.10.006 ◽

2007 ◽

Vol 59 (1) ◽

pp. 29-37 ◽

Cited By ~ 125

Author(s):

K ALSANTE ◽

A ANDO ◽

R BROWN ◽

J ENSING ◽

T HATAJIK ◽

...

Keyword(s):

Active Pharmaceutical Ingredients ◽

Drug Products ◽

Pharmaceutical Ingredients

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Membrane condenser as emerging technology for water recovery and gas pre-treatment: current status and perspectives

BMC Chemical Engineering ◽

10.1186/s42480-019-0020-x ◽

2019 ◽

Vol 1 (1) ◽

Cited By ~ 2

Author(s):

Adele Brunetti ◽

Francesca Macedonio ◽

Giuseppe Barbieri ◽

Enrico Drioli

Keyword(s):

Current Status ◽

Innovative Technology ◽

Water Recovery ◽

Treatment Unit ◽

Treatment Stage ◽

Treatment Technologies ◽

Pre Treatment ◽

And Control

Abstract The recent roadmap of SPIRE initiative includes the development of “new separation, extraction and pre-treatment technologies” as one of the “key actions” for boosting sustainability, enhancing the availability and quality of existing resources. Membrane condenser is an innovative technology that was recently investigated for the recovery of water vapor for waste gaseous streams, such as flue gas, biogas, cooling tower plumes, etc. Recently, it has been also proposed as pre-treatment unit for the reduction and control of contaminants in waste gaseous streams (SOx and NOx, VOCs, H2S, NH3, siloxanes, halides, particulates, organic pollutants). This perspective article reports recent progresses in the applications of the membrane condenser in the treatment of various gaseous streams for water recovery and contaminant control. After an overview of the operating principle, the membranes used, and the main results achieved, the work also proposes the role of this technology as pre-treatment stage to other separation technologies. The potentialities of the technology are also discussed aspiring to pave the way towards the development of an innovative technology where membrane condenser can cover a key role in redesigning the whole upgrading process.

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Towards 4th industrial revolution efficient and sustainable continuous flow manufacturing of active pharmaceutical ingredients

Reaction Chemistry & Engineering ◽

10.1039/d1re00483b ◽

2022 ◽

Author(s):

Cloudius Sagandira ◽

Sinazo Nqeketo ◽

Kanysile Mhlana ◽

Thembela Sonti ◽

Paul Watts ◽

...

Keyword(s):

Pharmaceutical Industry ◽

Continuous Flow ◽

Industrial Revolution ◽

Flow Chemistry ◽

Active Pharmaceutical Ingredients ◽

New Paradigm ◽

Pharmaceutical Ingredients ◽

Continuous Flow Chemistry

Continuous flow chemistry has opened a new paradigm in both the laboratory and pharmaceutical industry. This review details the recently reported literature on continuous multistep telescoped synthesis of active pharmaceutical...

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Perpustakaan sebagai Teropong Profesionalisme Pustakawan

TIK ILMEU Jurnal Ilmu Perpustakaan dan Informasi ◽

10.29240/tik.v2i1.389 ◽

2018 ◽

Vol 2 (1) ◽

pp. 71

Author(s):

Aris Nurohman

Keyword(s):

Management Service ◽

Library Complexity ◽

And Control

Library is an institution that can not be separated from the role of librarians. Library dependence to the librarian is seen almost in the whole library complexity. Starting from planning, organizing, leadership, and control. Through this writing the authors will contribute a more real attachment between librarians and libraries. Based on some literature proves that between librarian and library can not stand alone. Starting from the management, service products and aspects of library accreditation assessment, librarians are instrumental in contributing enormously. Because of this dependence illustrates that the quality of the library will be seen from the quality of the librarian profession.

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Solvent-free headspace GC/MS method for sensitive screening of N-nitrosodimethylamine in drug products

Analytical Methods ◽

10.1039/d1ay01036k ◽

2021 ◽

Author(s):

Do Hee Lee ◽

Seongchul Park ◽

Su Hyeon Hwang ◽

Jeongmi Lee ◽

Han Bin Oh ◽

...

Keyword(s):

Mass Spectrometry ◽

Solvent Free ◽

Gas Chromatography Mass Spectrometry ◽

Headspace Gas Chromatography ◽

Active Pharmaceutical Ingredients ◽

Drug Products ◽

Pharmaceutical Ingredients ◽

Experimental Parameters ◽

Headspace Gas ◽

Headspace Gc

A solvent-free headspace gas chromatography – mass spectrometry (SF-HS-GC/MS) method was developed and validated for screening of N-nitrosodimethylamine (NDMA) in various active pharmaceutical ingredients (APIs) and drug products. Experimental parameters...

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Prospects for Using Radionuclide Research Methods for Diagnosing and Evaluating Effectiveness of Treating Consequences of Coronavirus Diseasr (COVID-19

Medical Radiology and radiation safety ◽

10.12737/1024-6177-2021-66-1-63-68 ◽

2021 ◽

Vol 66 (1) ◽

pp. 63-68

Author(s):

A Kudryavtsev ◽

A Kondakov ◽

S Korvyakov ◽

A. Sozykin ◽

P. Nikitin ◽

...

Keyword(s):

Distress Syndrome ◽

Vascular Wall ◽

Internal Organs ◽

Ischemic Brain ◽

Radionuclide Diagnostics ◽

And Control ◽

Inflammatory Changes ◽

Subsequent Rehabilitation

Purpose: to determine the role of nuclear medicine methods in the diagnosis and quality control of treatment and rehabilitation of patients with complications after coronavirus diseasr (COVID-19) The article provides a brief analysis of the incidence of COVID-19 and highlights the role of diagnosis, treatment and rehabilitation of patients suffering from the consequences of coronavirus diseasr after the end of the pandemic. The most common clinical manifestation of coronavirus diseasr is bilateral interstitial pneumonia, one of the complications of which is the development of acute respiratory distress syndrome, its pathogenesis is highlighted. It is also noted that the leading link in the development of the disease is a systemic lesion of the endothelial vascular wall, which is the cause of thrombosis and its complications, primarily pulmonary embolism, ischemic brain infarctions and cardiovascular catastrophes. Specific methods of radionuclide diagnostics are described for individual organs and systems: respiratory, cardiovascular, brain, and others. The need to diagnose and control the quality of treatment and rehabilitation of patients with post-inflammatory changes in the parenchyma of internal organs and a decrease in their functional ability due to sclerotic changes, patients with changes in the state due to the transition of inflammation to the chronic stage, as well as with an overactive immune response to inflammatory changes. Conclusion: at the stage of diagnosis and treatment of the consequences of a previous coronavirus diseasr and subsequent rehabilitation, molecular imaging methods are essential in a complex of studies.

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DOMESTIC APIS AND INTERMEDIATES – THE NEED OF THE HOUR

INDIAN DRUGS ◽

10.53879/id.55.09.p0005 ◽

2018 ◽

Vol 55 (09) ◽

pp. 5-6

Author(s):

George Patani ◽

Keyword(s):

Pharmaceutical Industry ◽

Multiple Representations ◽

Active Pharmaceutical Ingredients ◽

Current Crisis ◽

Pharmaceutical Ingredients ◽

Essential Drugs ◽

Current Events ◽

Dear Reader ◽

The Cost

Dear Reader, As I write this editorial, some of the current events that we are faced with in the pharmaceutical industry in INDIA, bears greatly on my mind. The exponential rise in the cost of a large number of APIs is causing great anguish and stress for formulation manufacturers. The rise in the cost of these APIs or their intermediates sourced from China is attributed as the reason for this increase. As a result, a number of essential drugs are experiencing shortages in various parts of our country. The year 2015 was declared as the year of ACTIVE PHARMACEUTICAL INGREDIENTS (APIs) by the Department of Pharmaceuticals. While we still await the announcement of concessions based on the multiple representations made to the various ministries, the current crisis maybe a god sent opportunity for the domestic API manufacturers to restart manufacturing a number of the APIs that were uneconomical due to price pressures from APIs produced in China

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College Campus Sexual Assault: The Contribution of Peers’ Proabuse Informational Support and Attachments to Abusive Peers

Violence Against Women ◽

10.1177/1077801217724920 ◽

2017 ◽

Vol 24 (8) ◽

pp. 922-935 ◽

Cited By ~ 11

Author(s):

Walter S. DeKeseredy ◽

Amanda Hall-Sanchez ◽

James Nolan

Keyword(s):

United States ◽

Sexual Assault ◽

Peer Support ◽

The United States ◽

Female College Students ◽

Campus Sexual Assault ◽

Community Needs ◽

And Control

Since the mid-1980s, researchers across the United States have uncovered high rates of sexual assault among female college students. However, to advance a better understanding of this gendered type of victimization, and to both prevent and control this problem, the research community needs to identify its major correlates. One that is consistently uncovered in North American campus survey work is negative peer support, especially that provided by male peers. Yet, some earlier studies have found that mixed-sex negative peer support, too, contributes to campus sexual assault. Using recent data from the Campus Quality of Life Survey conducted at a large residential school in the South Atlantic region of the United States, the main objectives of this article are to examine the role of mixed-sex negative peer support in campus sexual assault and to identify the groups of women most at risk of having friends who offer such support.

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Obesity: the modern view of a problem

Clinical Medicine (Russian Journal) ◽

10.18821/0023-2149-2016-94-5-333-338 ◽

2016 ◽

Vol 94 (5) ◽

pp. 333-338

Author(s):

Evgenii E. Achkasov ◽

S. I. Rapoport ◽

S. D. Runenko ◽

A. O. Razina

Keyword(s):

Health Risks ◽

Multidisciplinary Approach ◽

Overweight And Obesity ◽

Role Of Government ◽

Interdisciplinary Programs ◽

Treatment And Prevention ◽

Quality Of Food ◽

And Control

The article is a review of recent epidemiological observations concerning the prevalence of overweight and obesity in different countries among people of different gender, age. social and ethnic groups. It also presents and analyses health risks and comorbidities leading to disability and death as reported by domestic and foreign researchers. It was found that obesity has multifactorial pathogenesis directly related to energy balance, consumed and expended calories. The need of a multidisciplinary approach to the treatment and prevention of the disease is emphasized taking into consideration the influence of the environment and increasing urbanization on the development of the pathology as well as the role of government efforts to stimulate physical activity of the population in the framework of integral interdisciplinary programs and control over the quality of food. The priority areas for the correction of overweight include optimization of motor activity and diet correction.

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