drug product Articles
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Measurement of Elemental Impurities in a Higher Daily Dose Drug Product by USP <232>/<233> Using Ultrasonic Nebulization with ICP-AES Detection
Abstract: On January 1, 2018 the U.S. Pharmacopeia (USP) enacted new criteria for element impurities in finished drug products. These criteria, detailed in USP/, recommend analysis of drug products for element impurities by either ICP-AES or ICP-MS. Laboratories must measure impurities based on a J value for each drug product; drug products may be oral, parenteral (ex. intravenous, injection), or ...
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Brief Introduction of ADC Drug Production Technology
Drug-to-antibody ratio (DAR, drug-to-antibody ratio) The number of cytotoxic drugs connected to each antibody is the drug-to-antibody ratio (DAR). When the DAR increases, the drug metabolism rate of ADC drugs increases, the half-life decreases, and the systemic toxicity increases. Ideally, when the DAR is 4, the drug has the highest efficacy. Therefore, in actual production, the drugs with DAR ...
By BOC Sciences
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FDA Extends Comment Period for Proposed Rule for OTC Sunscreen Drug Products
On April 18, 2019, the Food and Drug Administration (FDA) published a Federal Register notice announcing that it is extending the comment period for its February 26, 2019, proposed rule that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph ...
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Embracing Q3D: FDA`s new elemental impurities guidance
Abstract: Elemental impurities have been topic of discussion since 2009 when the ICH commenced work to provide an international standard to limit the impurities in drug products and ingredients. FDA too has released its guidance on the control of elemental impurities in consistent with the implementation of ICH’s Q3D Elemental Impurities guideline. The FDA guidance also addresses the ...
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Fixing the paradigm for biopharmaceutical R&D: Where to start?
The basic thesis of this paper is that the R&D sector of the new medicines' business is experiencing evolutionary stress. Due to the failure of the regulatory framework and applied sciences to keep pace with advances in discovery, there is a bottleneck in the development phase of R&D. While improved process may help, there are still problems related to the products themselves, such as the need to ...
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Policy Management – DCSCA – Drug Supply Chain Integrity
When the Drug Quality and Security Act (DQSA) was signed by President Obama on November 27, 2013, advocates hoped that the confusing patchwork of State laws governing drug pedigree and tracing would finally be replaced by a comprehensive solution for the ‘3T’s’ (Transaction History, Transaction Statement, and Transaction Information) of the increasingly complex pharmaceutical ...
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Analysis of Cleaning Validation Compounds using the TOC Fusion Analyzer
Abstract By taking an active approach to prevent cross-contamination in pharmaceutical and cosmetic production, international agencies such as the USFDA, ICH, EC, Health Canada, and the WHO have established regulations and guidelines for effective cleaning and sanitization.1-6 With the potential side effects due to exposure, limiting carry-over of residual compounds into subsequent batches is ...
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Analysis of Cleaning Validation Compounds using the TOC Fusion Analyzer
Abstract By taking an active approach to prevent cross-contamination in pharmaceutical and cosmetic production, international agencies such as the USFDA, ICH, EC, Health Canada, and the WHO have established regulations and guidelines for effective cleaning and sanitization.1-6 With the potential side effects due to exposure, limiting carry-over of residual compounds into subsequent batches is ...
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Implementation of FDA’s new antibiotic rules
On Wednesday, December 11, 2013, the U.S. Food and Drug Administration (FDA) announced two coordinated actions based on its belief “that production use indications such as ‘increased rate of rate of weight gain’ or ‘improved feed efficiency’ are no longer appropriate for the approved conditions for medically important antimicrobial drugs.” First, it released ...
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Oxygen testing in pharmaceutical research & development - Case Study
As part of their pharmaceutical development, Almac use the Gaspace Advance Micro from Systech Illinois to test oxygen levels in pharmaceutical packaging. The Almac Group was founded by Sir Allen McClay in 2002 with its global headquarters located in Northern Ireland and extensive facilities in the UK, US and Asia Pacific. Almac offer the most comprehensive range of services extending from ...
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Rapid Viable Monitoring and Regulations for Pharmaceutical Manufacturers
Pharmacopoeias worldwide have promoted rapid or alternative microbiological methods for almost 20 years. All now have chapters in which the validation of alternative methods is described (e.g. United States Pharmacopeia (USP), or European Pharmacopoeia (EP) 5.1.6), and these chapters continue to evolve with frequent updates. Regulatory bodies have created specific pathways to facilitate the use ...
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University of Pavia, Lab. Pharmaceutical Technology and Law (PT&L) Italy - Case Study
“The BUCHI Encapsulator B-395 Pro is the instrument of choice on the market for the sterile encapsulation of cells into polymeric beads and capsules, and is integretable into a GMP process.” Customer name Prof. Bice Conti Company / Institution Université de Pavia, Lab. Pharmaceutical Technology and Law (PT&L), Dept. Drug Sciences, Italie Product lines Spray Drying and ...
By BUCHI
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Innovation management of Japanese pharmaceutical companies: the case of an antibiotic developed by Takeda
It is often argued that the Japanese pharmaceutical industry lacks international competitiveness partly because of its weakness in innovation – most new drugs developed by Japanese companies are imitative and lack appeal in overseas markets. To address this problem, I suggest a well-defined typology of drug innovation. I found in my previous studies that the dominant type of innovation among ...
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Ceramic membranes in the pharmaceuticals industry - Case Study
GlaxoSmithKline, the pharmaceuticals giant, cut operating costs at its drugs plant in Worthing UK, by replacing polymer with Star-Sep™ Ceramic Membranes The installation of a Star-Sep™ Ceramic Membrane system was a critical, yet proportionally low-cost component of GlaxoSmithKline’s anti-biotic drug processing system, enabling a multi-million pound investment to be recouped ...
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Futura Pens Deal with Cooper to Launch Erectile Dysfunction Gel In Europe
Executive Summary Futura Medical's novel OTC topical erectile dysfunction treatment MED3000 will be launched across numerous European markets by France's Cooper Consumer Health. You may also be interested in... Futura All Set For US FDA De Novo Application For Eroxon OTC ED Treatment Futura Medical is preparing to seek approval from the FDA to launch OTC in the US its MED3000 erectile ...
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How to Select Excipients in Drug Formulation?
The purpose of formulation development is to ensure that the drug is safe, effective, stable, and convenient to use. If the dosage form is improperly selected and if the prescription and process design are unreasonable, it will have a certain impact on the quality of the drug product, and even affect the drug’s efficacy and safety. Therefore, formulation research occupies a very important ...
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Pharmaceutical Companies Rely on Nitrogen
Pharmaceutical firms research, develop, and manufacture over-the-counter and prescription drugs and medicines. Usage of these drugs includes, but is not limited to, vaccinations, treatment for chronic conditions, and pain management. To protect the health and well-being of the public, the pharmaceutical industry is one of the most highly regulated industries. For instance, in the United States, ...
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Amorphous Content Determination in Medicine
In industrial production, the surface of the compound may become amorphous due to a small amount of structural damage. It is difficult for conventional instruments to detect this small amount of amorphous substance. Although the content of this amorphous substance is very low, it is very likely to affect the stability of the drug in the production and storage process, resulting in the failure of ...
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Project - Sublingual Exenatide
Liraglutide and exenatide are both belonging to the class of diabetes products called GLP-1 analogues. The GLP-1 analogues have established themselves in the past years as one of the superior drug classes for treatment of diabetes type II in terms of blood glucose lowering and weight loss. Because of the latter, they are being used more and more also in the treatment of obesity. Until now, both ...
By BioLingus AG
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Regulatory Guidelines for API-Excipient Compatibility Studies
Pharmaceutical excipients have important functions such as serving as carriers, improving drug stability, solubilization and slowing down the drug release. They are important ingredients that may affect the quality, safety, and effectiveness of the preparation. Classified by function and purpose, pharmaceutical excipients can be used in different drug forms, including: Injection, where ...
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