Manufacture Of Pharmaceutical Products Research Articles

Analytical Quality by Design

Throughout the 20th century, the notion of ‘quality’ underwent major changes. The concept of ‘Quality by Testing’, i.e. evaluating the quality of a product by testing it for some pre-defined parameters after completing the manufacturing process, started to be replaced by the enhanced approach of Quality by Design (QbD). In this concept, idealized by Joseph Juran [1], quality is initially conceived for the product, and then the product is manufactured and evaluated to reach that quality. Driven by the need to reduce costs and to encourage companies to improve their understanding of their products and manufacturing processes, pharmaceutical regulatory agencies, through the ICH (International Council on Harmonization), published the ICH Q8 guideline, highlighting the QbD strategy for pharmaceutical development [2]. This represented a significant step in replacing the existing quality paradigms in the conventional manufacturing of pharmaceutical products and paved the way to support development and production activities within a scientific, flexible environment, with a high level of quality, without the need for extensive regulatory surveillance. The higher level of understanding gained during development allows out-of-specification batches to be foreseen and ensures that the desired quality will be obtained at the end of the manufacturing process. The two pillars of the QbD concept are quality risk management and multivariate study of the outcomes (quality parameters) as functions of the inputs (materials, formulation and process inputs). At this point, Chemometrics emerged officially as a strategy to support the pharma regulatory requirements- the beginning of a joyful and long-life union.

Assessing the impact of non-governmental organization’s extension programs on sustainable cocoa production and household income in Ghana

Globally, cocoa is famous for the production of chocolates and beverages. However, it also serves as a source of raw material for the manufacturing of high-quality cosmetic and pharmaceutical products. Due to its high demand, cocoa is regarded as a major commodity for poverty alleviation in deprived cocoa farming communities. Government has therefore instigated relevant measures to address issues facing the sector by investing in extension programs. These programs act as information dissemination tools for teaching modern farming technologies and enhancing learning among farmers. This study highlighted the effects of the Cocoa Life Project (CLP) by Cooperative for Assistance and Relief Everywhere (CARE) International on farm productivity and income of 200 cocoa farmers in three districts of the Eastern Region, Ghana. Regression on covariates, Heckman’s treatment effects model, and propensity scores were used to test the robustness of the estimates. A positive association between extension program participation, farm productivity, and household income was discovered. Specifically, after correcting for selection bias, the estimated results of the Heckman’s model showed that the extension program significantly increased participating farmers’ cocoa yield by 14.3%. The effects on total farm income showed a significant increase of 25.1 and 42.9%, respectively from regression on propensity scores and the Heckman’s model. Across all three models, program participation led to an increase in total household income by 46.1, 31.7, and 69.3%, respectively. Other variables such as farming characteristics, institutional and demographic factors affected farmers’ income, depending on the estimation method used. This study reiterated the supporting role played by extension programs in enhancing cocoa production and increasing household income in Ghana. Conclusively, government and development partners should invest in extension programs by providing enough logistics, training qualified agents, and creating a conducive atmosphere to support learning and technology adoption.

Discriminating different Cannabis sativa L. chemotypes using attenuated total reflectance - infrared (ATR-FTIR) spectroscopy: A proof of concept

An original, innovative, high-throughput method based on attenuated total reflectance - Fourier’s transform infrared (ATR-FTIR) spectroscopy has been developed for the proof-of-concept discrimination of fibre-type from drug-type Cannabis sativa L. inflorescences. The cannabis sample is placed on the instrument plate and analysed without any previous sample pretreatment step. In this way, a complete analysis lasts just a few seconds, the time needed to record an ATR-FTIR spectrum. The method was calibrated and cross-validated using data provided by liquid chromatography - tandem mass spectrometry (LC–MS/MS) analysis of the different cannabis samples and carried out the statistical assays for quantitation. During cross-validation, complete agreement was obtained between ATR-FTIR and LC–MS/MS identification of the cannabis chemotype. Moreover, the method has proved to be capable of quantifying with excellent accuracy (75–103 % vs. LC–MS/MS) seven neutral and acidic cannabinoids (THC, THCA, CBD, CBDA, CBG, CBGA, CBN) in inflorescences from different sources. The extreme feasibility and speed of execution make this ATR-FTIR method highly attractive as a proof-of-concept for a possible application to quality controls during pharmaceutical product manufacturing, as well as on-the-street cannabis controls and user counselling.

Local Natural Product Development in the Era of Covid 19 Pandemic

Covid-19 is a pandemic disease that infects the respiratory system by cough and sneeze. Covid 19 infection rate in Indonesia is high. On March 2nd 2020, there was reported 2 confirmed cases of Covid-19 infection. Natural ingredients contain a secondary metabolite compound has the potential as an antimicrobial that can be used to kill microorganism as a source of the disease. Natural ingredients that are commonly used as antimicrobials such as bundung, betel leaf and lime peel. Pharmaceutical formulations from natural ingredients need to be made to obtain preparations that are beneficial to the community because they are safer and have minimal side effects. Based on this description, it is necessary to conduct training on the manufacture of pharmaceutical products from natural ingredients or local resources that are easy to make so it can be useful and beneficial for the community during the Covid-19 pandemic. The activities were carried out virtually, followed by the teacher council and students from High School 1 Kahayan Hilir. The activities carried out by providing information related to the efficacy of natural ingredients from local resources, training or workshops on the manufacture of pharmaceutical products and education regarding storing and how to use drugs correctly. This activity is expected to be useful and make a big contribution to the community during the Covid-19 pandemic.

Continuous manufacture of hydroxychloroquine sulfate drug products via hot melt extrusion technology to meet increased demand during a global pandemic: From bench to pilot scale

During pandemics and global crises, drug shortages become critical as a result of increased demand, shortages in personnel and lockdown restrictions that disrupt the supply chain. The pharmaceutical industry is therefore moving towards continuous manufacturing instead of conventional batch manufacturing involving numerous steps, that normally occur at different sites. In order to validate the use of large-scale industrial processes, feasibility studies need to be performed using small-scale laboratory equipment. To that end, the scale-up of a continuous process and its effect on the critical quality attributes (CQAs) of the end product were investigated in this work. Hydroxychloroquine Sulphate (HCQS) was used as the model drug, Soluplus® as a model polymeric carrier and both horizontal and vertical twin screw extruders used to undertake this hot melt extrusion (HME) study. Seven formulations were processed using a small-scale horizontal extruder and a pilot-scale vertical extruder at various drug loadings, temperature profiles and screw speeds. When utilising a horizontal extruder, formulations with the highest drug load and processed at the lowest screw speed and temperature had the highest crystallinity with higher drug release rates. Upon scale-up to a vertical extruder, the crystallinity of the HCQS was significantly reduced, with less variation in both crystallinity and release profile across the different extrudates. This study demonstrates improved robustness with the pilot-scale vertical extruder compared to lab-scale horizontal extruder. The reduced variation with the vertical extruder will allow for short increases in production rate, with minimum impact on the CQAs of the final product enabling high-performance continuous manufacturing with minimum waste of raw materials. Finally, this research provides valuable information for the pharmaceutical industry in accessing continuous technologies for the manufacture of pharmaceutical products, allowing for efficient utilisation of resources upon scale-up and mass production during global pandemics and drug shortages.

Studies on Chitosan, Chitin and Chitooligosaccharides and Their Biomedical Properties

Abstract Research in healthcare involves the use of natural resources in the manufacture of pharmaceutical products. Chito-oligosaccharides (CHOS) are described as homo- or heterooligomers of N-acetylglucosamine and D-glucosamine. As a starting material for CHOS production chitin or chitosan can be used. When it comes to the medical field, there are indications that CHOS may be developed and used as drugs against asthma, antibacterial agents, ingredients in wound-dressings and vectors in gene-therapy. The methods of production can rely on enzymatic conversions, chemical methods or combinations of these methods. There is ample literature concerning the biological effects of chitosans, but relatively little is known about the effects of CHOS, and the mechanisms behind observed bioactivities are generally poorly understood. This review is focused on the characterization of chitin and chitosan by presenting the biological properties, and on the enzymatic production of CHOS, and on further separation and purification methods for producing well-defined mixtures and also provides an overview of some of the most promising applications of CHOS.

SM2 The Consequences of Greater Net Price Transparency for Innovative Medicines in Europe: Insights from a Multi-Agent Simulation Model

Background: Price transparency of innovative medicines is a heavily debated topic and, despite no evidence suggesting that greater net price transparency (NPT) could benefit either the payers or the patients, it is believed by many stakeholders as a mechanism to promote competition and equity across markets. The aim of this study is to explore the effects of a policy requesting greater NPT in Europe on the achievable pharmaceutical pricing and access in different European countries. A computational multi-agent model representing the European country-level situation was developed to conduct counterfactual analyses of various NPT systems. In particular, the model considers only the case of manufacturers of in-patent pharmaceutical products acting as monopolists, hence not facing competition, when negotiating the price and reimbursement of new drugs. The results of the computational model indicate that lower-income markets could expect price increases under transparent conditions whereas higher-income markets could expect price decreases. A full NPT system encompassing higher- and lower-income European countries would not be viable as middle- and lower-income countries acting as rational economic agents would not give up their confidential agreement system with the pharmaceutical industry. A partial price transparency system could be a viable solution if entailing only the group of high-income countries committing to NPT and accepting a higher price than they could get in their present confidential rebate system, leaving all other countries free to opt for confidential discounts. Results from the computational model are fully in line with previous studies indicating an increasing imbalance between higher- and lower-income countries, with the latter likely to have to pay more for the same value that they get now. This goes against the spirit of Ramsey Pricing principles with which a mark-up would be implemented to countries featuring highly inelastic demand to ensure distributive justice amongst European markets.

Cloning and Expression of Serratia Marcescens Prodigiosin Gene in Ecoli XL1blue

Background and Objectives: Serratia is a gram-negative bacterium. The pigmentation property of Serratia Marcescens is used as a marker of dust particles in the environment and in the hospital. Today biopigments are also widely used in the manufacture and production of pharmaceutical products. Prodigiosin is a promising drug due to its reported properties of antifungal immunosuppressive and anti-proliferative activities. In the present study, cloning of pig gene- isolated from Serratia Marcescens in Ecoli XL1blue was performed. Subjects and Methods 60 Samples were taken from clinical sources of patients hospitalized with urinary tract infections in Saveh Hospitals. Serratia Marcescens were identified and isolated by different tests. The pig gene was cloned by T-A cloning using PTG-19 vector into the Escherichia coli XL1blue as host. Expression of cloned gene in recombinant colonies was evaluated by Real time PCR. The phylogenetic tree was plotted using clustalX and Mega5 software Results Screening of samples identified 12 isolates of Serratia Marcescens from then 4 isolates had pig gene. Expression of Pig gene in Escherichia coli XL1blue was confirmed by Real-Tima PCR. As a result of phylogenetic studies, some close relatives of serratia have been identified as candidates for further studies Conclusion Serratia Marcescens can be considered as a rich source of pigments with many applications and can be used as indigenous strains to produce Prodigiosin.

The economics of additive manufacturing: Towards a general cost model including process failure

The interest in Additive Manufacturing (AM) technology, also known as 3D printing, is unbroken. In many industries, however, stakeholders are struggling to understand AM's potential for manufacturing value creation. Most available literature on the cost of AM stresses the importance of ancillary processes and treats the relationship between process efficiency and capacity utilization. The most recently added - and overdue - aspect included in the extant AM costing literature considers the expected impact of so-called ill-structured costs, mainly relating to process failure and product rejection. Available research has investigated this aspect across a variety of technology types and process elements. This paper develops a new AM cost model that is generally specified so it can represent the probability and expected cost effect of failure events for all existing AM technologies. To demonstrate the implementation of this model, this paper applies it to the manufacture of pharmaceutical products (tablets) using the AM technology variant material jetting. The paper thus provides a robust indication of achievable unit cost levels, the cost effect of process failure, and also broaches the usefulness of cost models in guiding further process improvements.

Characterization of EstDR4, a Novel Cold-Adapted Insecticides-Metabolizing Esterase from Deinococcus radiodurans

Cold-adapted esterases are attracting increasing attention owing to their prospective use in biotechnology. In this study, a novel cold-adapted family Ⅳ esterase EstDR4 was identified and obtained from extremophile Deinococcus radiodurans (D. radiodurans). EstDR4 displayed significant substrate preference towards short and medium chain monoesters (C2–C12). It also showed regioselectivity, enantioselectivity and degradation effects on four insecticides. The optimum temperature and pH for EstDR4 activity were 30 °C and pH 8, respectively. Additionally, EstDR4 exhibited relatively high catalytic activity at 0 °C and high stability from 10–40 °C, with over 80% of its initial activity retained after 1 h of incubation. Moreover, EstDR4 activity was stimulated by Tween 80 and Triton X-100, and inhibited by metal ions such as Co2+, Cu2+ and Zn2+ and several organic solvents. Thus, this enzyme shows development potential for many industrial biotechnological applications, including the manufacture of thermolabile pharmaceutical products, cold-wash detergents and insecticide biodegradation.

Quantitative Evaluations with 2d Electrical Resistance Tomography in the Low-Conductivity Solutions Using 3d-Printed Phantoms and Sucrose Crystal Agglomerate Assessments.

Crystallization is a significant procedure in the manufacturing of many pharmaceutical and solid food products. In-situ electrical resistance tomography (ERT) is a novel process analytical tool (PAT) to provide a cheap and quick way to test, visualize, and evaluate the progress of crystallization processes. In this work, the spatial accuracy of the nonconductive phantoms in low-conductivity solutions was evaluated. Gauss–Newton, linear back projection, and iterative total variation reconstruction algorithms were used to compare the phantom reconstructions for tap water, industrial-grade saturated sucrose solution, and demineralized water. A cylindrical phantom measuring 10 mm in diameter and a cross-section area of 1.5% of the total beaker area was detected at the center of the beaker. Two phantoms with a 10-mm diameter were visualized separately in noncentral locations. The quantitative evaluations were done for the phantoms with radii ranging from 10 mm to 50 mm in demineralized water. Multiple factors, such as ERT device and sensor development, Finite Element Model (FEM) mesh density and simulations, image reconstruction algorithms, number of iterations, segmentation methods, and morphological image processing methods, were discussed and analyzed to achieve spatial accuracy. The development of ERT imaging modality for the purpose of monitoring crystallization in low-conductivity solutions was performed satisfactorily.

Effect of operating parameters on application based performance analysis of PDC: A recent review

Pulse detonation engines (PDEs) are advanced propulsion device for next generation of propulsion systems. The PDE combustion processes are filling of fuel-oxidizer, combustion reaction, blow down and purging. In conventional engine deflagration combustion takes places, which propagation speed is less (Ma < 1) rather than detonation combustion process. But detonation combustion process in pulse detonation engine takes place and its flame propagation speed is much higher than sonic (Ma = 1) velocity. So researchers are focusing on PDE combustion process and different propulsion performances enhancement process. Deflagration to detonation transition process takes placed inside the combustor due to effect of different operation conditions and combustor geometry. Further NOx emission mitigation techniques from Pulse detonation combustor (PDC) are big drawback to reduce the pollution. In these regards review studies on recent advances techniques on flame acceleration, NOx formation and propulsion performance have been indicated to increase the performance of the system. Further state of arts of application indicates that pulse detonation engine can be used for green manufacturing process, surface coating and pharmaceutical product manufacturing.

Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance.

The collection and assessment of individual case safety reports (ICSRs) is important to detect unknown adverse drug reactions particularly in the first decade after approval of new chemical entities. However, regulations require that these activities are routinely undertaken for all medicinal products, including older medicines such as generic medicinal products with a well-established safety profile. For the latter, the risk management plans no longer contain important risks, considered important safety concerns, on the basis that routine pharmacovigilance activity would not allow their further characterisation. Society assumes that unexpected adverse reactions causally related to pharmacological activity are very unlikely to be detected for such well-established medicines, but important risks can still occur. For these products, a change in the safety profile which is brand or source specific and usually local in nature, associated with failures with the adequate control of quality of manufacturing or distribution are important safety issues. These may be the consequence of manufacturing and pharmacovigilance quality systems that are not fully integrated over the product life cycle (e.g. inadequate control of quality defects affecting one or multiple batches; inadequate impact assessment of change/variation of manufacturing, quality control testing, storage and distribution processes; inadequate control over the distribution channels including the introduction of counterfeit or falsified products into the supply chain). Drug safety hazards caused by the above-mentioned issues have been identified with different products and formulations, from small molecules to complex molecules such as biological products extracted from animal sources, biosimilars and advanced therapy medicinal products. The various phases of the drug manufacturing and distribution of pharmaceutical products require inputs from pharmacovigilance to assess any effects of quality-related issues and to identify proportionate risk minimisation measures that often have design implications for a medicine which requires a close link between proactive vigilance and good manufacturing practice. To illustrate our argument for closer organisational integration, some examples of drug safety hazards originating from quality, manufacturing and distribution issues are discussed.Plain language summary Monitoring the manufacturing and quality of medicines: the fundamental task of pharmacovigilance Pharmacovigilance is the science relating to the collection, detection, assessment, monitoring, and prevention of adverse reactions with pharmaceutical products. The collection and assessment of adverse reactions are particularly important in the first decade after marketing authorisation of a drug as the information gathered in this period could help, for example, to identify complications from its use which were unknown before its commercialization. However, when it comes to medicines that have been on the market for a long time there is general acceptance that their safety profile is already well-established and unknown adverse reactions unlikely to occur. Nevertheless, even older medicines, such as generic drugs, can generate new risks. For these drugs a change in the safety profile could be the result of inadequate control of their quality, manufacturing and distribution systems. To overcome such an obstacle, it is necessary to fully integrate manufacturing and pharmacovigilance quality systems in the medicine life-cycle. This could help detect safety hazards and prevent the development of new complications which may arise due to the poor quality of a drug. Pharmacovigilance activities should indeed be included in all phases of the drugs’ manufacturing and distribution process, regardless of their chemical complexity to detect quality-related matters in good time and reduce the risk of safety concerns to a minimum.

Return of Benefit to Society of Publicly Funded Innovations to Combat COVID-19.

In response to the COVID-19 pandemic, significant public funds have been invested worldwide into the research, development, and manufacturing of pharmaceutical products to combat the novel coronavirus. Traditionally, intellectual property (IP) rights have been justified in the pharmaceutical sector because of the time and cost associated with drug discovery and development. However, if (a) the cost of research for COVID-19 related innovations have largely been subsidized by the public through public research grants; (b) the time for development has been significantly reduced through publicly funded initiatives; and (c) manufacturing has been de-risked through taxpayer funded advance purchase agreements, should IP rights be asserted on innovations that have largely already been paid for by the public?. There needs to be clear legal and regulatory frameworks, informed by policy objectives such as principles of “responsible research and innovation” and “global public good,” to ensure that outcomes of publicly funded efforts can ultimately reach the intended public. Without any access and production conditions associated with the use of public efforts, worldwide supplies to medical solutions that benefited from these public initiatives can be frustrated. This article proposes a legal framework to address future access and availability problems to medical innovations that benefit from publicly funded initiatives.

Artificial Intelligence: A New Paradigm for Pharmaceutical Applications in Formulations Development

Abstract: Artificial Intelligence is a branch of engineering that specializes in developing intelligent machines. The utilization of artificial intelligence in pharmaceutical technology has elevated over the years. Over the beyond few years, the sector of artificial intelligence has moved from largely theoretical research to real-international applications. Machine learning is an application of artificial intelligence that gives systems the capacity to automated learn and enhance from experience without being especially programmed. Machine learning (MI) ought to protect medicine around $100 billion yearly due to more efficiencies in clinical trials, higher insights for decision-making and innovative tools that could assist consumers, physicians, regulators and insurers to make informed decisions. Neural networks, fuzzy logic and genetic algorithms are unexpectedly developing technologies that would be applied to the formulation and manufacturing of pharmaceutical products. The present article, in brief describes the significance of AI within the manner of drug development after which seems on the numerous AI tools that are available at the disposal of a present-day pharmacist to aid in more efficient functioning. Key words: Artificial intelligence, Pharmaceutical technology, Drug development, Health care, Engineering.

Subcritical dimethyl ether extraction as a simple method to extract nutraceuticals from byproducts from rice bran oil manufacture

The byproducts of rice bran oil processes are a good source of fat-soluble nutraceuticals, including γ-oryzanol, phytosterol, and policosanols. This study aimed to investigate the effects of green technology with low pressure as the subcritical fluid extraction with dimethyl ether (SUBFDME) on the amount of γ-oryzanol, phytosterol, and policosanol extracted from the byproducts and to increase the purity of policosanols. The SUBFDME extraction apparatus was operated under pressures below 1 MPa. Compared to the chemical extraction method, SUBFDME gave the highest content of γ-oryzanol at 924.51 mg/100 g from defatted rice bran, followed by 829.88 mg/100 g from the filter cake, while the highest phytosterol content was 367.54 mg/100 g. Transesterification gave the highest extraction yield of 43.71% with the highest policosanol content (30,787 mg/100 g), and the SUBFDME method increased the policosanol level from transesterified rice bran wax to 84,913.14 mg/100 g. The results indicate that the SUBFDME method is a promising tool to extract γ-oryzanol and phytosterol and a simple and effective technique to increase the purity of policosanol. The study presented a novel technique for the potential use of SUBSFDME as an alternative low-pressure and low-temperature technique to extract γ-oryzanol and phytosterol. The combination of transesterification and the SUBFDME technique is a potential simple two-step method to extract and purify policosanol, which is beneficial for the manufacture of dietary supplements, functional foods and pharmaceutical products.

One‐Pot Access towards 4,5‐Disubstituted 2‐Amino‐1H‐imidazoles Starting from Mannich Substrates and their Transformation Utilities

An efficient protocol for the preparation of 4,5‐functionalised 2‐amino‐1H‐imidazoles as fragment‐like structures was developed in isolated yields up to 95 %. The demonstrated one‐pot manner includes an intramolecular oxidative annulation and ring cleavage sequence starting from Mannich precursors. The suggested one‐pot sequential synthetic methodology is easy to apply in automatic and robotic chemistry laboratories for which a rapidly increasing demand is foreseen because of the ongoing revolution in the field of continuous manufacturing of pharmaceutical drug substances and products. Further transformation utilities such as Groebke–Blackburn–Bienaymé 3CR and the formation of marine alkaloid analogs were also represented.

BIOLOGICAL IMPORTANCE OF MICROBES IN AGRICULTURE, FOOD AND PHARMACEUTICAL INDUSTRY: A REVIEW

Biotechnology is the most prominent and rapidly growing segment of the biological sciences that is making its diversified application in sustainable agriculture. Biofertilizers, biopesticides, bioherbicides, bioinsecticides, and many of the other fungal based and viral based insecticides, obtained using microorganisms, are some of the outcomes of biotechnology playing a key role in sustainable agriculture. Many of other important food products are also obtained by microbial fermentation. Different microbes are added to get the desired effect of food at the specific stages of food production process. Pharmaceutical microbiology includes the manufacturing of different pharmaceutical and medicinal products. This review article has a wide overview of microbes mainly used in agriculture, food industries, and pharmaceutical industries.

Investigation into powder tribo-charging of pharmaceuticals. Part I: Process-induced charge via twin-screw feeding.

Powder feeding is a crucial unit operation in continuous manufacturing (CM) of pharmaceutical products. Twin-screw feeders are typically employed to ensure the accurate mass flow of pharmaceutical materials throughout the production process. Here, contact and separation of particles can give rise to electrostatic charges, affecting feeder performance and final product quality. The knowledge of the material charging tendency would therefore be beneficial for both formulation and process design. At the early stage of product development, only a limited amount of material is available and the propensity of the powders to charge needs to be assessed on lab test equipment, which not necessarily represent the material state during processing. In this study, the tribo-charging behaviour of a set of common pharmaceutical materials (i.e., microcrystalline cellulose, D-mannitol, paracetamol and magnesium stearate) was experimentally evaluated. To this end, powder materials were let to flow over the stainless-steel pipes of the GranuCharge™ instrument. The resulting charge was compared to the one acquired during twin-screw feeding. In both cases, paracetamol exhibited the highest charging tendency followed by D-mannitol and microcrystalline cellulose and last by magnesium stearate. A good correlation was found for charge values obtained for both methods, despite the different tribo-charging mechanisms involved in the two set-ups. However, these differences in experimental set-ups led to diverse magnitudes and, in one case, polarity of charge. Additionally, an extensive material characterization was performed on the selected powders and results were statistically analyzed to identify critical material attributes (CMAs) affecting powder tribo-charging. A strong correlation was obtained between the measured charge and inter-particle friction. This indicated the latter as one of the most influencing material characteristic impacting the powder tribo-charging phenomenon of the selected materials.

Assessing the Impact of Different Light Sources on Product Quality During Pharmaceutical Drug Product Manufacture – Fluorescent Versus Light-Emitting Diode Light

Pharmaceutical scientists are often asked to assess the impact of modifications to the illumination in the manufacturing and product packaging environment on product quality. To assess the impact of switching light sources, four model compounds were exposed to standard fluorescent light, LED, and “yellow light” and the extent of drug photodegradation was determined. Photodegradation under LED light is generally reduced compared to fluorescent light and is often predictable if the UV–Vis absorption spectrum of the active pharmaceutical ingredient (API) and the spectral power distribution emitted by the various light sources overlap. However, lack of noticeable spectral overlap does not ensure absence of API photodegradation and may require additional assessment for selection of appropriate lighting conditions. A detailed evaluation of the API and solid formulation absorbance was performed to assess degradation risk for Compound A and Vitamin D3 when exposed to LED light. The light budget was established for Compound A, spanning all stages of the manufacturing process, under different illumination conditions to enable a complex supply chain. The results also demonstrate that while LEDs used in manufacturing areas are generally “better” compared to fluorescent lights, they are not replacing yellow lights for compounds sensitive to visible light.