Amarin Technologies https://amarintech.com/ Development, licensing and manufacturing of transdermal and topical products Tue, 19 Mar 2024 14:43:16 +0000 en-US hourly 1 https://wordpress.org/?v=6.4.3 The Future of Scientific Publishing https://amarintech.com/sustainable-future-in-the-pharmaceutical-sector-copy/ Tue, 19 Mar 2024 14:34:28 +0000 https://amarintech.com/?p=9754 Scientific publishing faces evolution: from prestigious journals to commercial giants. Concerns arise over access barriers, rising costs, and the emergence of predatory publishers. The future hinges on open access and digitalization, shaping a dynamic landscape for knowledge exchange.

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The Future of Scientific Publishing

Francisco Stefano – Director

Kimberley Pardo – Marketing and Business Development Analyst

 

The editing of the first academic journal took place in France on January 5, 1665, with the Journal des sçavans, followed by the English Philosophical Transactions on March 6 of the same year. 355 years have passed, and communication among scientists still relies mainly on the exchange of information through journal reading. The ease of publishing results, data, and ideas is an important part of scientific work and proper procedure. The future evolution of communication matters to everyone.

During the early publications (17th and 18th centuries) up until the mid-19th century, publications were in the hands and under the responsibility of Scientific Associations or other institutions that ensured their seriousness. From the Second World War onwards, perhaps due to the accelerated increase in scientific activity, publications began to migrate towards commercial publishers, and this trend has increased. As an example, we can take the case of the highly respected medical journal currently called the New England Journal of Medicine. It was born through the efforts of two professionals in 1812 and was bought by the Medical Society of Medicine in 1928, a non-profit organization. In contrast, The Lancet, the British medical journal that can be considered competitive with NEJM, was purchased in 1991 by Elsevier.

Today, the publishing market is close to $20 billion USD, half of which is generated by approximately 5 companies: Elsevier, Springer, Taylor and Francis, Wiley, and Sage. A significant number of smaller companies are entering this market, attracted not only by the current degree of growth but also by optimistic data suggesting continuous growth based on two “facts”: Open Access and the proliferation of publications that do not use paper, with writings reaching the public only in virtual form, greatly reducing production costs.

A prevailing concern is the existing difficulties in accessing both the consultation of works and the publication of one’s own results. These difficulties mainly arise with the most prestigious journals and are caused by the high cost that researchers must pay when submitting their work for publication or the price to pay for accessing the reading of an important work for their task.

 

Regardless of the high number of publications allowing a very important flow of exchange of knowledge and hypotheses within the scientific community, fears also arise in this same community that the control exercised by companies, perhaps not so rigid and meticulous, may facilitate the publication of invalid or false data.

 

These situations have created a new danger for scientific activity, the so-called “predatory publishers” who take advantage of the profuse demand for information exchange and publish in virtual journals with reduced costs. The working model of these predators involves charging low publication fees. The received work is reviewed with relatively low editorial effort and quickly accepted for publication.

The editorial task and its products are navigating an ocean of opportunities. The importance of showing the data on which the results are based, open access to publications, pre-reading are all paths that are seeking their definitive position.

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Sustainable Future in the Pharmaceutical Sector https://amarintech.com/sustainable-future-in-the-pharmaceutical-sector/ Tue, 27 Feb 2024 13:41:05 +0000 https://amarintech.com/?p=9741 Environmental sustainability is a fundamental pillar for maintaining a harmonious balance between humans and their natural environment. This implies creating programs that promote awareness of the environmental impact of our daily actions, as well as the products and services we consume.

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Sustainable Future in the Pharmaceutical Sector

Francisco Stefano – Director

Kimberley Pardo – Marketing and Business Development Analyst

 

Environmental sustainability is a fundamental pillar for maintaining a harmonious balance between humans and their natural environment. This implies creating programs that promote awareness of the environmental impact of our daily actions, as well as the products and services we consume. This culture of environmental awareness is essential to ensure that economic development is carried out sustainably, minimizing negative impact on the environment as much as possible.

Since the 1980s, attention to sustainability has been increasing. According to a 1987 United Nations report, sustainability is defined as “meeting the needs of the present without compromising the ability of future generations to meet their own needs.” Today, the importance of sustainability and its multiple dimensions, beyond environmental ones, have been highlighted by the United Nations’ 2030 Agenda for Sustainable Development and the 17 Sustainable Development Goals (SDGs).

Additionally, measuring carbon footprint, which assesses the amount of greenhouse gases emitted directly or indirectly by an organization, product, or activity, has become a fundamental aspect for evaluating the environmental impact of human activities and promoting more sustainable practices.

Sustainability: More than a trend, a commitment

What does it really mean to be sustainable? Becoming sustainable can be a slow process that lasts months, years, or even a lifetime. It invites us to be aware of the positive and negative effects our activities generate on the surrounding environment. This approach has become increasingly relevant, and as of September 2022, 26.1% of the 7,500 organizations that managed to enter the list of sustainable companies belonged to the health sector. This percentage includes not only pharmaceutical companies but also medical technology developers and healthcare service providers.

The pharmaceutical sector has already taken significant steps towards sustainability, with companies implementing specific strategies to reduce their carbon footprint. These strategies encompass aspects such as carbon, energy, heat, transportation, water, waste, and sustainable sourcing.

Challenges and Opportunities on the Road to Sustainability

Despite progress, pharmaceutical companies face significant challenges in addressing sustainability and social responsibility. The industry relies heavily on natural resources and ecosystem services, highlighting the importance of adopting practices that safeguard these resources.

Examples of Sustainability in the Pharmaceutical Sector

Some pharmaceutical companies are already leading the way towards sustainability. From packaging recycling initiatives to the implementation of cleaner technologies in production processes, these actions demonstrate a tangible commitment to the environment. Furthermore, being a sustainable company not only benefits the planet but also drives continuous improvement, strengthens relationships with customers and suppliers, and fosters transparency in all operations.

 

In conclusion, the sustainable future of the pharmaceutical sector requires collective effort and firm commitment. Companies that adopt sustainable practices not only contribute to a healthier planet but also reap long-term benefits that go beyond financial statements. The path to sustainability is undoubtedly a journey worth undertaking.

References:

https://hazrevista.org/rsc/2016/07/el-cuidado-del-medio-ambiente-clave-para-un-sector-farmaceutico-sostenible/https://klinea.eu/el-sector-farmaceutico-hacia-un-futuro-sostenible/https://indufarma.com.uy/sostenibilidad-en-la-industria-farmaceutica/https://www.cepal.org/es/temas/desarrollo-sostenible/acerca-desarrollo-sostenible

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Work-related accidents in the industry https://amarintech.com/work-related-accidents-in-the-industry/ Wed, 24 Jan 2024 17:39:46 +0000 https://amarintech.com/?p=9731 Work-related accidents pose a constant concern in the industry, where the safety and well-being of employees are paramount. In this article, we will explore the crucial measures that must be implemented to prevent accidents, the responsibilities of companies, and the tools available to ensure a safe work environment.

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Work-related accidents in the industry

Diego Fernandez - Production Planning and Control Responsible

Work-related accidents pose a constant concern in the industry, where the safety and well-being of employees are paramount. In this article, we will explore the crucial measures that must be implemented to prevent accidents, the responsibilities of companies, and the tools available to ensure a safe work environment.

Awareness and prevention

The high incidence of accidents in the workplace underscores the need to raise awareness about prevention and educate individuals on the proper use of available tools. A specialized occupational physician plays a key role in this process, not only conducting entry medical examinations but also carrying out periodic exams in collaboration with the Workers’ Compensation Insurance (ART). These exams assess risks and exposure, forming the basis for primary, secondary, and tertiary prevention.

 

Classification of accidents and influencing factors

An occupational accident is considered any sudden event that occurs due to or during the course of work, resulting in organic injury, functional or psychiatric disturbance, disability, or death. Workplace accidents and illnesses can be classified as:

  • Accidents occurring during tasks, even if different from the usual ones.
  • Accidents suffered at the workplace and during working hours.
  • “In itinere” accidents.

Factors influencing accidents include the social environment, worker error, unsafe acts coupled with mechanical or physical risks, the accident itself, and resulting harm or injury. These can be classified, among others, as:

  • Falls of persons.
  • Falls of objects.
  • Treading on, collisions with, or blows from objects.
  • Entrapment by an object or between objects.
  • Excessive efforts or incorrect movements.

 

Occupational risks and prevention

Occupational risks refer to hazards present in a specific profession or task that can lead to accidents or health problems. In most cases, workplace accidents occur due to hazardous conditions in equipment, machinery, work tools, and facilities, as well as unsafe attitudes or acts of workers while performing their activities.

 

Preventive institutions: SRT and ART

The Superintendence of Occupational Risks (SRT) ensures compliance with the right to health and occupational safety. Workers’ Compensation Insurance Companies (ART) provide in-kind benefits to affected workers, such as medical assistance, prosthetics, rehabilitation, and funeral services.

 

Industrial safety and worker protection

Industrial safety focuses on mandatory standards to prevent and protect against workplace accidents. Its goal is to maintain the physical, mental, and social well-being of workers by promoting the use of personal protective equipment, periodic medical checks, and ongoing training.

When a workplace accident occurs, companies may face serious sanctions and legal responsibilities. Prevention and ongoing training are essential to avoid negative consequences for the company and ensure the safety of employees.

 

In conclusion, preventing workplace accidents is essential to ensure a safe and healthy work environment. Collaboration between medical staff, the safety department, and workers is crucial to mitigate risks and foster a culture of safety in the industry. Adopting preventive measures not only protects employees but also contributes to the long-term success of the company.

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Uniting forces for a healthy future https://amarintech.com/in-the-current-crossroads-of-planetary-challenges-the-interrelation-between-the-climate-crisis-and-biodiversity-loss-serves-as-a-wake-up-call-for-humanity/ Tue, 16 Jan 2024 16:34:59 +0000 https://amarintech.com/?p=9720 In the current crossroads of planetary challenges, the interrelation between the climate crisis and biodiversity loss serves as a wake-up call for humanity. These two seemingly distinct phenomena are intrinsically intertwined, and the failure to address them collectively poses significant risks to the sustainability of life on Earth.

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Uniting forces for a healthy future

Francisco Stefano - Director

Kimberley Pardo - Marketing and Business Development Analyst

In the current crossroads of planetary challenges, the interrelation between the climate crisis and biodiversity loss serves as a wake-up call for humanity. These two seemingly distinct phenomena are intrinsically intertwined, and the failure to address them collectively poses significant risks to the sustainability of life on Earth.

The climate crisis and biodiversity loss are not isolated entities but rather interconnected in more than evident ways. Extreme climate changes impact ecosystems, contributing to the decline in biodiversity. In a vicious cycle, biodiversity loss weakens ecosystems’ ability to adapt to climate change, creating a perilous environmental imbalance.

Ecosystem resilience is compromised when we don’t equitably address both crises. Biodiversity richness allows ecosystems to face and recover from climate disruptions, while lack of action on the climate crisis can lead to the extinction of numerous species, threatening environmental stability.

 

The unified voice of over 200 medical journals: a global health emergency

This chorus of over 200 medical journals resonates worldwide, emphasizing the imperative need to simultaneously address the climate crisis and biodiversity loss as a single global health entity. The gathered information highlights that we cannot continue treating these crises in isolation, as their interrelation poses imminent risks to global health.

Historically, responses to the climate crisis and biodiversity loss have been fragmented, addressing each challenge separately. However, these medical journals underscore the reality that both problems are inherently connected. The lack of effective coordination between the Conferences of the Parties (COP) on climate change and biodiversity has been a hindrance to addressing these crises comprehensively, according to medical experts.

 

The vital role of healthcare professionals: active advocates for global health

In this critical scenario, healthcare professionals emerge as key actors in preserving global health. The call is clear: doctors and healthcare professionals are expected to take an active role as advocates for planetary health. Their expertise and knowledge are essential in communicating the urgency of addressing these crises and fostering changes both at an individual and public health policy level.

Extreme weather events, food and water shortages, and environmental degradation generate a cascade of impacts on human health, from the increase in infectious diseases to the exacerbation of mental health problems. Forced migration and the rise in poverty are also direct outcomes of these crises, emphasizing the inextricable interconnection between the environment and human health.

 

The call to global action: the medical journal as a platform for awareness

The call from these medical journals reinforces the need for the World Health Organization (WHO) to jointly declare the climate and biodiversity crisis as a global health emergency. Medical journals, as respected platforms in the health field, stand as crucial catalysts to raise public awareness and mobilize the medical community around these pressing issues.

Editors and authors of these journals play an essential role in providing up-to-date and evidence-based information on the impacts of these crises on human health. In doing so, they contribute to shaping an informed public opinion and activating the involvement of healthcare professionals in advocating for global solutions.

 

Conclusion: personal commitment in the global mosaic

In a world where planetary and human health are intertwined, personal commitment takes on a new dimension. The gathered information and the urgent call from medical journals urge us to reflect on collective responsibility. Addressing the climate crisis and biodiversity loss is not just a necessity; it is an unavoidable commitment to ensure a sustainable and healthy future for future generations

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Intestinal and brain connection: profound impact on neurodegenerative diseases https://amarintech.com/exploring-opportunities-in-transmucosal-drug-administration-a-comprehensive-approach-copy/ Fri, 12 Jan 2024 19:33:13 +0000 https://amarintech.com/?p=9715 The growing prevalence of Alzheimer's-type dementia, with over 35 million current cases and a projection to exceed 135 million by 2050, underscores the urgency of understanding and addressing challenges associated with neurodegenerative diseases.

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Intestinal and brain connection: profound impact on neurodegenerative diseases

Francisco Stefano - Director

Kimberley Pardo - Marketing and Business Development Analyst

The growing prevalence of Alzheimer’s-type dementia, with over 35 million current cases and a projection to exceed 135 million by 2050, underscores the urgency of understanding and addressing challenges associated with neurodegenerative diseases.

Microbiome vs microbiota

The microbiota is the set of microorganisms found in certain areas of the body, while the microbiome is the set of microorganisms that inhabit living beings along with the chemicals they produce.

 

Microbiome, what is it, and what is it for?

The microbiome is the community of microorganisms (bacteria, fungi, viruses, etc.) located in a defined space in multicellular living beings. In humans, it is especially found in the mouth, intestines, skin, and eyes. These groups are dynamic, and various environmental factors change their relative composition. In recent years, the gastrointestinal microbiome has received increasing interest, attributing a strong connection to various biological responses such as the regulation of intestinal homeostasis, immune defense, and different neuronal processes.

The intestinal microbiome forms a complex association with the central nervous system, synchronizing the intestines with the brain and modifying behavior and cerebral homeostasis through bidirectional communication. In this communication, various systems contribute, with the main agents being the Vagus nerve along with the enteric or intestinal nerve, and numerous metabolites produced by the microbiome (tryptophan, serotonin, short-chain fatty acids, etc.).

 

Future perspectives: new approaches in prevention

With the growing understanding of the gut-brain axis and neurodegenerative diseases, new therapeutic perspectives emerge. The composition and diversity of the intestinal microbiota can influence systemic inflammation, immune response, and the production of metabolites that affect brain health. Recent research suggests that imbalances in the microbiota could be related to the risk of neurodegenerative diseases, including Alzheimer’s.

Strategies focused on maintaining a healthy microbiota could be key in the prevention and management of these diseases. Modulating the microbiota through probiotics, prebiotics, and dietary changes emerges as a promising approach.

With a projection of over 135 million cases of Alzheimer’s expected by 2050, developing innovative strategies is imperative. Emerging research suggests that personalized approaches based on genetics and microbiotic profiles could revolutionize the prevention and treatment of neurodegenerative diseases.

 

Conclusion: towards an integrated future in brain health

In the ongoing advance of research on the gut-brain axis and neurodegenerative diseases, an exciting panorama of therapeutic possibilities is revealed. A profound understanding of this interrelation offers not only a clearer understanding of the underlying mechanisms of these diseases but also the promise of more effective preventive and management strategies. Understanding this connection provides new strategies in the prevention and management of neurodegenerative diseases. Nurturing a healthy microbiota through dietary and lifestyle adjustments can be a powerful tool to safeguard long-term brain health.

In summary, we are on the threshold of an integrated future in brain health, where deep understanding, proactive action, and data-driven innovation promise to transform how we address the complexities of Alzheimer’s on a global scale.

 

References:

https://www.ambito.com/lifestyle/microbiota/como-se-conecta-el-intestino-el-cerebro-y-que-puede-impactar-nuestro-estado-animo-n5442545

https://scielo.isciii.es/scielo.php?pid=S0212-16112016001000012&script=sci_arttext

chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.redalyc.org/pdf/4577/457745514008.pdf. Revista Médica del Instituto Mexicano del Seguro Social ISSN: 0443-5117 revista.medica@imss.gob.mx Instituto Mexicano del Seguro Social México

Nutrición y deterioro cognitivo – Virgilio Hernando-Requejo, Madrid 2016

 

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Exploring Opportunities in Transmucosal Drug Administration: A Comprehensive Approach https://amarintech.com/exploring-opportunities-in-transmucosal-drug-administration-a-comprehensive-approach/ Fri, 15 Dec 2023 12:34:35 +0000 https://amarintech.com/?p=9647 Many companies, once focused solely on developing transdermal patches, are now also venturing into transmucosal forms, such as oral films.

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Exploring Opportunities in Transmucosal Drug Administration: A Comprehensive Approach

By Roberto Gabach - Director & New Projects Manager

 

Many companies, once focused solely on developing transdermal patches, are now also venturing into transmucosal forms, such as oral films.

 

A closer look at transmucosal routes:

 

While the oral route remains the most widely used method of drug administration in human medicine, it can present challenges related to absorption and irritation. In several cases, these challenges can be overcome by parenteral routes, including transdermal and transmucosal pathways.

 

The intranasal route is a parenteral drug administration pathway categorized under transmucosal, along with buccal and rectal routes. The rectal route gained significance in our country in the ’60s when various products were presented in suppositories, with acetaminophen (paracetamol) standing out for pediatric fever control.

 

Both nasal and buccal routes (including sublingual) offer more predictable drug absorption compared to the rectal route, and many medications are currently being used or are under development through these pathways. Within the oral cavity, three areas are utilized for transmucosal drug passage: beneath the tongue (sublingual), between the upper molar gum and cheek (buccal), and between the incisor mucosa and upper lip (gingival). Among these, sublingual drug absorption is the highest, while gingival absorption is the lowest.

 

The nasal mucosa is a significant drug administration route, with a growing number of available and developing products. The intranasal route enhances systemic bioavailability for certain drugs by bypassing the first-pass hepatic effect. Additionally, some drugs may reach the central nervous system (CNS) via the nasal route, bypassing the blood-brain barrier. This access, known as “nose-to-brain” in English, allows drugs to reach the brain through the communication provided by the cribriform plate of the ethmoid bone, where vessels and nerves pass.

 

Advantages of intranasal drug administration include:

 

Non-invasive and painless

Easy administration

Favorable tolerance profile

Rapid absorption and onset of action

Absence of first-pass metabolism

Better bioavailability than the oral route for small molecules

Potential to enhance bioavailability using permeation enhancers

Limitations of intranasal drug administration include:

 

Limited by the relatively small absorption area

Limited potential to slow absorption time

Drug absorption may be affected by local nasal conditions

Absorption enhancers and surfactants may affect nasal mucosa

Nasal irritation may occur

Various strategies are employed to increase intranasal drug absorption, including the use of surfactants, bioadhesive agents, and agents with vasoactive properties. Certain surfactants have demonstrated the ability to increase nasal transmucosal absorption, even for large peptides and proteins. Vasoactive agents, on the other hand, increase local blood flow in the nasal mucosa, thereby enhancing drug diffusion into the bloodstream.

 

The first FDA-approved drugs with systemic activity via the nasal route were desmopressin, lipressin (currently discontinued), and intranasal oxytocin (currently discontinued). According to the Orange Book, all these products were approved before 1982.

 

Nasal formulations can take the form of sprays, drops, gels, suspensions, emulsions, liposomal and micellar forms, and microparticles. Compared to liquid nasal formulations, nasal gels are administered as a low-viscosity solution. Upon contact with the nasal mucosa, the polymer in the gel undergoes a conformational change, forming a gel.

 

Regarding the action of drugs administered nasally, they can have either local or systemic effects.

 

Conclusions and Reflections:

 

This brief analysis of nasal drug administration aimed to highlight its therapeutic potential and the pivotal role it may play in the future. With a continued commitment to excellence and innovation, Amarin is exploring the development of new drug administration forms, demonstrating its ability to adapt to an environment where science and technology are constantly evolving, providing effective and advanced solutions to emerging medical needs.

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Strategies to Deter Abuse in Transdermal Patches https://amarintech.com/strategies-to-deter-abuse-in-transdermal-patches/ Wed, 13 Dec 2023 17:40:18 +0000 https://amarintech.com/?p=9620 According to the World Health Organization, the abusive consumption of certain drugs and substances has increased in recent years, resulting in serious consequences for the population, including neurological damage, motor disabilities, addiction, overdoses, and even death. While traditional pharmaceutical forms such as tablets are frequently abused, transdermal patches, especially those containing opioids, should also be considered.

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Strategies to Deter Abuse in Transdermal Patches

Cecilia Prudkin Senior Analyst R&D

According to the World Health Organization, the abusive consumption of certain drugs and substances has increased in recent years, resulting in serious consequences for the population, including neurological damage, motor disabilities, addiction, overdoses, and even death. While traditional pharmaceutical forms such as tablets are frequently abused, transdermal patches, especially those containing opioids, should also be considered.

Health agencies, such as the Food & Drug Administration (FDA), endorse the implementation of measures to assess various aspects that prevent and discourage medication abuse. These measures span from packaging and labeling to storage, disposal, and formulation.

 

In this context, a method to discourage abuse, known as Abuse Deterrent Formulation (ADF), is defined as a strategy that can be implemented to make drug abuse more challenging or less appealing.

 

Pre-commercialization studies, conducted before a drug becomes available on the market, encompass research on potential clinical abuse, extraction methods, and various in vitro studies. These studies allow anticipation of potential abuse routes and the effects stemming from misuse of the medication.

 

On the other hand, post-commercialization studies provide specific information on abuse cases and evaluate the effects of anti-abuse strategies implemented in such cases. They also supply data on the impact of these strategies on abuse outcomes, such as addiction, overdose, and death.

 

Strategies to deter abuse can be incorporated both in drug administration and formulation, adapting to the most prevalent abuse route, whether inhalation, injection, or ingestion.

 

Examples of abuse-deterrent measures in administration include the use of pre-filled syringes with the exact medication dose or subcutaneous implants that can only be manipulated in medical environments. Physical barriers, such as tablets too resistant to be crushed, or chemical barriers, such as gelling agents preventing inhalation, can also be implemented.

 

Strategies can also focus on the drug’s formulation. The most common and easily applicable is to include an aversive agent; aversive agents are substances that cause a displeasing reaction in the user, such as pronounced itching or bitterness, or induction of vomiting. These sensations or reactions occur when the user employs the medication in a manner contrary to the doctor’s instructions. While this methodology does not prevent abuse, it makes the user’s experience less pleasant.

 

Another way to implement an ADF is to include an antagonistic agent in the formulation. Agonists are substances that can bind to different cellular receptors, producing physiological responses the body needs. Antagonists, on the other hand, inhibit receptor activation, blocking the agonist’s action.

Commonly abused or misused transdermal patches include those containing opioids such as fentanyl, morphine, and buprenorphine. However, anti-nausea patches, hormonal patches, antidepressants, and patches for symptoms of diseases like Parkinson’s or Alzheimer’s are also susceptible to abuse. Common abuse methods include applying multiple patches simultaneously, injection, inhalation, and transmucosal/oral routes.

 

Currently, there are no transdermal patch products on the market that incorporate strategies to deter abuse. However, the importance of exploring future developments that include these measures is recognized, considering the benefits these systems offer to the population, such as easy and convenient application.

 

These strategies focus on integrating an aversive agent into a location within the patch, preventing the transdermal delivery of the aversive agent but activating it if another route is used (intravenous, oral, etc.). This way, a quickly acting aversive effect can discourage continued abuse.

 

In addition to incorporating an aversive agent, there is the possibility of designing transdermal patches that integrate an agonist/antagonist pair. In this configuration, if the instructions are followed correctly, only the agonist will be activated transdermally. In situations of misuse, such as extraction in alcohol, the presence of the antagonist will nullify the agonist’s action, rendering the drug useless. It is crucial to highlight that in this design, it is ensured that the antagonist is not released antagonistically, ensuring the effectiveness of the anti-abuse approach.

 

Regarding product labeling, when there is data available that can significantly reduce the risk of abuse, such as potential side effects, it is advisable to include this information on the drug label. This would encompass in vitro, pharmacokinetic, or potential clinical abuse study results that contribute to highlighting the product’s effects when used through different administration routes or under diverse conditions.

 

Conclusion:

In response to the growing issue of drug abuse, especially in transdermal patches, strategies known as ADF have been implemented to deter these practices. From the pre-commercialization phase to drug formulation, measures have been proposed ranging from labeling to the inclusion of aversive agents and the design of agonist/antagonist pairs in patches to prevent the risks associated with abuse. Although there are currently no patches on the market with these strategies, various companies are working on their development, seeking to offer safer and more practical options for medication and substance administration.

 

 

References:

– Center for Drug Evaluation and Research, 05/06/2020. Transdermal and Topical Delivery Systems – Product Development and Quality Considerations | FDA

-J Multidiscip Healthc. 11/07/2018. An overview of abuse-deterrent opioids and recommendations for practical patient care – PMC (nih.gov)

– J Med Toxicol. 12/2012.

Tammi Schaeffer. Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics – PubMed (nih.gov)

– Abuse-Deterrent Opioids-Evaluation and Labeling | FDA

– https://www.who.int/es/news-room/fact-sheets/detail/opioid-overdose

– Abuse-deterrent formulations: transitioning the pharmaceutical market to improve public health and safety – PMC (nih.gov)

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How do we control the quality of transdermal patches? https://amarintech.com/how-do-we-control-the-quality-of-transdermal-patches/ Thu, 07 Sep 2023 17:19:49 +0000 https://amarintech.com/?p=9587 Transdermal patches present certain attributes that make the efficacy, safety, and quality of the product and must be controlled in the laboratory through analytical techniques to ensure the performance and safety of the transdermal delivery system (or TDS). Some of them correspond to tests that are common to other pharmaceutical forms. However, due to the particular characteristics of transdermal patches, there are specific procedures that apply to TDSs and that are described in internationally recognized regulations and pharmacopoeias.

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How do we control the quality of transdermal patches?

Florencia Cafisi– Chief Analytical Development

Transdermal patches present certain attributes that make the efficacy, safety, and quality of the product and must be controlled in the laboratory through analytical techniques to ensure the performance and safety of the transdermal delivery system (or TDS). Some of them correspond to tests that are common to other pharmaceutical forms. However, due to the particular characteristics of transdermal patches, there are specific procedures that apply to TDSs and that are described in internationally recognized regulations and pharmacopoeias.

Regulatory framework

Due to the increasing use of transdermal patches for the treatment of certain pathologies and the advantages that this route of administration represents in terms of patient compliance with the treatment and the absence of characteristic side effects, for example, of oral forms; Pharmacopoeias and international regulations have shown interest in defining those critical attributes that should be considered for quality control of transdermal patches.

USP has got  an exclusive section for the Control of Topical and Transdermal Products (<3> USP), in addition to encompassing some monographs such as Rotigotine, Clonidine, Estradiol and Nicotine transdermal patches. Patches are also referred to in the General Notes 07. Dosage Forms of the European Pharmacopoeia.

Besides, there are FDA and EMA guidelines and, in the region, ANVISA guide No. 20/2019, which also include to the development of these pharmaceutical forms and define considerations to be taken into account for registration of these products.

Amarin Technologies specializes in the development and production of matrix-type transdermal drug-in-adhesive delivery systems (drug dissolved in the adhesive matric) and has got Development and Quality Control Laboratories with specific equipment and personnel qualified and trained for this type of analysis.

 

Universal Tests 

The ICH Q6A guide defines the general guidelines for the Specifications of New Drugs and Products, including the following general quality attributes (which apply to all dosage forms):

  • Description: the appearance of the patch must be qualitatively described, listing the different components (adhesive matrix, release liner, backing film, overlay, separating foil), evaluating the behavior of the patch when removed from the pouch, detachment of the release liner, characteristics of the printing on the backing film, its shape, color and opalescence of matrix,  
  • Identification: the active principle(s) must be unequivocally identified by means of specific and easily implemented methods, using reference standards for comparative purposes.
  • Assay: to quantify the active principle content in the patches, the drug must be extracted from the matrix and dissolved in an appropriate solvent and then quantified using separation techniques (chromatographic, spectrophotometric, etc.), avoiding the interference of matrix components, degradation products, reagents, etc.
  • Impurities: Same as other pharmaceutical forms, the purity and safety of the patch must be ensured, testing those impurities that may be generated in the manufacturing process or throughout the useful life of the patch. In addition to organic impurities considered related substances of the active principle, risk assessment tools must be applied during the development stage to define, if applicable, the control strategy for monomers, residual solvents, elemental impurities, leachables, nitrosamines, etc.

 

Specific tests for transdermal patch

  • Uniformity of Dosage Unit: Each patch represents a unit dose and, as with other dosage forms, lot homogeneity must be ensured by assaying each patch individually and evaluating process variability and how close the content is to the label claim of the product (<905> USP or 2.9.40. EP).
  • Microbiological control: Transdermal patches are non-sterile dosage forms; therefore, they require analysis of microorganism counts (<61> USP or 2.6.12 EP) and investigation of certain pathogens (<62> USP or 2.6.13 EP).
  • Content of functional excipients: there may be some functional excipients within the formulation whose content must be controlled, such as permeation enhancers or antioxidants that prevent chemical degradation of the drug. This test depends on the composition of the formulation.
  • Crystals: when the active ingredient is dissolved in the adhesive matrix, it is necessary to ensure the absence of crystal formation since, in addition to jeopardizing the appearance of the patch, it reduces the amount of drug dissolved in the matrix available to be released and absorbed through the skin.
  • Dissolution: the in vitro release of the drug must be controlled to ensure the quality of the product. In transdermal patches, where the skin plays an important role in the absorption of the active ingredient, this test does not necessarily correlate with in vivo release, but it is used as a development tool and is also important to ensure batch homogeneity. The pharmacopoeias describe devices specially designed for the control of transdermal patches (<724> USP or 2.9.4. EP).
  • Average weight and dimensions: the control of matrix yield and patch dimensions assures the drug’s dose and is a simple control that is carried out in the laboratory.
  • Hermeticity: Allows to guarantee the integrity of the container during manufacturing and throughout the useful life of the product.
  • Adhesive Properties: Transdermal patches are formulated with an adhesive layer to ensure intimate contact with the skin and allow delivery of the desired drug dose. TDS adhesives should show easy removal of the release liner before use, adhere adequately to human skin after application, maintain adhesion to the skin for the prescribed period of use, and allow easy removal of the TDS at the end of the application use without leaving residue. or causing skin damage or other undesirable effect(s). The determination of in vitro adhesive properties (adhesive force, peel force, cohesiveness, tack, cold flow, all of them, described in <3> USP) is a quality control test that helps to evaluate lot-to-lot reproducibility and adhesive behavior in a substrate under standardized operating conditions.

 

The role of the Laboratories

The correct definition  of the critical quality attributes (CQAS) of the transdermal patches makes it possible to set an appropriate control strategy to guarantee the efficacy and safety of this pharmaceutical form. Amarin Technologies Laboratories have the resources and experience to design and carry on these controls effectively and in compliance with Good Manufacturing Practices.

 

 

References:

FDA Transdermal and Topical Delivery Systems – Product Development and Quality Considerations Guidance for Industry DRAFT GUIDANCE November 2019 Pharmaceutical Quality/CMC

EMA Guideline on quality of transdermal patches 23 October 2014 EMA/CHMP/QWP/608924/2014 Committee for Medicinal Products for Human Use (CHMP)

–  Guia n. 20 Guia sobre Requisitos de Qualidade para o Registro de Produtos Tópicos e Transdérmicos. Guia nº 20/2019 – versão 2 

– USP/NF 2023 y European Pharmacopeia 11.3.

ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, October 1999

Q8(R2) Pharmaceutical Development, August 2009

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The Importance of Supply Chain Management in the Pharmaceutical Industry https://amarintech.com/the-importance-of-supply-chain-management-in-the-pharmaceutical-industry/ Mon, 07 Aug 2023 13:46:49 +0000 https://amarintech.com/?p=9564 In the pharmaceutical business, supply chain management plays a fundamental role in delivering the necessary raw materials for the production of safe pharmaceutical forms intended for patients and end consumers. It also involves the precise and timely coordination of finished products not only for the domestic market but also for the export market.

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The Importance of Supply Chain Management in the Pharmaceutical Industry

Lucas Braga Genovese – Supply Chain Chief

In the pharmaceutical business, supply chain management plays a fundamental role in delivering the necessary raw materials for the production of safe pharmaceutical forms intended for patients and end consumers. It also involves the precise and timely coordination of finished products not only for the domestic market but also for the export market.

Security and Traceability in the Supply Chain:

Adhering to different regulations from national and international organizations, security is a primary concern in the pharmaceutical supply chain. Pharmaceutical products must be stored, transported, and handled safely to ensure they are not compromised in terms of quality, efficacy, and purity. Traceability is essential in the pharmaceutical supply chain to track the origin, location, and history of products at each stage. The ability to trace and document the flow of pharmaceutical products helps to ensure authenticity, identify potential issues, and facilitate corrective actions in the event of product recalls. For instance, the use of dataloggers, electronic devices that record data over time or in relation to location through internal or external instruments and sensors, is a concise example, both for purchasing raw materials and dispatching finished products.

 

Coordination and Communication in the Pharmaceutical Supply Chain:

Effective coordination and fluid communication among the different actors in the supply chain are critical aspects to ensure optimal and efficient operations. In the highly competitive environment of the pharmaceutical industry, where speed and accuracy are crucial, a well-coordinated supply chain can make the difference between a company’s success and failure.

To achieve proper coordination, it is essential to establish clear and efficient communication channels between raw material suppliers, manufacturers, distributors, pharmacies, or points of sale. This allows for real-time sharing of relevant information, such as inventory availability, market demand, changes in regulations, and any event that could affect product flow.

Furthermore, effective coordination involves careful synchronization of processes and activities at each stage of the supply chain. From raw material procurement to the delivery of the final product to the customer, each step must be perfectly aligned to avoid unnecessary delays and minimize associated costs.

Technology plays a fundamental role in facilitating coordination and communication in the pharmaceutical supply chain. Inventory management systems and product tracking technologies enable constant and precise monitoring of the location and status of medications throughout the entire chain. Additionally, electronic data interchange (EDI) streamlines administrative processes and reduces the likelihood of errors in information transmission.

An important aspect of coordination is the ability to adapt to unforeseen situations. The pharmaceutical industry may face unexpected challenges, such as raw material shortages, fluctuations in demand, or disruptions in transportation. An agile and well-coordinated supply chain enables a rapid and effective response to these events, minimizing their impact on pharmaceutical product availability and distribution.

Coordination and communication in the pharmaceutical supply chain are fundamental pillars to achieve efficient and successful operation. Through the implementation of sound practices and the proper use of advanced technologies, pharmaceutical companies can improve their responsiveness, optimize costs and, most importantly, ensure that medicines reach the patients who need them safely and in a timely manner. A well-coordinated supply chain is a competitive advantage that allows companies to position themselves as market leaders and significantly contribute to improving public health.

 

Regulations and Compliance in the Pharmaceutical Industry in Argentina:

In Argentina, the pharmaceutical industry is subject to rigorous regulation by the National Administration of Drugs, Foods, and Medical Devices (ANMAT). This entity plays a crucial role in authorizing and supervising medications, ensuring strict compliance with standards for quality, safety, and efficacy. Strict adherence to these regulations is vital in all stages of the supply chain.

ANMAT’s role as a regulatory body not only guarantees the safety and quality of medications reaching patients but also strengthens the confidence of healthcare professionals and the general public. Transparency and effective compliance with these norms are essential pillars for the success and reputation of any pharmaceutical company in the Argentine market.

The process of authorization and approval of medications by ANMAT is a comprehensive one, involving meticulous evaluation of clinical trials and scientific data to ensure product safety and efficacy. Moreover, ANMAT conducts periodic inspections and verifies compliance with Good Manufacturing Practices (GMP) at the facilities of manufacturers and distributors, ensuring a consistent standard of quality throughout the supply chain.

Compliance with regulations established by ANMAT extends to all stakeholders in the supply chain, including manufacturers, distributors, and pharmacies. Traceability and accurate documentation are crucial aspects in ensuring the authenticity and safety of medications at each stage of the process.

Additionally, commitment to regulatory compliance is also crucial when it comes to exporting products. Pharmaceutical companies aiming to enter international markets must comply with the specific regulations of each destination country, requiring additional effort in terms of supply chain management and adherence to the specific standards of the regulatory agency of the target country.

 

Logistical Challenges in the Distribution of Pharmaceutical Products in Argentina:

A significant point to consider is understanding the peculiarities and complexities when conducting imports in Argentina, as the government exercises strict control over purchases, directly impacting currency turnover and thus limiting/regulating this matter due to external factors such as lack of immediate liquidity from the banking system. In Argentina, there is a wholesale distribution system in the pharmaceutical supply chain. Manufacturers sell their products to wholesale distributors, who, in turn, supply pharmacies and other points of sale. These distributors play a key role in the distribution and logistics of pharmaceutical products at the national level. Given the vast geographic expanse of Argentina, the distribution of pharmaceutical products can face significant logistical challenges. Efficient transport and delivery of medications to different regions of the country can be particularly challenging, especially in rural or remote areas.

 

Conclusion:

Efficient supply chain management plays a fundamental role in the pharmaceutical industry, and its importance cannot be underestimated. A well-managed supply chain ensures that medications and pharmaceutical products reach patients in a timely and safe manner, ensuring product availability, cost reduction, and regulatory compliance. By acting efficiently on these factors, customer satisfaction can be significantly improved.

In conclusion, investing in supply chain management is essential for the success of pharmaceutical companies. Effective supply chain management not only guarantees product availability and cost reduction but also ensures the quality, safety, and efficacy of medications, which are crucial for patient confidence and public health protection. Therefore, it is crucial for pharmaceutical companies to recognize the strategic importance of investing in supply chain management and allocate the necessary resources to implement efficient practices and comply with quality and safety standards. Only through a solid and focused supply chain management can success, competitiveness, and a positive impact on public health be achieved.

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Quality by Design (QbD) – Quality as mainstay for the development of a medicated plaster. https://amarintech.com/quality-by-designqbd-quality-as-mainstay-for-the-development-of-a-medicated-plaster/ Thu, 08 Jun 2023 12:39:07 +0000 https://amarintech.com/?p=9494 The use of Quality by Design (QbD) concept to medicated plasters (patches) development gives us the certainty to obtain safety and reliable products for patients with verifiable efficacy, long before they enter their production stage.

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Quality by Design (QbD) - Quality as mainstay for the development of a medicated plaster.

José Maria Altinier – Galenic Development Supervisor

The use of Quality by Design (QbD) concept to medicated plasters (patches) development gives us the certainty to obtain safety and reliable products for patients with verifiable efficacy, long before they enter their production stage.

When medicated plaster development is considered, we normally focus on the clinical or pharmacological advantages that this pharmaceutical form has over others, such as providing a sustained release of the drug substance for several days, helping the patient to comply prolonged treatments or avoid the effect of first-pass hepatic metabolism, suffered by orally administered drugs. But we could ask ourselves, what place do we assign to quality in the development of these products.

Let’s talk about history. Quality management concept appears in pharmaceutical production from 1980s, with the first publications of a Good Manufacturing Practice (GMP) guidance, firstly in the United States and later in Europe. The objective in this first stage was to ensure that the products were manufactured in such a way that they meet the specifications and requirements for their use, also known as Quality Target Product Profile (QTTP), using the manufacturing steps monitoring and manufactured product attributes analysis as tools.

Already in the 1990s, the International Conference on Harmonization (ICH) was born as a result of the need to define common rules between good manufacturing practices developed by different countries. This institution was in charge of publishing the so-called ICH Guidelines, which focused on the different aspects of quality management. Three of these guides refer to good practices for the development of new products (ICH 8, 9 and 10), generating the term Quality by Design. The concept of Designing with quality refers to the fact that it is no longer enough for us to taking into control the manufacture of the products, avoiding errors occurrence that harm the product itself or the patients safety, it becomes necessary that the development focus on reducing the possibility of such errors emergence, studying and defining the attributes of the materials used, as well as the manufacturing parameters as starting points and using the analysis of the risks involved in each case as a fundamental tool.

Finally, at the beginning of the 2000s, this development strategy began to be considered and required by regulatory entities for the registration of new products, with the United States Food and Drug Administration (FDA) as a pioneer.

But, what do we mean by attributes and parameters, and most importantly, how can we analyze the risks in a product that does not yet exist and whose development we have just considered?

Before answering this question, let’s talk a little about Risk Analysis. These analyzes are normally carried out by experts in the different development aspects, who seek to identify and evaluate the factors that could have a negative effect on our product, both in its composition and in the processes to which it is subjected during its manufacture. Once identified and evaluated, actions can be taken to control, mitigate or eliminate them, in the best case.

Going back to our question, an experienced pharmaceutical developer can define a set of raw materials that could be used in the development of a new product, based on developer’s previous experience and availability of raw materials on the market. These materials would be composed of a drug substance, responsible for the therapeutic action and a set of excipients which would accompany the drug substance in the formula. Both drug substance and excipients have physical and chemical characteristics that we call attributes, which can have an impact on the product properties or on the way in which it is processed. Those attributes that produce a significant impact on the product must be identified and studied to define an acceptable value or range of variation for it, called specification. Once the specification is defined, only raw materials that comply with it may be used in manufacturing, mitigating the risk of a negative impact on the product properties or on the way in which it is manufactured.

The same concept is applied to the manufacturing process development. The speed, time, temperature, or any other variable that can be modified during the process, we call them parameters and like the attributes, parameters that can have a significant impact on the properties of the product will be identified and studied to define a value or acceptable range of variation, thus reducing the risk of a negative impact on the properties of the product.

With the definition of process parameters and raw materials attributes, we can generate what we call a design space, which is nothing more than a safe variation margin that guarantees that the product meets the requirements for which it was designed, providing to the patient, quality and safety.

In this way, through the risk analysis and the definition of a design space, we can generate a product that meets the requirements for which it was designed even before it enters in the commercial manufacturing stage, providing quality from its design.

Currently, this development concept for new products has become a working standard for the world industry and is applied by the most recognized pharmaceutical companies.

Developing medicinal patches under this work concept guarantees us to be able to provide patients with safety and reliable products with verifiable efficacy throughout their useful life.

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