Shaping the future of pharma
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There is a conventional way to think about Oral Films: as a formulation alternative to tablets. Easier to swallow, faster to dissolve, better adherence in certain patient populations. Useful, but secondary to the molecule. A recently announced licensing agreement in the Oral Films space challenges that framing. The deal combines [...]
The regulatory landscape of pharmaceutical development continues to evolve, and recent updates from the US Food and Drug Administration (FDA) highlight how companies will need to adapt their documentation and quality strategies in the coming years. The FDA has released a draft revision of the Common Technical Document (CTD) Quality [...]
New tools for more precise drug delivery systems Kimbelery Pardo – Marketing and Business Development Analyst The pharmaceutical industry is undergoing a period of profound transformation driven by the convergence of materials science, biology, and technology. In this context, smart biomaterials and nanotechnology are emerging as key tools for the [...]
Dermocosmetic patches are an effective and versatile alternative in aesthetics, with better absorption and visible effects on the skin. [...]
Effective sweat management is crucial for the success of medicinal patches, as it impacts both their adhesion and patient safety. Sweat accumulation at the patch-skin interface can compromise therapeutic efficacy by causing the patch to detach prematurely, preventing the release of the required drug dose. Additionally, prolonged moisture can lead [...]
Interchangeability guidances for transdermal systems need harmonization, as the next challenge to add uniformity and scientifical sense to the regulatory process. There are key differences among current guidances for interchangeability of transdermal systems, which could mean that a same clinical study is approved in one region and rejected in another one. [...]
In the pharmaceutical industry, computerized systems impacting GxP environments must adhere to strict regulations to ensure product quality and patient safety. A documented inventory is essential for controlling these systems, identifying their GxP impact, and assessing their associated risk levels. This inventory supports regulatory compliance, facilitates audits, and enables strategic [...]
The transportation of psychotropics within the pharmaceutical industry is a complex and highly regulated process due to their potential for abuse and impact on health. These medications require specialized handling and compliance with international and local regulations, including permits and comprehensive tracking of product movement. Key challenges include regulatory compliance, [...]
Since the Modern Age, creative individuals and entrepreneurs have sought to protect their inventions through patents, gaining legal advantages to capitalize on their ideas. Obtaining a patent grants exclusive rights, competitive advantages, and the possibility of generating income. However, it also presents challenges such as high costs, restrictions on access [...]
Discover the critical role of the microbiome in neurodegenerative diseases and the challenges facing current research. This blog explores the significance of the gut-brain connection, the bidirectional operation of the Central Nervous System-Gut-Microbiota axis, and the implications for conditions like Parkinson's and Alzheimer's. Despite emerging concerns about research validity, there [...]