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 not a recent invention. More than 3,000 years ago, Chinese and Egyptian cultures were already applying pharmaceutical preparations to the skin for therapeutic purposes. What is recent is the sophistication of the format: today, that same transdermal delivery logic is applied to cosmetic actives with technical precision [...]
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, the validation of computerized systems is a regulatory requirement, not an optional best practice. Every system with an impact on the GxP environment — Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice — must comply with applicable quality standards and be properly documented. Without this, [...]
The transportation of psychotropics within the pharmaceutical supply chain is one of the most regulated and operationally complex logistics processes in the sector. The reasons are well known: these substances act on the central nervous system, carry high diversion and abuse potential, and require storage conditions and traceability standards that [...]
Since the beginning of the Modern Age, inventors and companies have sought to protect their innovations through patents — the legal instrument granting temporary exclusivity over their developments. In the pharmaceutical industry, this mechanism carries particular weight: research cycles are long, regulatory approval costs are high, and the commercial exclusivity [...]
The relationship between the gut microbiome and neurodegenerative diseases is one of the most actively researched fields of the past decade. Accumulated preclinical and clinical evidence suggests the microbiota may play a key role in susceptibility to and progression of conditions such as Parkinson's and Alzheimer's disease. At the same [...]