Aptar Pharma and Nose-to-Brain Drug Delivery Excellence
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Aptar Pharma offers decades of experience in providing customers with technology and scientific service solutions to todays’ nasal drug delivery challenges. With specialized nasal drug delivery systems and analytical testing capabilities, Aptar Pharma is well positioned to help advance the latest innovations in orally inhaled and nasal drug products (OINDPs), including Nose-to-Brain technology.
Development of Nose-to-Brain drug delivery has been a focus area for Aptar Pharma as it provides a unique non-invasive pathway to delivering drug products directly through nasal cavity to the brain. Otherwise known as olfactory targeting, this process sends drug product to the roof of the nasal cavity where the critical olfactory nerve is located, providing absorptive access to the central nervous system (CNS) while bypassing the blood brain barrier (BBB). The trigeminal nerve in the turbinate region of the nasal cavity may also lead to direct brain transport. Aptar Pharma has invested in research to demonstrate drug delivery via the Nose-to-Brain pathway using their nasal delivery systems. This data has confirmed that targeted Nose-to-Brain drug delivery is possible using their optimized nasal drug delivery technologies.
Nose-to-Brain delivery is looking to target drug delivery to the turbinate and olfactory region of the nasal cavity. The olfactory region found in the roof of the nasal cavity is lined with olfactory epithelium that contains the olfactory nerve. When drug product is targeted to reach this nerve, it can provide a pathway to the central nervous system (CNS), bypassing the blood brain barrier (BBB).
Aptar Pharma has decades of experience in the development of nasal drug delivery systems and targeting delivery to specific areas of the nasal cavity. In support of their liquid and powder nasal spray technologies, Aptar Pharma’s specialist scientists provide advanced analytical testing and development services to build robust data-supported products for customers. Our cGMP analytical laboratories are staffed by dedicated scientists with specialized knowledge and experience in developing new OINDPs, including those with Nose-to-Brain drug delivery requirements. We offer unique approaches to development that include our Nasal Cast 3D in-vitro modelling, as well as in-silico PBPK modelling to arrive at optimized nasal products faster. Aptar Pharma also provides comprehensive nasal product repositioning and reformulation services that can make existing products more appealing to today’s customer. Aptar Pharma is well positioned to advance the next Nose-to-Brain product to market with data driven support.
Aptar Pharma provides strategic formulation development in tandem with the selection of the drug delivery system. By combining our unrivalled knowledge of our nasal system portfolio with specialized scientific knowledge, we’ve been able to advance numerous nasal products into the clinic and to market. Our goal is always to get your Nose-to-Brain product’s proof of concept (POC) into early clinical studies as quickly as possible. We have the skills and experience to optimize formulations for our delivery systems that will target your desired area of the olfactory region. Our experience and skills extend to supporting the sometimes-complex filing requirements of Nose-to-Brain products. Aptar Pharma also generates the required data sets in filing ready formats making it easy to include in your time-sensitive submissions. Manufacturing nasal product for early clinical studies can be a time-consuming process, but Aptar Pharma has established a network of qualified CDMOs that can fill your clinical trial materials (CTMs) at virtually any scale. We make early phase development of Nose-to-Brain products easier for our customers.
Aptar Pharma has built a global network of manufacturing and laboratory sites to support the needs of clients located around the globe. With specialized laboratories located in North America and Europe and manufacturing facilities on multiple continents, Aptar Pharma has the reach to support Nose-to-Brain projects at virtually any stage of development through to commercial drug delivery system supply. We are well versed in the requirements of the world’s leading regulatory bodies and can support clients in most markets around the world for both supply and services.
Learn more about NanopharmAptar Pharma has a proven track record of success in the area of nasal drug delivery with multiple market references using our nasal drug delivery systems. With a portfolio of single use platforms, including unidose liquid, unidose powder and bidose liquid nasal spray systems, Aptar Pharma has been able to support a number of commercial approvals with customers. Examples include Zomig®, Imitrex™, Valtoco®, Narcan®, and Spravato™ to name a few. One great example of how Aptar Pharma supports customers through development to commercialization is Upsher-Smith’s Tosymra™ (sumatriptan) 10 mg nasal spray for a migraine indication. The formulation required the use of a proprietary excipient to achieve blood levels similar to the 4mg subcutaneous injection. As a combination product submission, Aptar Pharma was able to provide the customer with optimized drug delivery systems, stage-specific development services, analytical testing and regulatory advice to support their successful filing requirements. More recently, Aptar Pharma participated in early preclinical and clinical research that assessed the viability of intranasal insulin. Insulin cannot normally cross the blood brain barrier, so the research concept was to deliver the drug to the brain and neuronal insulin receptors instead via injection. Aptar Pharma continues to support leading edge research for the development of new Nose-to-Brain products with customers.
Avoid the blood brain barrier (BBB)
The Nose-to-Brain pathway avoids transport issues across the BBB to reach the Central Nervous System (CNS) and can have higher bioavailability resulting in lower dosing requirements.
Olfactory nerve delivery
Reduces systemic side effects with targeted delivery to the selected nasal cavity region.
Fast acting region
Nasal cavity tissues offer high permeability and a rich supply of blood enabling rapid drug absorption for faster symptom relief.
Enhancing patient compliance
Avoids pain and fear of traditional needle injection delivery, enhancing patient compliance levels.
Delivering a precise amount of drug to a targeted region of the nasal cavity can be complex, requiring specialized knowledge. Our scientists start with a nasal drug delivery system that can accurately dispense a liquid spray or powder, emitting optimized droplet or particles, sized to reach the targeted region without significant deposition to other regions of the nasal cavity. They must also assess formulation and particle size parameters as well as the potential inclusion of permeation enhancers to achieve reliable Nose-to-Brain drug delivery. Most of the nasal cavity does not provide direct access to the central nervous system (CNS) so the product must be highly targeted in order to achieve reliable drug delivery for these purposes. Designing a robust Nose-to-Brain product can also provide regulatory approval advantages as well as cost savings.
By developing new products that use the Nose-to-Brain pathway, pharmaceutical companies can enjoy a wide range of benefits. This pathway can reduce the number of steps required in clinical trials, shorten timelines and minimize development costs. Pharmaceutical companies can also potentially extend the patent life of the nasal product, all while increasing consumer demand. For consumers, a non-invasive nasal spray or nasal powder format brings portability, convenience and potentially more effective treatment approaches with rapid onset of action. Working with Aptar Pharma on developing your next Nose-to-Brain product means you are partnering with one of the most experienced specialists in the field, with capabilities to accelerate the process from early scale clinical development to commercialization.
Aptar Pharma continues to focus on OINDP development and is advancing Nose-to-Brain drug delivery technology through proprietary research and expanded service offerings. The benefits of Nose-to-Brain drug delivery are clear for patients and pharmaceutical companies alike. With a range of new drugs and indications becoming viable options for this important delivery route, Aptar Pharma is positioned as a leader in the Nose-to-Brain drug delivery field.