OINDP Reformulation & Repositioning
Nanopharm has built extensive in-house expertise in reformulating and repositioning drug products for nasal drug delivery. With innovative core expertise in reformulation work, and unique modeling and analysis techniques we have developed a deep understanding of the many variables that can impact a nasal drug delivery product’s performance, stability, and compliance. From solubility studies to permeation enhancers and the use of in-vitro in-silico modeling and simulations, Nanopharm provides its customers with the comprehensive reformulation and repositioning capabilities needed to advance nasal products. Nanopharm fully supports these development programs with regulatory support as well as consultation regarding device selection from a range of suitable nasal drug delivery technologies.
Nanopharm OINDP Reformulation & Repositioning Expertise
Reformulating or repositioning conventional oral or injectable drug products requires specialized expertise and knowledge. It can result in nasal spray or nasal powder products that bring many benefits to marketers, Health Care Professionals (HCPs) and patients alike. From market differentiation to customer convenience, repositioned products can help extend the lifecycle of established products. The benefits also extend to patients by offering ease of use, portability, and a non-invasive drug delivery option. Reformulation of OINDPs can be a viable solution for a range of molecule types and many different therapeutic indications.
Nasal spray and nasal powder reformulations can provide faster onset of action, lower dosing, and reduced side effect profiles compared to some oral dosage forms, all in a portable, convenient, and non-invasive drug delivery format. This is particularly beneficial for biologics, which typically have low oral bioavailability.
The reformulation of injectables to nasal drug delivery avoids the need to administer the product in a medical setting by an HCP. It can also reduce possible side effects and avoids needle stick injuries. Repositioned nasal products are often designed to deliver the drug systemically and target the Central Nervous System (CNS).
Nanopharm’s expertise in nasal drug repositioning programs can solve the inherent challenges associated with the low administration volumes of nasal sprays, including solubility and stability. Permeation enhancers can be included in reformulations to accelerate absorption through the nasal cavity into the bloodstream, and mucoadhesives can help with longer retention times.
Reformulation to nasal drug delivery can offer innovative options for a number of applications including life cycle management possibilities, emergency use, controlled drugs and vaccines for a wide range of therapeutic categories.
OINDP Drug Reformulation & Repositioning Advantages Over Oral Dose
Repositioning oral dosage forms to nasal drug delivery products can bring numerous advantages. Nasal sprays or nasal powders can provide faster onset of action than oral dosage forms as they avoid the gastrointestinal system, and the drug is absorbed directly through the nasal mucosa into the bloodstream. This can be particularly important for biologics as they typically have low oral bioavailability. Oral products can require high doses of the API in order to account for first pass metabolism effects which can lead to side effects. Smaller API doses can be delivered via nasal spray applications; however they have dosing limits based on the spray volume. Nasal spray or nasal powder products are also easy to administer and don’t require swallowing or water to swallow pills.
OINDP Drug Reformulation & Repositioning Advantages Over Sterile Injectables
Repositioning injectable products to nasal drug delivery options can offer advantages over intravenous (IV) and intramuscular (IM) parenteral formulations. Injectables are often administered in a medical setting by an HCP. Repositioned nasal spray or nasal powder products can in most cases be self-administered by a patient, virtually anywhere with a convenient non-invasive nasal drug delivery system. Nasal drug delivery products can also be specifically designed for systemic drug administration and target the Central Nervous System (CNS). Nasal drug formulations may offer reduced side effect profiles compared to IV formulations with a potentially lower concentration of the drug in formulation. This is possible because you can directly target the local site of action. Nasal drug delivery also avoids patient fear of needle pain and the risk of needle stick injuries. Nasal powder systems are particularly effective in providing extended shelf life while avoiding costly cold chain requirements or complicated reconstitution procedures.
Formulation requirements for nasal drug delivery, either as a spray or a powder, offer many advantages over oral and injectable drug delivery. Nasal sprays administer a much lower volume of liquid or powder formulation than an injectable product would require. Therefore, nasal sprays require more advanced formulation expertise with the knowledge required to solubilize and stabilize a higher concentration of drug in the formulation. Nanopharm offers specialized reformulation expertise to address the associated solubility, stability and flow characteristics that are so important for repositioned nasal drug delivery products. Nasal drug delivery products sometimes require the addition of permeation enhancers to improve drug absorption through the nasal mucosa and into the bloodstream. They can also contribute to rapid onset of action. Mucoadhesives can be introduced to increase drug retention time in the nasal cavity allowing for the desired level of absorption to occur. Nanopharm’s nasal drug delivery experts can design the optimal formulation for the right nasal drug delivery system to deliver optimal performance. Our repositioning development programs consider a wide range of complex parameters that are important specifically to the nasal delivery route. Nanopharm uses sophisticated characterization and modeling techniques to help our scientists rapidly understand the critical properties of formulations that can impact the rate of absorption, drug deposition and plume geometries. We offer complete nasal drug repositioning services that bring reformulations of injectable and oral drug products to market.
Nasal Reformulation & Repositioning Applications
Nanopharm’s drug repositioning and reformulation services can bring benefits for a wide range of applications. These include emergency use applications, controlled drugs, and intranasal vaccines. Nasal spray products can offer timely administration with ease of use, control access to potent or controlled drugs for safety and provide a convenient non-invasive administration route. Nasal drug delivery can be used for a range of therapeutic categories including anaphylaxis, anxiety, arrhythmia, depression, diabetes, pain, controlled drugs, sedation, seizures, and many other CNS applications. Nanopharm also understands the importance of product lifecycle management and the importance of differentiation from competitors in a crowded marketplace. Repositioning existing drugs into nasal drug delivery formats can extend the overall life of a product and support patient preferences for convenient, non-invasive drug delivery. Using the U.S. FDA’s 505(b)(2) regulatory process can shorten a nasal product’s approval time, so it can potentially get to market faster and maintain market exclusivity longer.
