Nasal Drug Repositioning

Nasal Drug
Repositioning

The process of reformulating existing drugs into new dosage forms or for new indications goes by many different names. They include drug repositioning, repurposing, rediscovery, reformulating or even lifecycle management. Whatever you choose to call it, there are lots of good reasons to consider partnering with Aptar Pharma to reformulate your drug product into a nasal delivery device.

Aptar Pharma is a leading global expert in repositioning existing drug products to nasal spray or nasal powder formulations in their proprietary nasal delivery systems. Nasal drug repositioning can bring new life to mature drug products.

Nasal Repositioning of Drug Products
with Aptar Pharma

The benefits can be extensive from both a medical and business perspective.

  • Speed – Repurposing an existing product saves a great deal of time over identifying and developing a novel molecule from scratch. An approved drug that has already been proven safe and effective in humans, even if for a different indication, can reduce the data requirements for some development and clinical activities.
  • 505(b)(2) – For drug repositioning where the disease and intended use are similar to the original approved product, a 505(b)(2) regulatory pathway may be possible. A 505(b)(2) approach allows you to reference published data from a previously approved innovator product. This can save development requirements, clinical costs and shorten the time to market by years with additional exclusivity.
  • Drug Device Combination Product – As nasal spray and nasal powder devices are considered drug-device combination products, they must adhere to U.S. FDA CFR820 and equivalent regulations. Aptar Pharma has the regulatory experts to help guide customers through the nasal drug repositioning process so that they can more efficiently bring the newly repositioned nasal delivery drug to market faster with less regulatory risk.

 

Repositioning Candidates to Nasal Delivery with Aptar Pharma

Emergency and Crisis Nasal Repositioning

Nasal delivery devices can be ideal for repositioning an increasing range of emergency use drugs for indications such as seizures, anaphylaxis, drug overdoses or pain medications. In emergencies, rapid onset and simple non-invasive administration can make all the difference for patients.

Potent, Controlled & Scheduled Drugs

Aptar Pharma’s Unidose and Bidose nasal devices limit the quantity of highly potent or controlled (scheduled) drugs available in the device. This reduces the risk of abuse or accidental exposure.

Vaccines

Non-invasive and more convenient to administer, nasal vaccine delivery can provide reliable and pain-free administration to patients of all ages. Eliminates fear of needle injections and enhances patient compliance.

Lifecycle Management Opportunities

Mature products reaching the end of their patent life or market demand can benefit from a reformulation to a different, more convenient drug delivery method. Nasal drug delivery devices can provide increased product acceptance, higher levels of patient compliance and even extended patent protection in some cases.

Benefits of Drug Repositioning
to Nasal Drug Delivery

  • Nasal Repositioning Benefits for Oral Products – Nasal delivery can provide numerous advantages over traditional oral drug delivery including rapid onset of action, reduced side effect profiles and convenient administration. The nasal delivery pathway completely avoids the time consuming and harsh GI tract that can damage sensitive molecules.
  • Nasal Repositioning Advantages for Parenteral Products – Nasal delivery can provide advantages over parenteral (Injectable or IV) drug delivery. Nasal drug delivery provides rapid systemic or CNS drug delivery targeting via a simple, non-invasive administration as compared to parenteral (Injectable or IV) drug delivery. Nasal drug delivery can also allow for dosing lower concentrations of drug formulation, provide extended shelf life and offer attractive needle-free drug administration.
  • Market Preference for Nasal Delivery – Repositioned nasal formulations can deliver a wide range of drugs reliably and conveniently with Aptar Pharma’s nasal drug delivery systems. Nasal delivery can offer either local or systemic delivery opportunities, in a light, easy-to-carry, convenient and non-invasive format which is appealing to many patients.
  • Marketing Differentiation – Repositioning your product with one of Aptar Pharma’s nasal delivery systems opens up a world of opportunities to differentiate yourself from the competition. Nasal drug delivery provides a convenient format that is popular with patients. Combined with Aptar Pharma’s industry leading nasal drug delivery technologies, available with a variety of labeling and packaging customization options you can start making your product stand out from the crowd.

Emergency and Crisis Drug Nasal Repositioning

Key requirements for delivering emergency or crisis medications includes reliability, rapid onset, simple to use, portability and convenience. Aptar Pharma’s nasal delivery devices meet all of these challenging requirements through advanced device design.

Traditional emergency injectable products can require administration by a trained Health Care Professional (HCP), making treatment less accessible in emergency situations when outside of a medical setting. Complex autoinjector devices are more portable but bring the risk of accidental needle sticks and patient hesitancy from fear of needles into play.

Aptar Pharma’s nasal spray systems avoid these challenges with a simple, convenient to carry, robust nasal spray device that consistently delivers precise dosing. With 360 -degree functionality, Aptar Pharma’s pre-primed nasal devices can be administered from virtually any position, with single hand actuation. No special medical training is required to administer nasal sprays, so now everyone from family, caregivers and even the patient themselves can use them. Emergencies can happen anywhere.

Aptar Pharma’s nasal spray devices are extremely convenient to carry and are helping to revolutionize emergency medication administration. Explore the growing number indications that may be suitable for emergency use nasal delivery repositioning:

  • Anxiety disorders
  • Anaphylaxis (severe allergy – epinephrine)
  • Claustrophobia
  • Depression
  • Diabetes-related hypoglycemia
  • Epileptic seizures
  • Heart Arrhythmia
  • Opioid overdose

Potent, Controlled and Scheduled Drugs

Potent or controlled (scheduled) drugs pose special challenges to being administered outside of a medical setting.

Aptar Pharma’s Unidose and Bidose nasal spray devices contain only the minimum amount of drug formulation needed to dose these potentially life-saving products. This helps reduce the likelihood of abuse of controlled drugs or exposure to potent drugs.

In addition, Aptar Pharma’s Unidose and Bidose systems include tamper evident dose indicators so you always know exactly how many doses you have on hand.

Repositioning Vaccines

With the increasing importance of vaccination today, the market is seeking less invasive, more convenient and effective vaccine administration options. The administration of vaccines by nasal sprays and nasal powders avoids painful needle injections, potentially increasing compliance in patients of all ages.

Aptar Pharma’s nasal delivery spray systems can deliver precise doses of vaccine to the nasal cavity for optimal vaccine effectiveness.

Our Bidose nasal spray device offers two doses for cases where the vaccine requires coverage via both nostrils.  Whether you choose to reformulate an existing injectable vaccine or develop a new vaccine in a nasal delivery device, Aptar Pharma’s experienced technical teams can help you select the ideal device to make your vaccine both unique and effective.

Lifecycle Management Opportunities

Nasal drug delivery repositioning can breathe new life into existing drug products, extending their lifecycle in an improved format. Whether it is rediscovering drugs for new indications or simply repurposing established drugs in a nasal delivery format, nasal drug repositioning may help rejuvenate your molecule.

Reformulating previously approved medicines into nasal formulations can provide both convenience and compliance benefits to patients. Pharmaceutical and biotech companies can leverage new branding and product differentiation opportunities to maintain or gain market share in a competitive marketplace. Repositioned nasal drug products offer rapid onset of action, reliability, and convenience as an alternative delivery route, which can create fresh demand for declining mature products.

Aptar Pharma strategically offers its secure supply of advanced devices with proven analytical, formulation and regulatory support services in order to advance customer nasal repositioning projects at virtually any scale.

Nasal Repositioning Benefits for Oral Products

Nasal drug repositioning provides some distinct advantages over oral dosage forms, such as tablets and capsules, despite being one of the most well-established routes to systemic drug delivery available.

Rapid onset of action – Oral dosage forms offer much slower onset of action than nasal drug delivery as the drug must pass through the gastrointestinal (GI) system to be absorbed. Nasal drug delivery completely avoids this GI absorption and nasal formulations are absorbed directly through the nasal mucosa into the bloodstream.

Reduced side effect profile – When oral drugs pass through the GI system, they tend to suffer from first pass metabolic effects, whereby the concentration of the active pharmaceutical ingredient (API) is greatly reduced before it reaches systemic circulation. This is typically offset by increasing the level of API in the tablet or capsule, which can contribute to an increased side effect profile. Nasal drug delivery can use lower formulation concentrations potentially resulting in lower side effect profiles.

Convenient – Nasal delivery is portable, self-contained and convenient to dose anywhere. Oral delivery via tablet or capsule requires the ability to swallow potentially large solid formulations and may require the availability of water.

Direct Absorption – Nasal administration delivers the drug to the nasal mucosa where the drug can be absorbed directly and immediately into the blood stream, whereas oral formulations pass through the GI system, which can degrade some sensitive and complex APIs, making oral delivery ineffective.

Nasal Repositioning Benefits for Parenteral Products

Nasal drug delivery provides some distinct advantages over parenteral delivery routes. Parenteral drug delivery includes both intravenous (IV) and intramuscular (IM) injections which commonly offer rapid onset of action but must be administered in a medical setting.

Systemic CNS targets – Intranasal and IV formulations offer similar rapid onset of action, but nasal delivery routes use olfactory targeting which bypasses the blood-brain barrier that can otherwise block many small molecules from reaching the bloodstream. This direct absorption means nasal repositioning can create products targeting systemic administration and the central nervous system (CNS). Some therapeutic categories of drugs that may benefit from systemic drug delivery include anaphylaxis, anxiety, arrhythmia, depression, diabetes, pain, potent/controlled drugs, sedation, seizures, and vaccinations.

Simpler Administration – IV parenteral drugs require administration by a trained health care professional (HCP), whereas nasal sprays and nasal powders can be conveniently administered by an untrained family member or caregiver.

Lower Concentration of Drug – Nasal drug delivery can achieve the same drug concentration in blood circulation as IV routes, but with much lower drug product concentrations. The lower concentration of drug in nasal formulations may reduce the side-effect profile for the patient over traditional IV formulations.

Avoids Needle Dangers – Nasal sprays completely avoid the risk of needle sticks and disease (hepatitis) transmission possible with injectable or IV formulations. In addition, nasal delivery avoids patient compliance challenges because of fear of needles or painful injections.

Extended Shelf Life – Nasal powder can be formulated in a stable preservative free format that extends product shelf life and avoids the need for refrigeration or complicated drug reconstitution procedures.

Market Preference for Nasal Drug Delivery

Nasal drug delivery is growing in popularity with patients everywhere. As a convenient and non-invasive drug delivery route, nasal formulations bring many advantages, making them an attractive option for drug repositioning opportunities.

Device portability, safety, comfort, and ease-of-use are some of the key reasons cited by patients for their preference for nasal drug delivery options. The nasal administration of medications can also eliminate the need for costly health care professional administration enabling more patient empowerment. Non-invasive, needle-free nasal spray drug delivery also eliminates the risk of injury from needle sticks or disease transmission (Hepatitis B, HIV).

Marketing Differentiation Through Nasal Repositioning

Want to stand out in crowded market? Repositioning your product as a nasal formulation while the competition continues to sell their conventional oral or injectable drugs can differentiate your brand, improve sales and even create a new market space. With a shortened 505(b)(2) regulatory process, your unique product can get to market fast and maintain market exclusivity for longer.

Nasal drug delivery devices are attractive to end users because they are lightweight, easy to carry, simple to use and non-invasive to administer. Nasal formulations can often provide rapid onset of action so they can achieve symptom relief faster. And then there’s the drug device combination product itself.

Aptar Pharma offers a range of technologically advanced devices designed to meet the needs of many different products. With customized packaging and labeling options, you can take your brand differentiation even further. Repositioning your product with Aptar Pharma, in their advanced nasal drug delivery systems will open a host of differentiation opportunities to virtually any pharmaceutical company.

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