Nasal Drug Delivery Frequently Asked Questions

Are there advantages to nasal spray drug delivery over solid oral dosage forms like tablets or capsules?

Nasal sprays can provide a reduced side effect profile, as nasal sprays can use less Active Pharmaceutical Ingredient (API) to achieve dosing levels because they avoid the gastrointestinal (GI) system (and first pass metabolism effects). Nasal spray delivery can improve bioavailability and sensitive or complex oral formulations can sometimes degrade in the acidic GI system making it impossible to deliver the drug by oral forms. Nasal administered formulations absorb directly into the bloodstream via the nasal mucosa making rapid onset of action possible whereas oral drug delivery must pass through the GI system taking much longer to reach the bloodstream. Nasal drug delivery also provides a convenient, portable non-invasive drug delivery option for patients.

Is a nasal spray painful to use?

Aptar Pharma’s nasal spray systems can be used to deliver formulations via the nasal cavity, whether they are liquid or powder, safely and reliably with single hand actuation. The tip of the nasal spray technology is inserted into the end of the nostril and the actuator is depressed. Nasal sprays are light-weight, convenient and portable drug delivery systems and are non-invasive.

Do nasal sprays require refrigeration?

Refrigeration is a requirement related to the product formulation and not the nasal spray system. Some product formulations are unstable at room temperature and could then require refrigeration to remain stable. Aptar Pharma offers a Unidose powder nasal spray system that delivers dry powder formulations via the nasal delivery route. Because powder formulations do not include any water, they may be more stable for longer periods of time and often may not require refrigeration. Powder nasal spray systems can be alternatives to multi-dose liquid sprays.

Can nasal spray device products be used for emergency treatments reliably?

Nasal spray devices are compact and convenient to carry, so they can be on hand for any emergency situation. Our nasal spray systems can be developed to administer emergency use drugs virtually anywhere, without the need for a trained Healthcare Professional (HCP). Family, friends or caregivers could administer a nasal spray product without any special training.

Can Aptar’s nasal spray systems be used to deliver multiple doses or are they single dose only?

Aptar Pharma’s range of nasal spray systems include Unidose (single dose), Bidose (two doses) and Multi-dose (multiple doses) nasal spray systems. This range of options means there is likely a suitable nasal spray system option for most nasal drug product requirements, no matter how many doses are required.

Can nasal sprays be used for new drug products only?

No. In addition to developing new drugs expressly for nasal drug delivery options, many mature or existing drugs are repositioned from other dosage forms to benefit from nasal spray systems.

Can existing drug products, of a different dosage form, benefit from drug repositioning, repurposing or reformulations to nasal drug delivery formulations?

Yes. Nasal repositioning of an existing approved drug can reduce time to market, as it may require less new development and data to support its regulatory process. Repositioning is well understood regulatory pathway as nearly one third of all new drug approvals are repositioned drug products. Under a U.S. FDA 505(b)(2) filing, you may be able to reference published data from a previously approved similar product which can save you substantial development scope, reduce clinical costs and shorten time to market by years with an additional exclusivity period.

Can nasal drug delivery be used to target delivery of the drug to different parts of the nasal cavity?

Some drug products are designed to target specific regions of the nasal cavity so that the drug product can be absorbed rapidly through the nasal cavity tissue into the bloodstream for systemic applications. Nasal drugs can be designed to absorb and cross the blood brain barrier or absorb into the bloodstream for Central Nervous System (CNS) indications by targeting specific regions of the nasal cavity such as the turbinates. Aptar Pharma is highly experienced in developing formulations for a wide range of applications and can target their delivery with their nasal drug delivery technologies.

What is nose to brain drug delivery?

Olfactory targeting is sometimes more specifically called “Nose to Brain” drug delivery. Via this approach, the drug product is formulated and filled into a suitable nasal spray system that is optimized to deliver the drug formulation to a specific area of the nasal cavity. As the nasal spray contacts the region of nasal cavity tissue, it is quickly absorbed into the bloodstream and can reach the brain. This involves the drug being able to cross the blood-brain barrier with rapid onset of action.  Aptar Pharma makes nasal spray systems capable of targeting the Nose to Brain pathway.

Do nasal sprays offer a feature to protect the formulation from microbiological ingress?

The tip seal technology of the Aptar APF platform is designed to establish a physical barrier from the outside of the orifice in the nasal actuator to the inside of the pump. This barrier protects the inside from microbiological contamination.