Bidose (BDS) Liquid Nasal Spray System
Aptar Pharma’s Bidose (BDS) system is a market leader in simple-to-use, reliable two-shot nasal spray delivery devices. Ideal for a range of drug product applications that require precise intranasal dosing to both nostrils or those that require a second dose of product, Aptar Pharma’s patented Bidose nasal spray devices were specifically designed for ease of administration.
The Bidose Nasal Spray System with Proven Performance
Accurate and precise Bidose (BDS) nasal delivery
That’s exactly what our two shot nasal spray pump system is designed to do – deliver two precise liquid nasal spray doses from every pre-primed device.
Lightweight, compact, leak-resistant, and easy to carry as compared to traditional large and complex autoinjector devices.
Ready-to-use with no priming or shaking required. Our Bidose nasal spray device offers 360-degree functionality so the drug product can be administered from virtually any position.
Customers utilizing our Bidose nasal spray device have achieved commercial approval with the U.S. FDA and EMA, with many others in various stages of development.
Intuitive to use
Aptar Pharma’s Bidose nasal spray device requires no special training to administer, avoiding the need for administration by healthcare professionals (HCPs).
Ideal for repositioning existing drugs into new delivery formats or extending the product’s lifecycle. Our Bidose nasal spray device presents opportunities for product differentiation in crowded markets.
Aptar Pharma does more than just manufacture leading drug delivery devices. We also offer fully integrated analytical, development and manufacturing services that can take your idea from formulation to patient.
Wide Range of Applications
Nasal spray drug delivery can be ideal for a range of molecules and indications including local nasal applications (allergies), emergency / crisis / rescue (acute) use, CNS administration and olfactory targeting pathways.
Delivers two accurate metered nasal spray doses
Our Bidose liquid nasal spray system was designed to precisely and consistently deliver the required amount of drug formulation with each device actuation. We develop some of the most reliable and precise Orally Inhaled and Nasal Drug Product (OINDP) devices, for both intranasal and sublingual therapies, that can meet the needs of virtually any nasal delivery application. Aptar Pharma’s Bidose nasal spray system can reliably deliver fully metered doses with reproducible spray performance even for therapies that require high deposition in nasal or buccal cavity target areas. Aptar Pharma’s Bidose nasal spray pumps are also ideal for many drugs requiring administration via the nose-to-brain pathway, which allows therapeutic compounds to quickly enter the central nervous system (CNS) by targeting the upper part of the nasal cavity, or olfactory region. In addition, Aptar Pharma’s Bidose nasal spray systems can be used to deliver high dosage products whose formulation can’t be concentrated enough to fit into a single dose nasal spray device. Each dose from our Bidose nasal spray pump device can deliver up to 100 µL per actuation, with a total of 200 µL of nasal spray available from one Bidose nasal spray device.
Bidose nasal spray convenience
Carrying bulky autoinjectors for emergency use, including a backup, can be a real inconvenience. Aptar Pharma’s Bidose nasal spray device provides a smaller, more lightweight, leak resistant alternative that can deliver precise amounts of lifesaving medication along with a backup dose. Our non-invasive Bidose nasal spray device offers rapid onset delivery for a variety of molecules in a safe and portable format that enhances patient compliance and acceptance.
Flexible 360-degree functionality
Aptar Pharma’s Bidose nasal spray device offers critical 360-degree functionality. Our Bidose device delivers the precise dose every time from virtually any patient position. Always pre-primed, there is no need to shake or prepare the device prior to use. This level of functional flexibility demonstrates that Aptar Pharma’s Bidose liquid nasal spray systems are simple to use. They do not require a health care professional (HCP) to administer yet are reliable enough for emergency or acute use applications where fast and simple administration can be the key to saving lives.
Intuitive and easy to use systems
Aptar Pharma’s Bidose nasal spray systems are so simple and easy to use that patients, caregivers and HCPs can use them with ease and confidence. Our Bidose nasal spray systems are so intuitive, they require no special training to operate, so the drug can be administered whenever the patient needs it most. They are always ready-to-use, with no priming or shaking required, even in the most demanding emergency situations.
Proven with regulators
Our patented Bidose nasal spray system has been reviewed by the U.S. FDA and European regulatory authorities as part of an approval for a commercialized depression product. Our customers also have a host of other new products using our Bidose nasal spray device in various stages of development. These include products for a range of applications such as systemic or central nervous system (CNS) conditions as well as for emergency or lifesaving drugs. With over 100 million Aptar Pharma OINDP devices sold worldwide, thousands of people use our Unidose and Bidose nasal delivery systems every day across a range of therapeutic indications and treatment scenarios. In addition to our numerous customer references, Aptar Pharma’s track record of quality and compliance for nasal spray pumps is unmatched in the pharmaceutical and biotechnology industries.
Drug repositioning opportunities
Aptar Pharma’s Bidose nasal spray device provides a unique opportunity to reposition or repurpose existing drugs from other delivery routes. Whether you call it drug rediscovery, drug reformulation or even lifecycle management, our expertise and experience in adapting existing drug products to the nasal delivery route has helped numerous partners to extend the life of mature products, respond to unmet needs or provide brand differentiation. In some cases, such as with 505(b)2 filings, the drug repositioning process can also benefit from an accelerated regulatory timeline and longer exclusivity. In addition, nasal drug delivery can offer rapid drug absorption into the bloodstream, producing symptom relief sooner. With nasal spray delivery, the drug is delivered via the mucosa, bypassing the need to cross the blood brain barrier (BBB). The nasal delivery route also provides targeted local or systemic drug delivery options which avoid painful needle injections. Our Bidose nasal spray pump can strengthen your lifecycle management and drug reformulation initiatives, helping to bring new life to old drugs.
Aptar Pharma isn’t just a leading manufacturer of nasal spray devices. We can also provide formulation development, analytical services, regulatory support, device selection consulting and partnered manufacturing services that can take your idea from formulation to patient. We know our devices better than anyone so we can help with the device selection process, optimize formulation development for the selected device and leverage our decades of regulatory expertise as you work through the complex regulatory filing process. Our integrated offering means you can accelerate the development and production of your new or existing nasal spray product. We partner with our customers to help derisk their product. Our step-by-step support includes R&D, extractables and leachables tests, regulatory guidance and post launch support. Aptar Pharma takes you from formulation to patient.
Suitable for a Wide Range of Applications
New world of applications
There is an ever-expanding list of molecule types and indications that are potential applications for Aptar Pharma’s Bidose nasal spray system. Most commonly, nasal sprays have been used for local treatment of nasal conditions such as allergies and rhinitis. As the accuracy and reliability of nasal spray devices have improved, the range of possible drug formulations has continued to grow and now includes products for both systemic and Central Nervous System (CNS) applications. Because the nasal mucosa is more vascularized and thinner than the intestinal mucosa, nasal spray drug delivery provides more rapid absorption into the bloodstream than traditional oral dosage forms. Nasal spray drug delivery also bypasses hepatic and intestinal metabolisms encountered via oral delivery, which slows the absorption process in the gastro-intestinal (GI) system. Nasal delivery provides a fast acting and consistent option for drug delivery.
Central Nervous System (CNS) applications
Nasal sprays are an effective means of targeting delivery to the Central Nervous System (CNS) that can provide rapid drug absorption through the nasal mucosa. Compared to some molecules administered via Intra-Venous (IV) methods, nasal spray formulations can sometimes utilize lower drug concentrations because of the higher level of absorption efficiency by nasal delivery, thereby resulting in a reduced side effect profile for the patient. Some possible CNS applications for Aptar Pharma’s Bidose nasal spray system includes:
- Parkinson’s disease
- Brain cancer
- Alzheimer’s disease
Emergency / Acute use applications
Because of their portability and reliability, Aptar Pharma’s Bidose nasal spray device has become increasingly attractive for acute or emergency use applications. These can include formulations with rapid onset properties that current oral formulations cannot provide. Parenteral formulations can, in most cases, require administration by a trained Health Care Professional (HCP), making treatment less accessible in emergency situations outside of a medical setting. Complex autoinjector devices may allow individuals to administer emergency treatments quickly but they bring with them the risk of accidental needle sticks or patient hesitancy from fear of needles. Aptar Pharma’s Bidose nasal spray system avoids these challenges with a simple, convenient to carry, robust nasal spray device that consistently delivers precise dosing every time. With 360-degree functionality, Aptar Pharma’s Bidose nasal spray system can be administered from virtually any patient position, and with single hand actuation. No special medical training is required to administer drug product using our Bidose nasal spray device. Potential emergency use applications that may be suitable for nasal spray delivery include:
- Anxiety disorders
- Anaphylaxis (severe allergy – epinephrine)
- Diabetes-related hypoglycemia
- Epileptic seizures
- Heart Arrhythmia (Paroxysmal super-ventricular tachycardia)
Potent or controlled drug applications
Potent or controlled (scheduled) drugs pose special challenges to administer outside of a healthcare setting. Aptar Pharma’s Bidose nasal spray device contains only the amount of drug product needed to administer these potentially life-saving products. This means there is less excess drug product available to the patient or their entourage, reducing the likelihood of abuse of addictive or highly potent drugs. Aptar Pharma’s Bidose nasal spray system requires no priming and carry two available doses for rapid administration in virtually any position, and in any location. Nasal delivery formulations for:
- Opioid overdose treatment
- Anaphylaxis (severe allergy – epinephrine)
With the increased importance of vaccines, the market is seeking less invasive and more convenient ways to administer them. Their administration by nasal spray formulations avoids painful and invasive injections, potentially increasing vaccine acceptance by patients of all ages. Aptar Pharma’s Bidose nasal spray system can deliver a dose of vaccine to both nostrils, providing comprehensive coverage of the nasal cavity for optimal vaccine effectiveness. A range of vaccines could be formulated for a nasal spray device delivery including:
Bidose (BDS) Liquid Nasal Spray System Advantages
- One-Handed Actuation
- Limits Available Dose
- Proven Microbiological Integrity
- Tamper Evident Features
- Product Differentiation & IP
- Minimize High-Value API Use
Low actuation force allows one-handed administration
Our Bidose nasal spray devices were designed to require low actuation force allowing for one-handed use. Their easy-to-use design means that successful administration is possible by non-medical professionals such as parents, caregivers or even the patients themselves. This also makes our Bidose nasal spray pumps an attractive option for emergency use applications where intuitive and simple administration can make all the difference in saving lives.
Minimize risk of abuse
Aptar Pharma’s Bidose nasal spray systems are appropriate for applications where one or two doses are needed for treatment. The device contains only the amount of drug needed for each of the two doses. Our Bidose nasal spray pumps keep excess drug product away from patients and their entourage, particularly in cases where the drug may be addictive or requires a narrow therapeutic index.
The microbiological integrity of the formulation is protected as the formulation is only mixed at the moment of use.
Know your device is primed and ready
The integrated dose indicator clearly communicates the number of remaining doses to patients and helps HCPs to measure dose compliance. This makes it easy for patients to know how many pre-primed doses their nasal spray device has ready if they need them.
Stand out from the crowd
Our Bidose nasal spray device offers a variety of customization opportunities that can help to make your product stand out in a crowded marketplace. The resulting product differentiation can help support brand recognition and increase patient appeal. The use of Aptar Pharma’s proprietary Bidose nasal spray device, in some cases, can support IP protection of your valuable drug product.
Save costly API
Each Bidose nasal spray device is filled with a maximum of 200 µL (100 µL per actuation) with a total overfill of only 50 µL (25 µL per shot). With expensive API, using a delivery system that minimizes overfill conserves your valuable API, so you can maximize your production efficiency and product profitability.
Request More Information
Requesting information on Bidose (BDS) Liquid Nasal Spray System.