Innovation in Paediatric Drug Delivery with miniMist®

What is miniMist®?

• miniMist^® is an inhalation device for children that makes inhalation of pharmaceuticals easy and highly effective using gold standard methods.
• miniMist^® uses break-through technology and delivers treatments in a way they have never been done before.
• miniMist^® can be used as a single-use device or as a multi-dose, for chronic, acute or emergency use. It can be delivered aseptic or sterilized.

MiniMist® revolutionizes pediatric drug delivery

Increase adherence and improve outcomes for children, with easy-to-use, accurate devices for drug delivery through the Breease pacifier.

• Exceptional inhalation drug delivery, far better then competition.
• Increase treatment efficacy and reduce costs directly.
• Intuitive and truly child friendly.

MiniMist®
• Designed by doctors, proven by research
• Droplet size down to 2 microns
• Considerable more accurate delivery
• Increase adherence
• Affordable

Technical properties

Studies show at least 54%, on average and at best 90%, drug delivery into the deep lungs.

MMAD: 5.0 µm
GSD: 1.5
Drug flow rate 5-10 µL/s

• Uses the child’s tidal breathing instead of a timed deep breath which can be hard for small children to do.
• No unwanted nebulization outside the oral cavity that could accidentally hit the eyes or contaminate other subjects (parents or caregivers)
• The teat acts as a mouthpiece which doubles the delivered dose and releases the mist at the end of oral cavity.
• Low pressure system.

REQUEST FOR MINIMIST®

Product description

All material used to manufacture miniMist® are medical grade raw materials of USP class 6 which is the highest and cleanest material standard to be used in the human body. We will never take any chances when it comes to safety, and we offer only premium products to our customers.

NONE of the materials used in our products contain any hazardous or harmful substances such as BPA, BPS, phthalates, lead etc. Furthermore, they never contain latex or other allergens that will induce allergic reactions.

1. Pacifier platform

The breath-through pacifier consists of shield and teat. The shield is made of polypropylene (PP) and the teat is made of Thermoplastic elastomer (TPE).

2. Exchangeable inhalation capsule

The capsule is made of polypropylene (PP) and contains a high-end medical softmist nebulizer.

Design and sustainability

The product was designed by Swedish doctors and engineers as a product to help caregivers give their children the best inhalation device with easy compliance. All components and functions have been scrutinized for scientific reasons and is made to fit children both anatomically and physiologically. The doctors who have developed the products are all experts in the medical field and of course the respiratory tract of the child.

It’s designed to be both orthodontic and anticolic and does not have any know negative side effects.

It was also designed to have low carbon footprint and is made of materials that can be 100% recycled to new products. The carbon footprint equals a sip of coffee per product.

Our life-cycle analysis shows that:
Pacifier with one capsule is 0,13kg CO2e
Each capsule when changed is 0,017kg CO2e

A cup of coffee is 0,4kg CO2e brewed and ready.
LCA was performed by WSP using the ReCiPe 2016 Mid-point (H) v1.05.

Safety

Safety is of course paramount and extremely important and VivoLab AB tests ALL products at independent EU test facilities as well as on-site in line with production to guarantee the highest levels of safety.

Pacifier platform is tested according to EU regulation of pacifiers and toys and is always delivered with a Declaration of Conformity (DOC).

miniMist® has no safety issues for children under normal use.

Manufacturing

Pacifier platforms are produced and assembled in Sweden in a fully automated GMP-facility that guarantees a safe and clean product without contaminations.

The production site is regularly inspected and audited by external professionals and live up to the high standard of ISO 13485.

Usage

All liquid pharmaceutical compounds including biologics and nanocarriers. Because of low-pressure system, which deliveries the drug at 10-15 bar at max, it is especially suited to biotech compounds. The integrity and topography of formulation (mRNA, proteins-structures etc.) is intact and still effective after being aerosolized. This is not the case when it comes to all pMDIs or mesh-nebulizers.

Formulation near water (low-viscosity) can be used or dry powder to be mixed in solution.

Target group

Patient population ranges from newborn (surfactant for instance) to 5 years old.

Possible indications could be but are not limited to:

– Asthma and wheezing
– Viral exacerbations (RS, C19, seasonal influenza)
– Pneumonia
– Cystic Fibrosis
– Alfa-1 antitrypsin deficiency

“MiniMist® lets you deliver the right amount of medicine, to the right place and treat illnesses such as asthma and cystic fibrosis. It also facilitates use for caregivers and is non-scary for kids, vitally increasing treatment adherence. That means health outcomes and quality of life for kids go up while the cost of the treatment goes down, improving affordability.”

Request for MiniMist®