about iSPERSE

 

 
What is iSPERSE™?

iSPERSE (inhaled small particles easily respirable and emitted) is a proprietary new platform for inhaled drug delivery based on unique properties: dense, high drug load, engineered particles with highly efficient dispersibility and delivery to the airways.

Why dry powder?

Dry powder technologies possess several commercial advantages over nebulized liquid formulations, including ease of use, speed of dosing, improved portability, and enhanced intellectual property protection.

What are the first drug candidates with iSPERSE?

The first drug candidates from the iSPERSE platform are Pulmatrix’s dry powder (DP) iCALM therapies for use with hand held dry powder inhalers (DPIs). The iSPERSE platform enables Pulmatrix to optimize its DP iCALM therapies to be highly dispersible with a high drug payload to powder volume ratio, allowing for the efficient and reproducible delivery of iCALM doses across a wide range of potential patient populations, including patients with compromised lung function.

Why iSPERSE?

The high degree of aerosol efficiency and particle density engineered in Pulmatrix’s dry powder (DP) iSPERSE technology can be utilized to advantageously deliver a wide range of drugs via inhalation for both local and systemic drug delivery applications. The properties of iSPERSE have meaningful therapeutic and patient benefits, including the potential for single formulations with multiple drugs, effective inhaled drug delivery to patients with normal or impaired lung function, and the use of simple and convenient inhaler devices. With completion of comprehensive proof-of-concept validation of the iSPERSE platform along with extensive initial patent filings, Pulmatrix is now advancing a select number of proprietary iSPERSE drug candidates as well as actively pursuing iSPERSE partnerships with pharmaceutical companies to create novel therapeutics.

What are the advantages of iSPERSE?

iSPERSE allows the efficient airway delivery of higher drug loads in smaller masses of inhaled powder. The iSPERSE powders are small in geometric size and relatively dense, yet are highly dispersible and relatively flow rate independent with high emitted doses achieved even at low flow rates. This is in contrast to conventional DP technologies that rely on the use of lactose blending or low-density particles to facilitate dispersibility. The low energy required for dispersion coupled with the capacity for high drug loading, as well as the potential for inclusion of multiple drugs in iSPERSE compositions, facilitates the delivery of low potency or large molecule drugs to a comprehensive patient population across a wide range of inhalation flow rates.

The iSPERSE technology possesses many advantages over other DP technologies:

- Enabling inhaled delivery of large molecules and low potency drugs: The   iSPERSE powders are inherently dense and highly dispersible, and can be   formulated with high drug loads, allowing for the delivery of high drug payloads   per powder volume, enabling both large molecule (e.g., proteins, peptides,   antibodies) and low potency drug formulations.


- Effective patient dosing and administration: iSPERSE creates dry powders   with small geometric size that have good dispersibility across a range of flow   rates. This flow rate independence provides for reliable dose delivery to   patients with either normal or impaired lung function, as well as young children   who might require low flow rate dosing not attainable with conventional   technologies.


- A new paradigm for inhaled drugs, without lactose blending: iSPERSE uses   proprietary salt-containing formulations to enable the delivery of DPs, rather   than lactose blending. iSPERSE powders can contain as little as 20% or less   of salts and other excipients, in contrast to lactose blend DPs that typically   consist of > 80-90% lactose. Lactose blends have poor delivery efficiency and   typically only deliver < 20% of the drug to the lungs. Additionally, lactose   blends are also highly flow rate dependent, showing significant variability with   respect to emitted dose and aerodynamic size.


- Robust formulations supporting multiple drug combinations: iSPERSE salts   offer flexible and robust formulation capabilities and manufacturing, enabling   the delivery of small and large molecule drugs as well as drug combinations   (including triple drug combinations or higher), making iSPERSE a platform   ideally suited for the creation of branded generic, as well as other branded   products.


- Strong safety profile potential: In addition to drug molecules, iSPERSE dry   powders comprise exclusively simple salts and additional safe excipients, if   needed.


- Use of simple, convenient inhaler devices: The high iSPERSE powder   dispersibility facilitates the use of commercially available or proprietary simple   and passive capsule- or blister-based dry powder inhaler (DPI) devices.


- Ease of manufacture: iSPERSE powders are made via a straightforward,   proven one-step spray drying process with high and consistent yields.


- Strong patent protection: A strong intellectual property position on iSPERSE   is being pursued through multiple patent applications, encompassing   compositions, methods, and uses.


These advantageous features of the iSPERSE technology can enable the delivery of small molecule drugs, drug combinations (including triple drug combinations or higher), and macromolecule drugs (i.e., antibodies, peptides, proteins) at doses well in excess of those achievable by traditional DP lactose blend technologies, and with superior dose characteristics compared to low density engineered particles.

 
 
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