about advanced inhaled drug delivery technologies

iCALM therapies
iCALM unique multifactorial MOA

dry powder

Pulmatrix has developed dry powder (DP) iCALM formulations for hand held dry powder inhalers (DPIs). DP formulations possess several commercial advantages over nebulized liquid formulations, including ease of use, speed of dosing, improved portability, and enhanced intellectual property protection. Pulmatrix has optimized its DP iCALM formulations 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 a significant degree of pulmonary compromise.

inhaled small particles easily respirable and emittable (iSPERSE)™

The high degree of aerosol efficiency engineered in Pulmatrix’s dry powder (DP) iCALM formulations has led to the development of a new DP inhaled drug delivery technology termed iSPERSE™ that 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.

iSPERSE powders are small in geometric size and relatively dense, yet are highly dispersible and relatively flow rate independent with high emitted doses achieved 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 patients across a wide range of inhalation flow rates.

Advantages of iSPERSE

The iSPERSE technology possesses several advantages over conventional DP technologies:

- High drug loading enables inhaled delivery of large molecules and low potency drugs: The iSPERSE powders are inherently dense and highly dispersable, allowing for the delivery of high drug payloads per powder volume (up to 60-80% drug molecule(s)), enabling both large molecule (e.g., proteins, peptides, antibiotics, etc.) 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 cationic salt formulations to enable the delivery of DPs, rather than lactose blending. iSPERSE powders can contain as little as 20% or less of salts and excipients, in contrast to lactose blend DPs that typically consist of > 80-90% lactose and therefore only deliver < 20% of the drug to the lungs. Additionally, lactose blends are also highly flow rate dependent and show significant variability with respect to emitted dose and aerodynamic size.

- Robust formulations support multiple drug combinations: iSPERSE’s cationic 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 are comprised exclusively of generally regarded as safe (GRAS) salts and small quantities of 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 unit with high and consistent yields. - Strong patent protection: A strong IP 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. antibiotics, peptides, proteins, etc.) at doses well in excess of those achievable by traditional DP lactose blend technologies.

inhaled small particles easily respirable and emittable (iSPERSE)™

- single or combination (double, triple) drug formulations for local delivery (asthma, COPD, etc.)

- small or macromolecule (e.g., antibiotic, protein, etc.) drug formulations for local or systemic delivery.

For additional information on iSPERSE, download the or read our recent press releases relating to iSPERSE:

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