FORMULATION SERVICES

KelSie specializes in dry powder Formulation development, which encompasses processes that incorporate an Active Pharmaceutical Ingredient (API) into a drug product.  While biological activity is a prerequisite for a successful dosage form, it is not the sole determinant.  Factors such as stability, processibility, delivery, and availability to the target organ contribute to an efficacious pharmaceutical system.  

 
The following is a brief description of the key critical factors, which KelSie considers during formulation:

• Stability: A common concern when considering the option to reformulate an active ingredient into a dry powder is the likelihood of degradation.  In order to stabilize the active ingredients and assist in achieving the optimum properties, additives known as excipients are commonly introduced. These excipients improve the physical or chemical stability of the formulation, and function as a carrier for the active ingredient.  KelSie Biotech has successfully reformulated a wide array of small molecules, antibodies, proteins, nucleic acids, inorganics, antibiotics, and even live, attenuated vaccines into powders suitable for a variety of applications, such as respiratory delivery, stable suspension, and rapid dissolution, with minimal loss of activity.  

​

• Processibility: KelSie’s Senior Scientific and Management Staff have spent years developing and perfecting their bubble drying process on a wide variety of applications. Over the past few years they have turned their efforts to developing non-lactose based formulations, with great success.

​

• Delivery: Many pure organic substances are crystalline in nature and have an aerodynamic diameter too large to achieve deep lung penetration. Achieving an aerodynamic particle diameter of 1-5 µm, which is necessary for deep lung penetration, is the single most important design variable of a DPI formulation.  Our vast formulation experience, paired with our exclusive technology, affords us the ability to tailor design your dry powder according to your specific application.  KelSie has been testing its formulations with an Andersen cascade impactor, which is recommended by both the U.S. and European Pharmacopeias.

​

• Availability to Target Site: By generating specified particle sizes in the formulation/particle formation process, the active ingredients are able to reach the desired delivery location where the dry powder is dissolved and absorbed upon contact with the membrane, increasing the absorption rate and efficacy.  Delivery of APIs in this manner avoids the first-pass metabolism of the liver, and increases the bioavailability of the drug.  The onset of effects of the Active is also accelerated by the delivery directly to the bloodstream.

• ​

Each of KelSie’s formulations undergoes rigorous pre-and-post testing via high-performance liquid chromatography (HPLC), gas chromatography (GC), microbial and heavy metal screening as well as respirable fraction determination by Anderson cascade impaction, nuclear magnetic resonance (NMR) spectroscopy and scanning electron microscopy depending on the regulations, intended use and form factor.