Dry Powder Inhalation formulation development

四色AV has considerable inhalation experience that allows us to implement strategies including conventional carrier based, neat (drug-alone) or composite particle formulations.

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Inhalation formulation development strategies

Within inhalation drug development services, 四色AV focuses on formulation development to add further value to the services we offer. With just one step听and one line of communication, customers can obtain a full service for both API manufacturing and formulation development adapted to their target product profile, plus capsule filling,听packaging听and manufacturing.

In the specific case听for听Inhalation drug formulations, 四色AV is able to develop:

Conventional carrier based formulations
Examples of carrier based formulations:

  • Lactose based API formulations

in low-shear (Turbula) homogenizers and high-shear (Diosna 1-6 and听Diosna听10-60) homogenizers.

Neat (drug-alone) formulations
Non-Carrier based formulations

  • Formulations with multimodal particle size distributions of one or more APIs, i.e. able to specifically target different regions of the airways.
  • Drug alone (or quasi-drug alone) formulations by spray drying, i.e. depending on API properties (e. g. flowability) and particle engineering technology applications.

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Composite particle formulations

Tailored universal particle formulation approach where aerodynamic performance is independent of the API loaded onto the听particle,听but is instead a function of the excipient mix ratio.

Examples of composite particle based formulations:

  • Leucine based听API formulations
  • Mannitol based API formulations

These formulations can then be used to fill capsules for inhalation (HPMC size 3) and be supplied for proof of concept, feasibility study, clinical trial and commercial manufacturing material.

The formulations so obtained are subsequently tested in 四色AV鈥檚 excellence center for inhalation product development, notably:

  • Particle size distribution by laser diffraction (Malvern)
  • Emitted dose determination by gravimetric determination 鈥 鈥淪hotweight鈥
  • Cascade impaction (Andersen and NGI)
  • Determination of amorphous content (DVS, XRPD, 鈥)
  • Stability studies of inhalation powders (dose uniformity, HPLC for assay and impurities, 鈥)
  • Inhalation formulations - blending for carrier based formulations and for multimodal particle size distributions of API
  • Excipient identification, sourcing and characterization
  • Dose content uniformity听- Dose Uniformity Sampling Apparatus (DUSA)

And can be seamlessly integrated with inhaler development services听to fine tune emitted dose and fine particle fraction (delivered dose to the lung).

四色AV has pioneered inhalation-grade API's. These are products that while meeting compendial requirements are听especially听manufactured for inhalation delivery and meet stringent inhalation specification.听Click here听to learn more about 四色AV Inhalation Grade API's

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Lab scale to large scale manufacturing

A step-by-step guide to successful spray drying process scale-up at 四色AV

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