Drug Formulation Development

//Drug Formulation Development
Drug Formulation Development 2018-07-31T14:44:26-05:00

Aerosol Drug Formulation

ARE Labs can help you with the processing of your drug formulation and optimization for therapeutic inhalation delivery.   We specialize in respiratory formulation development and processing of drug formulations for aerosol inhalation delivery in dry powder, aqueous suspensions and solution forms.   We have experience in processing dry powder drug formulations using planetary ball milling, jet milling, spray drying, encapsulation with cyclone separation techniques for optimizing the drugs particle size and respirable mass for targeting specific nasal mucosal/intra-nasal, upper, lower, and/or deep lung deposition sites.

We also utilize charge masking techniques, controlled particle porosity and use FDA approved lung excipients for drug encapsulation.  We screen the API formulations drug using real-time laser diffraction particle sizers and cascade impactors for verification of drug particle size distribution.  ARE Labs can also assist you in aerosol delivery device selection and packaging options for your drug formulation and can conduct characterization testing for optimization for targeting the desired drug respired dose concentration.

If you have a API that you would like to deliver via the intra-nasal or pulmonary route we can help.

Some of the Formulation Services We provide

  • Nebulizer Formulations
  • MDI  Formulations
  • Dry Powder Inhaler Formulation
  • Intranasal/Nasal Mucosal Formulations
  • Solid suspension Formulations
  • Meter Dose Inhaler Formulations
  • Optimization of Existing Formulation
  • Dry Powder Inhaler Testing

  • Spray Drying Formulation
  • Encapsulation
  • Charge Masking
  • Jet-milling and Grinding
  • Excipient Screening
  • Cyclone Separation
  • pH, Viscosity and Porosity adjustments

  • High-Value Low-Dose API’s
  • Combination drug API and Device
  • Maximize Respirable Mass
  • Delivery Efficiency Optimization
  • Stability of Formulation
  • Device Optimization
  • Packaging Options for Dry Powders

Additional Information for Formulation Development and Validation

ARE Labs can formulate your API for respirable drug delivery in several different forms.  whether your drug is intended for Nebulizer, MDI , Dry Powder Inhalers or Nasal delivery devices we can have the expertise to develop your respirable platform.

Nebulizer Solutions

Custom formulation development for nebulized API’s to maximize respirable delivery efficiency.  Selection of buffers, pH balancing and total solute concentrations are engineered for your specific API.  The formulations are screened in numerous commercial off-the-shelf nebulizer and the formulation is optimized for broad spectrum device delivery.

Dry Powder Inhalers

Dry Powder formulation development consist of selecting the appropriate excipeint, calculating desired API loading, homogenization, milling or spray drying the API to the desired particle size and encapsulation for viscid materials.  Particle may also need processing for porosity to adjust particle densities.

Nebulizer Suspensions

Suspension formulation development is typically for water insoluble API’s, however, they can also be used to control the kinetics of the delivered drug.  Typically suspensions are developed in a similar fashion as dry powder formulations with the addition of hydrophillic encapsulation, charge masking and porosity adjustment to eliminate settling of the suspensions.

Some of our Other Related Aerosol Services We Offer:

ARE Labs can provide custom pharmaceutical formulation development for optimal respiratory deposition of various API’s.  Whether it is a solution, suspension, or dry powder we can help.

D-GH69010-BI-01

ARE Labs can provide testing for your custom formulation in off-the-self and custom designed devices