Formulation Development

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At PSR our team of experts starts the development process by an extensive patent landscape followed by Quality-By-Design (QbD) tools throughout all stages of development process. Design of Experiments (DOE) along with risk assessment strategies i.e. FMEA allows us to design trial strategies for experimentation purposes. Using this developmental approach allows us to meet our delivery timelines and helps us in providing our clients with cost-effective drug delivery solutions. PSR team has extensive experience working with the following processes and delivery methods:

PROCESSES

Fluid Bed Granulation (Wurster &Top Spray)

High Shear Granulation

Low Shear Granulation

Roller Compaction

Direct compression

Tabletting

Encapsulation

Tablet/Particle Coating (Aqueous & Solvent)

DOSAGE FORMS

Immediate Release Tablet/Capsule

Modified Release Tablet/Capsule

Extended Release Tablet/Capsule

Chewable Tablet

Oral Dissolving Tablets (ODTs)

Tablet in Capsule

Bilayer tablets

Capsules

Solutions

Suspensions including ER suspension

Our formulation development services include:

  • Formulation development for early safety studies
  • Prototype formulations for clinical trials
  • Prototype formulation screening studies
  • Formulation / process optimization
  • Preliminary process identification
  • Commercial formulation development for NCEs, NDE’s generics and OTC products
  • Process development optimization
  • Scale up / Technology Transfer