The first step to making it better is making it right

WellSpring provides formulation development and optimization for Phase I-III clinical trials, with a focus on solid, semisolid and non-sterile liquid oral formulations as part of a life cycle management program.  These services are custom tailored to each client’s needs.

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Formulation development involves devising novel formulations for NDA drugs or reverse engineering formulations for ANDA drugs and compounds that provide the appropriate dose and bioavailability characteristics for a medical indication.

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Our experts will guide you through decisions regarding release characteristics or bioavailability and solubility, and advise you on robust processes for tablets, capsules, creams, lotions, ointments and gels as well as non-sterile liquids and suspensions. We’ll work directly with your team to ensure all your formulation needs are met and your budgets are maintained.

Our staff delivers products that are bioavailable, stable and scalable to use in clinical trials and beyond.  Our typical volume ranges for manufacturing during formulation development are as follows:

  • Solid Dose: 1 - 18 kg
  • Semisolids: 1 - 4 kg
  • Oral Liquids and Suspensions: 250 mL – 100 L

Test article preparation and dose verification services are also available.

Here is a listing of WellSpring’s formulation development capabilities:

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When you’ve worked with WellSpring, you’ll begin to understand the extra dedication and attention to detail we bring to everything we do. That’s why it’s Made Better with WellSpring.

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