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ANI GLOBAL SOURCE IS A CULTURE OF INTEGRITY

Formulation Development


 

ANI Global Source 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.

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 processes. We’ll work directly with your team to ensure all your formulation needs are met, budgets are maintained and timelines achieved.

Our staff delivers products that are bioavailable, stable and scalable, ready for use in clinical trials and beyond.  

Our typical volume ranges for manufacturing during formulation development are:

Solid Dose: 1 - 18 kg

Semisolids (Creams, Ointments, and Gels requiring vacuum (deaeration)): 1-4 kg

Oral Liquids and Suspensions: 250 mL – 10 L

Test article preparation and dose verification services are also available.

Our formulation development capabilities:

Formulation Development Capabilities

  • Clinical and commercial formulations
  • Reference Listed Drug Reverse Engineering
  • Excipient Compatability
  • Solid, semisolid and liquid formulations
  • Highly potent compounds in oral liquid and semi-solid dose forms
  • Delayed or modified release formulations, including enteric-coated formulations
  • Low/high drug load
  • Orally disintegrated tablets (fast dissolve)
  • Taste-masking
  • Pediatric-masking

Clinical and Commercial Formulations

  • Tablet (immediate/modified/sustained/extended release)
  • Semisolid: Creams, gels, ointments, pastes, lotions
  • Capsule (immediate/modified)
  • Non-sterile solution/suspension/syrups
  • Powder-in-bottle

At ANI Global Source, we bring extra dedication and attention to detail we bring to everything we do. 


 

Facilities & Equipment
Specialized Product  Manufacturing Capabilities
Manufacturing & Packaging
Analytical Services
Formulation Development
Technology Transfer