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Early Phase Formulation Development Services

Early Phase Formulation Development Services

Our early-phase formulation development services are tailored to address specific drug delivery challenges.

Our early-phase formulation development services help to resolve drug delivery challenges encountered at both preclinical and clinical development stages of small molecules and peptides. We offer specific solutions to your preformulation and formulation needs through customized development strategies and designs.

Our expert team of scientists have successfully delivered projects in wide range of areas like incomplete dissolution, low solubility, low oral bioavailability and targeted drug delivery through in-depth molecular characterization, various solubilization and enabling technologies. At Aurigene, we provide solutions for: Toxicology studies Non-feasibility of high doses or strengths Studies in varied animal species Emesis, compound limitation Liquid dosage form requirement Precipitation of compounds at absorption sites.

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Our Services for Preclinical Formulation Development

Many hits and lead NCEs get shelved from pharmacological and toxicity screening despite high potency because of poor bioavailability or suboptimal formulation. As a leading CDMO, we have more than a decade of experience in helping our clients to overcome these challenges by enabling GLP toxicology studies.

Our preclinical formulations development approach considers but is not limited to:

  • Administration route (oral, parenteral and topical)
  • Animal species
  • Study duration
  • Excipient tolerability
  • Target exposure
  • Compound properties

NCE properties are assessed from pre-formulation studies suited to the discovery phase to obtain maximum information from minimum compound amounts.

Oral Bioavailability Enhancement Services

Our formulation team has the expertise in troubleshooting complex problems by banking various oral bioavailability strategies to accelerate your drug discovery program to the next phase.

Formulation development strategies are:

Solubilization strategies

  • Micellar solubilization
  • Complexation
  • pH adjustment/buffering
  • Cosolvents

Enabling technologies

  • Solid dispersions
  • Particle size reduction
  • Lipid-based drug delivery systems

Our data-driven approach enables our partners to advance candidates and select the most optimal formulation for a specific drug development phase.

Why Aurigene Pharmaceutical Services?

Services from early formulation to clinical manufacturing

Experience with advanced formulation technologies

Integration with biology services for in vitro and in vivo studies

Global accreditations

Virtual Tour

 

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