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Early Phase Formulation Development Services 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.

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Our Services for Preclinical Formulation Development Include

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 company, we have more than a decade of experience in helping our clients overcome these challenges by enabling preclinical and GLP toxicology studies.

Our preclinical formulation development approach considers but is not limited to

Oral formulation

  • Suspension
  • Solution
  • Solid dispersion
  • Enteric solid dispersion
  • Lipid based delivery (Emulsion/SMEDDS)
  • Micro/Nano-suspension

Parenteral formulation

  • Solution
  • Lyophilization
  • Emulsion
  • Nano-suspension

Oral Bioavailability Enhancement Services Include

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

Formulation development strategies are:

Solubilization strategies

  • Micellar solubilization
  • Complexation
  • pH modification/buffering
  • Cosolvents
  • Anti-precipitating agents

Enabling technologies

  • Solid dispersions
    • Spray drying
    • Rota-evaporation
    • Spray granulation technology
    • Hot melt extrusion
  • Particle size reduction
    • Micronization (Air-jet mill)
    • Nanosizing
  • Lipid-based drug delivery systems
    • Emulsion
    • SEDDS/SMEDDS
    • Lipid formulation filled in Soft gelatin capsules
Early Phase Formulation Development

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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Biologics Manufacturing Services

Our manufacturing services cater to both GMP and non-GMP manufacturing for pre-clinical development as well as GMP operation to support clinical or commercial needs for any recombinant proteins expressed in suspension mammalian culture or E. coli. ...

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Delivering 3 g dose of emetic and poorly bioavailable compound for 90 days repeated dose toxicity studies in dog

Background: Develop oral liquid dosage form of an IND candidate (small molecule) suitable for chronic toxicology studies in dogs. Must meet required systemic exposure and shall be dose proportional. Developed vehicle or used excipients shall be safe for chronic preclinical toxicology studies in dog. Challenges: Conventional suspension in dog resulted in low oral ...

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Revisiting the reaction of b-chloroacroleins with 2-aminophenol: a new observation

2008

The reaction of b-chloroacrolein with 1 equiv of 2-aminophenol in DMF proceeds smoothly to afford 11-hydroxy derivative of chromenoquinoline in good yield. This single pot method allows for a rapid access to a variety of chromenoquinolines or oxepinoquinolines depending on the nature of b-chloroacrolein used. The structures were established by spectroscopic data ...

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