Accugent Laboratories, Inc.
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Dosage Form Development

Accugent has significant experience in developing simple formulations that are suitable for parenteral, subcutaneous or ophthalmic dosing. We can optimize formulation parameters while maintaining chemical stability of the drug. We have experience in developing formulations for antisense oligonucleotides, DNA duplexes, siRNA and aptamers. We also have the analytical tools necessary to evaluate the manufacturability, performance and stability of these formulations.

We offer the following services:

Preformulation studies

  • Solubility in various media
  • Solubility/stability as a function of pH
  • pKa determination
  • Osmolality
  • Tm studies of oligonucleotides

Formulation development

Analytical development

Compatibility Testing

  • Filter compatibility
  • Compatibility with clinical dosing devices
  • Compatibility with manufacturing equipment
  • Excipient compatibility

Freeze-Thaw Studies

Pilot Stability Studies

  • At recommended storage and accelerated conditions
  • Stability information suitable for filing in regulatory applications

info@accugent.com

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Updated January 7, 2013
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