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Formulation
Research Development

Formulation development is Rubicon Research’s core competency and we routinely carry out development of generic formulations, specialty and novel formulations, consumer, and over-the-counter (OTC) formulations with desired sensorial attributes, excipient application studies, and placebo development.

Product development at Rubicon Research begins with product strategy development. Desired product attributes are identified and prototype formulations are developed to meet the desired product attributes. Critical process parameters (CPP) are identified and process optimization studies are carried out based on Quality by Design (QbD) principles. Based on the formula and process optimization studies, final composition and manufacturing process is recommended for bio study and scale-up.

Activities include

  • pH/ solubility profile
  • Excipient compatibility studies
  • Stage appropriate development of analytical methods
  • Formulation development
  • Lab-scale stability evaluation
  • Formulation / process optimization
  • Scale-up / technology transfer
  • Exhibit batch manufacturing
  • Commercial manufacturing and technical support

Rubicon Research can develop

  • oral solids
  • oral liquids
  • topical
  • sterile
  • ophthalmic
  • nasal
  • pulmonary
  • and high potency products

See our diverse dosage forms handling capability here.