Formulation Development Services

Pre-formulation Development
At Raleigh Molecular, we understand the significance of developing robust and compliant formulations for our clients. Beginning with thorough pre-formulation services, we assist our customers in identifying optimal dosage forms suitable for preclinical or clinical applications. Our analytical development services complement our preformulation work, enabling us to conduct comprehensive physico-chemical characterization using modern analytical techniques in-house for swift turnaround times. Raleigh Molecular evaluates and determines various parameters to guide you in arriving at the right formulation utilizing your API.

These may include:
  • Solubility of API in different media and solvents
  • Excipient compatibility studies
  • Dissolution of the active pharmaceutical ingredient (API)
  • Accelerated Stability Services under various conditions
  • Solid state analysis (polymorphs, particle size, particle shape etc.)

Formulation Development

Raleigh Molecular is well-equipped with the right equipment, facilities, and a team of highly dedicated formulation development specialists to assist you in achieving the optimal dosage form for your API and intended application. We ensure that any forms we develop are scalable, compliant, and ready for commercialization, meeting the specific needs and expectations of our customers.

We can formulate a wide range of sterile and non-sterile dosage forms including:
  • Oral Immediate Release – Solutions, Emulsions, Suspensions
  • Sterile Liquids – Solutions, Suspensions and nanoemulsion
  • Powders – Sterile and non-sterile powder filling
  • Injectable drugs (intravenous, and intramuscular, subcutaneous injectables)
  • Lyophilized formulations

Formulation Services and Capabilities

  • Formulation development for new chemical entities (NCE)
  • Optimization of existing formulations
  • Feasibility Studies
  • Excipient Compatibility selection and optimization
  • Physico-Chemical Testing
  • Process Scale-Up
  • Technology Transfers
  • Batch manufacture

Our formulation development services can be utilized either independently or in conjunction with our fully integrated services to expedite your drug development program.

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