Topical Formulation Development

Home Topical Formulation Development

Tergus offers comprehensive solutions for your topical formulation development needs. We have expertise working with a range of Active Pharmaceutical Ingredient (APIs) including all BCE class compounds (especially poorly soluble and poorly permeable compounds), New Chemical Entities (NCEs), small and large molecules, pro-drugs, proteins, peptides, enzymes, Spherical Nucleic Acid (SNA), microbiomes, and high potency compounds. Tergus provides reproducible and scalable formulations by using quality-by-design and risk mitigation to produce a robust topical dosage form appropriate for proof-of-concept, GLP, clinical trials (Phase I, II, III), and subsequent commercial manufacturing. We can ensure the fastest path to market by customizing each development path to meet your phase-appropriate needs, allowing us to reach critical “Go/No Go” decisions earlier and achieve faster results.

Formulation Development

Our Topical Formulation Services Include

Formulation Development

  • Complete NCE Generic and OTC product development
  • Repurposing Phase I or II dosage form clinical setbacks via turnkey formulation solutions
  • Manufacturing process optimization using QbD and CFR-compliant statistical software
  • Evaluation of innovative platforms and technologies
  • Expertise in developing non-infringing novel patentable formulations
  • IP review and risk mitigation strategies
  • Pre-clinical toxicology support
  • Addressing FDA deficiencies
  • Container closure selections
  • 510(k) medical devices

Semi-Solid Dosage Forms

  • Topical Foam
  • Nail Lacquers
  • Topical Aerosols
  • Hydrogel
  • Hydro-alcoholic Gels
  • Oleaginous Gels
  • Lipoid Gels
  • Emulgels
  • Transdermal gels
  • Deep penetrating gels
  • Creams
  • Lotions
  • Suspensions
  • Ointments
  • Ophthalmic Preparations
  • Pastes
  • Liposomes
  • Microencapsulation
  • Nano Emulsions
  • Topical Sprays
  • Topical solutions
  • Rectal Suppositories
  • Rectal Gels
  • Vaginal Creams
  • Vaginal Gels
  • Vaginal Pessaries

Formulation Development from Tergus Pharma on Vimeo.