Drug Formulation Expertise and Specialties

Let LATITUDE apply its deep and broad formulation expertise and experience to address your NCE and generics formulation needs, for a variety of drug compounds and substances.

Expedient and responsive services

  • Analytical method development & validation
  • Drug candidate evaluation
  • Deformulation/reverse engineering
  • Preformulation
  • Formulation development
  • Formulation involving DEA controlled substances (Schedule I-V)
  • Rapid formulation screening using templates
  • De novo and custom development
  • Stability and solubility testing, pH profile
  • Access to proprietary LATITUDE delivery technologies
  • Enhanced bioavailable tox formulations

Addressing formulation challenges

  • Insoluble compound or drug substance (brick dust)
  • Unstable compound or drug substance
  • Need for bioavailability enhancement
  • Injection site reaction (e.g., vein irritation)
  • CNS toxicity
  • Large dosage and/or bulky volume
  • Inadequate PK
  • Requires formulation IP for added patent protection

Dosage forms

  • Injectable – solutions, emulsions, liposome formulations, suspensions, etc.
  • Depot – subcutaneous (SC or subQ) and intramuscular for multiple day dosing of small molecules, peptides, proteins
  • Oral – solid and liquid filled capsules, tablets (immediate release, sustained release, extended release, delayed release, chewable, orally-disintegrating), coated, uncoated, multi-particulate, fast dissolving films, stable amorphous powder matrices (RFAP), solutions, suspensions
  • Topical – cream, lotions, ointment, gel, foam, patches, and others
  • Ophthalmic – complex ophthalmic solutions, emulsions and suspensions
  • Others – nasal sprays, pulmonary inhalation and others

Formulation of New Chemical Entity (NCE)

  • Small organic and inorganic compounds
  • Controlled substances (Schedule I-V)
  • Peptide biologics (hormones, growth factors, etc. )  1-25k MW
  • Proteins (antibodies, blood factors, etc.)  15-150k+ MW
  • Oligonucleotides plasmid DNA and RNA
  • Viral Vectors
  • Viruses
  • Polymers

Complex generic drug formulation development

Q1, Q2 and Q3 attributes for a variety of formats, including:

  • Ophthalmic suspensions
  • Injectable Nanoparticles
  • Microspheres
  • Liposome drug formulation

Intellectual property

Click here to download a PDF brochure of LATITUDE’s services capabilities.