Formulation development

CLS-logo.png The team at CLS can meet your formulation needs, developing “phase–appropriate”  formulations tailored to the characteristics of the API, for NCEs and generics alike.

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We offer a fast, cost-effective and flexible approach to formulation development of drug products:

  • The team has considerable expertise in developing and testing formulations from simple to complex (e.g. powders, solids, liquids, creams, gels, slow-release, fast release) across a range of delivery routes (oral, nasal, inhalable, injectable, topical).
  • The team works alongside material science, DMPK investigators and toxicologists to design effective formulation screening programs to de-risk your program and solve challenges with formulation development.

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Drug product development

Our drug product development cycle ensures high quality and personalisation to your needs:

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Developability assessment: De-risking your candidate selection

We assess the developability of your candidate selection with key processes and matrix assessments.

Do the physical properties of the API ft with the bioavailability requirements?

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Do the physical properties of the API fit with the process requirements?

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Analytical capabilities

  • Compendial in vitro dissolution testing (USP I and II)
  • Dynamic dissolution testing (apparatus I-VII)
  • Stability assessment of developed formulations (chemical & physical, short term & ICH, standard & accelerated conditions, in use studies) 
  • In vitro precipitation studies
  • Biologic stability (e.g. ADC’s, proteins)

Pre-formulation capabilities

  • pH solubility profile in bio-relevant media
  • pKa, Log P, Log D
  • Salt and polymorph screens
  • Solubility & stability in solvents and excipients
  • Full physico-chemical characterization of your API : 
    • Spectroscopic & Chromatographic characterization and benchmarking, purity assessment 
  • Preliminary identification of all dosage forms based on pre-formulation and in vitro ADME assessment (BCSI-IV)

Formulation capabilities

  • Design of well-tolerated pre-clinical dose vehicles in support of PK/PD and toxicological investigations
  • API processing (amorphous solid dispersions, micronization/milling, powder blending)
  • Tailored formulations for any route of administration (oral, injectable, inhalation, topical)
  • Bioequivalence of generics
  • IVBE studies, Q3 sameness assessment 
  • Pre-clinical testing of all dosage forms (solid, liquids, etc)
  • Dissolution systems (Apparatus I-V) oral, inhalation, etc)

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