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.
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.
Drug product development
Our drug product development cycle ensures high quality and personalisation to your needs:
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?
Do the physical properties of the API fit with the process requirements?
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 :
- SEM, PSD, DVS, DSC, TGA, XRPD
- 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)
