Our team at CLS can help meet your formulation characterization needs, providing the analytical insight and support you need to develop ‘phase-appropriate’ formulations tailored to the characteristics of the API. This includes support for pre-formulation and clinical studies for New Chemical Entities (NCEs), as well as services relevant to generic product development.
We offer a fast, cost-effective and flexible approach to the characterization of drug product formulations:
- Our team has considerable expertise in developing methods and testing both simple and complex formulations (e.g. powders, suspensions, creams, gels, modified-release products) across a range of delivery routes (oral, nasal, inhalable, injectable, topical)
- We work alongside material scientists, DMPK investigators and toxicologists to design effective analytical approaches to formulation screening, helping you to de-risk your development programs and respond to challenges during scale-up and manufacture
Developability assessment: De-risking your candidate selection
We can work with you to select appropriate techniques and methods to assess the developability of Active Pharmaceutical Ingredients (APIs), helping you select the most relevant formulation to ensure bioavailability while also considering the processability of the API.
Do the physical properties of the API ft with the bioavailability requirements?
Do the physical properties of the API fit with the process requirements?
- 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)
- 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)
Capabilities supporting formulation development
We provide extensive support to your formulation development programs, including pre-clinical API development and formulation characterization:
- 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)
- Bioequivalence (Q3 sameness) studies in support of generic development, including method development for API-specific particle sizing using Morphologically Directed Raman Spectroscopy
- Pre-clinical testing of all dosage forms (powders, suspensions, emulsions, creams and gels)
- Dissolution analysis for oral and inhalation products (USP Apparatus I-V)