Every year, thousands of drug candidates are abandoned due to poor solubility and an inability to show exposure in animal models. Formulation can profoundly impact drug release, absorption, and metabolism, which influence the resulting PK profile and the associated PD response. Late-stage discovery and preclinical formulations enable meaningful efficacy by maximizing exposure with minimal material usage, improving a molecules chance of becoming a viable drug candidate.
With OptiForm® Select formulation screening (formerly known as Hot Rod Chemistry® formulation screening), Catalent provides formulation development tools/services to support acute preclinical in vivo efficacy testing. Using DMPK modeling, Catalent provides guidance into your preclinical / clinical study design with an improved understanding of your molecule’s developability and insights into drug absorption, metabolism and distribution.
Coupling formulation science with DMPK analysis, Catalent bridges the gap between discovery and development to reduce risks and determine potential obstacles before making big investments in later development stages. Catalent’s specialized capabilities and experience supplement your expertise and help you move more molecules from discovery to development.
FORMULATIONS FOR PRECLINICAL TESTING
OptiForm® Select formulation screening (formerly known as Hot Rod Chemistry®) is a formulation screening technology designed to solubilize drug candidate compounds and prepare them for acute (<5 days) efficacy testing in preclinical models. OptiForm Select formulation screening quickly and inexpensively alleviates the bottleneck between in vitro hits and in vivo results.
Offered as both an off the shelf kit and rapid lab service, OptiForm Select formulation screening is used in over 200 pharmaceutical, biotechnology and academic laboratories worldwide. OptiForm Select formulations utilize excipients that are GRAS and can be found in FDA approved therapeutics. The formulations have been tested with a number of small molecules regarded as highly insoluble including taxol, griseofulvin and probucol. 95% of compounds tested have proven to be soluble in at least one OptiForm® Select formulation.
Once you have tested your molecule in preclinical models, Catalent will analyze your PK results using our DMPK modeling software. These data are used to develop an improved understanding of your molecule’s developability and your molecule’s drug absorption, metabolism and distribution. Our dedicated advisor will provide guidance on your preclinical and clinical study design with insight into human dosing strategies, leading to improved development decisions for your molecule.
OptiForm® Select Kit for Oral Dosing
Each OptiForm® Select formulation screening kit contains eight non-toxic, orally available formulations that increase the solubility, bioavailability and stability of oral drug candidates. Kits can be used in your lab to quickly and easily screen your molecule for solubility and to support acute in vivo preclinical efficacy testing. Once PK data is available, our DMPK experts will perform modeling to predict human PK and help direct continued development.
The OptiForm® Select Rapid Formulation Service is available for drug candidates being delivered intravenously or for those company’s interested in a more thorough preclinical stage formulation program for oral delivered compounds. Using our formulation expertise, Catalent focuses on formulating your molecule for efficacy studies as rapidly as possible while minimizing the amount of API required. Once PK data is available, our DMPK experts will perform modeling to predict human PK and help direct continued development.
OPTIFORM® SOLUTION SUITE
Integrated solutions and expertise to advance your molecule quickly
Comprehensive informed strategies for your early development path.
Customized programs to meet your goals and development needs
AFTER OPTIFORM® SELECT
As the #1 global leader in drug development, Catalent has the passion to help you determine a molecule’s potential and unlock it. In the early phase, understanding a molecule’s weaknesses and applying the right formulation technology can be the key to success. Catalent offers comprehensive early-phase services utilizing data-driven science and a portfolio of technologies to overcome challenges so that you make smart choices about your development strategy and get to the clinic fast.
- API Characterization & Optimization: polymorph screening, salt-form selection & pre-formulation testing
- Bioavailability Enhancement: Micronization, lipid systems, and amorphous dispersions
- GLP test materials: Formulation development for toxicology studies
- GMP clinical materials: CTM for Phase I studies
Catalent offers the broadest portfolio of technologies designed to deliver your molecule:
- Bioavailability Solutions – Access our broad portfolio of bioavailability solutions, including spray drying, particle size reduction, lipid delivery and salt form optimization, to solve your most challenging bioavailability issues.
- Better Treatments – As a leader in drug delivery, we have the most innovative technologies and deepest scientific, regulatory and product development expertise to improve the performance of your products from discovery to market.
Depth of Supporting Expertise
Our focused studies and extensive analytical offerings provide best in class support that will help ensure your project’s success.
- Method Development and Validation
- Drug Substance, Drug Product Release and Stability Testing
- API Product Characterization
- Drug Excipient Compatibility
- Product Optimization
- Scale Up and Validation
- Regulatory Consulting