Hot Rod Chemistry®
Every year, hundreds of drug candidates are abandoned due to poor solubility. Formulation technology becomes a key enabler for ensuring continued development. Discovery-stage formulations enable meaningful efficacy and toxicity assessment by maximizing exposure upon administration with minimal material usage. Pharmatek’s Hot Rod Chemistry® (HRC) is a formulation screening technology designed to solubilize drug candidate compounds and prepare them for testing in animal models. Discovery formulation screening is a useful precursor to formal formulation development and is appropriate for lead selection and optimization. While it does not eliminate the need for rigorous preformulation testing and formulation development at the later stage, HRC is a useful tool for assessing a compound’s efficacy during late-stage discovery.
Offered as both an off the shelf kit and an in-house service, HRC can be used as part of any drug discovery program. HRC is currently used in over 200 pharmaceutical, biotechnology and academic laboratories around the world. By quickly and inexpensively testing compounds, HRC alleviates the bottleneck between in vitro hits and in vivo results, drastically improving its chances of becoming a viable drug candidate. Additionally, compounds previously shelved can now be reevaluated using the kit.
Safe – Effective – Fast
HRC 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 HRC formulation.
HRC began as a rational approach to formulating compounds, one that took the black magic out of formulation chemistry. HRC has become a vehicle for streamlining the drug discovery process, simultaneously lowering costs and increasing the number of viable drug candidates in the drug development pipeline.
HRC Kit for Oral Dosing
Each HRC kit contains eight non-toxic, orally available formulations that increase the solubility, bioavailability and stability of oral drug candidates. Each formulation has been created using functional excipients that are GRAS and can be found in FDA approved therapeutics.
HRC kit formulations are designed for oral dosing. The formulations that are liquid at room temperature can be dosed to your animals via syringe (oral gavage). Larger animals may be easily dosed with hard gelatin capsules from Capsugel. Capsugel has a Licap™ capsule that seals, thus allowing dosing of liquid or semi-solid formulations in hard gelatin capsules.
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HRC Rapid Formulation Service for Oral and Injectable Dosing
The HRC Rapid Formulation Service is available for drug candidates being delivered intravenously or for those company’s interested in a more thorough discovery stage formulation program or their oral delivered compounds. Using our formulation expertise, Pharmatek focuses on formulating your molecule for efficacy studies as rapidly as possible while minimizing the amount of API required.
Pharmatek’s scientists review information regarding the compound’s structure and physiochemical properties. An initial solubility screen of excipients compatible with the selected route of administration and dosing protocol is performed. Based on target concentration and the resulting solubility data, promising formulations are selected for prototype development. These prototypes are monitored for physical stability at ambient conditions. The most successful formulations are supplied to the client in a formulation report, which includes: formulation composition, physical stability data, materials and supplier contact information, formulation instructions, and aqueous solubility data.
If you are interested in learning more about Pharmatek’s HRC Rapid Formulation Development Service, please contact us for details.