Formulation and process development can be a complex and a time-consuming effort. It can take months depending on the physical and chemical properties of the active pharmaceutical ingredient and the complexity of the dosage form being developed.
To assist companies with an efficient and cost-effect means for developing products which will be production ready and meet regulatory requirement, RhoTau Pharma Services LLC has expanded our capabilities to provide formulation and process development laboratory services for emerging and established pharmaceutical and related health care companies. We have expertise in developing ethical, generic, over-the-counter (OTC), nutraceuticals, vitamins, and veterinary products. We specialize in the design and development of solid dosage forms from material characterization through preparing finished dosage forms such as tablets, capsules, pellets and powders for feasibility evaluation.
RhoTau Pharma Services LLC draws on decades of formulation, manufacturing and regulatory affairs experience. Dr. Robert Timko, President, has over 40 years of experience in all aspects of drug development from compound selection, preformation, and formulation and process development through and including scale-up and production troubleshooting. Dr Timko has worked with the FDA and various other Health Authorities such as the EMA, Canada, China, Brazil, Japan and South Africa to ensure that the developed dosage forms meet local regulatory requirements.
Our partner in this endeavor, AC Compacting (Paul Bick, Owner) has been involved in the pharmaceutical industry for over 60 years as a vendor/supplier of tablet presses and related processing equipment. AC Compacting provides the necessary equipment, manufacturing technology expertise, and facilities required to develop robust formulations and processes that can be successfully replicated at the production scale. An approximately 2,000 sq. ft. Test Laboratory can accommodate multiple programs concurrently in a team environment. We have a range of capabilities to develop formulations and manufacturing processes at scales from about 10 grams to 10 kilograms. We operate in a non-clinical environment to provide rapid formulation and process development at a fraction of the cost charged by other development providers. This approach allows for a timely turnaround and quick analysis of formulation and processing changes based on performance and economics. Product development at a very competitive cost can happen from concept to final product in months rather than possibly years in a more traditional facility.
We are able to evaluate the physical and mechanical attributes of your active ingredients, excipients, and formulations using a state of the art compression simulator. We can suggest excipients that would be best suited to mix with your active ingredient from a processing perspective. Our facility has equipment to do spray drying, extrusion and spherization, wet or dry granulation, fluid bed processing, and high shear mixing. We also have the capability to compress tablets, fill capsules, and coat powders, pellets, tablets, and capsules. As our capabilities are always expanding, if you don’t see a technology you require, please contact us.