As a fundamental part of the pharmaceutical product development, an appropriate formulation development contributes to the optimal drug delivery performance, stability, and pharmacokinetics (PK), potency. With clear awareness of the significant role of physicochemical properties gained from API and excipients in determination of the optimal dosage form, composition and process techniques, our scientists have great capability to offer you the highly efficient formulation designing services. To meet your requirements for preclinical and clinical use, the teams from BOC Sciences will work with external providers to make a knowledge and technology transfer for satisfying drug product manufacture and scale-up activities of unit operations.
Before conducting pharmaceutical drug product formulation activities, pre-formulation studies are initiated. In the pre-preparation stage, the physical and chemical properties of the active drug component (API) were determined. The knowledge gained from API helps to select appropriate salt or polymorphic forms and supports the design and development of initial dosage forms for preclinical and clinical use.
Based on the profound knowledge of properties of your drug candidates and inactive components, our scientists will guide you through decisions and provide advice to design the most appropriate formulations regarding the release characteristics or bioavailability. Our experts are specialized in designing and development of various dosage forms, including tablets, capsules, creams, lotions, ointments, gels, non-sterile liquids and suspensions as well as sustained or extend formulations.
With decades of experiences in the pharmaceutical industry, our experts have an insightful perception for the importance of adhering to the highest standards of quality, development of robust analytical procedures and efficiently testing and controlling the raw materials, intermediates and final products. Our quality control teams will work with you to establish some high standard criteria in all stages of drug development (from laboratory process development to production, to regulatory data submission).
Generic drugs are gaining increasing attentions from many pharmaceutical manufacturers for its more cost-effectiveness when compared with the innovator counterparts. The generic consistency evaluation is composed by quality conformance and efficiency consistency. Evaluation of pharmaceutical quality conformance is defined to determine whether your generic drug preparation and reference formulations are consistent with the key quality indexes such as the dissolution and related substances. Treatment efficacy consistency is evaluated by bioequivalence assay.
Why choose BOC Sciences?
BOC Sciences is capable of providing the most promising formulation timely and cost-effectively to accelerate your project timelines. Our formulation capabilities mainly include early safety studies, prototype formulations for clinical trials, preliminary process identification and commercial formulation development such as the generic drugs.