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This webinar examines how to accelerate formulation development in order to address poor drug solubility using Translational Pharmaceutics, showcasing examples of how Translational Pharmaceutics has been used across all phases of clinical development:

Typically, in the development of dry powder inhaler (DPI) formulations the use of a stable crystalline form of the active pharmaceutical ingredient (API) is desired. However, often in order to produce crystalline particles of suitable size for inhalation, micronization processes will be required, resulting in surface amorphous material which may affect the efficacy of the product. If required, additional conditioning/processing steps may then be applied to the API (or to ensure drug product stability under use) without requiring any additional solid state characterization of the API in the drug product.

This webinar will summarise how a fully integrated development plan can bring together the needs of the drug product team and the clinical development team.

This webinar will explore some of the challenges faced by industry today and discuss how early drug development timelines can be accelerated, whilst at the same time conserving cash flow.

Join us and learn how to overcome challenges in order to deliver a successful MR formulation. Using case studies, we will describe the specialized formulation technologies that are available in order to achieve an optimal target product profile, and the use of innovative, adaptive clinical programs where human PK data is used to optimize modified release formulation compositions in real-time.

Presented at AAPS 2019: An integrated CMC and clinical development program successfully identified a commercializable formulation of DRGT-46 meeting required taste and PK attributes as per the Target Product Profile. Real time, adaptive GMP ensured formulation development decisions were taken based on human clinical data.

Modified-release (MR) formulations are in high demand. For formulators, they enable drugs to be released in the optimal gastrointestinal (GI) locations to achieve and maintain desirable plasma concentrations for extended periods, avoiding undesirable excursions outside the therapeutic range.

This webinar summarizes the key findings of the recent Tufts CSDD research into Translational Pharmaceutics, the innovative approach to drug development. It demonstrates significant time savings of >12 months and financial gains of >$100 million per drug approved.

HBI-3000 (sulcardine sulfate trihydrate; Bai, et al. 2012) is a multi-ion channel blocker with effects on INa-Peak, INa-Late, ICa,L, and IKr with similar in vitro potencies across these various ion channels in human atrial cardiomyocytes. It is being eveloped by HUYA Bioscience International® (HUYABIO™) for the conversion of recent onset atrial fibrillation (AF).

Clinical studies involving the administration of 14C radio labelled drug substances provide critical information during development.The main application is the regulatory ADME study to assess the mass balance, routes and rates of elimination, and to provide plasma, urine and faecal samples for metabolite profiling and structural identification.

Presented at AAPS 2019: Phase I drug development for oncology compounds is traditionally conducted directly in patient populations. Oncology molecules have historically been cytotoxic, meaning their safety and risk:benefit profile makes them unviable for dosing in healthy subjects. While this ensures reduced nonclinical requirements, rapid access to patient data and an earlier assessment of efficacious potential, it can also present challenges. For example, patients recruited in Phase I trials typically are at end of life care and will be taking multiple co-medications and have multiple co-morbidities (e.g. liver and kidney function may vary greatly among the recruited subjects). Practically, recruiting patients into Phase I studies can also be problematic, requiring multiple clinical sites and protracted recruitment times for what would traditionally be single site, quickly recruited healthy volunteer studies.

Presented at AAPS 2019: Aqueous solubility is a prerequisite for oral absorption of a drug and the pH-dependence of aqueous solubility is critical information to guide formulation development strategies. The purpose of this study was to evaluate the physical property modules in two commercially available in-silico modelling programs in predicting the pH solubility profiles as described by the ionization constant (pKa) and the intrinsic solubility of the unionized form.