12 / 91 resources displayed
-
Webinar
Developing an Oral Modified Release (MR) Formulation - Challenges and Considerations for Achieving Success
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.
-
Scientific Posters
AAPS 2019 Poster - Rapid Transition of a Novel Celecoxib Formulation from a Fit-for-Phase Presentation to a Commercializable Product Using an Innovative Integrated Drug Development and Clinical Testing Platform
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. Program efficiencies included minimization of drug substance consumption, lean regulatory CMC data packages and a reduction in overall upfront CMC investments. The accelerated initiation of a Phase 1 study using an SDD PiB, and rapid transition to commercializable sachet formulation to support Phase III studies was achieved in less than 18 months.
-
Webinar
Overcoming the Challenge of Poorly Soluble Drugs
How to Optimize Enabled Drug Products with Rapid Formulation Development and Clinical Testing (RapidFACT®).
-
Whitepaper
Alternative Strategies for Development of Modified Release Dosage Forms
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.
-
Webinar
Tufts CSDD Study Assessing the Financial Benefits of Translational Pharmaceutics®: A Platform for Accelerating Product Development
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.
-
Scientific Posters
HBI-3000: A Novel Drug for Conversion of Atrial Fibrillation - Phase 1 Study Results
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).
-
Scientific Posters
APS 2019 Poster - Clinical formulation development for poorly soluble 14C labelled molecules
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.
-
Scientific Posters
AAPS 2019 Poster- Applications and Benefits of Healthy Volunteer Trials to Accelerate Oncology Drug Development
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.
-
Scientific Posters
AAPS 2019 Poster- Comparison of Two In-Silico Modeling Programs, ADMET Predictor® and Percepta® to Predict Intrinsic Solubility and pKa of Poorly Soluble Drugs
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.
-
Scientific Posters
AAPS 2019 Poster- A Phase I Study Allowing Clinical Screening of Multiple Solubility-Enhancement Formulation Technologies, and an Assessment of Food, PPI and Dose Linearity Assessment with the Selected Formulation of BOS172767, in Healthy Volunteers
Presented at AAPS 2019: Translational Pharmaceutics was used to evaluate three BOS172767 formulations in on a integrated clinical study, and successfully identified the micronized capsule as the new lead formulation. This formulation had superior exposure compared to the IR reference capsules, and approximate proportional increase in exposure up to 800 mg. The food effect observed at 100 mg was reduced compared to that previously seen at 200 mg (FIH capsule) and elevated gastric pH (subjects taking PPIs) had minimal effect on exposure. A Level C IVIVC was achieved with a biorelevant dissolution test, which provides valuable information for future formulation development and setting of product specifications.
-
Scientific Posters
AAPS 2019 Poster- Development of a Solubilised Capsule Formulation Using Co-Micronization and Precipitation Inhibition
Presented at AAPS 2019: Both micronisation and co-micronisation can improve the rate and extent of drug dissolution. However, co-micronisation of Drug A with a precipitation inhibitor HPC and further blending with a wetting agent SLS could significantly increase the drug dissolution to achieve a supersaturated state for Drug A. In the presence of a precipitation inhibitor, the solubilized drug was maintained in the metastable over a period of time with a slow precipitation rate. The addition of precipitation inhibitor has successfully maintained Drug A in the solubilized form for an extended period allowing greater potential for drug absorption. In vivo studies will be conducted to evaluate the bioavailability of the final formulation. The final results demonstrate the co-micronisation process manage to improve the bioavailability of the poorly soluble drug investigated.
-
Scientific Posters
EuPFI 2019 Poster-Development of a Paediatric Oral Suspension of a Novel Drug for the Treatment of Kidney Disease
The aim of this development programme was to develop anaqueous,multi-dose oral suspension formulation of a novel drug candidate at a concentration of 20mg/ml that would be appropriate for the treatment of kidney disease in paediatric patients aged 2 years and older. A liquid formulation was favoured over a coated granule formulation.