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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.
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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.
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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.
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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.
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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.
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Fact Sheet
Formulation Strategies for Poorly Soluble Molecules
With nearly 30 years of experience, Quotient has established a broad suite of technologies and formulation approaches to address these complex solubility challenges. Our approach allows us to dramatically speed up the optimization of your drug products to improve oral bioavailability.
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Case Studies
Druggability Technologies
Druggability Technologies (DRGT) is developing DRGT-46 as a novel therapy for pain. Gabor Heltovics, CEO of DRGT, explains how Quotient Sciences enabled the rapid development, clinical assessment and commercial readiness of its DRGT- 46 product using integrated services across Quotient’s network of harmonized development and manufacturing sites in the UK and US.
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Webinar
From candidate selection through to proof-of-concept
Building a robust understanding of your API characteristics matched against your development programme goals, supports the efficient transition of drug products from candidate selection through to proof-of-concept. Starting @ 4pm (BST-UK), 11pm (ET), 8am (PT) and 6pm (BST-UK), 1pm (ET), 10am (PT)
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Fact Sheet
PBPK Modelling & Simulation
Quotient is a leading expert in the application of physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) science to drug development. Using GastroPlus™ we advise our clients on the potential in vivo performance of drugs and formulations to inform product and clinical development strategies.
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Scientific Posters
How do I quickly develop first-in-human (FIH) dosage forms and avoid CMC delays whilst achieving proof-of-concept (POC)?
Choosing the appropriate dosage form for first-in-human/Phase I trials Pharmacy preparation or GMP manufacturing? Bridging to robust and scalable Phase II drug products Flexible and adaptive clinical manufacturing strategies for patient trials Integrating pharmaceutical sciences and clinical testing
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Webinar
Accelerating drug product development from early phase to scale up and commercialisation
This webinar covers a real-world case study with Druggability Technologies, a specialty pharmaceutical company, which utilized Quotient’s integrated approach to advance the development of DRGT-46, a novel, fast-acting formulation of celecoxib, using proprietary super-API compositions developed by DRGT.
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Whitepaper
Application of a Novel ‘Make and Test in Parallel’ Strategy to Investigate the Effect of Formulation on the Pharmacokinetics of GDC-0810 in Healthy Subjects
GDC-0810, administered orally, was used in Phase I and II clinical studies to treat estrogen receptor positive breast cancers.