The use of electrospraying as a means of drug loading into mesoporous silica particles for enhanced dissolution, presented at the 13th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical (PBP) Technology 2022.

Presented at CRS 2023, "Development of a Multi-Pill Abuse Resistant (MPAR®) Multiparticulate Modified Release Formulation to Prevent Opioid Overdose"

Presented at EuPFI 2023, "Taste Assessment Study of Tenapanor Pediatric Solution Formulations". Find out about how we can help accelerate your Pediatrics drug development program.

Presented at ASCP 2023, "A Phase 1 SAD and MAD Trial of EVX-101, a Novel Gastro-Retentive Prolonged Release". Find out about how Quotient Sciences can help accelerate your drug development program.

This white paper describes the benefits of our approach to poorly soluble drugs in terms of drug product performance and clinical decision-making, including case studies that demonstrate significant time and cost savings.

Unlock the benefits of the Translational Pharmaceutics® platform for your drug program

Pharmaceutical R&D activity continues to grow significantly year-on-year with increasing numbers of molecules in development. Yet despite increases in spending the industry struggles with poor R&D productivity, citing lengthy drug development times, increasing costs and high rates of molecule attrition. 

The Tufts Center for the Study of Drug Development (CSDD) examined an innovative approach to accelerating drug development, Translational Pharmaceutics®, and quantified the savings to drug developers from applying the approach across the industry portfolio of investigational drugs. 

Translational Pharmaceutics® integrates real-time manufacturing and clinical testing to make drug products available for clinical trials more quickly and flexibly than is the case for traditional drug development. Translational Pharmaceutics® projects were compared to industry benchmarks, and the financial benefits were quantified on reduced industry R&D costs and increased returns from earlier sales. 

In a report from the Tufts Center for the Study of Drug Development (CSDD), data were obtained for different types of Translational Pharmaceutics® projects. Topline results included mean total benefits ranging from $102.6 million to $290.1 million and mean timeline savings of >12 months per approved new drug, compared to traditional multi-vendor development paradigms.

Download a copy of the Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results.

Modified-release (MR) formulations are in high demand in today's drug development strategies.

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.

Learn more about our capabilities for modified-release.

Types of modified-release dosage forms we work with:

Oncology drugs dominate today’s research focus with over >5500 molecules in development, representing over 35% of the total industry pipeline. 10 new oncology drugs were approved by the FDA in 2019, of which half had an orphan indication and all had been granted priority review. Given the number of molecules in development, there is increasing pressure on development
teams to identify successful drug candidates as quickly as possible, and accelerate patient access, particularly where no effective therapies are currently available.

A rare disease is defined as one affecting less than 200,000 people (in the US) or no more than five in 10,000 of the general EU population. 

There are approximately 7,000 rare diseases, affecting an estimated 30 million people in each of the US and EU. Worldwide, there are over 300 million people living with one or more identified rare diseases, representing 3.5% - 5.9% of the global population. 

The development of new treatments to address these unmet clinical needs clearly represents an important global health priority. Historically, commercial pressures meant the challenges and cost of developing such medicines were not cost-effective given the projected financial returns. In recent years, however, there has been a sea change in industry activity as evidenced by the increasing prevalence within drug development pipelines and the numbers of new molecules reaching the marketplace. Between 2016-2019, 82 of the 175 new FDA approvals were for rare diseases. Regulatory authorities have sought to encourage and motivate industry to develop drugs for these serious medical conditions through the creation of a supportive infrastructure.

This white paper will discuss four principal CMC challenges for the developers of orphan drugs and the potential solutions which are emerging:

• Development of patient-centric dosage forms based upon molecule properties and patient needs
• Rapid accelerated optimization and validation of product performance in humans
• Tailored manufacturing and supply of drug products into patient trials
• Rapid scale-up and commercial manufacturing of low-volume products

Modified-Release (MR) drug delivery can also have commercial benefits and is prevalent as part of product life-cycle management (LCM). Modest reformulation of an already approved drug from an IR to MR format allows both line and patent extension opportunities and continued market exclusivity.