Formulation Strategies for Poorly Soluble Molecules

Info Sheet , Spray Drying , Drug Product Optimization , Formulation Development , Oncology

Formulation Strategies for Poorly Soluble Molecules

Overview

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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Integrated Pharmacy Compounding and GMP Manufacturing Fact Sheet

Info Sheet , Translational Pharmaceutics

Integrated Pharmacy Compounding and GMP Manufacturing Fact Sheet

Overview

Quotient Sciences provides integrated pharmacy compounding, formulation, GMP manufacturing and clinical testing solutions to help clients achieve their proof-of-concept (POC) milestone quickly, saving them precious development time and money.  Begin your First-in-Human (FIH) Phase I testing with a fit-for-purpose, simple pharmacy preparation, and then seamlessly transition to a scalable, solid oral GMP drug product for Phase II trials, all within one organization.

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Accelerating Development of 505(B)(2) Product

Info Sheet , Translational Pharmaceutics , Formulation Development

Accelerating Development of 505(B)(2) Product

Overview

Quotient has significant experience in 505(b)(2)
product development and can support you in efficiently turning your innovative ideas into successful products. Over the past several years, the FDA’s 505(b)(2) regulatory pathway has enabled the approval of a variety of differentiated dosage forms for existing molecules. There has been an increasing number of product approvals in the US using this approach and similarly, in the EU, the Hybrid Medicine Authorization process can provide new product opportunities for previously approved compounds.

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Developing a Poorly Tasting Drug Substance into a Palatable Dosage Form

Info Sheet , Pediatrics , Formulation Development

Developing a Poorly Tasting Drug Substance into a Palatable Dosage Form

Overview

Many drug substances are extremely bitter or have other aversive attributes, which can make developing palatable drug products extremely challenging. This is a common problem seen in medicines spanning all therapeutic areas, from antibiotics and painkillers to antihistamines and decongestants. The careful design and development of formulated oral drug products is key to ensuring patient acceptability and compliance for achieving the desired clinical outcomes.

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Project Management at Quotient Sciences

Info Sheet , Translational Pharmaceutics , Commercial Manufacturing , Clinical Trial Manufacturing , Real-Time Manufacturing , Formulation Development , First-in-Human

Project Management at Quotient Sciences

Overview

Quotient is an innovative drug development and manufacturing partner supporting clients from candidate selection to commercial launch. With expertise in end-to-end Project Management and integrated project teams, we make drug development easier for our customers and dramatically reduce the time and cost of getting new medicines to patients.

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Global Clinical Trial Supplies

Info Sheet , Pediatrics , Clinical Trial Manufacturing , Real-Time Manufacturing , Formulation Development , Clinical Pharmacology

Global Clinical Trial Supplies

Overview

We understand the challenges of managing clinical trials at numerous sites, in multiple countries. Quotient Sciences can ease the headache of global product supply logistics and accelerate your proof-of-concept timeline. We’ll develop and manufacture your drug product, and then seamlessly integrate into a flexible packaging, labelling & distribution strategy, tailored to your clinical trial.

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Drug Substance Synthesis and Manufacturing Info Sheet

Info Sheet , Drug Substance

Drug Substance Synthesis and Manufacturing Info Sheet

Overview

At Quotient Sciences, we understand that every molecule and program is different, and that there is no single manufacturing solution. We take an agile and flexible approach with our customers programs, offering bespoke drug substance synthesis and manufacturing, helping to accelerate molecules from candidate selection to clinical proof-of-concept and onwards towards commercial scale. Our drug substance team works closely with our customers to ensure they have made the right decision, for the right molecule, at the right time.

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Bioanalytical Services

Info Sheet , Bioanalysis

Bioanalytical Services

Overview

At Quotient Sciences, our dedicated team consists of globally recognized experts with significant experience of delivering our client’s highly challenging projects. Our bioanalytical chemists have over 40+ years of experience in supporting all stages of drug development, from early preclinical through to First-in-Human, Phase I and onwards to Phase II- III studies. By combining depth of knowledge and the use of state-of-the-art equipment, we can help you develop life changing medicines and take them to market quickly and efficiently.

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Isotope Labelling

Info Sheet , Human ADME , Isotopic Labeling

Isotope Labelling

Overview

With over 30 years of successful delivery on-site, Quotient Sciences' highly trained chemists have extensive chemical and radiochemical knowledge and the experience
required to supply consultancy and advice on the most suitable labelling positions for a variety of molecular entities.
Trust us to deliver on time in, in full – 98% delivery rate at Quotient Sciences.

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Microbiology Services

Info Sheet , Analytical Services

Microbiology Services

Overview

At Quotient, our qualified and experienced microbiologists pride themselves on applying their knowledge and skills to ensure that pharmaceutical drug substances and drug products are safe and meet today’s rigorous quality specifications and regulatory standards.

We also work closely with our own clinics and other clinical research units to provide a rapid results service within 24 to 48 hours to support extemporaneous
preparations.

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