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Kuecept

Concept Formulation Design

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Kuecept

Kuecept Ltd is a specialist pharmaceutical contract research organisation supporting clients with the early phase development of low solubility, poorly bioavailable compounds. Our patented drug delivery technologies and formulation expertise in oral and parenteral dosage form design and development are used to fast track compounds through preclinical efficacy studies and toxicity testing and into clinic with robust, stable and improved performance products.

In parallel, our technologies can also be used to reformulate existing pharmaceutical, OTC or nutraceutical products to extend patent protection or create innovative new line extensions.

Formulations for low solubility, poorly bioavailable compounds

Kuecept’s strength is the combination of highly skilled and experienced staff and a specific focus on developing enabling formulations for low solubility, poorly bioavailable compounds. Having worked in this area for a number of years, we have gained a unique expertise and know-how in this specialist field that guarantees our clients high quality and robust services during every stage of preclinical and early clinical phase drug development.

Formulation prototype development for clinical evaluation

As a seamless extension of your own R&D team, we work to understand your drug candidates and their intended use and then use our proven experience, drug delivery technologies and creativity to guide you through preclinical safety and efficacy studies and into formulation prototype development for clinical evaluation.

Our technologies are used to:

  • Assess the development potential of poorly soluble compounds using our advanced drug profiling technologies
  • Identify the most suitable route to improve drug solubility and bioavailability
  • Design and develop appropriate formulation strategies to support preclinical safety and efficacy studies as well as accelerate entry into clinic (Fast in Man service)
  • Improve sub-optimal release profiles by developing alternatives such as fast dissolving, controlled or modified / targeted release dosage forms
  • Formulate APIs with complex physical or chemical characteristics such as low melting point, hygroscopic tendency or physically instability
  • Reformulate existing pharmaceutical, OTC or nutraceutical products to extend patent protection or create innovative new line extensions

For more information on these services, please see the product list for more details.

Drug substance physicochemical profiling

Since inception, we have successfully partnered over 50 international customers on programs ranging from drug substance physicochemical profiling and lead compound selection through to developing enabling formulations to support clinical investigations. Our highly qualified and experienced staff have performed nearly 200 research studies on over 100 active materials and have successfully transferred many compounds into clinical studies.

Providing research to commercialisation of in house developed technologies

Based on previous experiences within the pharmaceutical industry, the founders of Kuecept recognised a need for developing new enabling technologies and processes to facilitate the rapid identification and production of soluble intermediates for poorly soluble compounds and which could be incorporated into a wide range of conventional oral and parenteral dosage forms for preclinical and clinical use.

In July 2007, funded solely by the existing shareholders, Synectix Pharmaceutical Solutions Ltd was incorporated to address these issues and started trading as a 100 % privately owned company. After nearly three years of rapid growth and having seen several technoloiges developed and implement in both preclinical and clinical trials, in Jan 2010 the company name was changed to Kuecept Ltd . This name change reflects the shift in focus of the business, from providing consultancy based support services to providing research to commercialisation of in house developed technologies for use in the production of high quality and improved performance dosage forms for pharmaceutical and biopharmaceutical actives.

Head Office:
Tredomen Business and Technology Centre
Ystrad Mynach
Hengoed
CF82 7FN

Tel: +44 (0) 845 084 0553
Fax: +44 (0) 844 4435344
enquiries@kuecept.com
www.kuecept.com

Research and Innovation Centre:
16/17 Station Close
Potters Bar
Hertfordshire
EN6 1TL

To request a quote or to learn more about our drug delivery technologies and services, please contact: Dr Mark Saunders, development director on Tel: +44 (0) 845 084 0553 or e-mail: msaunders@kuecept.com.

Drug Delivery Technologies

Next generation technolgies for today's challenging medicines.

Low bioavailability of poorly soluble drugs is a common problem in drug development and can have negative consequences for patients. Independent studies have shown that approximately 30% of existing drugs and between 60%-70% of drugs in development have poor absorption due to low water-solubility. This is critical because the efficacy of a drug depends on…

Drug Profiling and Lead Candidate Selection

For pharmaceutical and biotech companies, it is important to find out as early as possible which drug candidates are worth investing in for research and development. Ideally this should happen before the expensive preclinical formulation development and evaluation phases begin.

Current screening methods in early preclinical phases of drug development are based on simple in vitro assays which have weaknesses that severely restrict their ability to make predictions about how drugs will perform in vivo. Based on the research of Dr Abdul Basit, a recognised leading authority in gastroenterology, Kuecept has integrated a suite of…

Formulation Concept Design

After completion of preclinical safety and efficacy studies, the next step is to establish the best formulation strategy to accelerate entry into early stage clinical development.

After a comprehensive review of the preformulation and preclinical pharmacokinetic and pharmacodynamic data, we ensure a quality by design approach to formulation concept design based upon your clinical targets and resources available. Utilising state-of-the-art and scalable technologies in particle processing and drug physical form manipulation, we can screen for and manufacture soluble intermediates which can…

Formulation Prototype Development

At Kuecept, our scientists are experienced in the development of customised dosage forms for specific administration routes, including oral and parenteral drug delivery.

Formulation prototype development studies are designed and performed with attention to every detail, from use of excipients that are generally recognised as safe (GRAS) to identification and prevention of potential stability and processing problems that may be encountered during scale up manufacture. The types of formulation development studies conducted at Kuecept vary and reflect the…

Rapid Preclinical Formulation Screening

As a specialist formulation development company, we recognise that new compounds, especially those with poor aqueous solubilities, have a better chance of succeeding if properly formulated for animal safety and efficacy testing.

In the perpetual haste to complete various steps of a drug development plan, formulations of new drugs may not be given sufficient consideration for initial preclinical evaluation, resulting in the development of suboptimal or unstable dosing vehicles and ultimately poor drug absorption. Furthermore, the constraints of business mean that formulators often have less time, money…
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