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Form and Formulation

Here at Sygnature Discovery, we offer specialised expertise in early-stage drug formulation. Leveraging years of experience, we efficiently advance your compounds through preclinical studies and reduce risks as you move into clinical development.

Our talented team of scientists can assist you in crafting robust pre-clinical development strategies. These strategies are tailored to the unique characteristics of each individual Active Pharmaceutical Ingredient (API). Through access to our well-equipped form and formulation development laboratories, we can rapidly and unbiasedly identify the most phase-appropriate development approach. This approach helps to overcome even the most complex bioavailability or stability challenges.

Working closely with our colleagues in Process Chemistry and Scale-Up, Drug Metabolism and Pharmacokinetics (DMPK), Pharmacology, and Separation Science, we can apply the right tools to solve the most complex challenges in your project.

Form and Formulation Services

The Form and Formulation team is prepared to expedite your molecule’s journey from the lab to the clinic. We offer comprehensive suite of services designed to accelerate and mitigate risks in your project.

Our range of services include:

  • Solid Form Analysis
  • Polymorph Screening
  • Salt and co-crystal Screening
  • CMC Activities
  • Pre-clinical formulation with delivery to in-vivo pharmacology
  • Early clinical formulation

 

Form and Formulation Services

Solid Form Analysis

Understanding the solid form properties of a material can significantly impact other studies. For instance, small scale batches from chiral SFC might be amorphous and dissolve readily, but process chemistry and scale-up could produce a crystalline form, affecting solubility and in vivo performance.

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Salt and Co-crystal Screening

Salts and co-crystals offer unique opportunities for IP (intellectual property), enhance the bioavailability, taste mask and improve stability of your compound.

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Polymorph Screening

Identifying the most suitable polymorph of your drug candidate is critical. It impacts the physicochemical properties such as solubility, stability, bioavailability and manufacturability of both the compound and formulation. In short, it can sometimes ‘make or break’ your formulation.

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CMC Activities

Our Form and Formulation team offers a wealth of information to assist your Chemistry, Manufacturing, and Controls (CMC) team in advancing your molecule towards clinical trials.

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Pre-Clinical Formulation & in-vivo Pharmacology Delivery

Our skilled team and state of the art laboratories have the capabilities to screen, test and develop conventional and novel enabling formulations to give your compound the best chance of success.

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Early Clinical Formulation

Our objective is to design a stable, practical and robust formulation that effectively overcomes your molecule’s challenges.

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