services

Research & Development

R & D

From the discovery of your new Co-Crystal to the optimization of your process, Polycrysalline has a unique experience in dealing with your solid form. Saving your time and de-risking your API development with high-quality data driven information

Polymorph Screening

The knowledge of solid-state properties in an early stage of drug development helps to avoid manufacturing problems, to fine-tune the performance of drugs and provides space for innovations. By definition, every new crystal form is novel and not possible to predict how many different crystal forms can be prepared, how to prepare any crystal forms and the properties of any crystal forms as yet unknown.

How can we help you?

  • Identify under what conditions the polymorphs are formed
  • Discover which forms are relevant for development
  • Determine what are the properties of each polymorph
  • Improve the therapeutic activity of drugs
  • Better bioavailability of drugs

Preformulation Studies

With a broad experience in  the study and modification of the physical mechanical and chemical properties of an API, the goal is to select the proper form and enhance its performance to push it forwards into animal and human trials.

Amorphous Dispersion

The amorphous form does not possess a defined order in its arrangement. Although the amorphous form is the most soluble form, it exhibits the lowest stability. Amorphous compounds are produced in the conditions when precipitation is kinetically faster than crystallisation and crystalline disorder caused by processing (i.e. milling or micronisation).

It is also possible that more than one distinct amorphous phase may be formed from the same substance. In analogy with the phenomenon of crystalline polymorphism, this behaviour has been termed “amorphous polymorphism”.

How can we help you?

  • Amorphous materials can significantly increase bioavailability of poorly-water soluble drugs
  • Understanding the crystallization of amorphous material is crucial for process development

Co-crystals Screening

Co-crystals are drug solids defined as multicomponent molecular crystals in which at least one of the compounds is an active pharmaceutical ingredient (API). Salts are considered different from co-crystals provided that they are crystals formed by ionic multicomponent.

How can we help you?

  • Investigate the formation of co-crystals when the API itself is not sufficiently soluble or stable, or is difficult to formulate or manufacture
  • Possibility of discovering new patentable solid forms

Salts Screening

Salt formation is one of the primary solid-state approaches used to modify the physical properties of APIs. However, a major limitation within this approach is that the API must possess a suitable (basic or acidic) ionisable site. In comparison, co-crystals offer a different pathway, where any API regardless of acidic, basic or ionisable groups, could potentially be co-crystallized.

How can we help you?

  • Investigate the formation of salts when the API itself is not sufficiently soluble or stable, or is difficult to formulate or manufacture
  • Possibility of discovering new patentable solid forms

Solid Form Selection

For the selection of the optimal API, several solid forms may be available from one molecule. We provide an effective comparative programmethat will lead to a better orientation and targeted selection of the optimum solid form of a certain pharmaceutical molecule with requested properties.

  • In vitrobioequivalence studies, which are less variable, easier to control, and can predict thein vivobioequivalence, saving time and cost
  • Study of the dissolution rate profile of various forms
  • Stability evaluation of various forms at different conditions of temperature and humidity
  • Identification of the best physical form for pre-formulation

Process Optimization

We can optimise synthetic and crystallization processes, thus ensuring flexible and robust procedures that can easily be transferred with optimised and consistent bulk properties.

Route Scouting

Our team has a proven history of achievement with complex chemistry challenges and can support you to synthesize any challenging molecules by designing new synthetic routes and high quality.

  • Optimise and re-design your synthesis route with respect to synthesis time, the environmental impact, yield and purification.
  • Increase the efficiency of your processes.

Process Development

We can optimise synthesis and crystallization processes, ranging from synthetic route scouting to process scale-up allowing for batches of grams to kilograms of small-scale production, while ensuring flexible and robust procedure that can easily be transferred to pilot-scale, and finally to high volume industrial production of API that exhibit consistent, and optimised, physical and bulk properties.

Process Impurities

Impurities contained in drug substances might occur from intermediates, excipients, degradation or manufacturing as an unwanted by-product.

  • We are able to isolate, characterize and synthesise process related impurities for use as standard materials.
  • We can support you establishing a proper control system involving manufacturing conditions and developing suitable analytical methods.

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