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PolyCrystalLine

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PolyCrystalLine

PolyCrystalLine was founded in 2005 as a business idea developed in an academic context. The company was born out of the Molecular Crystalline Engineering (MCE) group of research coordinated by Professor Dario Braga in the Department of Chemistry “G. Ciamician” of the University of Bologna.

Polymorph screening & crystallisation process optimisation

The MCE group has been working for many years in the field of crystal polymorphism and is one of the most specialised in Italy. In decades of collaboration with the pharmaceutical industry, the MCE group has developed its own techniques to induce and check the formation of polymorphic or solvate (generally hydrated) crystal forms.

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In 2007 PolyCrystalLine moved its activities out of the Department of Chemistry, transferring its university know-how into a dedicated site in the suburbs of Bologna.

In September 2009 PCL moved premises into larger custom-built laboratories and offices in Medicina.

Research contract organisation

PolyCrystalLine is a young dynamic company which has established itself as a leader in research and characterisation of solid-state compounds, especially in the pharmaceutical sector.

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We have developed a university background into a business venture; blending academic know-how with business-like agility and flexibility. By working closely with the academic world, we are able to apply an innovative and avant-garde approach to the solving of scientific, commercial and patenting problems.

Our extensive experience in the characterisation of solid-state compounds and the study of polymorphism has led to the development of specific and flexible research protocols. These can be adapted to meet the needs of the pharmaceutical industry. We are able to satisfy the most varied research needs and budget requirements, ranging from in-depth analysis of APIs and compounds/solvates to quick low-cost screening and studies involving patent issues.

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Contact

PolyCrystalLine
Via F.S. Fabri 127/1
Medicina 40059
Bologna
Italy
Tel. +39 (0) 51 6970791
Email: Info@polycrystalline.it
Web-site: www.polycrystalline.it

Amorphous Screening

In our laboratory we are able to produce amorphous materials using several techniques such as spray drying, quench cooling, desolvation, etc.

The stability of an amorphous phase is also investigated by solid state NMR and RAMAN spectroscopy techniques and we are able to evaluate the conditions of conversion into the crystalline phase.Stability ScreeningThe stability of API with temperature, pressure, mechanical stress and humidity is assessed by diffraction, spectroscopic, calorimetric and thermogravimetric methods. Conversion and interconversion of…

Analytical Services

PolyCrystalLine has its own research laboratory equipped with the most up-to-date advanced technology. The laboratory operates according to the Good Laboratory Practice (GLP) directives.

A modular approach makes it possible to customise research projects and analysis methods together with the client step by step, thus providing more specific and effective solutions.It is thanks to this approach that the company is able to satisfy the most varied research needs and budget requirements; ranging from quick, low-cost screening and in-depth analysis…

Dissolution Tests

The thermodynamic solubility and dissolution rates of APIs are performed at different pH values, using a dissolution tester and methods as described in the “European Pharmacopoeia (2.9.3)”. These tests allow the selection of the most suitable crystal form

Dynamic Vapour Sorption

The water vapour or sorption properties of pharmaceutical materials such as excipients, drug formulations and packaging films are recognised as critical factors in determining their storage, stability, processing and application performance. Moisture sorption properties are routinely determined for pharmaceutical materials and have traditionally been evaluated by storing samples over saturated salt solutions of established relative humidities and then regularly weighing until equilibrium is reached.

However, there are a number of disadvantages with these methods, including:The prolonged period of time taken for the samples to reach equilibrium using a static method, often many days and sometimes many weeks.Inherent inaccuracies as the samples have to be removed from the storage container to be weighed which can cause weight loss or gain.Static…

Method Development and Validation

PolyCrystalLine provides the development of analytical methods for the following applications:

Quality assessment of APIs, starting material and final productCharacterization of APIsQuantity assessment of APIs and formulated APIsICH ValidationThe methods developed are validated for testing scientific integrity following ICH guidelines, including preparation and validation protocols and reports.Method TransferPolyCrystalLine provides and follows the transfer of the method developed where it is needed to perform the analyses within…

Optimisation

PolyCrystalLine provides custom synthesis using a modular approach ranging from milligrams to half kilogram scale; PCL offers its know-how to optimise different parameters during the crystallisation processes to obtain a desirable crystal form, particle size, yield, etc.

These services are performed using a Design of Experiments (DOE) approach: a structured, organised method used to determine the relationship between the different factors affecting a process and the output of that process. It involves designing a set of experiments in which all relevant factors are varied systematically. This approach leads to the identification of…

Polymorph Screening

Polymorphic forms of a drug substance can have different chemical and physical properties, including melting point, chemical reactivity, apparent solubility, dissolution rate, optical and mechanical properties, vapour pressure and density. These properties can have a direct effect on the ability to process and/or manufacture the drug substance and the drug product, as well as on drug product stability, dissolution, and bioavailability.

Thus, polymorphism can affect the quality, safety, and efficiency of the final product.PolyCrystalLine provides customized "hand-made" crystallization experiments for the polymorph quest, such as the choice of solvent, solvent mixture, temperature, support media and slurry interconversion.

Quantification

Quantization methods are validated in order to quantify specific crystal forms or amorphous content in API mixtures and tablets (formulated compounds).

Depending on the physical-chemical API characteristics, one of the following techniques is chosen to obtain high accuracy, specificity and sensitivity:X-ray powder diffractionThermal analysis (DSC)Spectroscopic analysis (FT-IR, FT-RAMAN)The methods are built following GLP compliances and validated according to ICH guidelines.In addition, for multiphase mixtures, such analysis reveals quantitative composition

Salt & Co-crystal Screening

PolyCrystalLine can explore the formation of API salts and co-crystals with pharmaceutically acceptable guest molecules using different stoichiometric ratios

Two types of screening can be performed:Solvent free screening e.g. grinding, kneading (solvent drop assistant), melting, etc.Solvent based screening e.g. evaporation, precipitation, slurry, etc.New solid forms will be investigated in terms of solubility, polymorphism, and solvate formation

Structure Determination

An in-depth knowledge of the API molecular and crystal structure is of great importance in order to understand crystal properties e.g. density, molecular packing, surface, etc.

Our crystallographic know-how allows us to determine API structure from single crystal analysis using X-ray single crystal diffractometry to compute "error free" powder diffraction patterns for comparison with those measured on bulk materials thus assessing amorphous content.A crystal structure can be determined from a powder diffraction pattern using the Rietveld method, but in most cases…
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Quick Contact PolyCrystalLine
Quick Contact PolyCrystalLine


Quick Contact PolyCrystalLine
Quick Contact PolyCrystalLine
Quick Contact PolyCrystalLine


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