Co-Crystal Screening, Laboratory Quality Assessment

PolyCrystalLine

Founded in 2005, PolyCrystalLine is an active company located in Bologna (Italy).

PCL is a recognised leader in the study and analysis of solid-state compounds, focussing on the pharmaceutical industry.  By collaborating with academic bodies, PCL can employ a creative and inventive rationale to challenges in research, industry and patenting.

PCL's industry know-how and understanding of both polymorphism research and in the classification of solid-state substances has allowed the to design adaptable and product-specific procedures, which can be tailored to the requirements of pharmaceutical industries.  We are fully GLP certified and have the flexibility to meet a wide range of scientific demands and funding limitations.  Research areas include everything from  the detailed analysis of active pharmaceutical ingredients,  solutions and compounds to fast, inexpensive screening and patent research.more

Services include:

  • Polymorph Screening
  • Salt & Co-Crystal Screening
  • Amorphous Screening
  • Stability Screening
  • Thermal Screening
  • Formulation Studies
  • Laboratory Quality Assessment
  • Crystal Form Quantification
  • Dissolution Testing
  • Chemical Structure Determination

Patent and Literature Search

Patent and literature search is the first step of every project in order to know and identify all relevant publications and patents.

This is possible thanks to our crystallographic, scientific, technical and patent databases. This information allows us to evaluate the patentability of the innovation found and suggest the best way for the protection of possible patent rights.

Project Consulting

PolyCrystalLine addresses complex issues arising in the preparation of the regCMC section of an IND.

For example, we can optimize characterization research to focus on an API crystalline form with the most desirable physical

properties. By doing so we can guide the customer in choosingthe optimal drug form. If an undesirable polymorph in uncovered in either scale up and/or process transfer to other site(s), PolyCrystalLine experts will determine the root-cause and will propose appropriatecorrective actions for remediation.

PolyCrystalLine experts use a comprehensive multi-technique approach, which, as an example, may include several cutting-edge analytical techniques:X-ray diffraction (PXRD, structure determination, etc.) Spectroscopy (FTIR, Raman, NMR, etc,) Thermal analysis (DSC, TGA)Microscopy (optical, electron) Surface characterization (vapor sorption kinetics, specific surface area, etc.)

We help navigate through complex experimental design, parameter choosing, data interpretation,and data correlation.

Finally we address potential changes, which may occur during physical transformation processes such as crystallization, drying, spray drying, milling, blending, granulation, tabletting, and others.

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.

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.

APIS/Polymorphs 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 diffraction
  • Thermal analysis (DSC)
  • Spectroscopic analysis (FT-IR, FT-RAMAN)
  • s.s. N.M.R.

In addition, for multiphase mixtures, such analysis reveals quantitative composition.

Optimization-Synthesis

PolyCrystalLine have specialist knowledge of optimization procedures for the various factors during the crystallization processes to achieve a viable crystal form, particle size and yield.

  • Synthesis optimization
  • Production of small batches of the API
  • Polymorph -salt/co-crystal screening
  • Process Design
  • Process Optimization
  • Scale-up until 20 Litres

QA 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.

The GMPc authorization is granted on chemical/physics analysis for qualitative and quantitative determination of active ingredients, intermediates and finished products with the following techniques:

  • X-ray powder diffraction,
  • FT-IR/RAMAN spectroscopy,

PolyCrystalLine provides analysis and studies on Highly Potent and Cytotoxic products.less

Articles

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Documents

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Experts

  • As president of PolyCrystalLine s.r.l, Stefano Luca Giaffreda is an expert in the characterisation of solid state materials with experience in amorphous chemistry, structure determination and polymorphism screening.

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PolyCrystalLine
Via F.S. Fabri
40059, Medicina
Italy

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