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Crystal Pharmatech, INC

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North Brunswick, New Jersey, US

About Crystal Pharmatech, INC

Crystal Pharmatech is a technology-driven contract research organization (CRO) that focuses on materials science and engineering for drug development. We partner with clients to ensure comprehensive solutions for their needs in solid-state research, crystallization process development, and preformulation... Show more »

Crystal Pharmatech is a technology-driven contract research organization (CRO) that focuses on materials science and engineering for drug development. We partner with clients to ensure comprehensive solutions for their needs in solid-state research, crystallization process development, and preformulation studies. We guide clients in the discovery and selection of the optimal solid phase for drug development using all aspects of pre-formulation studies, including API process and formulation development, regulatory support and intellectual property protection.

Founded in 2010, Crystal Pharmatech has business relationships with over 150 global pharmaceutical companies. High quality service, a culture of confidentiality, and fast turnaround with cost-effective pricing are our trademarks. As we continue to grow, Crystal Pharmatech will always keep customers our number one priority. We will also continue to be at the forefront of innovation in the field of solid-state chemistry so that our customers can reap the benefits of key discoveries in an ever changing field.

Our Scientific Advisory Board includes global leaders in drug development covering amorphous dispersions, co-crystals, crystallization, solid forms, formulation and pre-formulation. The role of our board is all encompassing while we search for new scientific areas for internal and external projects.

Selected Publications

  • Ann W. Newman, Robert M. Wenslow. Solid form changes during drug development: good, bad, and ugly case studies. AAPS Open 2016
  • Yaling Wang, Alex M. Chen. Stereoselective Synthesis of Drugs and Natural Products Chapter 56 - Crystallization-based Separation of Enantiomers, John Wiley & Sons Inc., 2013
  • Ping Li, Chu Yueying, Lin Wang, Robert M. Wenslow, etc. Structure Determination of Theophylline-Nicotinamide Cocrystal: A Combined Powder XRD, 1D Solid-State NMR, and Theoretical Calculation Study. Cryst Eng Comm, 2014, Accepted Manuscript
  • Yuejun Song, Bo Tan, Lianyan Wang, Robert M. Wenslow, ect. Physicochemical characterization of felodipine-kollidon VA64 amorphous solid dispersions prepared by hot-melt extrusion. J Pharm Sci, 2013, 102(6): 1915-23
  • Ann W. Newman. Specialized Solid Form Screening Techniques. Org Proc Res Dev, 2013, 17, 457-471
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Our Services (30)


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SSNMR

Solid State Nuclear Magnet Resonance Spectroscopy
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Dynamic Vapor Sorption

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Polarized Light Microscopy

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Particle Size Distribution

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Thermogravimetric Analysis (TGA)

Thermogravimetric Analysis
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Differential Scanning Calorimetry (DSC)

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X-Ray Powder Diffraction

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Protein Crystallization Screening and Optimization

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Crystallization is a critical unit operation in API manufacturing. Desired product quality attributes can be obtained economically with high efficiency through well-designed and controlled crystallization processes. Successful crystallization development is based on a fundamental understanding of physicochemical and engineering... Show more »

Crystallization is a critical unit operation in API manufacturing. Desired product quality attributes can be obtained economically with high efficiency through well-designed and controlled crystallization processes. Successful crystallization development is based on a fundamental understanding of physicochemical and engineering principles, implementation and development of technologies and expertise in specialized areas.

  • Purification
  • Polymorphic Isolation
  • Particle Attributes Control
  • Chiral Separation
  • Process Optimization
  • Technology Application
  • Technology Thansfer
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Particle Analysis and Characterization

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Focused Analytical Solids Testing (FAST)

Crystal Pharmatech is offering FAST for many routine analyses encountered during pharmaceutical development. The FAST concept is directly aligned with our goal of partnering with organizations instead of merely providing data. Every FAST result will be accompanied with... Show more »

Focused Analytical Solids Testing (FAST)

Crystal Pharmatech is offering FAST for many routine analyses encountered during pharmaceutical development. The FAST concept is directly aligned with our goal of partnering with organizations instead of merely providing data. Every FAST result will be accompanied with interpretation that is aimed at solving your specific development needs. We also promise FAST lives up to its' acronym with our timing and quality guarantee. We're not happy unless you're happy. With FAST, you can have the solid state characterization lab you've always wanted in-house.

Test Item Sample Amount (mg) Turnaround Time (working days)
X-ray Power Diffraction (XRPD) 2-50 2
DSC (10 °C/min) 2-20 2
mDSC (30 °C/min) 2-20 2
TGA (10 °C/min) 2-20 2
Particle Size Analysis (PSD) 50-100 2
Polarized Light Microscopy (PLM) 2-20 2
Dynamic Vapor Sorption (DVS) 20-100 5
Solid State NMR (ssNMR) 200-500 5
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Physicochemical Testing

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Understanding the physicochemical risks associated with your compound are paramount to successful formulation development. Crystal Pharmatech will systematically evaluate your compound and clearly map out the risks going forward.

Areas that are evaluated include:

  • Physical Form
  • Solubility
  • Chemical Stability
    -... Show more »

Understanding the physicochemical risks associated with your compound are paramount to successful formulation development. Crystal Pharmatech will systematically evaluate your compound and clearly map out the risks going forward.

Areas that are evaluated include:

  • Physical Form
  • Solubility
  • Chemical Stability
  • Physical Stability
  • Excipient Compatibility
  • Process Incuced Transformations
  • Formulatability
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Solubility and Dissolution Testing

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It is critical to understand the solubility of a compound in a wide variety of solvents and vehicles for early pharmacokinetic and formulation studies. An understanding of solubility and solid forms is needed to help prevent crystallization from supersaturated solution formulations and prevent form conversion in suspension... Show more »

It is critical to understand the solubility of a compound in a wide variety of solvents and vehicles for early pharmacokinetic and formulation studies. An understanding of solubility and solid forms is needed to help prevent crystallization from supersaturated solution formulations and prevent form conversion in suspension formulations. We have well established vehicle platforms and workflows to quickly and accurately assess compound solubility (kinetic and equilibrium) and stability so that the proper vehicle is chosen for your particular study. Our scientists will work with you to find a formulation that ensures that a consistent and sufficient level of API is dosed to every animal.

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Single Crystal X-Ray Diffraction (SCXRD)

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Growing crystals acceptable for single crystal x-ray diffraction (SCXRD) structure determination is challenging and requires patience, intuition, and care. Our researchers have a high level of expertise in single crystal growth techniques and the physical and chemical properties of the material are examined to determine the best... Show more »

Growing crystals acceptable for single crystal x-ray diffraction (SCXRD) structure determination is challenging and requires patience, intuition, and care. Our researchers have a high level of expertise in single crystal growth techniques and the physical and chemical properties of the material are examined to determine the best crystallization techniques.

Our methods include:

  • Slow evaporation
  • Slow cooling
  • Vapor diffusion
  • Liquid diffusion
  • Sitting/hanging drop
  • Sublimation
  • Co-crystallants
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Solid Form Screening

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We know that the needs in early development are different from the needs in late development and we tailor our approach based on information from the client and our experience with a wide range of compounds. At Crystal Pharmatech, we utilize a unique screening approach that combines the speed of automated screening with the... Show more »

We know that the needs in early development are different from the needs in late development and we tailor our approach based on information from the client and our experience with a wide range of compounds. At Crystal Pharmatech, we utilize a unique screening approach that combines the speed of automated screening with the quality of manual screening. Our scientists will provide a screen that is on scale with your early or late stage compound. The information obtained can be used to select a form, help develop or modify existing crystallization and formulation processes, or provide intellectual property.

Benefits of our solid form screening and selection services include:

  1. Polymorph/Salt/Cocrystal Screening
    • Improving physical properties such as stability, hygroscopicity, and melting point
    • Increasing bioavailability for weak acids and bases or neutral compounds
  2. Amorphous Solid Dispersion Screening
    • Improving the absorption of poorly soluble drugs by developing dispersion formulations
    • Identifying key risks, such as chemical and physical stability of resulting dispersions
    • Evaluating dispersions in early and late phase formulations
  3. Thermodynamic Form Relationship
    • Determining the thermodynamically stable form
    • Providing a thorough understanding of the thermodynamic relationships among the relevant solid phases of your API
    • Defining the critical controls and conditions to prevent conversion of the desired form
  4. Solid Form Evaluation and Selection
    • Collecting the right information on relevant solid forms for direct comparison
    • Recommending the best solid form based on the properties of the material and your development plan
    • Providing ideas on alternative forms and formulations for long term strategic considerations
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Product Development, Testing, and Packaging

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Characterization of an API or drug product is critical to determine if a single form or multiple solid forms are present. A wide variety of solid-state techniques are available in our laboratory to provide a comprehensive picture of your material. This type of information is important from a scientific, regulatory, and... Show more »

Characterization of an API or drug product is critical to determine if a single form or multiple solid forms are present. A wide variety of solid-state techniques are available in our laboratory to provide a comprehensive picture of your material. This type of information is important from a scientific, regulatory, and intellectual property standpoint. Whether it is a simple TGA analysis or a multi-dimensional ssNMR project, we will identify the most appropriate and most efficient method to identify and quantify solid phases in your drug substance and drug product samples.

Our solid state characterization services include:

  • Routine Physical Characterization of API and Formulation Samples
  • Identification of Crystalline Phases in API and Formulation Samples
  • Quantification of Crystalline or Amorphous Content
  • Identification of Phase Separation in Dispersion Samples
  • Investigation of Salt Disproportionation
  • Thermodynamic Stability Mapping of Different Polymorphs
  • Particle Size Method Development and Validation
  • Solvate/Hydrate Determination and Characterization
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Structural Biology

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Transmitted Light Microscopy

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Imaging & Spectroscopy

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Material Testing Services

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Microscopy

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Biochemistry & Molecular Biology

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Spectroscopy

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Biology

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Engineering and Fabrication

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Formulation Services

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Physical Analysis Methods

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Calorimetry

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Chemistry and Materials

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Optical Microscopy

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Analytical Chemistry Services

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Thermal Analysis Services

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Robert Wenslow

Vice President Business Development

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