Pharmaceutical Characterization

When working with pharmaceuticals, understanding physiochemical properties of APIs, excipients and finished product is crucial. In today’s age of Process Analytical Technology (PAT) and Quality by Design (QbD), regulatory authorities look favorably upon drug development partnerships with Contract Research Organizations (CROs) that have specific areas of expertise in material characterization.

Early identification and understanding of Critical Quality Attributes (CQAs) are essential steps in the process. From a QbD perspective, scientists, researchers, and regulators look for consistency, both in physical and chemical attributes. PTA is here to help you define, specify, and control the critical quality attributes of your materials. Backed by Micromeritics with 50+ years of instrumentation and application development used for solving real-life process and quality problems with pharmaceutical and biological products, Particle Testing Authority (PTA) is uniquely positioned to offer our customers expertise that is unrivalled by other contract analytical services laboratories.

Our Analyses Provide Solutions:

  • Streamlining Pharmaceutical Development
  • Preformulation Solutions [PAGE BASED OFF OF MIC TO BE ADDED LATER]
  • Identification/Evaluation of API, Excipient, and Blended Material Critical Quality Attributes
  • Excipient Screening
  • Drug Carrier Pharmacokinetics
  • Lab Services for Implementing QbD and PAT initiatives in line with ICH Q6A, Q8, Q9, and Q10 Guidelines
  • Formulations and Drug Delivery [PAGE BASED OFF OF MIC TO BE ADDED LATER]

  • Using Materials Science to Model and Predict Material Behavior
  • Process Design and Pilot Scale-Up [PAGE BASED OFF OF MIC TO BE ADDED LATER]
  • Characterization Solutions for Robust Quality Control
  • Raw Material Qualification
  • Assessment of Lot-to-Lot Variability
  • Assistance in Quality Investigations and CAPAs

PTA can be trusted as your materials characterization solution for pharmaceutical materials, medical devices, nutraceuticals, and other FDA-regulated products. Through the use of advanced analytical testing systems, PTA provides solutions for the optimization of your drug development and production processes. Whether you are outsourcing your pharmaceutical testing and analysis for a short-term project, extending your resources, creating a stop gap until you build the capabilities in-house, or experience needs that grow along with your business; the Particle Testing Authority is the ideal partner for you.

We also are DEA-licensed, FDA-registered, and cGMP-compliant.

Analytical Services

Crystallite Size, Concentration, Shape, and Morphology

USP <729> Globule Size Distribution of Lipid Injectable Emulsions

USP <788> Particulate Matter in Injections

USP <789> Particulate Matter in Ophthalmic Solutions

USP <429> Light Diffraction Measurement of Particle Size Ph. Eur. 2.9.31 Particle Size Analysis by Laser Light Diffraction JP 10 Laser Diffraction Measurement of Particle Size

USP <811> Powder Fineness

Surface Area (Gas Adsorption, BET) [link to…]
USP <846> Specific Surface Ara Ph. Eur. 2.9.26 Specific Surface Area by Gas Adsorption JP 3.02 Specific Surface Area by Gas Adsorption

Density (True, Apparent, Bulk, TAP, Carr index) [link…]
USP <699> Density of S olids – Gas Pycnometry Ph. Eur. 2.2.42 Density of Solids JP 3.03 Powder Particle Density Determinations

Porosity (Gas Adsorption, Mercury Porosimetry) [link…]
USP <267> Porosimetry by Mercury Intrusion
Ph. Eur. 2.9.32 Porosity & Pore Size Distribution of Solids by Mercury Porosimetry

Powder Rheology and Flow Characterization [link…]
USP <1174> Powder Flow
Ph. Eur. 2.9.36 Powder Flow

Dynamic Vapor Sorption (DVS) [link…]
USP <1241> Water Solid Interaction in Pharmaceutical Systems

Additional Analysis

System Stability by Zeta Potential or Particle Migration Kinetics
Volumetric Vapor Sorption
Surface Energy (IGC)
XRD
SEM-EDX [link to Microscopy page]
Thermal Analysis (DSC and TGA) [link to Thermal Analysis page]
Zeta Potential

Method Development / Validation

  • Method Development Services
  • Method Validation Services
  • Method transfer documentation
  • Secure Method and Validation storage for future projects

The extensive variety of technical capabilities and expertise available at Particle Testing Authority allow us to offer comprehensive testing and analysis services which will support pharmaceutical development in areas such as pre-formulation and formulation as well as assure quality of the manufacturing process.

 

To determine which tests and analyses we can employ to meet your needs and to submit your samples, click here, or call xxx-xxx-xxxx to discuss your testing requirements.

Excipient Screening Services

Determination of the most cost-effective and fundamentally appropriate excipients to use in a formulation is critical. Understanding the properties of excipients that affect stability, binding properties, compaction, compression, and compatibility can be difficult without extensive material characterization. Let the experts at Particle Testing Authority provide you with information that will enable you to generate a compendium of data for each of your excipient candidates.

 

With a full suite of physical characterization, thermal analysis, and surface energy analytical tools, PTA has the ability to provide you with the information necessary to make decisions based on current science and technology. Many customers have found tremendous cost savings in formulation development when using our services.

PTA Analyses Include:

  •  Particle size
  • Particle Shape
  • Density
  • BET Specific Surface Area Density
  • Surface Energy
  • IGC (Inverse Gas Chromatography)
  • TGA
  • DSC (Differential Scanning Calorimetry)
  • MDSC (Modulated Differential Scanning Calorimetry)

Preformulation Services & Support

Preformulation is a multidisciplinary development of a drug candidate. Material characterization techniques play a key role in a QbD approach during preformulation activities by determining the physical and mechanical properties of APIs, excipients, and blends. This helps to ensure stability bioavailability, and lot-to-lot consistency of materials while beginning to define your design space and overall control strategy.

 

During this phase, research is directed to APIs and excipients, both as individual components and blends. Identification and evaluation through physical measurements include:

Formulation Support for Solid, Semi-Solid, and Liquid Forms

With physiocochemical data derived from preformulation studies, the formulation scientist can leverage this information to assess initial compatibility of formulation components and begin activities surrounding process design. During this phase of the development, importance is placed on optimization of the formulation development of the final dosage form and process design. Also during this phase, consideration is given to factors affecting scale-up from bench top to pilot scale.

 

In QbD, this phase is focused on providing a defined design space to meet FDA and ICH guidelines. Within this area of focus, greater detail is developed for Critical Materials Attributes (CMA) and Critical Process Parameters (CPP).

Formulation and Blend Characterization

  •  API particles (Dry and Suspensions)
  • Excipient Screening [same link as earlier]
  • Lipid, Liposome, Polymer, and Polysaccharide drug delivery mechanisms
  • Characterization of particulate morphology (surface characteristics) after micronization, milling, and grinding that may affect material performance.

 

Particle Testing Authority has a complete line of analytical tools to characterize your formulations. We specialize in wet and dry (roller compact) granulation characterization. New emphasis is being placed on characterization tools throughout the production process. From ribbon density and porosity to wet granulation density and porosity, PTA has the experience and analytical capability to provide you with the answers that you seek. We have helped numerous customers overcome processing problems that have been linked to the physical characteristics of the granulation form of a drug. Knowing the porosity and density at this step will help you to predict material movement and behavior throughout the process as well as behavior of the material on the press.

Process Design and Pilot Scale-Up

During this phase of development, emphasis is placed on evaluating options available to manufacture, purify, and characterize the final formulation by focusing on how Critical Quality Attributes (CQA) can impact Critical Process Parameters (CPP). Using the principles of QbD and experimental design, a design space with proven acceptable processing ranges is created that will produce a rugged, robust control strategy to meet established Quality Target Product Profiles and may allow for parametric (real-time) product release).

 

Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e. during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality.