Pharmaceuticals

  • Effect of relative humidity on acetaminophen tablet properties prepared by different techniques

    Amount of moisture content present in solid dosage forms plays a major role in influencing the physicochemical properties of tablets such as dissolution rate, disintegration time, hardness, etc....
  • Evaluation of the Blending Process of Pharmaceutical Granules with Magnesium Stearate by ESP

    Magnesium Stearate (MgSt) is a widely used lubricant for preventing tablet compression trouble. It is known that the powder characteristic of MgSt is different among MgSts manufactured by different...

  • Effusivity as a useful tool in Powder Characterization

    Join researchers from Long Island University's School of Pharmacy as they discuss their work in applying C-Therm's ESP system in powder characterization. Thermal effusivity is a powerful tool in...

  • Basics of Thermal Effusivity Application as a PAT Tool in the Pharmaceutical Industry

    Description: Learn about how the thermal property of effusivity (thermal inertia) can be leveraged in profiling various operations in processing of powders within the pharmaceutical industry. This...

  • On the Path to PAT

    At a recent workshop on controlling tablet lubricants, attendees learned how PAT (process analytical technology) devices can identify processing inconsistencies long before those flaws have a...

  • New Methods for the PAT Toolbox

    Instrument suppliers are moving a growing number of analytical techniques out of the lab and onto the manufacturing floor.

  • Greater Consistency, Better Quality

    This article provides insights into how to use PAT in R&D and describes the advantages of introducing it in the design process.

  • PAT and the Electronic Hand

    This article dicusses the benefits of PAT in the pharmaceuticals industry.

  • Rational design of L-arginine formulations for the paediatric

    Taste has an important role in the development of oral pharmaceuticals, with respect to patient acceptability and compliance, and is one of the prime factors determining the market penetration and...

  • Characterization of the Performance of Bin Blenders: Part 2

    In part two of a series of three articles, mixing rates and mechanisms are examined using rectangular bin blenders and two free-flowing mixtures.

  • The Role of PAT in Pharmaceutical R&D

    Several strategies for R&D use and implementation and some examples are covered for PAT. Manufacturing and R&D must communicate and form a feedback mechanism to implement the best of what works,...

  • Modernizing Pharmaceutical Manufacturing

    An important initiative is taking shape at FDA’s Center for Drug Evaluation and Research (CDER) as officials seek to encourage manufacturers to apply modern process analytical technology (PAT) to...

  • In Search of Consistency

    Drugmakers and the FDA see greatest payback potential in new manufacturing technologies designed to reduce process variability.

  • Monitoring Blend Uniformity with Effusivity

    The authors describe the measurement of the effusivity of blended and unblended commercial pharmaceutical formulations to effectively differentiate between materials and then to determine if the...

  • IQPC Press Release

    Thought Leaders Congregate to Discuss Process Analytical Technology (PAT) Barriers and Facilitators

    October 27, 2005, Fredericton - Dr. Nancy Mathis, President and CEO of Mathis Instruments, is...

  • PAT 101

    Drugmakers and Instrumentation Vendors Share Best PAT Practices

    The U.S. FDA’s Process Analytical Technology (PAT) initiative promises to bring pharmaceutical manufacturing into the 21st century...

  • It’s All About Quality

    FDA's recent cGMP update has sent industry into a tailspin. In this exclusive article, FDA inspectors, former FDA-ers and pharma legal experts offer direction to comply with the new cGMP...

  • Process Analytical Technology: A First-Birthday Standardization Update

    The author describes the efforts of the standards committees to establish guidelines for PAT implementation and the impact of the guidelines on the industry.

  • A Vision for Standards in Process Analytical Technology

    Process Analytical Technology (PAT) is a vision for the future of process control management during the next decade. This article outlines that vision and the role that voluntary consensus...

  • FDA Guidance for Industry: Powder Blends

    Unit Sampling and Assessment

    This guidance is intended to assist manufacturers of human drug products in meeting the requirements of 21 CFR 211.110 for demonstrating the adequacy of mixing to...

  • Explorations in Effusivity

    It was more than the free wine that brought a crowd of 80 pharma professionals and equipment makers to the fourth annual Mathis Effusivity Seminar in Baltimore last month. Thermal effusivity is...

  • FDA Publishes Final PAT Guidance

    The Food and Drug Administration has published the final guidance on process analytical technology (PAT). The
    document, Guidance for Industry: Process Analytical Technology—A Framework for...

  • FDA Guidance for Industry: PAT

    A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

    This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that...

  • Press Release from ASTM on Formation of E55 Committee

    Process Improvements in Pharmaceutical Manufacturing

    W.CONSHOHOCKEN, Pa., 25 March 2004--ASTM International, one of the largest voluntary standards development organizations in the world,...

  • Process Analytical Technology and ASTM Committee E55

    ASTM Committee E55 will facilitate the implementation of the PAT framework through the active participation of industry, academia, and the FDA. This cooperation will be crucial as a drug quality...

  • IQPC Press Release

    Dr. Nancy Mathis, President and CEO of Mathis Instruments, is spearheading the kick-off event at the upcoming IQPC PAT Business Strategies Summit being held on December 5-7th in Philadelphia. An...

  • In-line Monitoring tool for Magnesium Stearate Blending End-Point Determination

    In September 2004, the US Food and Drug Administration released a Process Analytical Technology (PAT) guidance document to encourage the pharmaceutical manufacturing industry improve their...

  • Thermal PAT Tool for Blend Uniformity

    Process Analytical Technology (PAT) initiatives by the FDA have motivated vendors to introduce innovative, new technologies to the pharmaceutical field. A noteworthy example from Mathis Instruments...

  • Pharmaceutical Shipping Containers

    Vaccines and many other pharmaceutical products are temperature sensitive and must be shipped in such a way as to maintain the temperature of the products within a tight window. This can be...

  • Standard Test Method for the Measurement of Thermal Effusivity of Raw and Process Materials

    This standard describes the method of use for a PAT system to measure a physical property (effusivity) that has practical application in monitoring blending (uniformity and lubrication), drying,...

  • Thermal Effusivity as a PAT to Optimize Blend Uniformity

    In October 2003, FDA released a draft guidance that introduced PAT to the pharmaceutical manufacturing industry [1]. PAT is a science based approach that focuses on the improvement of manufacturing...

  • Process Analytical Technology (PAT) Standardization Update

    Any parent will identify with the analogy between the development of Process Analytical Technology (PAT) and the development of a child. First, before there is a child, there is the desire to have...

  • AAPS 2005: An Automated Dryer Monitoring Mechanism

    This paper features an automated dryer monitoring mechanism that facilitates on-line end point detection in a fluidized bed process.

  • Manufacturing: Improve Your Productivity

    Mathis ESP is a powerful, new tool for manufacturers that can supplement your release protocols or replace them. It provides critical information at key production stages to improve your...

  • USP General Information Chapter 1073 Effusivity

    Effusivity (also known as thermal effusivity) is a thermal property present in materials of all formats—solid, liquid, paste, powder, and gas. Effusivity measures the rate at which a material can...

  • Formulation and Process Engineering

    Mathis ESP is a powerful, new tool for formulation development and production scale-up. It is simple to use, and allows you to optimize formulations quickly and cost-effectively. Effusivity is an...

  • Effusivity as a PAT to Optimize, Monitor and Control Fluid Bed Drying

    This paper points out the advantages and disadvantages of several drying monitoring techniques and examines thermal effusivity measurements as an alternative within a PAT framework.

  • Novel Use of Effusivity as Predictor of Granulation Endpoint & Effect of Load Size

    A 33–1 -fractional factorial experimental design was used to elucidate the use of effusivity in predicting wet granulation end-point in high-shear mixers. Power consumption was also monitored and...

  • A Novel Technique for Determination of Real Time Blend Uniformity

    Purpose. To introduce a new technique for monitoring powder blend uniformity in a manner that allows on-line control. The existing blenders can be retrofitted to allow for real time monitoring...

  • Stages of Technical Evaluation

    There are three stages that form part of any investigation of our effusivity instrument to determine its sensitivity to blend uniformity monitoring within a formulation. These stages have been...

  • Blend Uniformity Group Phase 1

    Mathis Instruments Ltd. (Mathis) has developed a technology that has the potential to measure blend uniformity during mixing. The technology has been tried in an off line format internally and...

  • Data Mining Collaboration: Effusivity vs %LC

    Effusivity does not measure the amount of active ingredient, but rather the uniformity of the major components in the blend. An assumption must be made that uniformly blended excipients will...

  • Blend Uniformity Group Phase 2

    Blend-Tech (BT) has technology that has the potential to measure blend uniformity during mixing. The end goal is to work collaboratively with blender manufacturers on a solution that can be easily...

  • Cost Recovery for Blend Uniformity Testing with Effusivity

    There are several components of potential economic benefit of improved blend uniformity testing common to any pharmaceutical company and an additional component for generic producers. Estimates...

  • Effusivity of Edible Powders

    The Mathis Technology is an effective and simple instrument to determine powder blend uniformity. This is important to not only pharmaceutical companies (see B24) but also to food processors. A...

  • Effusivity as a Method of Detecting Powder Homogeneity for Pharmaceuticals

    When powdered components are blended during drug production, timing is critical. If the blending period is too short, the agitation has been insufficient to produce a homogeneous product. If...

  • Determining the Test Mass

    When the Mathis Technology is used to evaluate pharmaceutical powders, it is a requirement to understand
    the mass of the material tested to meet the FDA requirements that test samples be between 1...

  • Application of Effusivity as PAT Tool for Roller Compaction

    The aim of this study was to examine the relationship between physical characteristics of compacted ribbons and their thermal effusivity in an attempt to evaluate the feasibility of using...

  • Wet Granulation Endpoint Determination with Effusivity

    The objective was to determine end point wet granulation of microcrystalline cellulose (Avicel 101) using solid state rheological and effusivity measurements.

  • Monitoring the Effect of Moisture on Dextrose with Effusivity

    Dextrose Monohydrate (Emdex®) is commonly used in pharmaceutical industry as a tabletting excipient for orally disintegrating tablets. The purpose of this study was to see the effect of moisture at...

  • Additive Effect of Magnesium Stearate and Stear-O-Wet on Wet Granulation

    The purpose of this study was to determine the effect of magnesium stearate and stear-o-wet on wet granulation while adding the lubricants during the wet granulation process and then measuring the...

  • Determination of Optimal Blending Time

    To understand the blending process and determine the optimal blending time for an experimental product using a PK blender equipped with thermal effusivity sensors. Compare the data obtained with...

  • A Novel Technique for Raw Material Quality Control

    Powders are blended together for pharmaceutical product manufacture and the consistency of those powders is critical to the quality of the product. Typically four or more individual components are...

  • Optimization of Technique for Nondestructive Evaluation of Powders

    Effusivity is a critical thermophysical property that can be measured during the production of powders. Since effusivity varies with the degree of mixing present in a blend of powders, the ability...

  • Measurements in Motion

    Mathis Technology is a useful and effective instrument to determine blend uniformity of powders for pharmaceuticals, food and other industries. When powders are blended during production, timing is...

  • Testing Powders

    This application note presents the advantages of using the Mathis Instruments TC-30™ to characterize powder samples. The Mathis Instruments TC-30™ is a flexible, high performance, rapid,...