Powder Testing Techniques for Tablet Manufacture - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Powder Testing Techniques for Tablet Manufacture
This article considers the different conditions to which the powder is subjected in the tableting process, and discusses which powder properties should be measured to accurately reflect likely powder behavior in the process.


Pharmaceutical Technology
Volume 36, Issue 3, pp. s12-s16

Choosing the best powder characterization techniques

Successful processing requires a powder that is compatible with all stages of the process. Because it is important to understand how the powder will behave under many different conditions, applying a single powder testing technique may not give adequate information. Historically, the pharmaceutical industry has relied on parameters such as Hausner Ratio and Carr's Index, which are both derived from tapped density techniques. More recently, the industry has begun to use shear testing.

These approaches do have some relevance when trying to access information to support optimization of the press. Shear testing, for example, was developed, and remains widely used, for the design and troubleshooting of hoppers. This test provides valuable shear strength data that is relevant to design and operation of the feed hopper and to the compression stage, in which applied stresses are even higher. However, shear testing may not be the best technique for generating data to support other parts of the tablet manufacturing process, in which applied stresses are far lower.


Figure 2: Shear data classifies these two excipients as closely similar while flow energy measurements show that in certain circumstances they can behave quite differently.
For example, the shear data presented in Figure 2a for vanillin and ethylvanillin classifies them as closely similar. However, as shown in Figure 2b, the dynamic flow energy measurements tell a different story, suggesting that the materials can behave differently in certain circumstances. Flow energies are generated by measuring the axial and rotational forces acting on a paddle as it rotates through a powder sample (3). Downward rotation of the paddle imposes a forcing, bulldozing action while an upward traverse measures a flow energy more closely associated with gravity induced flow. The data suggests that while these two materials may behave similarly in the hopper, and in terms of how they cohere in the finished tablet, they will behave very differently in the feed frame. The ease with which the materials flow into the feed frame, and subsequently into the die, as well as their response to a range of blade designs, are all likely to be different.


Figure 3: For this system, tapped density data are less sensitive than flow energy measurements in detecting changes in powder flowability.
Similarly, tapped density measurements can differ from flow energy measurements. Although tapped density measurements do detect changes that indicate differences in powder properties, they are far less sensitive than dynamic techniques in specifically measuring flow properties (see Figure 3). Variability in a material, which could go on to impact flow behaviour in the tablet press, might be undetected by tapped density measurements.

Looking across the tablet-making process in its entirety highlights the properties that could be measured to optimize performance at each step. These include:

  • Shear properties—for the design, operation, and troubleshooting of hoppers
  • Bulk properties such as permeability and compressibility—to assess the response of the powder to air, the ease with which displaced air will be dispersed, and how the blend will be impacted by compression
  • Dynamic properties that directly quantify flowability under different conditions—for optimizing flow through the feed frame, assessing the impact of different paddle designs, investigating the effect of air on powder flowability, and quantifying de-aeration behaviour.

Dynamic testing can also be used to assess powder stability and is therefore a useful tool for investigating the likelihood of attrition, segregation, and/or agglomeration.

Together these measurements form a database of properties that can be used to tightly define an optimal blend specification. Furthermore, such data would support investigation into which parameters in upstream processes ultimately dictate performance in the press and the quality of the final product. Such strategies are highly beneficial in pushing towards more efficient manufacture on the basis of secure knowledge.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Source: Pharmaceutical Technology,
Click here